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Tag: Zyn

  • Haypp Reports Q3 2025 Results Amid U.S. Expansion Investments

    Haypp Reports Q3 2025 Results Amid U.S. Expansion Investments

    Haypp reported Q3 2025 net sales of SEK 952.1 million ($95.2 million), an 0.8% increase, driven by strong performance in nicotine pouches, which accounted for 68% of total oral nicotine volume with like-for-like (LFL) volume growth of 21% (LFL excludes the impact of the ZYN shortage, U.S. state closures, and tobacco sales discontinuations.) Gross margin rose to 18.8%, while adjusted EBITDA reached SEK 53.0 million ($5.3 million) and adjusted EBIT was SEK 33.4 million ($3.3 million). Operating profit fell to SEK 6.2 million ($620,000) and net profit to SEK 4.5 million, reflecting a SEK 17.2 million ($1.7 million) litigation settlement.

    Key developments included the return of ZYN to the U.S. market, early indicators of strong sales, and continued growth in Swedish and German vaping and heated tobacco products, which now make up over 70% of Haypp’s Emerging segment. UK nicotine vaping and HnB sales will be discontinued in Q4 2025 pending regulatory clarity.

    “[The] U.S. return of Zyn, U.S. market developments and gross margin expansion strengthen our foundation for growth,” said Gavin O’Dowd, Haypp president and CEO. “The benefits of Zyn’s return will be realized in Q4 2025 with promising early indicators.”

    Haypp also completed most of its global e-commerce platform migration, improving infrastructure for agile growth. CEO Gavin O’Dowd emphasized that U.S. market developments, innovative product availability, and gross margin expansion are strengthening the company’s foundation for future growth.

  • PMI Reports Strong Q3 Based on Smoke-Free Surge

    PMI Reports Strong Q3 Based on Smoke-Free Surge

    Today (October 21), Philip Morris International reported strong third-quarter 2025 results, with adjusted diluted earnings per share rising 17.3% to $2.24, while reported EPS increased 13.2% to $2.23. The company said it achieved record smoke-free gross profit, supported by higher volumes and favorable pricing. Net revenues grew 5.9% on an organic basis, and adjusted operating income rose 7.5%, driven by strong performance in smoke-free products, despite a 3.2% decline in cigarette volumes.

    PMI’s smoke-free portfolio continued to expand rapidly, now accounting for 41% of total net revenues and 42% of gross profit. Volumes of smoke-free products rose 16.6%, led by the IQOS heated tobacco line and ZYN nicotine pouches. IQOS strengthened its market share across Europe and Asia, while ZYN’s U.S. offtake surged 39% following its return to full availability. The e-vapor brand VEEV also posted a 91% jump in shipments, solidifying PMI’s diversified presence across smoke-free categories.

    Reflecting this momentum, PMI raised its full-year adjusted EPS guidance and boosted its quarterly dividend by 8.9% to $1.47 per share. CEO Jacek Olczak said the company’s smoke-free business “continues to outgrow the industry by a clear margin,” adding that PMI is “on track to exceed” its 2024–2026 growth targets. Despite regulatory challenges in some markets, the company remains focused on transitioning adult smokers toward smoke-free alternatives and expanding its portfolio in 100 markets worldwide.

  • PMI Launches VEEV in South Africa, Expands Smoke-Free Portfolio

    PMI Launches VEEV in South Africa, Expands Smoke-Free Portfolio

    Philip Morris South Africa (PMSA) launched its VEEV e-cigarette this week, completing the company’s trio of smoke-free products in the country alongside IQOS heated tobacco and ZYN nicotine pouches, according to BizCommunity. This makes South Africa one of just 20 countries globally offering all three categories, underscoring PMSA’s commitment to providing adult smokers with scientifically backed alternatives to combustible cigarettes.

    Jonathan Kwak, Director of Smoke-Free Products at PMSA, said the launch gives “adult smokers more options than before when considering scientifically substantiated alternatives to smoking” and is a critical step toward eliminating cigarette use. PMI says it has invested over $14 billion globally since 2008 in research and development of smoke-free products, which are now available in 97 markets and used by more than 41 million adult consumers worldwide.

    While emphasizing that quitting all tobacco and nicotine remains the best choice, Kwak said that switching entirely to smoke-free products can significantly reduce exposure to harmful chemicals produced by burning tobacco. “With our expanding offering, we aim to accelerate South Africa’s transition to a smoke-free future, aligning with harm-reduction principles already embraced in other public-health fields,” he said.

  • Haypp Group Returns ZYN to U.S. Online Portfolio

    Haypp Group Returns ZYN to U.S. Online Portfolio

    Haypp Group announced that ZYN nicotine pouches are once again available for online purchase through its U.S. platforms, Nicokick.com and Northerner.com. According to the company’s press release, the relaunch covers 10 products that received FDA Marketing Granted Orders, offered in 3 mg and 6 mg strengths across flavors such as cinnamon, spearmint, wintergreen, and citrus.

    Peter Grafström, President of Haypp Group U.S., said the move is centered on compliance and adult-only access. “As a responsible online retailer, our priority is ensuring Nicokick and Northerner provide 21 and over consumers with responsible access to tobacco leaf-free alternatives to traditional tobacco products,” he said. The company emphasized its Legal Age Access Only Program and regulatory alignment as key safeguards.

    Haypp said ZYN has been one its top sellers, accounting for 46% of total U.S. sales on Nicokick and Northerner in Q2 2024. With more than 200 smoke-free nicotine alternatives now available across its U.S. e-commerce sites, Haypp says the relaunch reflects both strong consumer demand and the growing role of online retail in the nicotine pouch category.

    For more information, visit Nicokick and Northerner. 

  • FDA Launches Pilot to Fast-Track Nicotine Pouch Reviews

    FDA Launches Pilot to Fast-Track Nicotine Pouch Reviews

    The U.S. Food and Drug Administration is set to fast-track reviews of nicotine pouches from Philip Morris International, Altria, Reynolds American, and Turning Point Brands in a pilot program launching Monday, according to Reuters. According to transcripts of an agency meeting last Friday, the agency aims to complete assessments by December, providing a quicker path to market for products like Zyn, on!, Velo, Fre, and Alp. The initiative comes amid pressure from the Trump administration to accelerate approvals and streamline the review process for the fastest-growing category of U.S. tobacco alternatives.

    The pilot program will reportedly feature reduced and expedited reviews, more frequent communication between FDA staff and companies, and a focus on essential scientific and safety data, including product characterization, manufacturing consistency, and abuse-liability information. For products already on the market without full authorization, the process could remove uncertainty over legality and potential enforcement actions. Tobacco firms have long lobbied for a faster FDA authorization route, noting that lengthy reviews have allowed competitors to capture market share in the meantime.

    “Adult nicotine and tobacco consumers are increasingly seeking nicotine pouches as a smoke-free alternative, and the industry is rapidly growing in response,” said Laura Leigh Oyler, vice president of U.S. Regulatory Affairs at Haypp Group, who will be speaking at GTNF 2025 in Brussels on the U.S. regulatory landscape. “These consumers deserve a marketplace of FDA-reviewed product choices to support their journey away from more harmful products. 

    “It makes sense that our government should also work to meet the demands of citizens, supporting a regulatory regime that quickly reviews well-designed and well-tested products from responsible and compliant manufacturers. This is a positive step not just for the regulator and the regulated industry, but for the millions of American adults looking for products they can trust.”

  • PMI Reaffirms 2025 EPS Outlook on IQOS, ZYN Momentum

    PMI Reaffirms 2025 EPS Outlook on IQOS, ZYN Momentum

    Philip Morris International reaffirmed its 2025 earnings forecast today (September 2) at the Barclays Global Consumer Staples Conference, projecting reported diluted EPS of $7.24–$7.37 and adjusted diluted EPS of $7.43–$7.56, representing 13–15% growth versus last year. PMI reported better-than-expected combustible volume recovery in Turkey and Egypt, alongside continued growth in IQOS, ZYN, and VEEV globally.

    “With strong volume momentum over the summer months, including IQOS and ZYN offtake, and despite increasing competition in smoke-free products, we are on track to deliver our full-year guidance of 13% to 15% adjusted diluted EPS growth in dollar terms, the strongest since 2011 excluding the pandemic recovery,” said Jacek Olczak, Chief Executive Officer.

    In the U.S., ZYN posted about 32% growth in the first eight weeks of Q3, prompting PMI to forecast shipment growth in line with offtake through year-end.

    An archived copy of the webcast is available at www.pmi.com/irapp.

  • Philip Morris International Reports Record Q2 Earnings

    Philip Morris International Reports Record Q2 Earnings

    Philip Morris International Inc. reported record second-quarter results today (July 22) driven by strong growth in its smoke-free portfolio and resilient performance in combustibles. Net revenues reached an all-time high, with smoke-free products—including IQOS, ZYN, and VEEV—accounting for 41% of total sales. Shipments of smoke-free products rose 11.8%, while gross profit from the category jumped over 23%.

    CEO Jacek Olczak highlighted a “reacceleration” in IQOS and ZYN sales, especially in Europe, Japan, and the U.S., where ZYN’s offtake rose 36% in June. PMI’s e-vapor brand VEEV more than doubled shipment volumes, now leading in several European markets.

    Combustible products like Marlboro remained stable, contributing to a 2.1% revenue increase despite expected volume declines. PMI also declared a quarterly dividend of $1.35 per share. Buoyed by strong year-to-date performance, the company raised its full-year earnings guidance.

    Click here for the full financial report.

  • FDA Begins Review of Zyn’s Modified Risk Claim

    FDA Begins Review of Zyn’s Modified Risk Claim

    The U.S. Food and Drug Administration (FDA) has officially begun its scientific review of modified risk applications for 20 Zyn nicotine pouch products, submitted by Swedish Match USA, Inc.

    Already authorized for sale in January 2025, the company is now seeking permission to market Zyn with a health-related claim: “Using Zyn instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

    FDA’s review will assess whether this claim is scientifically and legally justified under the Modified Risk Tobacco Product (MRTP) process. The agency will issue a final decision after reviewing scientific evidence, public comments, and recommendations from its Tobacco Product Scientific Advisory Committee (TPSAC).

    “It is a positive development that FDA is progressing the MRTP applications and we hope for an expeditious review,” a PMI spokesperson said. “Swedish Match has presented the agency with a substantive scientific package that the company believes supports authorizing ZYN as appropriate to promote public health. Providing accurate information on the relative risk of different nicotine products to America’s 45 million legal-age nicotine consumers will help accelerate switching to better alternatives than continued cigarette use—the most harmful form of nicotine consumption.”

    Public comments open June 18 at regulations.gov under docket FDA-2025-N-0835. The comment period will remain open for at least 180 days after publication of the Federal Register notice.

    TPSAC meeting details and redacted application materials will be released on a rolling basis at the FDA’s Center for Tobacco Products website.

  • PMI Execs Talk Financials

    PMI Execs Talk Financials

    Today (June 3), Philip Morris International presented at the 2025 dbAccess Global Consumer Conference, showcasing its strategic focus on smoke-free products amid a backdrop of both opportunities and challenges. The company reported strong growth in its smoke-free portfolio, while also managing a resilient combustible business through strategic price adjustments and cost management.

    PMI reported organic revenue growth between 6% and 8% and organic operating income growth of 10.5% to 12.5%. The company said it remains on course to have two-thirds of its revenue come from smoke-free products by 2030.

    PMI said its smoke-free product volume increased by more than 14%, and revenue from smoke-free products grew by over 20% organically. This category was led by its Zyn nicotine pouches, which saw over 50% growth in the U.S. during Q1 2025, and has plans for further expansion in Europe and other markets.

    IQOS experienced nearly 10% growth in Japan and over 7% in Europe despite regulatory challenges, with Veev holding the top position in five EU markets, focusing on profitable growth.

    Emmanuel Babeau, CFO of PMI, said the company plans to expand IQOS in the U.S. and enter new markets such as Turkey, Brazil, and India, and expects to reach a net debt to EBITDA ratio of 2x by the end of 2026.

  • Reno Reporters Stumble into Counterfeit Zyn

    Reno Reporters Stumble into Counterfeit Zyn

    News 4-Fox 11 in Reno, Nevada, is reporting its investigation that found counterfeit Zyn products for sale at a local convenience store that looked identical to the legitimate brand. Last October, an employee of the station bought three cans of “Zyn,” which he said tasted different than usual. The cans were sent to McKinney Specialty Labs in Virginia for testing.

    “They really are misbranded and illegally on the market,” Dr. Roxana Weil, chief regulatory science officer at McKinney, said. The tested product only contained 4.5mg of nicotine, contrary to the 6mg advertised, and additionally contained six methyl nicotine, an additive that should not have been in there. The lab only tested for nicotine, so it’s unclear what else could be in the counterfeit product.

    Dr. Willie McKinney, CEO of McKinney, said, “It was a little bit of a surprise to see six methyl nicotine simply because it’s manufactured. It’s man-made.”

    Representatives from Philip Morris International, the makers of Zyn, and the store owner believe the counterfeit products likely came from a distributor.

    “Our findings are that these are produced from overseas,” said Brian Weinhaus, director for illicit trade at PMI. “They are not produced in the United States.”