Exhibit 99.2
For immediate release: Contact: Andy McCormick
July 15, 2002 212-573-1226
PFIZER ANNOUNCES SECOND-QUARTER 2002 RESULTS,
REAFFIRMS STRONG OUTLOOK FOR FULL-YEAR 2002
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SECOND-QUARTER NET INCOME UP 10 PERCENT TO $2.086 BILLION, DILUTED EPS UP
10 PERCENT TO $.33, BOTH FROM CONTINUING OPERATIONS EXCLUDING CERTAIN
SIGNIFICANT ITEMS AND MERGER-RELATED COSTS
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COMPANY REFINES FULL-YEAR 2002 EARNINGS FORECAST, EXPECTS
2002 DILUTED EPS OF $1.58 (21 PERCENT GROWTH), ON SAME BASIS
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FUTURE PFIZER PERFORMANCE TO BE DRIVEN BY
BROAD, DEEP, AND PATENT-PROTECTED PRODUCT LINE
AND REGULATORY FILINGS OF MAJOR NEW MEDICINES
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REPORTED SECOND-QUARTER NET INCOME INCREASED 7 PERCENT TO $1.957 BILLION AND
REPORTED DILUTED EPS UP 10 PERCENT TO $.32
NEW YORK, July 15 - Pfizer Inc said today that second-quarter net income
increased by 10 percent to $2.086 billion and diluted earnings per share (EPS)
increased by 10 percent to $.33, both from continuing operations excluding
certain significant items and merger-related costs.
Reported net income in the quarter increased 7 percent to $1.957 billion, and
reported diluted EPS increased 10 percent to $.32. Included in these numbers are
certain significant items and merger-related costs, which are detailed in the
attached financial schedules and supplemental information.
"Pfizer continues to stand apart from the industry based on our ability to
sustain balanced growth and investment and by our solid prospects for 2002 and
beyond," said Hank McKinnell,
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chairman and chief executive officer. "Those prospects are significantly
enhanced by today's separate announcement that Pfizer and Pharmacia have entered
into a definitive merger agreement. Together, our commercial and financial
strengths will offer greater opportunities to expand our business, improve
people's well-being, and increase shareholder value."
Revenues of $8.033 billion in the second quarter of 2002 were up 8 percent,
excluding a second-quarter prior-year accounting adjustment to harmonize Pfizer
and Warner-Lambert's methods of treating Medicaid and contract rebate accruals.
Pfizer's human pharmaceutical business achieved revenue growth of 9 percent to
$6.317 billion in the quarter (up 10 percent excluding the impact of foreign
exchange), on the same basis. Year-to-date prescription growth rates for
Pfizer's key human pharmaceutical products are at or above their therapeutic
category growth rates.
Product performance and regulatory highlights since the end of the first quarter
include:
- An agreement between Pfizer and Serono announced last week to
co-promote Serono's multiple sclerosis treatment Rebif (interferon
beta 1-a) in the U.S. Rebif complements Pfizer's broad portfolio of
products that treat neurological disorders, including Neurontin,
Aricept, Zoloft, and Geodon.
- Celebrex and Bextra, COX-2-specific inhibitors discovered and
developed by Pharmacia and co-promoted by Pfizer and Pharmacia,
continued to extend their lead over competitors. Bextra and Celebrex
together currently account for 23.6 percent of audited monthly new
prescriptions among U.S. non-steroidal anti-inflammatory drugs in
May.
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- Lipitor, the world's leading cholesterol-lowering medicine and the
largest-selling pharmaceutical of any kind, had second-quarter
worldwide revenue growth of 24 percent. In April, the Food and Drug
Administration (FDA) approved new recommended starting doses for
Lipitor. In addition to the previously recommended starting dose of
10 mg, the FDA has now approved a 20 mg dose and, for patients
requiring a reduction in LDL cholesterol of more than 45 percent, a
40 mg recommended starting dose. This change will allow health-care
professionals greater flexibility in treating the estimated 54
million Americans who are eligible for cholesterol-lowering drug
therapy. Lipitor has gained wide physician and patient acceptance
based on its ability to bring the vast majority of patients to
target cholesterol goals across the full dosing range.
- Viagra, for erectile dysfunction, achieved second-quarter revenue
growth of 10 percent worldwide. New prescription volume in the U.S.
increased to nearly one-half-million per month, resulting in the
highest quarterly number of new prescriptions since Viagra's launch
in 1998. In the U.K. and Japan, the two largest international
markets, Viagra achieved revenue growth, excluding the impact of
foreign exchange, of 18 percent and 16 percent, respectively.
- Zoloft achieved second-quarter worldwide revenue growth of 12
percent. Zoloft was approved in June by the FDA for the treatment of
premenstrual dysphoric disorder, which affects approximately 5
percent of women in the U.S. With this new indication, Zoloft is the
only selective serotonin reuptake inhibitor indicated for six
different psychiatric disorders.
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- Spiriva is the first once-a-day inhaled bronchodilator treatment for
chronic obstructive pulmonary disease and is co-promoted with
Boehringer Ingelheim, the discoverer and developer of the compound.
Spiriva was launched in six European markets, including Germany, in
June and also received national approval for marketing in the U.K.
and Spain.
- Vfend completed the European Mutual Recognition Procedure in March
and received FDA approval in May. Vfend is an important new
treatment for acute invasive aspergillosis and for other rare but
serious fungal infections. Vfend is scheduled for launch in the U.S.
in August and in many European countries beginning in September.
- Geodon, Pfizer's new novel antipsychotic therapy for the treatment
of schizophrenia, continued to demonstrate its efficacy and safety
to physicians worldwide. In June, the FDA approved Geodon for
injection, making it the first atypical antipsychotic medicine
approved in the United States for intramuscular (IM) use. This
approval provides the opportunity for continuity of care, allowing
physicians to begin treating patients on the intramuscular form and
to progress to the oral formulation. Geodon IM will be available
through hospitals and clinics beginning in September.
Karen Katen, executive vice president of the Company and president of the Pfizer
Pharmaceuticals Group, stated, "Pfizer markets eight of the world's 30
largest-selling medicines, more than any other pharmaceutical company. These
medicines -- Lipitor, Norvasc, Celebrex, Zoloft, Neurontin, Viagra, Zithromax,
and Zyrtec -- achieved revenues of more than $10.3 billion through the first
half of 2002, growing an aggregate 15 percent and representing 79 percent of the
Company's human pharmaceutical revenues."
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The competitiveness of Lipitor, Zoloft, Neurontin, Zithromax, and Geodon were
improved during the quarter by the addition of significant new labeling,
indications, or dosage forms. These product expansion approvals are part of an
R&D pipeline that contains 68 new product enhancements plus 94 new molecular
entities, for a total of 162 ongoing projects.
Pfizer now has five new chemical entities that were recently approved or are
undergoing regulatory review in the U.S. and/or the European Union: Vfend;
Geodon; Bextra (discovered and developed by Pharmacia); Spiriva (discovered and
developed by Boehringer Ingelheim); and Relpax. All five products are expected
to be launched in new markets during 2002. In addition, Pfizer will now
co-promote Rebif (discovered and developed by Serono), an important new
treatment for multiple sclerosis, in the U.S.
Pfizer anticipates completing regulatory filings in 2002 for use of pregabalin
in neuropathic pain, epilepsy, and generalized anxiety disorder and for use of
darifenacin in treating overactive bladder. Advanced-stage clinical studies are
continuing for several agents, including Exubera, an inhalable form of insulin
under co-development, co-manufacture, and co-marketing with Aventis, with the
participation of Inhale Therapeutic Systems, and the dual therapy agent
combining Lipitor and Norvasc, the world's leading cholesterol-lowering and
antihypertensive medicines. We are currently assessing our regulatory filing
strategy for Exubera with our partner Aventis.
Animal Health sales in the second quarter increased 11 percent to $274 million
(up 15 percent excluding the impact of foreign exchange), compared to the same
period in 2001. This strong performance reflected double-digit growth (excluding
the impact of foreign exchange) in both livestock and companion-animal product
lines. Our companion-animal products Revolution and
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Rimadyl and our livestock medicines Dectomax and RespiSure/ Stellamune showed
strong sales growth, excluding the impact of foreign exchange.
The full impact of the Company's implementation of Statement of Financial
Accounting Standards No. 142, Goodwill and Other Intangible Assets, reflected in
accordance with generally accepted accounting principles as of the beginning of
2002, resulted in a $410 million after-tax writedown (or $.07 per diluted share)
primarily related to impairment of goodwill in the Animal Health business, as
well as a writedown of certain intangible assets of various businesses.
Sales of Pfizer's Consumer businesses in the second quarter grew 5 percent to
$1.333 billion (up 7 percent excluding the impact of foreign exchange), compared
to the same period in 2001. Sales of Consumer Healthcare products grew 10
percent to $646 million (up 11 percent excluding the impact of foreign
exchange). Growth reflects strong acceptance of Listerine mouthwash as well as
the continued success of Listerine PocketPaks. In the Adams confectionery
business, sales in the quarter decreased 1 percent to $475 million (up 3 percent
excluding the impact of foreign exchange). Shaving product sales increased 2
percent to $162 million (up 4 percent excluding the impact of foreign exchange).
Sales of Tetra products remained approximately the same at $50 million (up 2
percent excluding the impact of foreign exchange). As previously announced, the
Company is exploring strategic options, including possible sale, for Tetra,
Adams, and the Schick-Wilkinson Sword shaving products businesses.
"Second-quarter diluted EPS from continuing operations, excluding certain
significant items and merger-related costs, of $.33 exceeds our previous
estimate of single-digit growth due to a reduction in the effective tax rate,"
said David Shedlarz, executive vice president and chief financial officer of the
Company. The effective tax rate for 2002 for continuing
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operations, excluding the cumulative effect of a change in accounting principle,
certain significant items, and merger-related costs, is now forecast at 23.5
percent.
"Earnings growth in the second quarter, and in fact in each quarter of 2002, is
affected by the changing impact of foreign exchange and the unusual pattern of
operating expenses in 2001," Mr. Shedlarz continued. Foreign exchange adversely
affected revenues in the quarter by $115 million, or 1.5%. The foreign-exchange
impact in the second half of the year, at current rates, is expected to be
favorable.
As illustrated in the following table, the concentration of operating expenses
in the fourth quarter of 2001 -- $800 million to $1.2 billion higher than any
other quarter of 2001 -- is significantly impacting the quarterly pattern of
2002 EPS growth.
OPERATING EXPENSES (SI&A AND R&D, $ BILLIONS)
Mr. Shedlarz remarked, "Year-over-year operating expense comparisons will remain
a challenge in the third quarter, resulting in anticipated third-quarter EPS
growth, excluding certain significant items and merger-related costs, in the low
double digits.
"Fourth-quarter EPS growth is expected to be exceptionally strong, reflecting
both a favorable foreign-exchange impact, at current exchange rates, and
favorable comparisons with the abnormally high expense levels during the fourth
quarter of 2001.
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"We have refined our full-year 2002 EPS target and now expect diluted EPS from
continuing operations, excluding the cumulative effect of a change in accounting
principle, certain significant items, and merger-related costs, of $1.58 (21
percent growth). Moreover, we anticipate double-digit full-year 2002 revenue
growth at current exchange rates, margin improvements, and continuing
investments in product support and in R&D (which is now expected to be about
$5.2 billion for the year). Synergies related to the Warner-Lambert merger are
now expected to be $1.8 billion for the year," Mr. Shedlarz stated.
"With our broad product portfolio, unsurpassed research scale, and global reach,
Pfizer continues to deliver strong performance," Dr. McKinnell concluded. "At
the same time - - as reflected in today's Pfizer/Pharmacia merger agreement
announcement -- we continue to look for and embrace innovative ways to move
`beyond number one' and to become the most valued company in the world for all
our constituencies, including investors."
INVESTORS SHOULD REFER TO TODAY'S SEPARATE PRESS ANNOUNCEMENT OF THE
PFIZER/PHARMACIA MERGER AGREEMENT FOR ADDITIONAL INFORMATION PERTAINING TO
CURRENT OPERATIONS AND RESULTS AS WELL AS TO PROJECTIONS OF FUTURE PERFORMANCE.
FOR ADDITIONAL DETAILS, PLEASE SEE THE ATTACHED FINANCIAL SCHEDULES, PRODUCT
REVENUE TABLES, AND SUPPLEMENTAL INFORMATION.
DISCLOSURE NOTICE: The information contained in this document is as of July 15,
2002. The Company assumes no obligation to update any forward-looking statements
contained in this document as a result of new information or future events or
developments.
This document and the attachments contain forward-looking information about the
Company's financial results and estimates, business prospects, and products in
research that involve substantial risks and uncertainties. You can identify
these statements by the fact that they use words such as "anticipate,"
"estimate," "expect," "project," "intend," "plan," "believe," and other words
and terms of similar meaning in connection with any discussion of future
operating or financial performance. Among the factors that could cause actual
results to differ materially are the following: the success of research and
development
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activities and the speed with which regulatory authorizations and product
launches may be achieved; competitive developments affecting our current growth
products; the ability to successfully market both new and existing products
domestically and internationally; difficulties or delays in manufacturing; trade
buying patterns; ability to meet generic and branded competition after the
expiration of the Company's patents; trends toward managed care and health-care
cost containment; possible U.S. legislation affecting pharmaceutical pricing and
reimbursement or Medicare; exposure to product liability and other types of
lawsuits; contingencies related to actual or alleged environmental
contamination; the Company's ability to protect its intellectual property both
domestically and internationally; interest rate and foreign currency exchange
rate fluctuations; governmental laws and regulations affecting domestic and
foreign operations, including tax obligations; changes in generally accepted
accounting principles; any changes in business, political, and economic
conditions due to the threat of future 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 mix; and the impact of acquisitions,
divestitures, restructurings, product withdrawals, and other unusual items,
including our ability to obtain the anticipated results and synergies from our
announced proposed acquisition of Pharmacia and the increased uncertainty
created by the integration of the two businesses, as well as the timing and
success of the announced exploration of strategic options of the Adams,
Schick-Wilkinson Sword, and Tetra businesses. A further list and description of
these risks, uncertainties, and other matters can be found in the Company's
Annual Report on Form 10-K for the fiscal year ended December 31, 2001, and in
its periodic reports on Forms 10-Q and 8-K (if any).
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PFIZER INC AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENT OF INCOME
(UNAUDITED)
(millions of dollars, except per share data)
* - Percentages may reflect rounding adjustments.
** - Calculation not meaningful.
1. The above financial statement presents the three-month and six-month
periods ended June 30, 2002 and July 1, 2001. Subsidiaries operating
outside the United States are included for the three-month and six-
month periods ended May 26, 2002 and May 27, 2001.
2. On January 1, 2002, we adopted the provisions of the Emerging Issues
Task Force (EITF) Issue No. 00-25, Vendor Income Statement
Characterization of Consideration Paid to a Reseller of the Vendor's
Products, which requires the cost of certain vendor consideration to
be classified as a reduction of revenue rather than as a marketing
expense. As a result, we restated the second quarter and first six
months of 2001 to reclassify certain marketing expenses from Selling,
informational and administrative expenses to Revenues. These
reclassifications have no effect on net income.
3. On January 1, 2002, we adopted Statement of Financial Accounting
Standards (SFAS) No. 142, Goodwill and Other Intangible Assets. As a
result of adopting SFAS No. 142, we recorded non-cash charges of $565
million ($410 million after-tax) in the first six months of 2002 with
$536 million ($393 million after-tax) for the impairment provisions
related to goodwill in our Animal Health business and $29 million
($17 million after-tax) for the impairment provisions related to
identifiable intangible assets. These charges are recorded as a
cumulative effect of a change in accounting principle as of the
beginning of 2002.
4. The financial results for the three-month and six-month periods ended
June 30, 2002 are not necessarily indicative of the results which
ultimately might be achieved for the current year.
PFIZER INC AND SUBSIDIARY COMPANIES
RESULTS FROM CONTINUING OPERATIONS
EXCLUDING CERTAIN SIGNIFICANT ITEMS AND MERGER-RELATED COSTS
(UNAUDITED)
(millions of dollars, except per share data)
1. The above financial information presents the three-month and six-month
periods ended June 30, 2002 and July 1, 2001. Subsidiaries operating
outside the United States are included for the three-month and six-
month periods ended May 26, 2002 and May 27, 2001.
2. On January 1, 2002, we adopted Statement of Financial Accounting
Standards (SFAS) No. 142, Goodwill and Other Intangible Assets. As a
result of adopting SFAS No. 142, we recorded non-cash charges of $565
million ($410 million after-tax) in the first six months of 2002 with
$536 million ($393 million after-tax) for the impairment provisions
related to goodwill in our Animal Health business and $29 million
($17 million after-tax) for the impairment provisions related to
identifiable intangible assets. These charges are recorded as a
cumulative effect of a change in accounting principle as of the
beginning of 2002.
3. Revenues as shown above for the second quarter and first six months of
2001 exclude the favorable impact of $175 million from a harmonization
adjustment of Pfizer/Warner-Lambert accounting methodology for Medicaid
and contract rebate accruals.
4. Income and diluted earnings per common share from continuing operations
before cumulative effect of a change in accounting principle as shown
above exclude the following items:
+ Represents the harmonization of Pfizer/Warner-Lambert accounting
methodology for Medicaid and contract rebate accruals included in
Revenues.
++ Included in Other (income)/deductions--net.
PFIZER INC
SEGMENT/PRODUCT REVENUES
SECOND QUARTER 2002
(UNAUDITED)
(millions of dollars)
* - Represents direct sales under license agreement with Eisai Co., Ltd.
** - Represents the harmonization of Pfizer/Warner-Lambert accounting
methodology for Medicaid and contract rebate accruals.
Certain amounts and percentages may reflect rounding adjustments.
Certain prior year data have been reclassified to conform to the current
year presentation.
PFIZER INC
SEGMENT/PRODUCT REVENUES
SIX MONTHS 2002
(UNAUDITED)
(millions of dollars)
* - Represents direct sales under license agreement with Eisai Co., Ltd.
** - Represents the harmonization of Pfizer/Warner-Lambert accounting
methodology for Medicaid and contract rebate accruals.
Certain amounts and percentages may reflect rounding adjustments.
Certain prior year data have been reclassified to conform to the current
year presentation.
PFIZER INC
SUPPLEMENTAL INFORMATION
QUESTIONS:
Q1) WHAT IS PFIZER'S FINANCIAL OUTLOOK FOR THE REMAINDER OF THE YEAR?
A1) We have refined our full-year 2002 EPS target range and now expect diluted
EPS from continuing operations, excluding the cumulative effect of a
change in accounting principle, certain significant items, and
merger-related costs of $1.58 (21%). Moreover, we anticipate double-digit
full-year 2002 revenue growth at current exchange rates, margin
improvements, and continuing investments in product support and in R&D
(which is now expected to be about $5.2 billion for the year).
Year-over-year operating expense comparisons will remain a challenge in
the third quarter, resulting in anticipated third-quarter EPS growth,
excluding certain significant items and merger-related costs, in the low
double digits.
Fourth-quarter EPS growth is expected to be exceptionally strong,
reflecting both a favorable foreign-exchange impact, at current exchange
rates, and favorable comparisons with the abnormally high expense levels
during the fourth quarter of 2001, which were $800 million to $1.2 billion
higher than any other quarter in 2001. Operating expenses in 2002, both
actual and projected, follow a more normal pattern. The following are
actual and projected operating expenses for the two years.
SI&A and R&D Expenses
($ billions)
Q2) HOW DID CHANGES TO ACCOUNTING REGULATIONS IMPACT PFIZER'S 2002 RESULTS?
A2) On January 1, 2002, we adopted the provisions of Statement of Financial
Accounting Standards (SFAS) No. 142, Goodwill and Other Intangible Assets.
Under the provisions of SFAS No. 142, intangible assets with indefinite
lives and goodwill are no longer amortized but are subject to annual
impairment tests. Separable intangible assets with finite lives continue
to be amortized over their useful lives. In the second quarter of 2002, we
determined and recorded, retroactive to the beginning of 2002 in
accordance with accounting principles generally accepted in the United
States of America, a non-cash charge of $536 million ($393 million
after-tax) for the impairment provisions as they relate to goodwill in the
Animal Health business. In the first quarter of 2002, we had recorded a
non-cash charge of $29 million ($17 million after tax), for the impairment
provisions as they relate to identifiable intangible assets. The aggregate
amount of these charges, $565 million ($410 million after tax), is
reported as the one-time cumulative effect of a change in accounting
principle for the first half of 2002.
Q3) WHAT WAS THE IMPACT ON PFIZER'S REVENUES FROM VOLUME, PRICE CHANGES, THE
EFFECTS OF FOREIGN EXCHANGE, AND THE 2001 ACCOUNTING HARMONIZATION?
Q4) HAS PFIZER ANNOUNCED ANY PRICE INCREASES FOR ITS U.S. PHARMACEUTICAL
PRODUCT LINES?
A4) Effective July 1, 2002, Pfizer increased the published prices of Glucotrol
XL (6.3%), Geodon (5.5%), Neurontin capsules (3.0%), Tikosyn (3.0%),
Accupril/ Accuretic (2.0%), Cardura (2.0%), Diflucan (2.0%), Femhrt
(2.0%), Lipitor 20 mg (2.0%), and Zithromax (2.0%).
Q5) WHAT SIGNIFICANT ADVANCES WERE ACHIEVED BY PFIZER'S PRODUCT PORTFOLIO
SINCE THE FIRST QUARTER?
A5) Pfizer had several events that will enhance sales of existing products and
strengthen the future product portfolio:
- Approval by the FDA of new recommended starting doses for Lipitor of
20 mg and, for patients that require a reduction in LDL cholesterol
of more than 45%, 40 mg
- Approval of the intramuscular form of Geodon in the U.S.
- Launch of Geodon in European markets, including Germany
- Approval of Vfend in the U.S., in addition to its European approval
in March
- Approval of Neurontin for post-herpetic neuralgia in the U.S.
- Approval of Spiriva in Europe and launch in six countries, including
Germany - Approval of Zithromax for three-day dosing of chronic
obstructive pulmonary disease in the U.S.
- Approval of Zoloft for premenstrual dysphoric disorder in the U.S.
- Approval of Relpax for migraine in Japan (the product was launched
in July 2002)
- Agreement with Serono to co-promote the multiple sclerosis drug
Rebif (interferon beta 1-a) in the U.S.
Q6) WHAT IS THE STATUS OF PFIZER'S PRODUCTS RECENTLY APPROVED OR UNDERGOING
REGULATORY REVIEW?
A6) Pfizer now has five new chemical entities that were recently approved or
are undergoing regulatory review in the U.S. and/or the European Union:
- Vfend, a new antifungal, was approved in both oral and intravenous
forms in the U.S. by the FDA in May 2002. Vfend completed the Mutual
Recognition Procedure in the E.U. in March 2002. Launch of Vfend in
the U.S. is expected in August and in Europe beginning in September.
- Geodon, a new antipsychotic, was launched in the U.S. in the first
quarter of 2001 and is currently achieving a 4.4% share of weekly
new prescriptions. Geodon has been approved in several major
European countries and was launched in Germany in April 2002, with
further launches to occur throughout 2002. Geodon intramuscular (IM)
form was approved in June 2002 by the FDA, making it the first
atypical antipsychotic approved in the U.S. for intramuscular use.
The approval of Geodon IM provides the opportunity for continuity of
care, allowing patients to begin treatment on the intramuscular form
and to progress to the oral formulation.
- Bextra (discovered and developed by Pharmacia Corporation), a new
selective COX-2 inhibitor for osteoarthritis, rheumatoid arthritis,
and primary dysmenorrhea, was launched in April in the U.S. by over
6,000 Pfizer and Pharmacia sales representatives. Bextra achieved a
5.6% share of U.S. new
prescriptions of NSAIDs in May. To date, the Bextra launch has had
little impact on the market share of Celebrex. Bextra was filed in
Europe in the third quarter of 2001.
- Spiriva, a muscarinic M3 antagonist for chronic obstructive
pulmonary disease discovered and developed by Boehringer Ingelheim
and co-promoted by Boehringer Ingelheim and Pfizer, completed mutual
recognition in the E.U. in April 2002. Spiriva was launched in
Germany and five other countries in June, with additional European
launches expected in the third quarter. Spiriva was filed in the
U.S. in December 2001.
- Relpax, a triptan for migraine, completed mutual recognition in the
E.U. in July 2001 and has been launched in the U.K., Italy, and
other markets. Pfizer received marketing approval for Relpax in
Japan and launched the product in July 2002. In the U.S., Pfizer
recently completed a cardiovascular physiology study requested by
the FDA in their approvable letter of December 2000. We are
currently analyzing the data and expect to file it shortly with the
FDA. We anticipate FDA approval by yearend 2002 and U.S. launch soon
thereafter.
All five products are expected to be launched in new markets during
2002.
Q7) WHAT REGULATORY FILINGS DOES PFIZER ANTICIPATE DURING 2002?
A7) Pfizer anticipates completing regulatory filings in 2002 for use of
pregabalin in neuropathic pain, epilepsy, and generalized anxiety disorder
and for use of darifenacin in treating overactive bladder.
Q8) HOW DID FOREIGN EXCHANGE FLUCTUATIONS AFFECT PFIZER'S RESULTS?
A8) Changes in foreign exchange rates had a negative effect on revenues in the
second quarter of $115 million, or 1.5%, and a negative effect on revenues
in the first half of $277 million, or 1.8%, due to the strengthening of
the dollar relative to most foreign currencies, including the Japanese yen
and Euro. Because of recent weakening of the dollar, the foreign-exchange
impact on revenues in the second half of the year, at current exchange
rates, is expected to be favorable.
Q9) HOW HAVE SALES OF LIPITOR PROGRESSED?
A9) Worldwide sales of Lipitor increased to $1.783 billion in the second
quarter, growth of 24% (up 25% excluding the impact of foreign exchange)
compared to the same period in 2001. Lipitor is the most widely prescribed
statin for lowering cholesterol and the most widely prescribed
pharmaceutical product of any kind in the world. Lipitor has gained wide
physician and patient acceptance based on
its ability to bring the vast majority of patients to target cholesterol
goals across the full dosing range. The safety profile and efficacy of
Lipitor have been demonstrated in more than 400 ongoing and completed
clinical trials involving over 80,000 patients and in more than 36 million
patient years of therapy.
In April 2002, the FDA approved new recommended starting doses for
Lipitor. In addition to the previously recommended starting dose of 10 mg,
the FDA has now approved a 20 mg dose and, for patients that require a
reduction in LDL cholesterol of more than 45%, a 40 mg recommended
starting dose. As in the past, therapy for patients requiring further
reductions can be adjusted up to the 80 mg dose. The new recommended
dosing will allow physicians greater flexibility in treating the estimated
54 million Americans eligible for cholesterol-lowering drug therapy in the
U.S. based on each patient's individual risk, with fewer dose adjustments.
In addition, the revised Lipitor labeling further supports the
implementation of national cholesterol guidelines that call for early and
intensive treatment in cholesterol management.
We will reinforce Lipitor's already vast clinical database by studying
this best-in-class therapy in a large program of additional clinical
trials. Beyond Lipitor's current leadership, there is a significant
opportunity for further growth, primarily through expansion of the statin
market. It is estimated that 54 million Americans are in need of medical
therapy for high cholesterol, but less than one-third of these people are
actually receiving treatment.
Q10) WHAT WAS THE REASON FOR THE CONTINUED SALES GROWTH OF NORVASC?
A10) Norvasc, the most-prescribed cardiovascular agent worldwide with nearly 26
billion patient days of therapy, showed global revenue growth of 1% in the
second quarter of 2002 to $886 million (up 3% excluding the impact of
foreign exchange), compared to the same period in 2001. Its success has
been driven by its outstanding efficacy, once-daily dosing, consistent
24-hour control of hypertension and angina, and excellent safety and
tolerability.
Norvasc is one of the treatment arms in ALLHAT, an NIH-sponsored landmark
hypertension trial that compares the benefits of older versus newer
antihypertensive agents on coronary heart disease, death, and myocardial
infarction in 42,000 patients. ALLHAT was recently completed, and results
are expected at the end of 2002.
This year, we expect to complete several clinical trials for
Lipitor/Norvasc dual therapy in patients with both high cholesterol and
high blood pressure. We expect Lipitor/Norvasc dual therapy to be
available to patients by 2004.
Q11) HOW IS CELEBREX PERFORMING?
A11) Celebrex is the #1 branded NSAID and the #1 COX-2-specific inhibitor in
the world. Pfizer and Pharmacia Corporation, the company that discovered
and developed Celebrex, co-promote this product in more than 60 countries.
In the countries where Pfizer and Pharmacia co-promote Celebrex, Pharmacia
records sales and Pfizer records a portion of revenue as alliance revenue.
In certain other countries, Pfizer directly records sales of the product.
The product provides relief of a variety of painful conditions, including
the pain and inflammation of osteoarthritis (OA), adult rheumatoid
arthritis (RA), acute pain, and primary dysmenorrhea in adults. In
addition, Celebrex is approved to reduce the number of adenomatous
colorectal polyps in familial adenomatous polyposis (FAP) -- a rare and
devastating genetic disease that may result in colorectal cancer -- as an
adjunct to usual care. Celebrex provides strong efficacy, excellent
tolerability, and a proven safety profile. With the recent approval for
acute pain and primary dysmenorrhea in the U.S., Celebrex is now the
COX-2-specific inhibitor approved to treat the broadest range of
conditions.
The Celebrex launch remains the most successful of any drug in the history
of the pharmaceutical industry. Celebrex is currently receiving more than
2.2 million total prescriptions a month in the U.S., which makes it the #1
prescribed arthritis brand in that market. Year-to-date through May 2002,
about 11.2 million U.S. total prescriptions had been written for Celebrex,
about 14% more than for Vioxx, another COX-2-specific inhibitor. Since
launch, more than 35 million patients have been prescribed Celebrex
globally. Outside the U.S., Celebrex continues to outpace the overall
anti-arthritic market. It is the #1 selective COX-2 inhibitor in Europe on
a unit basis.
In June, after a comprehensive review of the Celecoxib Long-term Arthritis
Safety Study (CLASS) data, the FDA approved revised labeling for Celebrex.
The new prescribing information includes additional gastrointestinal (GI)
safety data showing the estimated cumulative incidence of upper GI ulcer
complications and symptomatic ulcers for Celebrex patients at 0.78% versus
an annual NSAID category rate of 2-4%. Additionally, the revised label
also includes data indicating that there was no increased risk for serious
cardiovascular (CV) adverse events observed compared to the non-specific
NSAID comparators (diclofenac and ibuprofen). These CV events included
heart attack, stroke, and unstable angina.
Q12) HOW DID ZOLOFT PERFORM?
A12) Worldwide sales of Zoloft, a selective serotonin re-uptake inhibitor
(SSRI) for the treatment of depression, increased 12% (also up 12%
excluding the impact of foreign exchange) to $574 million in the second
quarter, compared to the same period in 2001. Zoloft is the most
prescribed SSRI in the U.S. The product has sustained strong growth
notwithstanding the launch of generic fluoxetine, and
Zoloft's growth is expected to continue. Zoloft is currently outpacing
market growth in the U.S. and other key markets.
Zoloft has proven efficacy, safety, and tolerability across a broad range
of depression and anxiety disorders. This is important from a clinical
perspective, as there is significant co-morbidity between depression and
anxiety disorders: 50% of patients with depression also have an anxiety
disorder during a 12-month period. A new meta-analysis of data pooled from
five double-blind, 12-week studies of patients with severe major
depression showed that significantly more patients treated with Zoloft
responded to therapy than did patients treated with fluoxetine. Depression
affects approximately 20 million Americans and can be mild, moderate, or
severe.
In May, the FDA approved Zoloft for treatment of premenstrual dysphoric
disorder (PMDD). PMDD is distinguished from premenstrual syndrome (PMS) by
the severity of symptoms, the degree of impact on a woman's daily
activities, and the presence of a distinct mood change. In the U.S.,
approximately 5% of women experience PMDD. Pfizer will maintain the brand
name Zoloft in the marketing of this new indication.
Anxiety disorders for which Zoloft is approved include panic disorder,
obsessive-compulsive disorder (OCD) in adults and children, and
post-traumatic stress disorder (PTSD) in adults. Zoloft is the only SSRI
indicated for both the acute and long-term treatment of OCD in children
and adolescents. With the approval for the treatment of PMDD, Zoloft is
the antidepressant in the U.S. market with the most approved indications
across mood and anxiety disorders.
Filings were submitted to the FDA for pediatric depression in December
2001 (which qualified Zoloft for a six-month patent extension) and for
social anxiety in January 2002. Social anxiety is a chronic anxiety
disorder affecting approximately 10 million Americans.
Q13) HOW DID NEURONTIN PERFORM?
A13) Sales of Neurontin increased 6% (also up 6% excluding the impact of
foreign exchange) to $458 million in the second quarter, compared to the
same period in 2001. Restraints to production capacity in 2001 impacted
sales growth in the first and second quarter of 2002. More than 8 million
patients have been prescribed Neurontin in the U.S. since its approval.
Neurontin is the number one acute epilepsy drug in the U.S. and worldwide.
Neurontin has also been approved in more than 50 markets for treatment of
a range of neuropathic pain conditions. Neurontin was approved by the FDA
in
May for the management of post-herpetic neuralgia (PHN). PHN is most
commonly described as pain in the area affected by herpes zoster,
persisting at least three months after healing of the herpes zoster skin
rash. Herpes zoster is a painful viral infection also known as shingles.
In the United States alone, more than one million new cases of herpes
zoster are diagnosed each year. Approximately 10-15% of all patients with
herpes zoster develop PHN, which, once established, can persist for many
years. Neurontin is the first oral medication approved in the U.S. for
this condition.
Q14) HOW DID ZITHROMAX PERFORM?
A14) Zithromax sales decreased 4% (down 3% excluding the impact of foreign
exchange) to $251 million in the second quarter, compared to the same
period in 2001, in part due to a mild flu season. Zithromax is the
most-prescribed brand-name oral antibiotic in the U.S. and the
second-largest-selling antibiotic worldwide. The product is recognized by
physicians for its broad efficacy, compliance advantages, favorable
side-effect profile, and a good-tasting liquid formulation for children.
In May 2002, the FDA approved Zithromax as the first and only three-day
regimen for the treatment of acute bacterial exacerbations of chronic
obstructive pulmonary disease (COPD), with Zithromax given at a dose of
500 mg once daily. COPD is the fifth leading cause of death worldwide and
the fourth leading cause of death in the U.S. and is responsible for
500,000 hospitalizations in the U.S. per year.
In the first quarter of 2002, Pfizer launched the Zithromax oral
suspension as both a single-dose regimen and a three-day regimen for the
treatment of acute otitis media in pediatric patients. Acute otitis media
is the most common infection in young children, accounting for at least 30
million sick child visits to doctors each year. The approval was based on
a recent study, where a single dose of Zithromax oral suspension was as
effective in curing children's otitis media infections as 10 days of
twice-a-day Augmentin.
Q15) WHAT FACTORS ACCOUNT FOR VIAGRA'S PERFORMANCE?
A15) Viagra is the world's most recognized pharmaceutical brand. Worldwide
sales of Viagra grew 10% (up 11% excluding the impact of foreign exchange)
to $385 million in the second quarter, compared to the same period in
2001. The product is among the most widely prescribed medications, with
over 120 million prescriptions having been written since launch by nearly
600,000 physicians for more than 20 million men worldwide, including 12
million men in the U.S. New prescription volume in the U.S. increased 10%
compared to the same period last year. About half of American men aged 40
to 70 are affected with ED to some degree. In the U.K. and Japan, the two
largest international markets for Viagra, the product achieved revenue
growth, excluding the impact of foreign exchange, of 18% and 16%,
respectively, in the second quarter of 2002 compared to 2001.
Viagra allows many men with erectile dysfunction (ED) to achieve
erections, leading to an improvement in their sexual health. A growing
body of medical evidence from over 100 completed or ongoing clinical
studies continues to demonstrate the excellent efficacy and safety profile
of Viagra:
- An extensive long-term study of approximately 1,000 men with ED
taking Viagra for 4-5 years found that 96% of them remain satisfied
with the treatment. The data also found Viagra to be well tolerated,
with a low discontinuation rate (1-2%).
- A placebo-controlled study of men taking two or more
antihypertensive medications showed that Viagra improved erections
in 70% of men with severe vascular disease, and the side effects
were no different from those seen in healthy men with ED.
- Studies demonstrate that the efficacy and safety of Viagra were
similar in black and Hispanic American men as in white patients.
More than 79% and 89% of black and Hispanic American men,
respectively, reported improved erections, and 81% and 90%,
respectively, reported improved ability for sexual intercourse.
- Viagra has been found to be effective at treating erectile
dysfunction associated with the use of psychotropic medications
(antidepressants and antipsychotics) and when treating men with
erectile dysfunction secondary to radiation therapy for prostate
cancer.
- Analysis of efficacy and treatment satisfaction data collected from
partners of patients in clinical trials has shown that partner
responses parallel those of the patients and are highly
statistically significant compared to placebo.
- A placebo-controlled study of men with ED and chronic stable angina
who exercised up to a level of exertion double that experienced by
most people during sexual activity demonstrated that Viagra patients
exercised longer and experienced no serious adverse events, further
reinforcing the product's excellent cardiovascular safety.
- Numerous anecdotal reports and small studies have suggested that
Viagra is effective and safe when used in the treatment of pulmonary
arterial hypertension in both children and in adults, a condition
that is generally fatal. A clinical development program is underway
to further investigate this as a potential future use of Viagra.
Q16) HOW DID DIFLUCAN PERFORM?
A16) Sales of Diflucan decreased 1% (up 1% excluding the impact of foreign
exchange) to $245 million in the second quarter, compared to the same
period in 2001. This sales volume, after 14 years on the market, reflects
the unique features and benefits of Diflucan and the medical need that it
continues to fulfill. It treats systemic fungal infections, often present
in critically ill hospitalized
patients, as well as fungal infections of the mouth (thrush), throat, and
esophagus. Diflucan is also effective as a single-dose oral treatment for
vaginal candidiasis.
In June 2001, Pfizer announced that it would offer Diflucan at no charge
to HIV/AIDS patients in the 50 least-developed countries, as identified by
the United Nations, where HIV/AIDS is most prevalent. The Diflucan
Partnership was developed in cooperation with the United Nations and the
World Health Organization and expands upon the existing South African
Diflucan Partnership Program, a collaboration between Pfizer and the South
African Ministry of Health. Patient numbers and clinical sites continue to
increase, with more than 2 million doses dispensed and more than 27,000
prescriptions processed. The program has now been launched in Uganda,
Swaziland, Botswana, Namibia, and Lesotho. An additional seven countries
will be receiving Diflucan by the end of 2002: the Democratic Republic of
Congo, Malawi, Mozambique, Tanzania, Rwanda, Zambia, and Zimbabwe.
In the 50 least developed countries with an HIV prevalence of greater than
one percent, roughly 12 million people are reported to be infected with
HIV/AIDS. Although Diflucan is not a treatment for HIV/AIDS, it has proven
highly effective in treating two opportunistic infections, cryptococcal
meningitis and esophageal candidiasis, that afflict large numbers of
people with AIDS. Cryptococcal meningitis is a life-threatening brain
infection caused by the yeast Cryptococcus neoformans. Of those suffering
from untreated meningitis, the mortality rate is more than 90%.
Q17) WHAT FACTORS DROVE ZYRTEC'S GROWTH?
A17) Sales of Zyrtec, a leading prescription antihistamine in the U.S., grew
20% to $302 million in the second quarter, compared to the same period in
2001. Among established prescription antihistamines, Zyrtec continues to
be the fastest-growing in new prescriptions in the U.S. year-to-date,
achieving growth at more than five times the market rate. This growth can
be attributed to strong performances by Zyrtec syrup, which continues to
be the most-prescribed antihistamine syrup in the U.S., and Zyrtec-D 12
Hour, launched in the third quarter of 2001. Zyrtec-D 12 Hour is still the
only prescription oral antihistamine/decongestant combination medicine
approved to treat both year-round indoor and outdoor allergies as well as
nasal congestion. With 30% of all allergy sufferers also experiencing
nasal congestion, and with decongestant combinations accounting for about
one fifth of total U.S. antihistamine prescriptions, a significant
opportunity exists for Zyrtec-D.
Zyrtec provides strong, rapid, and long-lasting relief for seasonal and
perennial allergies and hives (chronic idiopathic urticaria) with
once-daily dosing. In two
two-day clinical studies conducted in an artificially controlled pollen
environment, Zyrtec began working in about one hour, compared to about
three hours for Claritin. In the same studies, Zyrtec provided twice the
symptom relief as Claritin.
Most people with allergies have both indoor and outdoor allergies, but
indoor allergies are tougher to treat. Unlike some other prescription
allergy medications, Zyrtec has a proven history of treating both
year-round indoor and seasonal outdoor allergies. It is also indicated for
use in children as young as two years old, and can be safely used to treat
allergies in children six years or older with mild-to-moderate asthma. In
December 2001, Pfizer submitted a supplemental filing to the FDA with
additional safety and efficacy data for use of Zyrtec in children age six
months to two years. Based on this filing, Pfizer received a six-month
patent extension for Zyrtec.
Q18) WHAT ARE SOME OF THE KEY BENEFITS OF ARICEPT?
A18) Aricept continues to be the world's leading medicine for the symptomatic
treatment of Alzheimer's disease (AD). In the U.S., U.K., France, Germany,
and Japan, Aricept is co-promoted by Pfizer and Eisai Co., Ltd., the
company that discovered and developed the compound, with Eisai recording
sales and Pfizer recording a portion of profit as alliance revenue. In
certain countries, Pfizer directly records sales of the product.
About 10% of people over 65 suffer from AD, including 4 million Americans.
U.S. society spends as much as $100 billion a year for AD. By 2050, it is
estimated that nearly 14 million Americans will suffer from this disease.
Aricept has been taken for more than 710 million patient days by more than
1.7 million patients in the U.S. with mild-to-moderate AD to enhance or
maintain cognition and function by preserving levels of the
neurotransmitter acetylcholine in the brain. In controlled clinical trials
of up to six months, more than 80% of patients taking Aricept experienced
improved cognition or no further decline compared to 58% of patients on
placebo. In one study, 48 weeks of treatment with Aricept produced a delay
of more than two years to placement in a nursing home compared with less
than eight weeks of therapy with Aricept. A 3,500-patient study presented
at a meeting of the American Geriatrics Society found that annual
healthcare costs of patients with AD treated with Aricept for more than
nine months averaged about $4,200 less than patients not receiving
treatment. Aricept is well tolerated, with a low incidence of side
effects, offers convenient, once-daily dosing, and can be taken with or
without food.
Pfizer and Eisai are progressing in development of a new indication of
Aricept for vascular dementia. In a placebo-controlled study presented at
a recent meeting of the American Association for Geriatric Psychiatry,
treatment with Aricept
significantly improved the cognitive and global function of patients with
vascular dementia. A second, placebo-controlled study presented at a
meeting of the American Academy of Neurology also showed that treatment
with Aricept significantly improved the cognitive and global function of
patients with vascular dementia. This condition, characterized by
cognitive decline caused by a single, localized stroke or series of
strokes, is second only to AD as a cause of dementia. Up to one third of
all diagnosed dementia cases are vascular dementia.
Q19) HOW IS GEODON PERFORMING?
A19) Geodon has been launched in Sweden, Germany, the United States, and 21
other markets. Sales for the second quarter of 2002 totaled $48 million,
up 119%, compared to the same period in 2001 due to the relatively low
sales in the second quarter of 2001 following the initial stocking of the
trade in the U.S. in the first quarter of 2001. Geodon has been prescribed
for over 250,000 patients worldwide. In the U.S., it is available on the
formularies of all state Medicaid programs, the Veterans Administration,
and more than 1,200 hospitals. In Europe, where the product is sold under
the trade name Zeldox, launches of both the oral and intramuscular form
will occur throughout 2002 and 2003.
Discovered and developed by Pfizer, Geodon is a serotonin and dopamine
antagonist that is effective in treating the wide range of positive,
negative, and depressive symptoms associated with schizophrenia. Positive
symptoms include visual and auditory hallucinations and delusions. The
harder-to-treat negative symptoms include blunted affect, social
withdrawal, and lack of motivation. Schizophrenia is a chronic illness
that requires lifelong treatment, affects approximately 1% of the world's
population, and is estimated to cost more than $104 billion in hospital
costs, medications, health-care services, and lost productivity annually.
In June 2002, the intramuscular (IM) formulation of Geodon was approved in
the U.S., where it is the first atypical antipsychotic medicine approved
for IM use. Acute agitation in patients with psychosis is one of the most
common psychiatric emergencies and is characterized by uncooperative or
even violent behavior. IM medicines are important in this setting because
of their rapid onset of action. Geodon IM works quickly and without the
excessive sedation and movement disorders that are distressing to patients
and are common to other widely prescribed treatment options. Geodon IM
allows continuity of care, as physicians rapidly control patients with
acute symptoms of psychotic behavior with the IM formulation and then
maintain the patient with Geodon Oral. Pfizer is also studying Geodon in
mania and is developing an oral suspension dosage form.
An eight-week multicenter study of 296 patients with acute schizophrenia
or schizoaffective disorder showed that Geodon was as effective against
both
positive and negative symptoms as Risperdal, without the weight gain and
prolactin elevation seen with Risperdal and with a lower incidence of
extrapyramidal side effects. A six-week multicenter study of 299 patients
with acute schizophrenia or schizoaffective disorder showed that Geodon
was as effective against both positive and negative symptoms as Zyprexa,
without the adverse changes in insulin levels, blood lipid levels, and
body weight seen with Zyprexa. Significant weight gain, associated with
many currently available antipsychotic medicines, is distressing and
stigmatizing to patients and often results in non-compliance. Patients who
gain weight may also be at greater risk for cardiovascular complications
such as increased lipid levels and poor glycemic control.
Geodon is associated with a small prolongation of the QTc interval of the
electrocardiogram, an effect seen with certain other marketed medicines
and some antipsychotics. To date, the post-approval clinical experience
with Geodon has been consistent with the clinical trials program. Our
post-marketing safety reports show no increased risk associated with QTc
prolongation, including no cases of torsade de pointes arrhythmia, no
increase in the overall mortality rate, and no signals of increased
cardiovascular risk.
Q20) HOW IS THE BEXTRA LAUNCH GOING?
A20) Bextra was launched in the U.S. in April 2002 for the relief of pain and
inflammation of osteoarthritis (OA), adult rheumatoid arthritis (RA), and
primary dysmenorrhea. Bextra is off to a very good start and has already
achieved a 5.6% share of new prescriptions of the NSAID market as of May.
Celebrex and Bextra together achieved new prescription share of 23.6%.
Pfizer and Pharmacia Corporation, the company that discovered and
developed Bextra, co-promote this product in most major world markets. In
the countries where Pfizer and Pharmacia co-promote Bextra, Pharmacia
records sales and Pfizer records a portion of revenue as alliance revenue.
In certain other countries, Pfizer directly records sales of the product.
Bextra offers once-daily dosing for OA and RA patients. The product has a
significantly lower incidence of endoscopically detected gastroduodenal
ulcers versus traditional NSAIDs (naproxen, ibuprofen, and diclofenac) and
significantly less dyspepsia versus naproxen. In controlled comparative
arthritis trials of up to 26 weeks, Bextra in daily doses of 10 mg or 20
mg demonstrated an incidence of edema and hypertension similar to
comparator NSAIDs.
Results of two investigational studies published in the May 2002 Journal
of the American Dental Association showed that Bextra dosed at 20 mg and
40 mg provided relief for the treatment of pain associated with dental
surgery. The results showed comparable pain relief to Tylox (oxycodone 10
mg/ acetaminophen 1,000 mg), a schedule 2 narcotic.
Q21) WHAT IS THE REGULATORY STATUS OF RELPAX?
A21) Relpax, an oral 5-HT 1b/1d agonist for the acute treatment of migraine,
has been launched in 24 countries worldwide, including most of Europe and,
earlier in July, Japan. Launches will continue throughout 2002. Relpax has
been approved in the E.U. in dosage levels of 20 mg, 40 mg, and 80 mg. In
the U.S., Pfizer completed a cardiovascular physiology study requested by
the FDA in their approvable letter of December 2000. With resubmission of
this data to the FDA, Pfizer anticipates approval by yearend 2002, with a
U.S. launch to follow.
The efficacy, safety, and tolerability of Relpax were established in ten
randomized, double-blind, placebo-controlled studies involving more than
13,000 migraine sufferers and over 70,000 migraine attacks as part of a
global clinical program. Headache response, defined as a reduction in
headache severity from moderate or severe pain to mild or no pain, was
assessed up to two hours after dosing. Data from these trials demonstrate
that up to 77% of patients treated with an 80 mg dose and 65% of patients
treated with a 40 mg dose experienced headache relief at two hours. The
medical journal Neurology recently accepted for publication a second
Relpax Phase III clinical trial, again demonstrating the excellent
efficacy of Relpax 40 mg and 80 mg over Imitrex 50 mg and 100 mg.
Migraine is a common and debilitating medical disorder, experienced by
more than 28 million people in the U.S. alone (18% of women and 6% of
men). More than 10% of adults in Europe suffer from migraine. Despite the
often chronic and disabling nature of migraines -- symptoms of which
include severe headache pain, nausea, and sensitivity to light or sound --
the vast majority of sufferers have never been diagnosed or treated with
prescription medication.
Q22) WHAT IS THE REGULATORY STATUS OF PFIZER'S NEW ANTIFUNGAL VFEND?
A22) Vfend, a new antifungal, was approved in both oral and intravenous forms
in the U.S. by the FDA in May and in the E.U. in March. Launch of Vfend is
anticipated in August in the U.S. and beginning in September in Europe.
In the U.S., Vfend is indicated for primary treatment of acute invasive
aspergillosis and salvage therapy for rare but serious fungal infections
caused by the pathogens Scedosporium apiospermum and Fusarium spp. In
Europe, Vfend is also approved for the treatment of fluconazole-resistant
serious invasive Candida infections (including C. krusei). In the largest
prospective comparative clinical trial ever conducted in invasive
aspergillosis, a deadly fungal infection occurring in immune-compromised
patients, 53% of patients who received Vfend had a successful response at
12 weeks of treatment, compared to 32% of those who received amphotericin
B. The survival rate of the Vfend-treated patients
was 71% versus 58% of those in the amphotericin B arm. The number of
hospitalized patients at risk for serious fungal infections is growing as
more patients undergo bone marrow/stem cell and solid organ transplants as
well as aggressive chemotherapy for cancer. Fungal infections in these
immune-compromised patients are associated with high morbidity and
mortality and require prompt and effective treatment.
Vfend can be administered both orally and intravenously, unlike most
currently available treatments, which are available in intravenous form
only. This allows for flexibility in patient care with Vfend, permitting
step-down therapy from intravenous to oral administration and potentially
allowing the patient to be discharged from the hospital sooner.
Q23) WHAT IS THE STATUS OF SPIRIVA?
A23) Spiriva was approved by regulatory authorities in Europe in April 2002.
The product was launched in six countries, including Germany, in June.
Spiriva, discovered and developed by Boehringer Ingelheim, is the first
once-a-day inhaled bronchodilator treatment for chronic obstructive
pulmonary disease (COPD) and a significant advance over other treatment
options. It will be co-promoted worldwide by Pfizer and Boehringer
Ingelheim. COPD is a chronic respiratory disorder that includes chronic
bronchitis and emphysema and is characterized by limited airflow
accompanied by symptoms such as dyspnea (shortness of breath), cough,
wheezing, and increased sputum production. According to the World Health
Organization, about 600 million people suffer from COPD, though many are
undiagnosed. The disease claims three million lives annually. It is
estimated that one in five smokers will develop COPD, which is the
fifth-leading cause of death worldwide and the fourth-leading cause of
death in the U.S.
Data from clinical trials involving more than 3,000 patients worldwide
have demonstrated that Spiriva is highly effective, providing sustained
bronchodilation with significant symptomatic improvement in dyspnea. Data
from these studies also indicate that Spiriva reduced exacerbations of
COPD, resulting in fewer hospitalizations and improved patient
health-related quality of life. Spiriva also was shown to be well
tolerated, with dry mouth as the main side effect.
In September 2001, Boehringer Ingelheim and Pfizer presented new data on
Spiriva at a meeting of the European Respiratory Society. Spiriva was
shown to be effective in treating patients with COPD and to be superior to
the long-acting beta agonist salmeterol in several key measurements. In a
six-month study involving 623 COPD patients, Spiriva was shown to be
significantly superior to salmeterol in lung function. There was no
evidence of a loss of effectiveness of Spiriva during the study. Patients
receiving Spiriva reported a statistically
significant improvement in dyspnea, the most disabling respiratory symptom
for patients with COPD, versus placebo, whereas patients receiving
salmeterol did not. Spiriva patients also reported statistically
significant improvement in health-related quality of life. Data from other
clinical trials presented at scientific meetings also show Spiriva to be
superior to ipratropium bromide in several key measurements.
In April 2002, Boehringer Ingelheim and Pfizer presented new data on
Spiriva at the annual meeting of the American Thoracic Society. Patients
who used Spiriva were able to exercise over 20% longer than patients who
used placebo. In addition, patients who used Spiriva experienced less
shortness of breath both while exercising and during activities of daily
living.
Q24) WHAT IS THE STATUS OF PFIZER'S CO-PROMOTION OF REBIF WITH SERONO?
A24) Last week, Pfizer and Serono announced an agreement to co-promote Serono's
multiple sclerosis (MS) treatment Rebif (interferon beta 1-a) in the U.S.
Rebif has been shown to decrease the frequency of clinical exacerbations
and delay the accumulation of physical disability associated with
relapsing forms of MS. Rebif is recommended for use at a dosage of 44 mcg
three times per week injected subcutaneously. Under the terms of the
agreement, Pfizer will pay Serono an up-front fee of $200 million, which
will be capitalized and amortized over the life of the product. Pfizer
will share all commercialization and development costs in the U.S. and
will receive a payment based on Rebif sales in the U.S. Serono will record
all sales and continue to distribute the product in the U.S. The product
will be sold under the Rebif brand name. Serono will be the sole marketer
for Rebif in the rest of the world. MS is a chronic inflammatory condition
of the nervous system and is the most common non-traumatic neurological
disease in young adults. MS affects approximately 350,000 Americans. While
symptoms can vary, the most common symptoms of MS include blurred vision,
numbness or tingling in the limbs, and problems with strength and
coordination. The relapsing forms of the disease are the most common forms
of MS.
Q25) WHAT IS THE STATUS OF THE PFIZER FOR LIVING SHARE CARD PROGRAM?
A25) On January 15, we launched an innovative prescription benefit program
called the Pfizer for Living Share Card. The program is designed to help a
targeted group of patients access tools to manage their health. The
program includes three elements: a membership card that enables patients
to receive up to a 30-day supply of a Pfizer medicine for $15, a help line
to assist low-income senior citizens in learning about other health-care
services and benefits, and easy-to-read health information on 16 common
medical conditions.
The Pfizer Share Card is available to Medicare enrollees with annual gross
incomes of less than $18,000 ($24,000 for couples) who lack
prescription-drug coverage or who are not eligible for Medicaid or any
other publicly funded prescription benefit programs. The projected
financial impact of this program is included in Pfizer's current revenue
and earnings growth guidance for 2002 through 2004.
The response to the Share Card has been overwhelmingly positive. The
Pfizer Share Card can be used at more than 48,000 retail pharmacies
nationwide, representing 93% of all U.S. pharmacies. Since the program's
announcement, the Share Card call center has:
- Received more than 940,000 inquiries
- Received more than 560,000 requests for applications
- Reviewed more than 250,000 completed applications
- Enrolled more than 170,000 members, and
- Filled more then 280,000 Pfizer prescriptions.
We are actively reaching out to people who may be eligible for the Share
Card by organizing enrollment days at senior centers, churches, and
community groups.
Q26) HOW DID THE ANIMAL HEALTH BUSINESS PERFORM?
A26) In the quarter, Animal Health sales increased 11% to $274 million (up 15%
excluding the impact of foreign exchange), compared to the same period in
2001. This strong performance reflected double-digit growth (excluding the
impact of foreign exchange) in both livestock and companion-animal product
lines. Our companion-animal products Revolution and Rimadyl and our
livestock medicines Dectomax and RespiSure/Stellamune showed strong
growth, excluding the impact of foreign exchange.
Q27) HOW DID PFIZER'S CONSUMER BUSINESSES PERFORM?
A27) Sales of Pfizer's consumer businesses, which include consumer healthcare
products, Adams confectionery products, Schick-Wilkinson Sword shaving
products, and Tetra fish-food products, grew 5% (up 7% excluding the
impact of foreign exchange) to $1.333 billion in the second quarter,
compared to the same period in 2001. Sales of Consumer Healthcare products
grew 10% (up 11% excluding the impact of foreign exchange) to $646 million
due to strong performances of Listerine mouthwash and Listerine
PocketPaks.
Q28) WHAT IS THE STATUS OF THE ADAMS, SCHICK-WILKINSON SWORD, AND TETRA
BUSINESSES?
A28) In June, Pfizer announced it was exploring strategic options for the Adams
confectionery business and the Schick-Wilkinson Sword shaving products
business, including possible sale. Headquartered in Parsippany, New
Jersey, Adams is one of the world's largest providers of confectionery
products. Adams conducts business in over 70 countries and has
approximately 12,000 employees worldwide. Schick-Wilkinson Sword is the
world's second largest producer of shaving products. Schick-Wilkinson
Sword is headquartered in Milford, Connecticut, conducts business in more
than 50 countries, and has approximately 3,500 employees worldwide. In
March, Pfizer announced that it was exploring strategic options for the
Tetra aquarium and pond supplies division, including possible sale. The
Tetra business has approximately 700 employees in the U.S., Germany, the
U.K., France, Italy, and Japan.
Q29) WHAT ARE PFIZER'S COST-SAVINGS EXPECTATIONS FROM THE INTEGRATION OF PFIZER
AND WARNER-LAMBERT?
A29) By year-end 2002, we now anticipate $1.8 billion in merger-related cost
savings. Savings stem from increased purchasing power of the combined
entity, the reduction of operating expenses, the closure of redundant
facilities, and the elimination of redundant positions in the work force.
Integration, restructuring, and transaction costs of $2.5 billion
(excluding costs associated with the termination of the failed
Warner-Lambert/American Home Products merger) have been recorded from the
close of the transaction through the end of the second quarter of 2002
($166 million recorded in the second quarter of 2002). We now anticipate
total merger-related costs through 2002 (excluding the AHP break-up fee)
of about $2.8 billion.
Q30) WHAT WERE THE PRINCIPAL FACTORS AFFECTING OTHER (INCOME)/DEDUCTIONS --
NET?
The reduction in interest income is primarily a factor of significantly
lower short-term interest rates in 2002 versus 2001. Amortization of
goodwill and intangibles is lower in 2002 versus 2001 as a result of the
adoption of SFAS No. 142 -- Goodwill and Other Intangible Assets.
Q31) WHAT IS PFIZER'S EFFECTIVE TAX RATE FOR 2002?
A31) The 2002 effective tax rate for continuing operations, excluding the
cumulative effect of a change in accounting principle, certain significant
items, and merger-related costs, has been reduced to 23.5%, due primarily
to product mix and tax planning initiatives. The tax rate of 21.7% in the
second quarter, from continuing operations excluding certain significant
items and merger-related costs, reflects this lower full-year rate as well
as a catch-up adjustment for the first quarter.
Q32) WHAT IS THE STATUS OF PFIZER'S SHARE-PURCHASE PROGRAM?
A32) In May 2002, the company completed its existing share-purchase program,
authorized in June 2001, under which it purchased 120 million shares at a
cost of $4.8 billion. Recently, the company also announced a new
authorization to purchase up to $10 billion worth of the company's common
stock. This current program has now been increased to $16 billion and will
be completed during 2003.
Q33) WILL PFIZER BE HOLDING A CONFERENCE CALL?
A33) Pfizer will be holding a conference call for analysts and investors to
discuss the Pfizer/Pharmacia transaction and second-quarter earnings at
11:00AM today. To ensure universal access, the conference call will be
simultaneously broadcast over Pfizer's corporate website -- www.pfizer.com
-- and will be archived for five days thereafter.