Philip Morris International Announces Collaboration with KT&G on U.S. Regulatory Submissions for KT&G’s New Heat-Not-Burn Products
Philip Morris International (PMI) has announced a memorandum of understanding with KT&G, South Korea's leading tobacco and nicotine product manufacturer. This collaboration aims to advance their shared vision of a smoke-free future, focusing on the U.S. market. The agreement follows a previous arrangement granting PMI exclusive rights to commercialize KT&G's smoke-free products globally, excluding South Korea.
The partners plan to work on Pre-Market Tobacco Product Application (PMTA) submissions for KT&G's new heat-not-burn products selected by PMI for U.S. commercialization. PMI's CEO, Jacek Olczak, emphasized the importance of the heat-not-burn category in making cigarettes obsolete in the U.S. As of June 30, 2024, PMI's smoke-free products were available in 90 markets, with an estimated 36.5 million adult users worldwide. Smoke-free business accounted for approximately 38% of PMI's total first-half 2024 net revenues.
Philip Morris International (PMI) ha annunciato un memorandum d'intesa con KT&G, il principale produttore di tabacco e prodotti a base di nicotina della Corea del Sud. Questa collaborazione ha l'obiettivo di promuovere una visione condivisa di un futuro senza fumo, con un focus sul mercato statunitense. L'accordo segue un'intesa precedente che conferiva a PMI diritti esclusivi per commercializzare i prodotti senza fumo di KT&G a livello globale, escludendo la Corea del Sud.
I partner pianificano di lavorare sulle domande di prodotto per tabacco pre-mercato (PMTA) per i nuovi prodotti heat-not-burn di KT&G selezionati da PMI per la commercializzazione negli Stati Uniti. Il CEO di PMI, Jacek Olczak, ha sottolineato l'importanza della categoria heat-not-burn per rendere obsoleti i sigarette negli Stati Uniti. A partire dal 30 giugno 2024, i prodotti senza fumo di PMI erano disponibili in 90 mercati, con circa 36,5 milioni di utenti adulti nel mondo. Il segmento senza fumo ha rappresentato circa il 38% dei ricavi netti totali di PMI nel primo semestre del 2024.
Philip Morris International (PMI) ha anunciado un memorándum de entendimiento con KT&G, el principal fabricante de productos de tabaco y nicotina de Corea del Sur. Esta colaboración tiene como objetivo avanzar en su visión compartida de un futuro sin humo, centrándose en el mercado estadounidense. El acuerdo sigue a un arreglo anterior que otorgó a PMI derechos exclusivos para comercializar los productos sin humo de KT&G a nivel mundial, excluyendo Corea del Sur.
Los socios planean trabajar en las solicitudes de productos de tabaco pre-comercialización (PMTA) para los nuevos productos de calentamiento sin quemar de KT&G seleccionados por PMI para su comercialización en EE. UU. El CEO de PMI, Jacek Olczak, enfatizó la importancia de la categoría de calentamiento sin quemar para reemplazar los cigarrillos en EE. UU. Hasta el 30 de junio de 2024, los productos sin humo de PMI estaban disponibles en 90 mercados, con aproximadamente 36.5 millones de usuarios adultos en todo el mundo. El negocio sin humo representó aproximadamente el 38% de los ingresos netos totales de PMI en la primera mitad de 2024.
필립 모리스 인터내셔널 (PMI)는 한국의 선두 담배 및 니코틴 제품 제조업체인 KT&G와의 양해각서를 발표했습니다. 이 협력은 미국 시장에 초점을 맞춰 담배 없는 미래에 대한 공유 비전을 발전시키는 것을 목표로 하고 있습니다. 이 협정은 PMI에게 KT&G의 무연 제품을 한국을 제외한 전 세계에서 독점적으로 상업화할 수 있는 권리를 부여하는 이전 합의에 이어서 체결되었습니다.
파트너들은 PMI가 미국에서 상업화하기 위해 선정한 KT&G의 새로운 가열 비연소 제품에 대한 사전 시장 담배 제품 신청서 (PMTA) 제출 작업을 진행할 계획입니다. PMI의 CEO인 야첵 올차크는 미국에서 담배를 대체하는 데 있어 가열 비연소 카테고리의 중요성을 강조했습니다. 2024년 6월 30일 기준으로 PMI의 무연 제품은 90개 시장에서 판매되고 있으며, 전 세계적으로 약 3650만 명의 성인 사용자가 있습니다. 무연 사업은 PMI의 2024년 상반기 총 순수익의 약 38%를 차지했습니다.
Philip Morris International (PMI) a annoncé un protocole d'accord avec KT&G, le principal fabricant de produits du tabac et de nicotine en Corée du Sud. Cette collaboration vise à faire progresser leur vision commune d'un avenir sans fumée, en mettant l'accent sur le marché américain. L'accord fait suite à un arrangement précédent accordant à PMI des droits exclusifs pour commercialiser les produits sans fumée de KT&G à l'échelle mondiale, à l'exclusion de la Corée du Sud.
Les partenaires prévoient de travailler sur les demandes de produits du tabac avant mise sur le marché (PMTA) pour les nouveaux produits de chauffe non brûlants de KT&G sélectionnés par PMI pour la commercialisation aux États-Unis. Le PDG de PMI, Jacek Olczak, a souligné l'importance de la catégorie des produits de chauffage sans combustion pour rendre les cigarettes obsolètes aux États-Unis. Au 30 juin 2024, les produits sans fumée de PMI étaient disponibles sur 90 marchés, avec environ 36,5 millions d'utilisateurs adultes dans le monde. L'activité sans fumée représentait environ 38 % des revenus nets totaux de PMI au premier semestre 2024.
Philip Morris International (PMI) hat ein Memorandum of Understanding mit KT&G, dem führenden Hersteller von Tabak- und Nikotinprodukten in Südkorea, angekündigt. Diese Zusammenarbeit zielt darauf ab, ihre gemeinsame Vision einer rauchfreien Zukunft voranzutreiben, wobei der Fokus auf dem US-Markt liegt. Die Vereinbarung folgt einem früheren Arrangement, das PMI die exklusiven Rechte einräumt, die rauchfreien Produkte von KT&G weltweit zu vermarkten, mit Ausnahme von Südkorea.
Die Partner planen, an Vorab-Anträgen für Tabakprodukte (PMTA) für die neuen erhitzten, nicht brennbaren Produkte von KT&G zu arbeiten, die von PMI für die Vermarktung in den USA ausgewählt wurden. Der CEO von PMI, Jacek Olczak, betonte die Bedeutung der Kategorie der nicht brennbaren Produkte, um Zigaretten in den USA obsolet zu machen. Zum 30. Juni 2024 waren die rauchfreien Produkte von PMI in 90 Märkten erhältlich, mit schätzungsweise 36,5 Millionen erwachsenen Nutzern weltweit. Das rauchfreie Geschäft machte etwa 38 % der gesamten Nettoumsätze von PMI im ersten Halbjahr 2024 aus.
- Expansion of PMI's smoke-free product portfolio through collaboration with KT&G
- Potential entry into the U.S. market with new heat-not-burn products
- Smoke-free business accounts for 38% of PMI's total first-half 2024 net revenues
- PMI's smoke-free products available in 90 markets with 36.5 million estimated adult users
- None.
This collaboration between Philip Morris International (PMI) and KT&G marks a significant step in the evolving landscape of tobacco alternatives, particularly in the heat-not-burn category. The memorandum of understanding signals PMI's strategic move to expand its smoke-free product portfolio in the important U.S. market, leveraging KT&G's innovative technologies.
The partnership's focus on regulatory submissions, specifically the Pre-Market Tobacco Product Application (PMTA), is a critical aspect. Gaining FDA authorization is a complex and resource-intensive process and this collaboration could potentially accelerate the introduction of new heat-not-burn products to the U.S. market. This is particularly important given the FDA's stringent requirements and the competitive advantage that comes with regulatory approval.
From an investor's perspective, this move aligns with PMI's long-term strategy of transitioning away from traditional cigarettes. The company's substantial investment of
However, investors should note that:
- The memorandum is non-binding, which means the collaboration could still face hurdles or changes.
- The timeline for potential product launches in the U.S. remains uncertain, given the regulatory process.
- The success of these new products in the U.S. market is not guaranteed, even with FDA approval.
Overall, while this collaboration presents opportunities for PMI to strengthen its position in the smoke-free market, the real impact on the company's financial performance and market share will depend on successful execution and consumer adoption of these new products.
The collaboration between PMI and KT&G on U.S. regulatory submissions for new heat-not-burn products is a strategic move in navigating the complex regulatory landscape of tobacco alternatives. The focus on Pre-Market Tobacco Product Applications (PMTAs) is particularly noteworthy.
Key regulatory considerations include:
- FDA's stringent review process: PMTAs require extensive scientific data demonstrating that the product is "appropriate for the protection of public health." This involves comprehensive toxicological, behavioral and population-level impact studies.
- Modified Risk Tobacco Product (MRTP) potential: Given that PMI has previously obtained MRTP authorizations for IQOS, they may pursue similar designations for these new products, which could provide a significant market advantage.
- Regulatory timeline uncertainties: The FDA's review process can be lengthy and unpredictable. Investors should be aware that even with this collaboration, the path to market could take several years.
The mention of PMI's existing FDA authorizations for IQOS and Swedish Match's General snus products demonstrates the company's experience in navigating U.S. regulatory pathways. This expertise could be valuable in expediting the process for KT&G's products.
However, it's important to note that regulatory success is not guaranteed. The FDA has become increasingly scrutinous of new tobacco and nicotine products, particularly those appealing to youth. The agency's evolving stance on flavored products and marketing restrictions could impact the potential product range and go-to-market strategies.
For investors, this regulatory collaboration represents both opportunity and risk. Success could open up a significant new market segment for PMI, but delays or setbacks in the regulatory process could impact timelines and projected revenues from these new products.
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
KT&G’s new platform products are expected to be launched first outside the
“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
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
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:
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Email: InvestorRelations@pmi.com
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Email: David.Fraser@pmi.com
Source: Philip Morris International
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