Pfizer 2015 Annual Report Download - page 26

Financial Review
Pfizer Inc. and Subsidiary Companies
2015 Financial Report
25
(MILLIONS OF DOLLARS) Year Ended December 31, % Change
PRODUCT PRIMARY INDICATIONS 2015 2014 2013 15/14 14/13
All other Sterile Injectable Pharmaceuticals(e) Various 2,563 1,855 1,954 38 (5)
Infusion Systems(k) Various $403 $—$ —*—
Biosimilars(l) Various $63$—$ —*—
Other Established Products(m) Various $106 $—$ —*—
OTHER(n) $506 $451 $364 12 24
Total Lyrica(b) Epilepsy, post-herpetic neuralgia and diabetic peripheral
neuropathy, fibromyalgia and neuropathic pain due to spinal cord
injury
$4,839 $5,168 $4,595 (6)12
Total Viagra(c) Erectile dysfunction $1,708 $1,685 $1,881 1(10)
Total Alliance revenues(o) Various $1,312 $957 $2,628 37 (64)
(a) The Innovative Products business is composed of two operating segments: GIP and VOC.
(b) Lyrica revenues from all of Europe, Russia, Turkey, Israel and Central Asia countries are included in Lyrica-GEP. All other Lyrica revenues are included in
Lyrica-GIP. Total Lyrica revenues represent the aggregate of worldwide revenues from Lyrica-GIP and Lyrica-GEP.
(c) Viagra revenues from the U.S. and Canada are included in Viagra-GIP. All other Viagra revenues are included in Viagra-GEP. Total Viagra revenues represent
the aggregate of worldwide revenues from Viagra-GIP and Viagra-GEP.
(d) Includes Eliquis, Rebif and Enbrel (in the U.S. and Canada through October 31, 2013).
(e) All other GIP, and All other V/O are a subset of GIP and VOC, respectively. All other Legacy Established Products, All other Peri-LOE Products and All other
Sterile Injectable Pharmaceuticals are subsets of Established Products.
(f) In 2015, all revenues were composed of Prevnar 13/Prevenar 13. In 2014 and 2013, revenues were composed of the Prevnar family of products, which
included Prevnar 13/Prevenar 13 and, to a much lesser extent, Prevenar (7-valent).
(g) The Established Products business consists of GEP, which includes all legacy Hospira commercial operations. Commencing from the acquisition date,
September 3, 2015, and in accordance with our domestic and international reporting periods, our consolidated statement of income, primarily GEP’s operating
results, for the year ended December 31, 2015 reflects four months of legacy Hospira U.S. operations and three months of legacy Hospira international
operations.
(h) Legacy Established Products include products that lost patent protection (excluding Sterile Injectable Pharmaceuticals and Peri-LOE Products).
(i) Peri-LOE Products include products that have recently lost or are anticipated to soon lose patent protection. These products primarily include Celebrex, Zyvox
and Revatio in most developed markets, Lyrica in the EU, Pristiq in the U.S. and Inspra in the EU.
(j) Sterile Injectable Pharmaceuticals include generic injectables and proprietary specialty injectables (excluding Peri-LOE Products).
(k) Infusion Systems include Medication Management Systems products composed of infusion pumps and related software and services, as well as I.V. Infusion
Products, including large volume I.V. solutions and their associated administration sets.
(l) Biosimilars include Inflectra (biosimilar infliximab), Nivestim (biosimilar filgrastim) and Retacrit (biosimilar epoetin zeta) in certain international markets.
(m) Includes legacy Hospira’s One-to-One contract manufacturing and bulk pharmaceutical chemical sales organizations.
(n) Other includes revenues from Pfizer CentreSource, our contract manufacturing and bulk pharmaceutical chemical sales organization, and revenues related to
our manufacturing and supply agreements with Zoetis.
(o) Total Alliance revenues represent the aggregate of worldwide revenues from Alliance revenues GIP and Alliance revenues GEP, which is included in All other
Legacy Established Products.
* Calculation not meaningful.
Revenues—Selected Product Descriptions
References to GIP, V, O, and GEP indicate the business to which the revenues relate. GIP = the Global Innovative Pharmaceutical segment;
V = the Global Vaccines business; O = the Global Oncology business; and GEP = the Global Established Pharmaceutical segment.
• Prevnar/Prevenar 13 (V), is our pneumococcal conjugate vaccine for the prevention of certain types of pneumococcal disease. Overall,
worldwide revenues for Prevnar/Prevenar 13 increased 46% operationally in 2015, compared to 2014. Foreign exchange had an
unfavorable impact on worldwide revenues of 6% in 2015, compared to 2014.
In the U.S., revenues for Prevnar increased 87% in 2015, compared to 2014, mainly due to continued strong uptake among adults
following the positive recommendation from the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on
Immunization Practices (ACIP) for use in adults aged 65 and older in the third quarter of 2014 and the success of the commercial
programs which helped to maximize vaccinations across all channels. We believe the “catch-up” opportunity (i.e., the opportunity to reach
adults aged 65 and older who have not been previously vaccinated with Prevnar) in adults in the U.S. will continue to be large given
current demographics and aging trends. However, the remaining population of adults aged 65 years and older will likely require additional
effort to capture. As a result, the opportunity will moderate over time as this “catch-up” opportunity becomes fully realized.
Internationally, revenues for Prevenar increased 9% operationally in 2015, compared to 2014, primarily reflecting increased volume in
emerging markets primarily due to Prevenar’s inclusion in additional national immunization programs in certain emerging markets. Foreign
exchange had an unfavorable impact on international revenues of 13% in 2015, compared to 2014.
In 2014, the ACIP voted to recommend Prevnar 13 for routine use to help protect adults aged 65 years and older against pneumococcal
disease, which for adults includes pneumonia caused by the 13 pneumococcal serotypes included in the vaccine. These ACIP
recommendations were subsequently approved by the directors at the CDC and U.S. Department of Health and Human Services, and
were published in the Morbidity and Mortality Weekly Report in September 2014 by the CDC. As with other vaccines, the CDC regularly
monitors the impact of vaccination and reviews the recommendations; in this case, however, the CDC announced formally that it will
conduct this review in 2018. Currently, we are working with a number of U.S. investigators to monitor the proportion of community-acquired
pneumonia caused by the serotypes included in Prevnar 13 and continue to observe trends.
In March 2015, the European Commission approved an expanded indication for the use of Prevenar 13 for the prevention of pneumonia
caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older. The Summary of Product Characteristics has
also been updated to include efficacy data from our landmark Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA),
which demonstrated statistically significant reductions in first episodes of vaccine-type pneumococcal community-acquired pneumonia
(CAP), including non-invasive/non-bacteremic CAP, and invasive pneumococcal disease (IPD) in adults aged 65 and older.