Proposed FDA Standard Could Avert 4.3 Million Deaths, $600 Billion in Annual Economic Damage Linked to Smoking VLNC Products Could Fully Supplant Conventional Highly Addictive Combusted Products in as Little as Two Years MOCKSVILLE, N.C., Sept. 30, 2025 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), the only tobacco products company that has for 27 years led and continues to lead the fight against the harms of smoking driven by nicotine addiction, today announced submission of public comments ...

Core Viewpoint - 22nd Century Group, Inc. is leading the tobacco harm reduction movement with its VLN products, which are designed to significantly reduce nicotine consumption and help smokers manage their addiction [1][14]. Group 1: Product Development and Market Adoption - The company has successfully launched VLN cigarettes, which contain 95% less nicotine than traditional cigarettes, and have been proven to reduce nicotine consumption [14][15]. - Early adoption of VLN products has been seen with partner brands Smoker Friendly and Pinnacle, with initial stocking orders shipped in August 2025 [2][7]. - The company is expanding its product offerings to include 100mm cigarettes and international versions tailored to consumer preferences [9]. Group 2: Regulatory Landscape - The FDA has proposed a new Tobacco Product Standard for Nicotine Yield, setting a maximum nicotine content of 0.7mg/g, which is supported by clinical documentation and real-world testing of VLN products [4][5]. - The proposed regulation has garnered strong support from public health advocates, emphasizing the importance of reducing nicotine levels in tobacco products [6]. Group 3: Research and Development - Ongoing research is investigating the link between non-GMO low nicotine tobacco genetics and lower levels of harmful Tobacco-Specific Nitrosamines (TSNAs), which are potent carcinogens [11]. - The company is committed to expanding its intellectual property portfolio in low nicotine genetics, enhancing its leadership in tobacco harm reduction [12]. Group 4: Future Outlook - The company aims to continue its mission of providing low nicotine technology and products that can improve public health and potentially save lives [13].

Core Insights - 22nd Century Group, Inc. is leading the fight against smoking-related health harms through its VLN reduced nicotine content products, which are the first and only combustible cigarettes authorized by the FDA to reduce health risks associated with smoking [1][2][4] Product Overview - VLN cigarettes contain 95% less nicotine than conventional cigarettes, supported by decades of independent clinical research demonstrating their effectiveness in reducing nicotine consumption, smoking rates, and increasing quit attempts [2][4] - The VLN product line is designed to provide smokers with non-addictive alternatives, allowing them to control their nicotine intake and potentially reduce tobacco use [2][4] Regulatory Status - The VLN product was originally authorized in December 2021, with a renewal process due in December 2026, and the company expects full FDA support for this renewal based on its compliance with the FDA's low nicotine mandate issued in January 2025 [2][4] Research and Development - The company is committed to ongoing R&D programs aimed at advancing reduced nicotine content in tobacco and introducing additional VLN-based products to offer more health-oriented alternatives to traditional tobacco products [2][4] Company Mission - 22nd Century Group aims to empower smokers to make informed choices regarding their nicotine consumption, promoting a healthier lifestyle by providing options that help avoid addictive levels of nicotine altogether [4][5]

Summary of Philip Morris International (PM) 2025 Conference Call Company Overview - **Company**: Philip Morris International (PM) - **Date**: June 03, 2025 - **Key Speaker**: Emmanuel Babeau, CFO Core Industry Insights - **Industry**: Tobacco and Smoke-Free Products - **Market Trends**: Strong growth in smoke-free product categories, particularly IQOS and ZYN, with expectations for continued expansion in various global markets. Key Points and Arguments Financial Performance - PM is on track for strong growth in revenue, operating income, and adjusted EPS before foreign exchange (Forex) impacts, primarily driven by the smoke-free portfolio [5][18] - In Q1 2025, PM reported nearly 10% adjusted market sales growth in Japan and over 7% in Europe, despite challenges such as flavor bans [6] - The company anticipates a significant impact from the flavor ban in Europe, estimating a loss of approximately 1 billion sticks in 2025 [6] Product Performance - **IQOS**: Continued strong growth, with a focus on expanding market share in various regions, including the Gulf countries, Indonesia, and Mexico [6][10] - **ZYN**: Exceptional performance in Q1 2025, with growth exceeding 50% in the US. The company expects to resolve out-of-stock issues by Q3 2025, leading to further consumer uptake [7][8][49] - **Vive**: The vaping product is being developed more tactically, with a focus on profitability and market presence in key EU markets [12][13] Multi-Category Strategy - PM is adopting a multi-category approach, integrating IQOS, ZYN, and Vive to enhance brand loyalty and consumer experience. This strategy is showing positive results in markets like Poland, Greece, and Romania [14][26] - The company emphasizes that these products do not cannibalize each other but rather strengthen the overall brand portfolio [14] Market Outlook - PM targets organic revenue growth of 6% to 8% and adjusted EPS growth of 10.5% to 12.5% for 2025, with a strong focus on smoke-free products [18][19] - The company aims for two-thirds of its revenue to come from smoke-free products by 2030, supported by ongoing market expansion and product innovation [20][22] Regulatory Environment - PM acknowledges the challenges posed by varying regulations across markets, with some countries still imposing bans on smoke-free products. However, there is optimism regarding tobacco harm reduction policies in the US and several European countries [66][68] - The new head of the FDA's Center for Tobacco Products (CTP) is expected to support tobacco harm reduction initiatives, which could positively impact PM's market strategies [70] Competitive Landscape - The US market for nicotine pouches is becoming increasingly competitive, with many brands aggressively discounting prices. PM maintains a premium positioning for ZYN, which is currently priced higher than many competitors [51][52] - Despite competition, PM remains the only brand with Premarket Tobacco Product Applications (PMTAs) approved for its full range of ZYN products, reinforcing its market leadership [54][55] Consumer Insights - The company notes a shift in consumer perception of nicotine, particularly with ZYN being viewed as a lifestyle product rather than just a nicotine source. This change is expected to facilitate broader acceptance of nicotine pouches in new markets [32][33][57] Additional Important Insights - PM's smoke-free products are associated with superior financial metrics, including higher revenue per unit and gross margin rates compared to combustible products [15][16] - The company is focused on long-term profit growth, with a commitment to progressive dividend policies and potential share buybacks once debt targets are met [63][64] This summary encapsulates the key insights and strategic directions discussed during the conference call, highlighting PM's robust growth trajectory and commitment to innovation in the tobacco industry.

Financial Data and Key Metrics Changes - Net revenue for Q1 2025 was $6 million, a 50% increase sequentially from $4 million in Q4 2024 [28] - Gross margin loss improved by 50% to a loss of $600,000 from the previous quarter [28] - Net loss from continuing operations improved to $3.3 million from $4.2 million in the preceding quarter [31] - Adjusted EBITDA loss significantly improved to $2.3 million from $3.9 million in Q4 2024 [31] Business Line Data and Key Metrics Changes - Total cartons sold were 476,000, an increase of 41% compared to 338,000 in Q4 2024 [29] - The company is focusing on two main segments: reduced nicotine premium products and value-focused CMO brands [9][10] Market Data and Key Metrics Changes - The combustible cigarette market is valued at $85 billion, facing increasing price pressures and regulatory scrutiny [6] - The company aims to serve consumers transitioning from high nicotine products to lower nicotine options, capitalizing on market dynamics [21] Company Strategy and Development Direction - The company is transitioning into a growth phase, focusing on expanding distribution and launching targeted marketing campaigns [12][20] - New product introductions include Smoker Friendly Black Label and additional SKUs for existing brands, aimed at increasing market share [14][15] - The company is not waiting for FDA regulations to finalize its strategy and has developed technology for low nicotine products already approved by the FDA [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about achieving breakeven EBITDA by Q4 2025, supported by improved pricing structures and volume growth [34][36] - The company is focused on restoring fiscal responsibility and improving balance sheet ratios through debt reduction and working capital improvements [27] Other Important Information - The company has reduced its outstanding debt to $3.9 million and executed a capital raise of approximately $5.4 million [31][32] - A lawsuit against Dorchester Insurance Company for $9 million in business interruption insurance is ongoing, with a trial date set for November 2025 [32] Q&A Session Summary Question: Do you still foresee a breakeven of EBITDA for the fourth quarter of this year? - Management confirmed they are on track to achieve breakeven in the latter half of the year [34] Question: Will CMO continue to grow from its first quarter level and will VLN kick in over the course of the year? - Management indicated that both Smoker Friendly and Pinnacle franchises are on a growth path, with state approvals expected to drive distribution [36] Question: Does the increase in accounts receivable indicate a need for additional financial capital? - Management stated they are comfortable with their cash runway following recent financing and attributed the increase in receivables to new customer agreements [38][39] Question: What is the expected timeline for collecting the accounts receivable balance? - Management noted that collections occur upon product delivery, following typical shipment terms [40] Question: What has been the share issuance dilution from the warrants? - Current shares outstanding include approximately 7 million shares issued under the recent warrant inducement offering, with additional warrants expected to be exercised [42] Question: Are there any implications for twenty second Century Group from competitors' earnings results? - Management highlighted that trends in the market, particularly the migration from Tier one to Tier four brands, present opportunities for the company [46][48] Question: Have we seen the worst of it in 2024 past, and are we now on a growth trajectory? - Management confirmed that they are now on a growth trajectory in terms of cartons, price, and revenue [49]