Philip Morris International Announces Collaboration with KT&G on U.S. Regulatory Submissions for KT&G’s New Heat-Not-Burn Products
30 Luglio 2024 - 12:00PM
Business Wire
Regulatory News:
Philip Morris International Inc. (PMI) (NYSE: PM) announces a
memorandum of understanding with KT&G, South Korea’s leading
manufacturer of tobacco and nicotine products.
Both PMI and KT&G recognize the importance of the U.S.
market to advance their shared strategic vision of a smoke-free
future. Following the companies’ announcement on January 30, 2023,
of an agreement providing exclusive rights for PMI to commercialize
KT&G’s innovative smoke-free products in markets outside South
Korea, this non-binding memorandum establishes the parties’ intent
to collaborate on regulatory submissions for those new KT&G
heat-not-burn products that PMI selects to commercialize in the
U.S.
KT&G’s new platform products are expected to be launched
first outside the U.S. Thereafter, the partners plan to work on a
Pre-Market Tobacco Product Application (PMTA) submission for review
by the U.S. Food and Drug Administration (U.S. FDA), in accordance
with the memorandum.
“We want every adult smoker who does not quit smoking to switch
to a science-backed, better alternative, for the benefit of their
own and public health. The heat-not-burn category, with different
tiers of FDA-authorized products, has a pivotal role to play in
making cigarettes obsolete in the U.S.,” said Jacek Olczak, PMI’s
Chief Executive Officer.
Philip Morris International: Delivering a Smoke-Free
Future
Philip Morris International (PMI) is a leading international
tobacco company, actively delivering a smoke-free future and
evolving its portfolio for the long term to include products
outside of the tobacco and nicotine sector. The company’s current
product portfolio primarily consists of cigarettes and smoke-free
products. Since 2008, PMI has invested over $12.5 billion to
develop, scientifically substantiate and commercialize innovative
smoke-free products for adults who would otherwise continue to
smoke, with the goal of completely ending the sale of cigarettes.
This includes the building of world-class scientific assessment
capabilities, notably in the areas of pre-clinical systems
toxicology, clinical and behavioral research, as well as
post-market studies. In 2022, PMI acquired Swedish Match – a leader
in oral nicotine delivery – creating a global smoke-free champion
led by the companies’ IQOS and ZYN brands. The U.S. Food and Drug
Administration has authorized versions of PMI’s IQOS devices and
consumables and Swedish Match’s General snus as Modified Risk
Tobacco Products and renewal applications for these products are
presently pending before the FDA. As of June 30, 2024, PMI's
smoke-free products were available for sale in 90 markets, and PMI
estimates that 36.5 million adults around the world use PMI's
smoke-free products. Smoke-free business accounted for
approximately 38% of PMI’s total first-half 2024 net revenues. With
a strong foundation and significant expertise in life sciences, PMI
announced in February 2021 its ambition to expand into wellness and
healthcare areas and, through its Vectura Fertin Pharma business,
aims to enhance life through the delivery of seamless health
experiences. For more information, please visit www.pmi.com and
www.pmiscience.com.
Forward-Looking and Cautionary Statements
This press release contains projections of future results and
goals and other forward-looking statements, including statements
regarding expected financial or operational performance; capital
allocation plans; investment strategies; regulatory outcomes;
market expectations; and business plans and strategies. Achievement
of future results is subject to risks, uncertainties and inaccurate
assumptions. In the event that risks or uncertainties materialize,
or underlying assumptions prove inaccurate, actual results could
vary materially from those contained in such forward-looking
statements. Pursuant to the “safe harbor” provisions of the Private
Securities Litigation Reform Act of 1995, PMI is identifying
important factors that, individually or in the aggregate, could
cause actual results and outcomes to differ materially from those
contained in any forward-looking statements made by PMI.
PMI's business risks include: excise tax increases and
discriminatory tax structures; increasing marketing and regulatory
restrictions that could reduce our competitiveness, eliminate our
ability to communicate with adult consumers, or ban certain of our
products in certain markets or countries; health concerns relating
to the use of tobacco and other nicotine-containing products and
exposure to environmental tobacco smoke; litigation related to
tobacco and/or nicotine use and intellectual property; intense
competition; the effects of global and individual country economic,
regulatory and political developments, natural disasters and
conflicts; the impact and consequences of Russia's invasion of
Ukraine; changes in adult smoker behavior; the impact of natural
disasters and pandemics on PMI's business; lost revenues as a
result of counterfeiting, contraband and cross-border purchases;
governmental investigations; unfavorable currency exchange rates
and currency devaluations, and limitations on the ability to
repatriate funds; adverse changes in applicable corporate tax laws;
adverse changes in the cost, availability, and quality of tobacco
and other agricultural products and raw materials, as well as
components and materials for our electronic devices; and the
integrity of its information systems and effectiveness of its data
privacy policies. PMI's future profitability may also be adversely
affected should it be unsuccessful in its attempts to introduce,
commercialize, and grow smoke-free products or if regulation or
taxation do not differentiate between such products and cigarettes;
if it is unable to successfully introduce new products, promote
brand equity, enter new markets or improve its margins through
increased prices and productivity gains; if it is unable to expand
its brand portfolio internally or through acquisitions and the
development of strategic business relationships; if it is unable to
attract and retain the best global talent, including women or
diverse candidates; or if it is unable to successfully integrate
and realize the expected benefits from recent transactions and
acquisitions. Future results are also subject to the lower
predictability of our smoke-free products performance.
PMI is further subject to other risks detailed from time to time
in its publicly filed documents, including PMI's Annual Report on
Form 10-K for the fourth quarter and year ended December 31, 2023,
and the Quarterly Report on Form 10-Q for the second quarter ended
June 30, 2024. PMI cautions that the foregoing list of important
factors is not a complete discussion of all potential risks and
uncertainties. PMI does not undertake to update any forward-looking
statement that it may make from time to time, except in the normal
course of its public disclosure obligations.
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Philip Morris International Investor Relations: Stamford,
CT: +1 (203) 904 2410 Lausanne: +41 582 424 666 Email:
InvestorRelations@pmi.com
Media: David Fraser Lausanne: +41 582 425 500 Email:
David.Fraser@pmi.com
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