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Financial Review
Pfizer Inc. and Subsidiary Companies
2013 Financial Report
29
* For applications in the EU, the dates set forth in this column are the dates on which the European Medicines Agency (EMA) validated our submissions.
(a) This indication for Eliquis (apixaban) was developed in collaboration with BMS.
LATE-STAGE CLINICAL PROGRAMS FOR ADDITIONAL USES AND DOSAGE FORMS
FOR IN-LINE AND IN-REGISTRATION PRODUCTS
PRODUCT INDICATION
Inlyta (Axitinib) Oral and selective inhibitor of vascular endothelial growth factor (VEGF) receptor 1, 2 & 3 for the
adjuvant treatment of renal cell carcinoma, which is being developed in collaboration with SFJ
Pharmaceuticals Group
Lyrica (Pregabalin) Peripheral neuropathic pain; CR (once-a-day) dosing
Sutent (Sunitinib) Adjuvant treatment of renal cell carcinoma
Tofacitinib A JAK kinase inhibitor for the treatment of psoriasis, ulcerative colitis and psoriatic arthritis
Vyndagael (Tafamidis meglumine) Adult symptomatic transthyretin cardiomyopathy
Xalkori (Crizotinib) An oral ALK and c-Met inhibitor for the treatment of ALK-positive first-line non-small cell lung cancer
NEW DRUG CANDIDATES IN LATE-STAGE DEVELOPMENT
CANDIDATE INDICATION
ALO-02 A Mu-type opioid receptor agonist for the management of moderate-to-severe pain when a continuous,
around-the-clock opioid analgesic is needed for an extended period of time
Bococizumab (RN316)
(PF-04950615)
A monoclonal antibody that inhibits PCSK9 for the treatment of hyperlipidemia and prevention of
cardiovascular events
Dacomitinib A pan-HER tyrosine kinase inhibitor for the first-line treatment of patients with advanced non-small cell
lung cancer with EGFR activating mutations, which is being developed in collaboration with SFJ
Pharmaceuticals Group
Ertugliflozin (PF-04971729) An oral SGLT2 inhibitor for the treatment of type 2 diabetes, which is being developed in collaboration
with Merck & Co., Inc.
Inotuzumab ozogamicin An antibody drug conjugate, consisting of an anti-CD22 monotherapy antibody linked to a cytotoxic agent,
calicheamycin, for the treatment of acute lymphoblastic leukemia
MnB rLP2086
(PF-05212366)
A prophylactic vaccine for prevention of Neisseria meningitidis serogroup B invasive disease in
adolescents and young adults (ages 11-25)
Palbociclib (PD-0332991)(a) An oral and selective reversible inhibitor of the CDK 4 and 6 kinases for the treatment of patients with
estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer,
recurrent advanced breast cancer and, in collaboration with the German Breast Group, high-risk early
breast cancer
PF-05280014 A potential biosimilar to Trastuzumab. Trastuzumab is a monoclonal antibody that binds and inhibits
HER2 for the treatment of HER2-positive breast cancer and gastric cancer
Tanezumab(b) An anti-nerve growth factor monoclonal antibody for the treatment of pain (on clinical hold)
(a) On February 3, 2014, we announced that the randomized Phase 2 trial of palbociclib achieved its primary endpoint by demonstrating a statistically significant
and clinically meaningful improvement in progression-free survival for the combination of palbociclib and letrozole compared with letrozole alone in post-
menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or newly diagnosed
metastatic breast cancer. Adverse events observed for the palbociclib arm were consistent with the known adverse event profile for this combination.
(b) The tanezumab program is under a partial clinical hold by the FDA pending our submission of additional nonclinical data. We anticipate submitting that data to
the FDA by the end of 2014. Subject to the removal of the partial clinical hold, we are planning to continue development of tanezumab for the treatment of
osteoarthritis, chronic low back pain and cancer pain. In October 2013, we entered into a collaboration agreement with Eli Lilly and Company to jointly develop
and globally commercialize tanezumab for those indications.
Additional product-related programs are in various stages of discovery and development. Also, see the discussion in the “Our Business
Development Initiatives” section of this Financial Review.
COSTS AND EXPENSES
Cost of Sales
Year Ended December 31, % Change
(MILLIONS OF DOLLARS) 2013 2012 2011 13/12 12/11
Cost of sales $9,586 $9,821 $ 12,500 (2) (21)
As a percentage of Revenues 18.6% 18.0%20.5%
2013 v. 2012
Cost of sales decreased 2% in 2013, compared to 2012, primarily due to the favorable impact of foreign exchange of 4%, which more than
offset the unfavorable impact of a shift in product mix due to the loss of exclusivity of certain products in various markets.