PFIZER, INC. Item 7.01 Regulation FD Disclosure
During the 39th Annual
Based on a preliminary view, the Company projects 2021 adjusted diluted earnings
per share (EPS)* in a range of
This preliminary financial guidance is subject to a number of assumptions,
factors and uncertainties, including, among others, the Company's current
expectations and assumptions regarding the impact of the COVID-19 pandemic and
COVID-19 vaccine supply and contracts, which remain dynamic. The Company expects
to provide further details when it issues its financial guidance in connection
with its press release announcing its financial results for the fourth quarter
of 2020 on
* Adjusted income and its components and adjusted diluted EPS are defined as
reported
The information contained in Item 7.01 of this Current Report on Form 8-K is
being furnished pursuant to Item 7.01 of Form 8-K and shall not be deemed
"filed" for purposes of Section 18 of the
Forward-Looking Statements
Except where otherwise noted, the information contained in this Current Report
on Form 8-K is as of
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This Current Report on Form 8-K contains forward-looking statements about our anticipated future financial performance 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," "assume," "target," "forecast," "guidance," "goal," "objective," "aim," "seek" 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, the
ability to meet anticipated pre-clinical or clinical endpoints,
commencement and/or completion dates for our pre-clinical or clinical
trials, regulatory submission dates, and/or regulatory approval and/or
launch dates, as well as the possibility of unfavorable pre-clinical and
clinical trial results, including the possibility of unfavorable new
clinical data and further analyses of existing clinical data;
• our ability to successfully address comments received from regulatory
authorities such as the U.S. Food and Drug Administration or the Europe
Medicines Agency , or obtain approval from regulators on a timely basis or
at all; regulatory decisions impacting labeling, manufacturing processes,
safety and/or other matters; the impact of recommendations by technical
or advisory committees; and the timing of pricing approvals and product
launches;
• claims and concerns that may arise regarding the safety or efficacy of
in-line products and product candidates, including claims and concerns
that may arise from the outcome of post-approval clinical trials, which
could impact marketing approval, product labeling, and/or availability or
commercial potential;
• the success and impact of external business-development activities,
including the ability to identify and execute on potential business
development opportunities; the ability to satisfy the conditions to
closing of announced transactions in the anticipated time frame or at
all; the ability to realize the anticipated benefits of any such
transactions in the anticipated time frame or at all; the potential need
for and impact of additional equity or debt financing to pursue these
opportunities; challenges integrating the businesses and operations;
disruption to business and operations relationships; risks related to
growing revenues for certain acquired products; significant transaction
costs; and unknown liabilities;
• competition, including from new product entrants, in-line branded
products, generic products, private label products, biosimilars and
product candidates that treat diseases and conditions similar to those
treated by our in-line drugs and drug candidates;
• the ability to successfully market both new and existing products,
including biosimilars;
• difficulties or delays in manufacturing, sales or marketing; supply
disruptions, shortages or stock-outs at our facilities; and legal or
regulatory actions;
• the impact of public health outbreaks, epidemics or pandemics (such as
the novel coronavirus disease of 2019 (COVID-19) pandemic) on our
business, operations and financial condition and results;
• risks and uncertainties related to our efforts to develop a vaccine and
potential treatment for COVID-19, as well as challenges related to their
manufacturing and supply, including among others, the uncertainties
inherent in research and development, including the ability to meet
anticipated clinical endpoints, commencement and/or completion dates for
clinical trials, regulatory submission dates, regulatory approval dates
and/or launch dates, as well as risks associated with clinical data
(including the Phase 3 data for the Pfizer-BioNTech COVID-19 vaccine
(BNT162b2)), including the possibility of unfavorable new preclinical or
clinical trial data and further analyses of existing preclinical or
clinical trial data; the ability to produce comparable clinical or other
results, including the rate of vaccine effectiveness and safety and
tolerability profile observed to date, in additional analyses of the
Phase 3 trial and additional studies or in larger, more diverse
populations upon commercialization; the ability of BNT162b2 to prevent
COVID-19 caused by new virus variants; the risk that more widespread use
of the vaccine will lead to new information about efficacy, safety, or
other developments, including the risk of additional adverse reactions,
some of which may be serious; the risk that clinical trial data are
subject to differing interpretations and assessments, including during
the peer review/publication process, in the scientific community
generally, and by regulatory authorities; whether and when additional
data from the BNT162 mRNA vaccine program will be published in scientific
journal publications and, if so, when and with what modifications;
whether regulatory authorities will be satisfied with the design of and
results from these and any future preclinical
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and clinical studies; when other biologics license and/or emergency use
authorization applications may be filed in particular jurisdictions for
BNT162b2 or any other potential vaccines; whether and when any other
applications that may be pending or filed for BNT162b2 may be approved by
particular regulatory authorities, which will depend on myriad factors,
including making a determination as to whether the vaccine's benefits
outweigh its known risks and determination of the vaccine's efficacy and,
if approved, whether it will be commercially successful; decisions by
regulatory authorities impacting labeling, manufacturing processes,
safety and/or other matters that could affect the availability or
commercial potential of a vaccine, including development of products or
therapies by other companies; disruptions in the relationships between us
and our collaboration partners or third-party suppliers; the risk that
other companies may produce superior or competitive products; the risk
that demand for any products may no longer exist; risks related to the
availability of raw materials to manufacture a vaccine; challenges
related to our vaccine's ultra-low temperature formulation and attendant
storage, distribution and administration requirements, including risks
related to handling after delivery by Pfizer ; the risk that we may not be
able to successfully develop non-frozen formulations; the risk that we
may not be able to create or scale up manufacturing capacity on a timely
basis or have access to logistics or supply channels commensurate with
global demand for our vaccine, which would negatively impact our ability
to supply the estimated numbers of doses of our vaccine within the
projected time periods indicated; whether and when additional supply
agreements will be reached; uncertainties regarding the ability to obtain
recommendations from vaccine technical committees and other public health
authorities and uncertainties regarding the commercial impact of any such
recommendations; and competitive developments;
• trends toward managed care and healthcare cost containment, and our
ability to obtain or maintain timely or adequate pricing or favorable
formulary placement for our products;
• the impact of any U.S. healthcare reform or legislation or 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;
• U.S. federal or state legislation or regulatory action and/or policy
efforts affecting, among other things, pharmaceutical product pricing,
intellectual property, reimbursement or access or restrictions on U.S.
direct-to-consumer advertising; limitations on interactions with
healthcare professionals; as well as pricing pressures for our products
as a result of highly competitive insurance markets;
• legislation or regulatory action in markets outside of the U.S. ,
including China , affecting pharmaceutical product pricing, intellectual
property, 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 of the U.S. to possible capital
and exchange controls, economic conditions, 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;
• legal defense costs, insurance expenses, settlement costs and
contingencies, including those related to actual or alleged environmental
contamination;
• the risk and impact of an adverse decision or settlement and the adequacy
of reserves related to legal proceedings;
• the risk and impact of tax related litigation;
• any significant breakdown, infiltration or interruption of our
information technology systems and infrastructure;
• the risk that our currently pending or future patent applications may not
be granted on a timely basis or at all, or any patent-term extensions
that we seek may not be granted on a timely basis, if at all;
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• our ability to protect our patents and other intellectual property,
including against claims of invalidity that could result in loss of
exclusivity and in response to any pressure, or legal or regulatory
action by, various stakeholders or governments that could potentially
result in us not seeking intellectual property protection for, or
agreeing not to enforce intellectual property related to, our medicines,
including potential vaccines and treatments for COVID-19;
• interest rate and foreign currency exchange rate fluctuations, including
the impact of possible currency devaluations in countries experiencing
high inflation rates;
• governmental laws and regulations affecting our operations, including,
without limitation, tax obligations and changes affecting the tax
treatment by the U.S. of income earned outside of the U.S. that may
result from pending and possible future proposals, as well as further
clarifications and/or interpretations of, or changes to, existing laws
and regulations, including the U.S. Tax Cuts and Jobs Act of 2017;
• any significant issues involving our largest wholesale distributors,
which account for a substantial portion of our revenues;
• the impact of the increased presence of counterfeit medicines in the
pharmaceutical supply chain;
• any significant issues related to the outsourcing of certain operational
and staff functions to third parties; and any significant issues related
to our joint ventures and other third-party business arrangements;
• 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;
• any changes in business, political and economic conditions due to actual
or threatened terrorist activity, civil unrest or military action;
• the impact of product recalls, withdrawals and other unusual items;
• trade buying patterns;
• the risk of an impairment charge related to our intangible assets,
goodwill or equity-method investments; and
• the impact of, and risks and uncertainties related to, restructurings and
internal reorganizations, as well as any other corporate strategic
initiatives, and cost-reduction and productivity initiatives, each of
which requires upfront costs but may fail to yield anticipated benefits
and may result in unexpected costs or organizational disruption.
We cannot guarantee that any forward-looking statement will be realized. 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 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
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