-
Third-Quarter 2016 Revenues of $13.0 Billion, Reflecting 10%
Operational Growth -
Third-Quarter 2016 Revenues for Pfizer Standalone (Excluding Legacy
Hospira) of $11.9 Billion, Reflecting 3% Operational Growth -
Third-Quarter 2016 Reported Diluted EPS(1) of $0.21,
Adjusted Diluted EPS(2) of $0.61 -
Narrows Certain 2016 Financial Guidance Ranges and Incorporates Impact
of Decision to Discontinue Global Development of Bococizumab
NEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) reported financial results for third-quarter
2016 and narrowed certain 2016 financial guidance ranges.
On September 3, 2015, Pfizer acquired Hospira, Inc. (Hospira).
Consequently, financial results for the third quarter and first nine
months of 2016 include legacy Hospira global operations while financial
results for the third quarter and first nine months of 2015 include only
one month of legacy Hospira U.S. operations but no financial results
from legacy Hospira international operations(3).
On June 24, 2016, Pfizer acquired Anacor Pharmaceuticals, Inc. (Anacor).
Therefore, financial results for the third quarter and first nine months
of 2016 reflect approximately three months of legacy Anacor operations,
which were immaterial.
On September 28, 2016, Pfizer acquired Medivation, Inc. (Medivation).
Therefore, financial results for the third quarter and first nine months
of 2016 reflect three business days of legacy Medivation operations,
which were immaterial.
The Company manages its commercial operations through two distinct
businesses: Pfizer Innovative Health (IH)(4) (formerly the
Innovative Products business) and Pfizer Essential Health (EH)(4)(5)
(formerly the Established Products business). Financial results
for each of these businesses are presented in the Operating Segment
Information section located at the hyperlink below.
Some amounts in this press release may not add due to rounding. All
percentages have been calculated using unrounded amounts. References to
operational variances(6) pertain to period-over-period growth
rates that exclude the impact of foreign exchange as well as the
negative currency impact related to Venezuela. Results for the third
quarter and first nine months of 2016 and 2015 are summarized below.
OVERALL RESULTS | |||||||||||||||||||||||||||
($ in millions, except
per share amounts) |
Third-Quarter | Nine Months | |||||||||||||||||||||||||
2016 | 2015 | Change | 2016 | 2015 | Change | ||||||||||||||||||||||
Revenues | $ | 13,045 | $ | 12,087 | 8 | % | $ | 39,196 | $ | 34,804 | 13 | % | |||||||||||||||
Reported Net Income(1) | 1,320 | 2,130 | (38 | %) | 6,355 | 7,132 | (11 | %) | |||||||||||||||||||
Reported Diluted EPS(1) | 0.21 | 0.34 | (37 | %) | 1.03 | 1.14 | (10 | %) | |||||||||||||||||||
Adjusted Net Income(2) | 3,726 | 3,728 | — | 11,782 | 10,449 | 13 | % | ||||||||||||||||||||
Adjusted Diluted EPS(2) | 0.61 | 0.60 | 2 | % | 1.91 | 1.67 | 15 | % |
REVENUES | |||||||||||||||||||||||||
($ in millions) | Third-Quarter | Nine Months | |||||||||||||||||||||||
2016 | 2015 | % Change | 2016 | 2015 | % Change | ||||||||||||||||||||
Total | Oper. | Total | Oper. | ||||||||||||||||||||||
Innovative Health | $ | 7,332 | $ | 6,752 | 9 | % | 10 | % | $ | 21,471 | $ | 19,120 | 12 | % | 15 | % | |||||||||
Essential Health | $ | 5,712 | $ | 5,335 | 7 | % | 10 | % | $ | 17,725 | $ | 15,683 | 13 | % | 18 | % | |||||||||
EH Standalone
(Excl. Legacy Hospira) |
4,583 | 5,005 | (8 | %) | (5 | %) | 14,259 | 15,353 | (7 | %) | (2 | %) | |||||||||||||
Legacy Hospira | 1,129 | 330 | * | * | 3,466 | 330 | * | * | |||||||||||||||||
Total Company | $ | 13,045 | $ | 12,087 | 8 | % | 10 | % | $ | 39,196 | $ | 34,804 | 13 | % | 16 | % | |||||||||
Pfizer Standalone
(Excl. Legacy Hospira) |
$ | 11,915 | $ | 11,757 | 1 | % | 3 | % | $ | 35,730 | $ | 34,474 | 4 | % | 7 | % |
* Indicates calculation not meaningful.
2016 FINANCIAL GUIDANCE(7)
Pfizer’s updated 2016 financial guidance is presented below.
Revenues | $52.0 to $53.0 billion | ||
(previously $51.0 to $53.0 billion) |
|||
Adjusted Cost of Sales(2) as a Percentage of Revenues | 21.5% to 22.0% | ||
(previously 21.0% to 22.0%) |
|||
Adjusted SI&A Expenses(2) | $14.2 to $14.7 billion | ||
(previously $13.7 to $14.7 billion) |
|||
Adjusted R&D Expenses(2) | $7.8 to $8.1 billion | ||
(previously $7.4 to $7.8 billion) |
|||
Adjusted Other (Income)/Deductions(2) | Approximately ($600 million) of income | ||
(previously approx. ($500 million) of income) |
|||
Effective Tax Rate on Adjusted Income(2) | Approximately 24.0% | ||
Adjusted Diluted EPS(2) | $2.38 to $2.43 | ||
(previously $2.38 to $2.48) |
On November 1, 2016, Pfizer announced the decision to discontinue
development of bococizumab. As a result, 2016 financial guidance for
Adjusted R&D expenses(2) was negatively impacted by $0.3
billion and Adjusted Diluted EPS(2) was negatively impacted
by $0.04. A reconciliation of these financial guidance components is
presented below.
Adjusted R&D Expenses(2) | Adjusted Diluted EPS(2) | |||||
Updated 2016 Financial Guidance Excluding the Anticipated Impact of the Decision to Discontinue Development of Bococizumab |
$7.5 to $7.8 billion | $2.42 to $2.47 | ||||
Anticipated Impact of the Decision to Discontinue Development of Bococizumab — Midpoint of ranges impacted by: |
$0.3 billion | ($0.04) | ||||
2016 Financial Guidance Provided on November 1, 2016 | $7.8 to $8.1 billion | $2.38 to $2.43 | ||||
EXECUTIVE COMMENTARY
Ian Read, Chairman and Chief Executive Officer, stated, “Our business
continues to perform well as demonstrated by the quarter’s financial
results. Our Innovative Health business executed strongly behind the
latest product launches, and our two recent acquisitions — Medivation
and Anacor — are providing new near-term opportunities to potentially
drive incremental growth for the business as its product pipeline
continues to mature. We see this business as highly focused on those
therapeutic areas where it is best positioned to deliver value to
patients.
“Within the Essential Health business we continued to refine the
portfolio with the announced acquisition of the small molecule
anti-infectives franchise from AstraZeneca and the announced sale of the
Hospira infusion systems portfolio to ICU Medical. In addition, later
this month we will begin shipping Inflectra, a biosimilar to Remicade®(8)
that will be the first biosimilar monoclonal antibody to be available in
the U.S. We remain confident that we will be well-positioned in the
emerging biosimilars market with our broad pipeline. With continued
strength in emerging markets, the sterile injectables business and the
biosimilars portfolio, we anticipate the Essential Health business will
be able to transition to a modest revenue growth business on an overall
portfolio basis.
“By maintaining our overall high level of financial flexibility and
discipline, we are in a strong position to support the strategic
initiatives for each business and will remain opportunistic to business
development activity in addition to continuing to actively manage our
cost structure,” Mr. Read concluded.
Frank D’Amelio, Chief Financial Officer, stated, “Overall, I am pleased
with our third-quarter 2016 financial results and with our ability to
continue delivering shareholder value through prudent capital
allocation. We grew revenues by 3% operationally, excluding the impact
of foreign exchange and legacy Hospira operations. We also continued to
deliver significant value directly to shareholders by returning $10.5
billion to shareholders through dividends and share repurchases in the
first nine months of 2016, including the completion of a $5 billion
accelerated share repurchase agreement in June 2016. Additionally, we
announced and completed the acquisition of Medivation in the third
quarter of 2016.
“We raised the midpoint of the range for our 2016 Revenue guidance
primarily to reflect our strong performance to date and the inclusion of
legacy Medivation operations in fourth-quarter 2016. The midpoint of our
range for our 2016 Adjusted Diluted EPS(2) guidance was
negatively impacted solely due to our decision to discontinue
development of bococizumab. Excluding this impact, the midpoint of our
range for our 2016 Adjusted Diluted EPS(2) guidance would
have increased by $0.02,” Mr. D’Amelio concluded.
QUARTERLY FINANCIAL HIGHLIGHTS (Third-Quarter 2016 vs. Third-Quarter
2015)
Third-quarter 2016 revenues totaled $13.0 billion, an increase of $957
million, or 8% compared to the prior-year quarter, reflecting
operational growth of $1.2 billion, or 10%, partially offset by the
unfavorable impact of foreign exchange of $224 million, or 2%. Excluding
the third-quarter 2015 and 2016 contributions from legacy Hospira
operations and foreign exchange, Pfizer-standalone revenues increased by
$381 million operationally, or 3%.
Innovative Health Highlights
-
IH delivered strong revenue growth again this quarter, up 10%
operationally, driven by continued growth from key brands including
Ibrance, primarily in the U.S., Eliquis globally as well as Xeljanz,
Lyrica and Chantix/Champix, all primarily in the U.S. Compared to the
year-ago quarter, Ibrance revenue more than doubled while global
operational revenue growth for Eliquis and Xeljanz was 92% and 86%,
respectively. -
This strong third-quarter 2016 operational performance was achieved
despite the loss of Rebif alliance revenue compared to the prior-year
quarter due to the year-end 2015 expiry of the collaboration agreement
to co-promote Rebif in the U.S. as well as lower revenues for Enbrel
in most developed Europe markets, primarily due to biosimilar
competition. -
Global Prevnar/Prevenar 13 revenues were down 2% operationally. In the
U.S., Prevnar 13 revenues decreased 3% driven by an expected decline
in revenues for the Adult indication due to a high initial capture
rate of the eligible population following its successful
fourth-quarter 2014 launch, which resulted in a smaller remaining
“catch up” opportunity compared to the prior-year quarter, partially
offset by the impact of favorable timing of government purchases for
the pediatric indication. Internationally, Prevenar 13 revenues grew
1% operationally driven by a modest increase in uptake for the Adult
indication.
Essential Health Highlights
-
EH revenues increased 10% operationally, primarily due to the
inclusion of legacy Hospira operations, and to a lesser extent, the
performance of the EH Standalone Sterile Injectables(9)
portfolio, partially offset by the loss of exclusivity and associated
generic competition for certain Peri-LOE products(9),
primarily Lyrica and Zyvox, both primarily in most developed Europe
markets. -
Revenues excluding the contribution from the legacy Hospira portfolio
(EH Standalone) declined 5% operationally, reflecting a 15%
operational decline from the Peri-LOE Products(9) portfolio
and a 4% operational decline from the EH Standalone Legacy Established
Products(9) portfolio, partially offset by 7% operational
growth from the EH Standalone Sterile Injectable Pharmaceuticals(9)
portfolio. -
EH revenues in emerging markets increased 9% operationally, primarily
driven by the inclusion of legacy Hospira operations as well as 20%
operational growth from the EH Standalone Sterile Injectable
Pharmaceuticals(9) portfolio and 3% operational growth from
the EH Standalone Legacy Established Products(9) portfolio.
GAAP Reported(1) Income Statement Highlights
SELECTED TOTAL COMPANY REPORTED COSTS AND EXPENSES(1) | |||||||||||||||||||||||||||||||
($ in millions)
(Favorable)/Unfavorable |
Third-Quarter | Nine Months | |||||||||||||||||||||||||||||
2016 | 2015 | % Change | 2016 | 2015 | % Change | ||||||||||||||||||||||||||
Total | Oper. | Total | Oper. | ||||||||||||||||||||||||||||
Cost of Sales(1) | $ | 3,085 | $ | 2,219 | 39 | % | 30 | % | $ | 9,111 | $ | 6,238 | 46 | % | 40 | % | |||||||||||||||
Percent of Revenues | 23.6 | % | 18.4 | % | N/A | N/A | 23.2 | % | 17.9 | % | N/A | N/A | |||||||||||||||||||
SI&A Expenses(1) | 3,559 | 3,270 | 9 | % | 11 | % | 10,414 | 9,761 | 7 | % | 10 | % | |||||||||||||||||||
R&D Expenses(1) | 1,881 | 1,722 | 9 | % | 10 | % | 5,360 | 5,342 | — | 1 | % | ||||||||||||||||||||
Total | $ | 8,525 | $ | 7,211 | 18 | % | 17 | % | $ | 24,885 | $ | 21,340 | 17 | % | 16 | % | |||||||||||||||
Other (Income)/Deductions––net(1) | $ | 1,417 | $ | 661 | * | * | $ | 2,815 | $ | 670 | * | * | |||||||||||||||||||
Effective Tax Rate on Reported Income(1) | 17.7 | % | 21.0 | % | 15.8 | % | 23.4 | % | |||||||||||||||||||||||
* Indicates calculation not meaningful.
The increase in third-quarter 2016 Other deductions––net(1)
was primarily driven by an impairment charge as a result of the pending
Hospira Infusion Systems transaction.
The diluted weighted-average shares outstanding declined by 105 million
shares compared to the prior-year quarter due to Pfizer’s share
repurchase program, primarily reflecting the impact of a $5 billion
accelerated share repurchase agreement executed in March 2016 and
completed in June 2016.
Adjusted(2) Income Statement Highlights
SELECTED TOTAL COMPANY ADJUSTED COSTS AND EXPENSES(2) | |||||||||||||||||||||||||||||||
($ in millions)
(Favorable)/Unfavorable |
Third-Quarter | Nine Months | |||||||||||||||||||||||||||||
2016 | 2015 | % Change | 2016 | 2015 | % Change | ||||||||||||||||||||||||||
Total | Oper. | Total | Oper. | ||||||||||||||||||||||||||||
Adjusted Cost of Sales(2) | $ | 2,957 | $ | 2,108 | 40 | % | 31 | % | $ | 8,584 | $ | 6,037 | 42 | % | 36 | % | |||||||||||||||
Percent of Revenues | 22.7 | % | 17.4 | % | N/A | N/A | 21.9 | % | 17.3 | % | N/A | N/A | |||||||||||||||||||
Adjusted SI&A Expenses(2) | 3,531 | 3,276 | 8 | % | 10 | % | 10,342 | 9,726 | 6 | % | 9 | % | |||||||||||||||||||
Adjusted R&D Expenses(2) | 1,873 | 1,725 | 9 | % | 9 | % | 5,336 | 5,334 |
— |
— | |||||||||||||||||||||
Total | $ | 8,361 | $ | 7,109 | 18 | % | 16 | % | $ | 24,262 | $ | 21,098 | 15 | % | 15 | % | |||||||||||||||
Adjusted Other (Income)/Deductions—net(2) |
($168 | ) | ($90 | ) | 86 | % | 61 | % | ($547 | ) | ($410 | ) | 33 | % | 56 | % | |||||||||||||||
Effective Tax Rate on Adjusted Income(2) | 22.7 | % | 25.8 | % | 23.3 | % | 25.3 | % | |||||||||||||||||||||||
A full reconciliation of Reported(1) to Adjusted(2)
financial measures and associated footnotes can be found starting on
page 20 of the press release located at the hyperlink below.
RECENT NOTABLE DEVELOPMENTS (SINCE AUGUST 2, 2016)
Product Developments
-
Chantix/Champix (varenicline) — In September 2016, the U.S.
Food and Drug Administration’s (FDA) Psychopharmacologic Drugs
Advisory Committee and Drug Safety Risk Management Advisory Committee
reviewed data from EAGLES (Evaluating Adverse Events in a Global
Smoking Cessation Study) evaluating the neuropsychiatric safety of
Chantix. The Committees recommended by a majority vote to remove the
boxed warning regarding serious neuropsychiatric adverse events from
the Chantix labeling. The role of the Advisory Committees is to
provide recommendations to the FDA; however, the FDA makes the final
labeling decisions. Earlier this year, Pfizer submitted to the FDA a
supplemental New Drug Application (sNDA) requesting updates to the
Chantix labeling based on the safety and efficacy outcomes of EAGLES.
In addition to requesting removal of the boxed warning, Pfizer
proposed retaining the Warnings and Precautions section in the
labeling regarding serious neuropsychiatric events occurring in
patients attempting to quit smoking and updating it with EAGLES data.
Pfizer believes that such a warning would sufficiently inform
prescribers of the possibility that these types of events may occur. -
Ibrance (palbociclib) — Pfizer announced in September 2016
that the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion
recommending that Ibrance be granted marketing authorization in the
European Union (EU) for the treatment of women with hormone
receptor-positive, human epidermal growth factor receptor 2-negative
locally advanced or metastatic breast cancer. The CHMP’s positive
opinion is for Ibrance to be used in combination with an aromatase
inhibitor, as well as in combination with fulvestrant in women who
have received prior endocrine therapy. The CHMP’s opinion will now be
reviewed by the European Commission (EC). -
Inflectra (infliximab-dyyb) — Pfizer announced in October 2016
that it will begin shipment of Inflectra, a biosimilar of Remicade®(8)
(infliximab) to wholesalers in the U.S. in late November 2016.
Inflectra will be introduced at a 15% discount to the current
wholesaler acquisition cost (WAC) of Remicade®(8), its
reference product. WAC is not inclusive of discounts to payers,
providers, distributors and other purchasing organizations. Pfizer
holds exclusive commercialization rights to Celltrion’s Inflectra in
the U.S., and has already successfully introduced Inflectra in other
markets across the globe. -
Inlyta (axitinib) — At the annual meeting of the European
Society for Medical Oncology (ESMO 2016) in October 2016, Pfizer
announced data from two ongoing, investigational Phase 1b studies of
Inlyta combined with a checkpoint inhibitor:-
In one study, Inlyta was combined with pembrolizumab, a PD-1
inhibitor known as Keytruda®(10) and marketed by Merck,
known as MSD outside the United States and Canada (Merck/MSD), in
treatment-naïve patients with advanced renal cell carcinoma (RCC).
The study was designed to establish dosing and evaluate the safety
and anti-tumor activity of Inlyta when combined with pembrolizumab
in first-line treatment of advanced RCC. Early indicators from the
study point to strong response rates for this combination, with 37
patients (71.2%, confidence internal 56.9, 82.9) achieving
objective responses (three complete responses and 34 partial
responses); 10 patients had stable disease and 5 patients had
disease progression. -
Preliminary results from a similar, separate study (JAVELIN Renal
100) combining Inlyta with avelumab, an investigational, fully
human anti-PD-L1 IgG1 monoclonal antibody that is being
co-developed by Merck KGaA, Darmstadt, Germany (Merck KGaA) and
Pfizer, were also presented and suggested evidence of anti-tumor
activity for this combination. In this study, five out of six
patients treated so far had confirmed partial responses (objective
response rate 83.3%, 95% confidence interval: 35.9, 99.6) and one
patient with tumor shrinkage not meeting partial response criteria
had stable disease.
-
In one study, Inlyta was combined with pembrolizumab, a PD-1
Based on these Phase 1 results, two independent global Phase 3 trials
evaluating these combinations — Inlyta plus pembrolizumab and Inlyta
plus avelumab — each compared with Sutent (sunitinib) in first-line
advanced RCC are now enrolling patients.
-
Sutent (sunitinib malate) — At ESMO 2016, Pfizer presented
results from the Phase 3 S-TRAC clinical trial (Sunitinib Trial as
Adjuvant Treatment of Renal Cancer) investigating Sutent as an
adjuvant therapy. The trial showed Sutent extended disease-free
survival by more than one year versus placebo in patients who were at
high risk for recurrence after surgical resection of RCC. The results
were also published online by The New England Journal of Medicine.
Based on the results of S-TRAC, Pfizer is in discussions with global
regulatory authorities to determine potential next steps. -
Trumenba (rLP2086, Meningococcal Serogroup B Bivalent Recombinant
Lipoprotein vaccine) — In October 2016, Pfizer announced that the
U.S. Centers for Disease Control and Prevention’s (CDC) Advisory
Committee on Immunization Practices (ACIP) voted to recommend the
following for Trumenba:-
For persons at increased risk for meningococcal disease and for
use during serogroup B outbreaks, 3 doses of Trumenba should be
administered at 0, 1-2, and 6 months. -
When given to healthy adolescents who are not at increased risk
for meningococcal disease, 2 doses of Trumenba should be
administered at 0 and 6 months. If the second dose is given at an
interval of less than 6 months, a third dose should be given at
least 6 months after the first dose.
-
For persons at increased risk for meningococcal disease and for
The ACIP recommendation will be forwarded to the director of the CDC and
the U.S. Department of Health and Human Services for review and
approval. Once approved, the recommendations are published in the Morbidity
and Mortality Weekly Report (MMWR). In 2015, the CDC’s ACIP
recommended serogroup B meningococcal (MenB) vaccination for certain
persons aged 10 years and older at increased risk for meningococcal
disease. They also recommended that a MenB vaccine series may be
administered to adolescents and young adults 16 through 23 years of age
(preferred age 16 through 18) to provide short-term protection against
most strains of MenB disease. In October 2014, Trumenba was granted
Accelerated Approval by the FDA for active immunization to prevent
invasive disease caused by Neisseria meningitidis serogroup
B in individuals 10 through 25 years of age.
-
Xalkori (crizotinib) — In August 2016, Pfizer announced that
the EC has approved Xalkori for the treatment of adults with
ROS1-positive advanced non-small cell lung cancer (NSCLC). In the EU,
Xalkori is also indicated for treatment of adults with anaplastic
lymphoma kinase (ALK)-positive advanced NSCLC. In March 2016, Xalkori
was approved by the FDA for patients with metastatic NSCLC whose
tumors are ROS1-positive. -
Xtandi (enzalutamide) — In October 2016, Pfizer and Astellas
Pharma Inc. announced that the FDA approved a sNDA to update the U.S.
product labeling for Xtandi capsules to include new clinical data
versus bicalutamide from the TERRAIN study. The data demonstrate
improvement in radiographic progression-free survival (rPFS) in
patients with metastatic castration-resistant prostate cancer (CRPC)
who were treated with Xtandi compared to patients who were treated
with bicalutamide. The TERRAIN study evaluated men with metastatic
CRPC and the results from this study were published in The Lancet
Oncology. The updated label includes data that enzalutamide
reduces the risk of radiographic progression or death by 40% compared
with bicalutamide, showing a median rPFS of 19.5 months for the
enzalutamide group versus a median of 13.4 months for the bicalutamide
group (hazard ratio = 0.60 [0.43, 0.83]; 95% confidence interval)
based on an analysis recommended by the FDA. The safety profile of
enzalutamide was consistent with results of earlier enzalutamide
trials.
Pipeline Developments
A comprehensive update of Pfizer’s development pipeline was published
today and is now available at www.pfizer.com/pipeline.
It includes an overview of Pfizer’s research and a list of compounds in
development with targeted indication and phase of development, as well
as mechanism of action for candidates from Phase 2 through registration.
-
Avelumab (PF-06834635, MSB0010718C) — In October 2016, Merck
KGaA and Pfizer announced that the EMA has validated for review Merck
KGaA’s Marketing Authorization Application (MAA) for avelumab, for the
proposed indication of metastatic Merkel cell carcinoma (MCC), a rare
and aggressive skin cancer, which impacts approximately 2,500
Europeans a year. If approved, avelumab could be the first approved
treatment indicated for metastatic MCC in the EU. The avelumab
metastatic MCC MAA submission is supported by data from JAVELIN Merkel
200, a multicenter, single-arm, open-label, Phase 2 study of 88
patients with metastatic MCC whose disease had progressed after at
least one chemotherapy treatment. -
Bococizumab (PF-04950615, RN316) — Pfizer announced in
November 2016 the discontinuation of the global clinical development
program for bococizumab, its investigational Proprotein Convertase
Subtilisin Kexin type 9 inhibitor (PCSK9i). The totality of clinical
information now available for bococizumab, taken together with the
evolving treatment and market landscape for lipid-lowering agents,
indicates that bococizumab is not likely to provide value to patients,
physicians, or shareholders. As a result, Pfizer has decided to
discontinue the development program, including the two ongoing
cardiovascular outcome studies. -
Ertugliflozin (PF-04971729) — Pfizer and Merck/MSD announced
in September 2016 that a Phase 3 study (VERTIS SITA2) of
ertugliflozin, an investigational oral SGLT2 inhibitor for the
treatment of patients with type 2 diabetes, met its primary endpoint.
Both 5 mg and 15 mg daily doses of ertugliflozin showed significantly
greater reductions in A1C (an average measure of blood glucose over
the past two to three months) of 0.69% and 0.76%, respectively,
compared with placebo (p<0.001, for both comparisons), when added to
patients on a background of sitagliptin (100 mg/day) and stable
metformin (≥1500 mg/day). These study results were presented for the
first time during the 52nd Annual Meeting of the European
Association for the Study of Diabetes (EASD). Merck/MSD and Pfizer
plan to submit New Drug Applications to the FDA for ertugliflozin and
two fixed-dose combinations (ertugliflozin plus Januvia®(11) (sitagliptin)
and ertugliflozin plus metformin) by the end of 2016, with additional
regulatory submissions outside of the U.S. to follow in 2017. -
PF-04518600 — At ESMO 2016, Pfizer presented the latest
safety, anti-tumor activity and biomarker data from a first-in-human
single-agent study of investigational immunotherapy PF-04518600, an
OX40 agonist, in a variety of advanced cancers. Preliminary results
evaluating 25 patients suggest that PF-04518600 is tolerated up to 3
mg/kg and showed early anti-tumor activity. -
PF-06438179 (infliximab-Pfizer) — Pfizer announced in
September 2016 that the confirmatory study (REFLECTIONS B537-02)
evaluating the efficacy, safety, and immunogenicity of PF-06438179
(infliximab-Pfizer) compared to Remicade®(8) (infliximab)
met its primary endpoint. The trial demonstrated equivalent efficacy
of the proposed biosimilar PF-06438179 to the originator product as
measured by the American College of Rheumatology 20 (ACR20) response
at Week 14. PF-06438179 is being developed as a potential biosimilar
to Remicade®(8). In February 2016, Sandoz acquired the
rights from Pfizer for the development, commercialization and
manufacture of PF-06438179 in the 28 countries that form the European
Economic Area (EEA). Under the terms of the agreement, Pfizer retains
commercialization and manufacturing rights to PF-06438179 in countries
outside the EEA.
Corporate Developments
-
In October 2016, ICU Medical Inc. (ICU Medical) and Pfizer announced
that they entered into a definitive agreement under which ICU Medical
will acquire all of Pfizer’s global infusion therapy net assets,
Hospira Infusion Systems (HIS), for approximately $1 billion in cash
and ICU Medical stock. HIS includes IV pumps, solutions and devices.
Under the terms of the agreement, Pfizer will receive approximately
$400 million in newly issued shares of ICU Medical common stock and
$600 million in cash from ICU Medical, subject to customary
adjustments for net working capital. Upon completion of the
transaction, which the companies expect to occur in the first quarter
of 2017 subject to customary closing conditions including required
regulatory approvals, Pfizer will own approximately 16.6% of ICU
Medical. Pfizer has also agreed to certain restrictions on transfer of
its shares for at least 18 months. -
In September 2016, Pfizer announced the completion of its acquisition
of Medivation for approximately $14.3 billion in cash ($13.9 billion,
net of cash acquired). Pfizer continues to expect the transaction to
be immediately accretive to Adjusted Diluted EPS(2) by
approximately $0.05 in the first full year following the close, with
additional accretion and growth anticipated thereafter(12).
Medivation is now a wholly-owned subsidiary of Pfizer. -
In September 2016, Pfizer announced that, after an extensive
evaluation, the company’s Board of Directors and Executive Leadership
Team determined that Pfizer is best positioned to maximize future
shareholder value creation in its current structure and will not
pursue splitting Pfizer Innovative Health and Pfizer Essential Health
into two, separate publicly-traded companies at this time. Pfizer will
move forward with a focus on its strategic priorities to grow and
increase operational efficiency to be more competitive. -
In September 2016, Pfizer entered into an exclusive option and license
agreement with OncoImmune, Inc. (OncoImmune) for ONC-392, a novel,
potentially differentiated preclinical anti-CTLA4 monoclonal antibody
in a deal worth up to $250 million in upfront and potential milestone
payments. Under the terms of the agreement, Pfizer plans to evaluate
ONC-392 up until a certain agreed-upon time to determine whether it
will exercise its option to exclusively license ONC-392 as well as any
other OncoImmune anti-CTLA4 antibodies. If Pfizer exercises its option
under the agreement, Pfizer would be responsible for all development
and potential commercialization of the program, and OncoImmune would
be eligible to receive potential developmental and commercial
milestone payments as well as royalties, tiered from mid-single up to
low-double digits, on sales of any potential resulting products. -
Pfizer announced in August 2016 that it entered into an agreement with
AstraZeneca to acquire the development and commercialization rights to
its small molecule anti-infectives business, primarily outside the
U.S. The agreement includes the commercialization and development
rights to the newly approved EU drug ZaviceftaTM
(ceftazidime-avibactam), the marketed agents MerremTM/MeronemTM
(meropenem) and ZinforoTM (ceftaroline fosamil), and
the clinical development assets aztreonam-avibactam (ATM-AVI) and CXL
(ceftaroline fosamil-AVI). Under the terms of the agreement, Pfizer
will make an upfront payment of $550 million to AstraZeneca upon the
close of the transaction and a deferred payment of $175 million in
January 2019. In addition, AstraZeneca is eligible to receive up to
$250 million in milestone payments, up to $600 million in
sales-related payments, as well as tiered royalties on sales of
ZaviceftaTM and ATM-AVI in certain markets. The transaction
is expected to close in the fourth quarter of 2016, subject to
customary closing conditions, including antitrust clearance in certain
jurisdictions. -
In August 2016, Pfizer acquired all the remaining equity in Bamboo
Therapeutics, Inc. (Bamboo), a privately held biotechnology company,
focused on developing gene therapies for the potential treatment of
patients with certain rare diseases relating to neuromuscular
conditions and those affecting the central nervous system, for $150
million, plus potential milestone payments of up to $495 million
contingent upon the progression of key assets through development,
regulatory approval and commercialization. Pfizer previously purchased
a minority stake in Bamboo in the first quarter of 2016 for a payment
of approximately $43 million. This acquisition provides Pfizer with
several clinical and pre-clinical assets that complement its rare
disease portfolio, an advanced recombinant Adeno-Associated Virus
vector design and production technology, and a fully functional Phase
1/2 gene therapy manufacturing facility. Bamboo is now a wholly-owned
subsidiary of Pfizer.
Please find Pfizer’s press release and associated financial tables,
including reconciliations of certain GAAP reported to non-GAAP adjusted
information, at the following hyperlink:
http://www.pfizer.com/system/files/presentation/Q3_2016_PFE_Earnings_Press_Release_nafsdukf.pdf
(Note: If clicking on the above link does not open up a new web page,
you may need to cut and paste the above URL into your browser’s address
bar.)
For additional details, see the associated financial schedules and
product revenue tables attached to the press release located at the
hyperlink referred to above and the attached disclosure notice.
(1) |
Revenues is defined as revenues in accordance with U.S. generally accepted accounting principles (GAAP). Reported net income is defined as net income attributable to Pfizer Inc. in accordance with U.S. GAAP. Reported diluted earnings per share (EPS) is defined as reported diluted EPS attributable to Pfizer Inc. common shareholders in accordance with U.S. GAAP. |
|
(2) |
Adjusted income and its components and Adjusted diluted EPS are defined as reported U.S. GAAP net income(1) and its components and reported diluted EPS(1) excluding purchase accounting adjustments, acquisition-related costs, discontinued operations and certain significant items (some of which may recur, such as restructuring or legal charges, but which management does not believe are reflective of our ongoing core operations). Adjusted cost of sales, Adjusted selling, informational and administrative (SI&A) expenses, Adjusted research and development (R&D) expenses and Adjusted other (income)/deductions are income statement line items prepared on the same basis as, and therefore components of, the overall Adjusted income measure. As described in the Management’s Discussion and Analysis of Financial Condition and Results of Operations––Non-GAAP Financial Measure (Adjusted Income) section of Pfizer’s Quarterly Report on Form 10-Q for the fiscal quarter ended July 3, 2016, management uses Adjusted income, among other factors, to set performance goals and to measure the performance of the overall company. Because Adjusted income is an important internal measurement for Pfizer, we believe that investors’ understanding of our performance is enhanced by disclosing this performance measure. We report Adjusted income, and certain components of Adjusted income, in order to portray the results of our major operations––the discovery, development, manufacture, marketing and sale of prescription medicines, vaccines, medical devices and consumer healthcare (OTC) products––prior to considering certain income statement elements. See the accompanying reconciliations of certain GAAP Reported to Non-GAAP Adjusted information for the third quarter and first nine months of 2016 and 2015. The Adjusted income and its components and Adjusted diluted EPS measures are not, and should not be viewed as, substitutes for U.S. GAAP net income and its components and diluted EPS. |
|
(3) |
Pfizer’s fiscal year-end for international subsidiaries is November 30 while Pfizer’s fiscal year-end for U.S. subsidiaries is December 31. Therefore, in accordance with Pfizer’s domestic and international reporting periods, Pfizer’s consolidated financial statements for the three and nine months ended September 27, 2015 reflect only one month of legacy Hospira U.S. operations but no financial results from legacy Hospira international operations. |
|
(4) |
Effective in second-quarter 2016, Pfizer’s operating structure was |
|
(5) |
Effective as of the beginning of 2016, Pfizer’s entire contract manufacturing business, Pfizer CentreOne, is now part of Pfizer Essential Health. Pfizer CentreOne consists of (i) legacy Pfizer’s contract manufacturing and active pharmaceutical ingredient sales operation, including manufacturing and supply agreements with Zoetis Inc. (previously known as Pfizer CentreSource or PCS); and (ii) legacy Hospira’s One-2-One sterile injectables contract manufacturing operation. Prior to 2016, PCS was managed outside of Pfizer’s operating segments and its revenues were reported as other business activities. Prior period PCS operating results have been reclassified to conform to the current period presentation as part of Essential Health. |
|
(6) |
References to operational variances in this press release pertain to period-over-period growth rates that exclude the impact of foreign exchange as well as the negative currency impact related to Venezuela. The operational variances are determined by multiplying or dividing, as appropriate, our current year U.S. dollar results by the current year average foreign exchange rates and then multiplying or dividing, as appropriate, those amounts by the prior-year average foreign exchange rates. We believe presenting these operational variances provides useful information in evaluating the results of our business because exchange rate changes, while part of our ongoing business, can mask positive or negative trends in the business and are not within our control. |
|
(7) | The 2016 financial guidance reflects the following: |
-
Pfizer does not provide guidance for GAAP Reported financial measures
(other than Revenues) or a reconciliation of forward-looking non-GAAP
financial measures to the most directly comparable GAAP Reported
financial measures on a forward-looking basis because it is unable to
predict with reasonable certainty the ultimate outcome of pending
litigation, unusual gains and losses, acquisition-related expenses and
potential future asset impairments without unreasonable effort. These
items are uncertain, depend on various factors, and could have a
material impact on GAAP Reported results for the guidance period. -
Does not assume the completion of any business development
transactions not completed as of October 2, 2016, including any
one-time upfront payments associated with such transactions. -
Exchange rates assumed are a blend of the actual exchange rates in
effect through third-quarter 2016 and mid-October 2016 exchange rates
for the remainder of the year. -
Guidance for 2016 revenues reflects the anticipated negative impact of
$1.8 billion due to recent and expected generic competition for
certain products that have recently lost or are anticipated to soon
lose patent protection. -
Guidance for 2016 revenues also reflects the anticipated negative
impact of $1.4 billion as a result of unfavorable changes in foreign
exchange rates relative to the U.S. dollar compared to foreign
exchange rates from 2015, including $0.8 billion due to the estimated
significant negative currency impact related to Venezuela. The
anticipated negative impact on adjusted diluted EPS(2)
resulting from unfavorable changes in foreign exchange rates compared
to foreign exchange rates from 2015 is approximately $0.20, including
$0.08 due to the estimated significant negative currency impact
related to Venezuela. -
Guidance for adjusted diluted EPS(2) assumes diluted
weighted-average shares outstanding of approximately 6.2 billion
shares.
(8) |
Remicade® is a registered U.S. trademark of Janssen Biotech, Inc. |
|
(9) | The following are certain product categories within Essential Health: |
-
Sterile Injectable Pharmaceuticals include generic injectables and
proprietary specialty injectables (excluding Peri-LOE Products). -
Peri-LOE Products include products that have recently lost or are
anticipated to soon lose patent protection. These products primarily
include Lyrica in certain developed Europe markets, Pristiq globally,
Celebrex, Zyvox and Revatio in most developed markets, Vfend and
Viagra in certain developed Europe markets and Japan, and Inspra in
the EU. -
Legacy Established Products include products that have lost patent
protection (excluding Sterile Injectable Pharmaceuticals and Peri-LOE
Products).
Definitions for all Essential Health product categories can be found in
the footnotes to the product revenue tables on page 36 of the press
release located at the hyperlink above.
(10) |
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. |
|
(11) |
Januvia® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. |
|
(12) |
Pfizer calculates projections regarding the expected accretive impact of the acquisition based on internal forecasts of Adjusted Diluted EPS(2). These accretion projections should not be considered a substitute for GAAP measures. The determinations of the amounts that are excluded from the accretion calculations are a matter of management judgment and depend upon, among other factors, the nature of the underlying expense or income amounts. Pfizer is unable to present quantitative reconciliations because management cannot reasonably predict with sufficient reliability all of the necessary components of the comparable GAAP measure. Pfizer has excluded from the accretion calculations the impact of purchase accounting adjustments, acquisition-related costs, discontinued operations and certain significant items. Such items can have a substantial impact on GAAP measures of financial performance. |
DISCLOSURE NOTICE: Except where otherwise noted, the information
contained in this earnings release and the related attachments is as of
November 1, 2016. We assume no obligation to update any forward-looking
statements contained in this earnings release and the related
attachments as a result of new information or future events or
developments.
This earnings release and the related attachments contain
forward-looking statements about our anticipated future operating and
financial performance, business plans and prospects, in-line products
and product candidates, strategic reviews, capital allocation,
business-development plans, the benefits expected from our acquisitions
of Hospira, Inc. (Hospira), Anacor Pharmaceuticals, Inc. (Anacor) and
Medivation, Inc. (Medivation) and our pending acquisition of
AstraZeneca’s small molecule anti-infectives business, and plans
relating to share repurchases and dividends, among other things, that
involve substantial risks and uncertainties. You can identify these
statements by the fact that they use future dates or use words such as
“will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,”
“expect,” “project,” “intend,” “plan,” “believe,” “target,” “forecast,”
“goal,” “objective,” “aim” and other words and terms of similar meaning.
Among the factors that could cause actual results to differ materially
from past results and future plans and projected future results are the
following:
-
the outcome of research and development activities, including, without
limitation, the ability to meet anticipated pre-clinical and clinical
trial commencement and completion dates, regulatory submission and
approval dates, and launch dates for product candidates, as well as
the possibility of unfavorable pre-clinical and clinical trial
results, including unfavorable new clinical data and additional
analyses of existing clinical data; -
decisions by regulatory authorities regarding whether and when to
approve our drug applications, which will depend on the assessment by
such regulatory authorities of the benefit-risk profile suggested by
the totality of the efficacy and safety information submitted;
decisions by regulatory authorities regarding labeling, ingredients
and other matters that could affect the availability or commercial
potential of our products; and uncertainties regarding our ability to
address the comments in complete response letters received by us with
respect to certain of our drug applications to the satisfaction of the
FDA; -
the speed with which regulatory authorizations, pricing approvals and
product launches may be achieved; -
the outcome of post-approval clinical trials, which could result in
the loss of marketing approval for a product or changes in the
labeling for, and/or increased or new concerns about the safety or
efficacy of, a product that could affect its availability or
commercial potential; -
risks associated with interim data, including the risk that final
results of studies for which interim data have been provided and/or
additional clinical trials may be different from (including less
favorable than) the interim data results and may not support further
clinical development of the applicable product candidate or indication; -
the success of external business-development activities, including the
ability to satisfy the conditions to closing of announced transactions
in the anticipated time frame or at all, including our ability and the
ability of ICU Medical, Inc. (ICU) and AstraZeneca to satisfy the
conditions to closing the sale of our Hospira infusion systems net
assets to ICU, and the acquisition of the small molecule
anti-infective business from AstraZeneca, respectively; -
competitive developments, including the impact on our competitive
position of new product entrants, in-line branded products, generic
products, private label products and product candidates that treat
diseases and conditions similar to those treated by our in-line drugs
and drug candidates; -
the implementation by the FDA and regulatory authorities in certain
other countries of an abbreviated legal pathway to approve biosimilar
products, which could subject our biologic products to competition
from biosimilar products, with attendant competitive pressures, after
the expiration of any applicable exclusivity period and patent rights; -
risks related to our ability to develop and launch biosimilars,
including risks associated with « at risk » launches, defined as the
marketing of a product by Pfizer before the final resolution of
litigation (including any appeals) brought by a third party alleging
that such marketing would infringe one or more patents owned or
controlled by the third party; -
the ability to meet generic and branded competition after the loss of
patent protection for our products or competitor products; -
the ability to successfully market both new and existing products
domestically and internationally; - difficulties or delays in manufacturing;
- trade buying patterns;
-
the impact of existing and future legislation and regulatory
provisions on product exclusivity; - trends toward managed care and healthcare cost containment;
-
the impact of any significant spending reductions or cost controls
affecting Medicare, Medicaid or other publicly funded or subsidized
health programs or changes in the tax treatment of employer-sponsored
health insurance that may be implemented, and/or any significant
additional taxes or fees that may be imposed on the pharmaceutical
industry as part of any broad deficit-reduction effort; -
the impact of U.S. healthcare legislation enacted in 2010—the Patient
Protection and Affordable Care Act, as amended by the Health Care and
Education Reconciliation Act—and of any modification, repeal or
invalidation of any of the provisions thereof; -
U.S. federal or state legislation or regulatory action affecting,
among other things, pharmaceutical product pricing, reimbursement or
access, including under Medicaid, Medicare and other publicly funded
or subsidized health programs; the importation of prescription drugs
from outside the U.S. at prices that are regulated by governments of
various foreign countries; restrictions on direct-to-consumer
advertising; limitations on interactions with healthcare
professionals; or the use of comparative effectiveness methodologies
that could be implemented in a manner that focuses primarily on the
cost differences and minimizes the therapeutic differences among
pharmaceutical products and restricts access to innovative medicines;
as well as pricing pressures for our products as a result of highly
competitive insurance markets; -
legislation or regulatory action in markets outside the U.S. affecting
pharmaceutical product pricing, reimbursement or access, including, in
particular, continued government-mandated reductions in prices and
access restrictions for certain biopharmaceutical products to control
costs in those markets; -
the exposure of our operations outside the U.S. to possible capital
and exchange controls, expropriation and other restrictive government
actions, changes in intellectual property legal protections and
remedies, as well as political unrest, unstable governments and legal
systems and inter-governmental disputes; - contingencies related to actual or alleged environmental contamination;
-
claims and concerns that may arise regarding the safety or efficacy of
in-line products and product candidates; -
any significant breakdown, infiltration or interruption of our
information technology systems and infrastructure; -
legal defense costs, insurance expenses, settlement costs, the risk of
an adverse decision or settlement and the adequacy of reserves related
to product liability, patent matters, government investigations,
consumer, commercial, securities, antitrust, environmental,
employment, tax issues, ongoing efforts to explore various means for
resolving asbestos litigation, and other legal proceedings; -
our ability to protect our patents and other intellectual property,
both domestically and internationally; -
interest rate and foreign currency exchange rate fluctuations,
including the impact of possible currency devaluations in countries
experiencing high inflation rates and the volatility following the
United Kingdom (U.K.) referendum in which voters approved an exit from
the EU; -
governmental laws and regulations affecting domestic and foreign
operations, including, without limitation, tax obligations and changes
affecting the tax treatment by the U.S. of income earned outside the
U.S. that may result from pending and possible future proposals; -
the end result of any negotiations between the U.K. government and the
EU regarding the terms of the U.K.’s exit from the EU, which could
have implications on our research, commercial and general business
operations in the U.K.; -
any significant issues involving our largest wholesaler customers,
which account for a substantial portion of our revenues; -
the possible impact of the increased presence of counterfeit medicines
in the pharmaceutical supply chain on our revenues and on patient
confidence in the integrity of our medicines; -
any significant issues that may arise related to the outsourcing of
certain operational and staff functions to third parties, including
with regard to quality, timeliness and compliance with applicable
legal requirements and industry standards; -
any significant issues that may arise related to our joint ventures
and other third-party business arrangements; - changes in U.S. generally accepted accounting principles;
-
uncertainties related to general economic, political, business,
industry, regulatory and market conditions including, without
limitation, uncertainties related to the impact on us, our customers,
suppliers and lenders and counterparties to our foreign-exchange and
interest-rate agreements of challenging global economic conditions and
recent and possible future changes in global financial markets; and
the related risk that our allowance for doubtful accounts may not be
adequate; -
any changes in business, political and economic conditions due to
actual or threatened terrorist activity in the U.S. and other parts of
the world, and related U.S. military action overseas; - growth in costs and expenses;
- changes in our product, segment and geographic mix;
-
the impact of purchase accounting adjustments, acquisition-related
costs, discontinued operations and certain significant items; -
the impact of acquisitions, divestitures, restructurings, internal
reorganizations, product recalls, withdrawals and other unusual items,
including our ability to realize the projected benefits of our
cost-reduction and productivity initiatives, including those related
to our research and development organization, and of the internal
separation of our commercial operations into our current operating
structure; -
the risk of an impairment charge related to our intangible assets,
goodwill or equity-method investments; - risks related to internal control over financial reporting; and
-
risks and uncertainties related to our recent acquisitions of Hospira,
Anacor and Medivation, including, among other things, the ability to
realize the anticipated benefits of the acquisitions of Hospira,
Anacor and Medivation, including the possibility that expected cost
savings related to the acquisition of Hospira and accretion related to
the acquisitions of Hospira, Anacor and Medivation will not be
realized or will not be realized within the expected time frame; the
risk that the businesses will not be integrated successfully;
disruption from the transactions making it more difficult to maintain
business and operational relationships; significant transaction costs;
and unknown liabilities.
We cannot guarantee that any forward-looking statement will be realized,
although we believe we have been prudent in our plans and assumptions.
Achievement of anticipated results is subject to substantial risks,
uncertainties and inaccurate assumptions. Should known or unknown risks
or uncertainties materialize or should underlying assumptions prove
inaccurate, actual results could vary materially from past results and
those anticipated, estimated or projected. Investors should bear this in
mind as they consider forward-looking statements, and are cautioned not
to put undue reliance on forward-looking statements. A further list and
description of risks, uncertainties and other matters can be found in
our Annual Report on Form 10-K for the fiscal year ended December 31,
2015 and in our subsequent 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 subsequent reports on Form 8-K.
The operating segment information provided in this earnings release and
the related attachments does not purport to represent the revenues,
costs and income from continuing operations before provision for taxes
on income that each of our operating segments would have recorded had
each segment operated as a standalone company during the periods
presented.
This earnings release may include discussion of certain clinical studies
relating to various in-line products and/or product candidates. These
studies typically are part of a larger body of clinical data relating to
such products or product candidates, and the discussion herein should be
considered in the context of the larger body of data. In addition,
clinical trial data are subject to differing interpretations, and, even
when we view data as sufficient to support the safety and/or
effectiveness of a product candidate or a new indication for an in-line
product, regulatory authorities may not share our views and may require
additional data or may deny approval altogether.
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Contacts
Pfizer Inc.
Media
Joan Campion,
212-733-2798
or
Investors
Chuck
Triano 212-733-3901
Ryan Crowe 212-733-8160
Bryan Dunn
212-733-8917
Source: Pfizer Inc.
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