Core Insights - 22nd Century Group, Inc. is launching a 2025 growth strategy that leverages both internal and external brand assets across multiple categories, with a focus on their VLN® reduced nicotine products [1][4] - The company reported a challenging but transformative year in 2024, indicating a reset of nearly all business aspects and a focus on growth for 2025 [4] Financial Performance - For Q4 2024, net revenues decreased to $4.0 million from $5.9 million in Q3 2024, reflecting a 45.4% decline [6][10] - Gross profit for Q4 2024 was a loss of $1.3 million, compared to a loss of $0.6 million in the previous quarter [6][10] - Operating loss increased to $4.1 million in Q4 2024 from $3.4 million in Q3 2024, while net loss rose to $4.2 million from $3.6 million [6][10] - Adjusted EBITDA loss was $3.9 million, compared to a loss of $3.2 million in the previous quarter [6][10] Product Line Highlights - Cigarette net revenues were $3.3 million in Q4 2024, down from $4.1 million in Q3 2024, despite an increase in carton volumes to 228 thousand from 156 thousand [7][11] - Filtered cigars net revenues decreased to $0.8 million from $1.7 million in the previous quarter, attributed to lower volumes [7][11] - VLN® cigarette net revenues were $(0.1) million in Q4 2024, reflecting rebates and marketing incentives for products already in distribution [7][11] Strategic Developments - The company announced the first VLN® partner brand with Smoker Friendly, ready for shipment in Q2 2025, and is in discussions for additional partner brands [6][8] - A new five-year expanded license and manufacturing agreement was signed with Smoker Friendly, covering 11 existing products and eight new premium products [6][8] - The company has complied with the FDA's proposed new tobacco product standard for nicotine yield, with VLN® being the only combustible cigarette that meets the new standard of a maximum nicotine level of 0.7 mg/g [6][8]

Core Viewpoint - 22nd Century Group, Inc. is set to discuss its 2024 fourth quarter and full year results during a webcast on March 20, 2025, highlighting its role in nicotine harm reduction and product innovation in the tobacco industry [1][2]. Group 1: Company Overview - 22nd Century Group is pioneering nicotine harm reduction in the tobacco industry, enabling smokers to take control of their nicotine consumption [4]. - The company's flagship product, the VLN cigarette, contains 95% less nicotine than traditional cigarettes, providing an alternative that helps reduce nicotine consumption [5][7]. - The company operates a 60,000 square foot facility in Mocksville, North Carolina, capable of producing over 45 million cartons of combustible tobacco products annually, with room for expansion [6]. Group 2: Product and Technology - The proprietary reduced nicotine tobacco blends are developed using patented technologies that regulate nicotine biosynthesis in the tobacco plant, ensuring full flavor and high yield with significantly lower nicotine content [7]. - The extensive patent portfolio positions the company as the sole provider of low nicotine combustible cigarettes in the United States and key international markets [7]. Group 3: Upcoming Events - The webcast will feature Larry Firestone, chairman and CEO, and Dan Otto, CFO, who will review financial results and discuss the company's progress and plans for 2025 [2][3].

Core Insights - 22nd Century Group has signed an agreement with Smoker Friendly to launch Smoker Friendly VLN branded reduced nicotine content cigarette products, marking the first VLN partner brand [1][4] - The introduction of these products will include gold and menthol SKUs, expanding the VLN branding in Smoker Friendly outlets [2] - The partnership builds on a customer relationship of over 10 years and aims to advance VLN in the market through a staged rollout pending state approvals [3][4] Financial Overview - As of May 31, 2024, total assets for 22nd Century Group amounted to $23.554 billion, an increase from $23.132 billion in February 2024 [3] - Current assets increased to $19.181 billion from $18.746 billion, with cash and cash equivalents rising to $2.402 billion [3] - Total stockholders' equity reached $16.664 billion, up from $16.279 billion, indicating a positive trend in the company's financial health [3] Company Background - 22nd Century Group is recognized as a pioneering nicotine harm reduction company, focusing on enabling smokers to control their nicotine consumption [7] - The flagship product, VLN® cigarettes, contain 95% less nicotine than traditional cigarettes, providing an alternative for smokers [8][10] - The company operates a facility in Mocksville, North Carolina, capable of producing over 45 million cartons of combustible tobacco products annually [9]

Core Viewpoint - Emerging Growth Research has released a new initiation report on 22nd Century Group, highlighting significant operational and financial restructuring under new management, with the remaining issue being the warrant overhang [1][3]. Financial Performance - The new management has successfully reduced operating cash losses in the first nine months of 2024 and decreased the Company's debt load in early 2025 [3]. - The Company anticipates reaching EBITDA breakeven by Q4 2025, driven by stabilized CMO sales, a revamped VLN® strategy, and disciplined expense management [3]. Market Position and Strategy - 22nd Century Group provides contract manufacturing services for conventional tobacco products and sells its proprietary VLN® very-low-nicotine tobacco products, focusing on nicotine harm reduction [5]. - The Company aims to enable smokers to take control of their nicotine consumption, positioning itself as a pioneer in the tobacco industry [5]. Outlook and Challenges - Despite past concerns regarding bankruptcy and share dilution, the outlook for the Company has improved significantly, with a focus now on growth and profitability [4]. - The shares of 22nd Century Group remain undervalued due to historical restructuring efforts and lingering bankruptcy risks from late 2023 [4].

Company Overview - 22nd Century Group, Inc. is a pioneering nicotine harm reduction company in the tobacco industry, focusing on enabling smokers to control their nicotine consumption [4] - The company has developed its flagship product, the VLN cigarette, which contains 95% less nicotine than traditional cigarettes, providing an alternative for smokers [5][7] Product Details - VLN cigarettes are designed to help traditional cigarette smokers reduce their nicotine consumption significantly [5] - The proprietary reduced nicotine tobacco blends are created using patented technologies that regulate nicotine biosynthesis in the tobacco plant, ensuring full flavor and high yield with reduced nicotine levels [7] Manufacturing Capabilities - The company operates a 60,000 square foot facility in Mocksville, North Carolina, capable of producing over 45 million cartons of combusted tobacco products annually, with potential for expansion [6] Upcoming Events - Larry Firestone, the CEO, will present at the Emerging Growth Conference on February 19, 2025, at 10:50 am Eastern Time, providing an overview and opening the floor for questions [1][2]

Core Points - 22nd Century Group, Inc. has regained compliance with the Nasdaq Minimum Bid Price Requirement for continued listing [1][2] - The CEO expressed satisfaction with the compliance status, emphasizing the commitment to long-term shareholder value [2] - The company focuses on nicotine harm reduction, offering products that allow smokers to control their nicotine consumption [3][5] Company Overview - 22nd Century Group is a pioneering company in the tobacco industry, specifically targeting nicotine harm reduction [2] - The flagship product, VLN cigarettes, contains 95% less nicotine than traditional cigarettes, aiming to help smokers reduce their nicotine intake [3][5] - The company operates a 60,000 square foot manufacturing facility in Mocksville, North Carolina, with an annual production capacity of over 45 million cartons of combusted tobacco products [4] Product and Technology - The proprietary reduced nicotine tobacco blends are developed using patented technologies that regulate nicotine biosynthesis in the tobacco plant [5] - The extensive patent portfolio ensures that the company holds the only low nicotine combustible cigarette in the United States and key international markets [5]

Core Viewpoint - The FDA has proposed a new Tobacco Product Standard that aims to significantly reduce nicotine levels in cigarettes, which could lead to a decrease in smoking-related morbidity and mortality, with 22nd Century's VLN products positioned to benefit from this regulation [1][6]. Group 1: FDA Proposed Standard - The proposed standard sets a maximum nicotine content of 0.7 mg per gram of tobacco in cigarettes and certain combusted tobacco products, expected to take effect in two years after final approval [2]. - The FDA anticipates that this standard could prevent approximately 48 million youth and young adults from initiating smoking by the year 2100 [6]. Group 2: 22nd Century's Position - 22nd Century's VLN products are the only combustible cigarettes authorized by the FDA as reduced nicotine content products, already compliant with the new standard and available in over 5,000 stores nationwide [2][3]. - The company emphasizes its commitment to nicotine harm reduction, providing smokers with a choice to control their nicotine consumption through products that contain 95% less nicotine than traditional cigarettes [5][8]. Group 3: Industry Impact - The FDA's proposal is seen as a potential game-changer in public health policy, aiming to reduce the burden of tobacco-related diseases and save lives [3][6]. - The proposed rule is expected to facilitate the commercial adoption of reduced nicotine products, which could lead to a significant shift in the tobacco industry landscape [3][4].

Core Viewpoint - The FDA has proposed a new Tobacco Product Standard that aims to significantly reduce nicotine levels in cigarettes and certain combusted tobacco products, which could lead to a decrease in smoking-related morbidity and mortality. 22nd Century Group's VLN products are highlighted as compliant with this new standard, positioning the company for potential growth in commercialization and distribution [1][2][6]. Group 1: FDA Proposed Standard - The proposed standard sets a maximum nicotine content of 0.7 mg per gram of tobacco in cigarettes and certain other combusted tobacco products, expected to take effect two years after final approval [2]. - The FDA anticipates that this standard could prevent approximately 48 million youth and young adults from initiating smoking by the year 2100 [6]. Group 2: 22nd Century Group's Position - 22nd Century Group's VLN products are the only combustible cigarettes authorized by the FDA as reduced nicotine content products, currently available in over 5,000 stores across the U.S. [2][3]. - The company has been committed to nicotine harm reduction for 26 years, and the FDA's proposal is seen as a significant opportunity for commercial adoption of its VLN products [3]. Group 3: Product and Manufacturing Capabilities - VLN cigarettes contain 95% less nicotine than traditional cigarettes and have been proven to reduce overall nicotine consumption [5]. - The company operates a 60,000 square foot manufacturing facility in Mocksville, North Carolina, capable of producing over 45 million cartons of combusted tobacco products annually, with room for expansion [7]. Group 4: Technological Innovation - 22nd Century Group utilizes patented technologies to create proprietary reduced nicotine tobacco blends, ensuring they have the only low nicotine combustible cigarette in the U.S. and critical international markets [8].

Industry Trends and Market Opportunity - The FDA estimates that 13 million smokers could benefit from reduced nicotine cigarette policies in the first five years, highlighting a significant public health opportunity [1] - The reduced nicotine cigarette market mirrors the growth of non-alcoholic beer and spirits, as consumers seek alternatives to traditional products [1] - The FDA's policy proposal to mandate reduced nicotine content in cigarettes has cleared review by the U.S. Office of Management and Budget, indicating regulatory progress [3] Company Overview and Product Innovation - 22nd Century Group is a pioneer in nicotine harm reduction, offering VLN cigarettes with 95% less nicotine than traditional cigarettes [2] - The company's proprietary technology regulates nicotine biosynthesis in tobacco plants, enabling full flavor and high yield with significantly reduced nicotine content [2][6] - VLN cigarettes are the only FDA-authorized combustible tobacco products under the Modified Risk Tobacco Product designation, available in over 5,000 stores nationwide [7] Manufacturing and Expansion Capabilities - The company operates a 60,000 square foot manufacturing facility in Mocksville, North Carolina, with an annual production capacity of over 45 million cartons of combusted tobacco products [2] - The facility has additional space for expansion, supporting future growth in production [2] Regulatory and Policy Developments - The reduced nicotine cigarette policy, initiated during the Trump administration, has gained momentum under the Biden administration, reflecting bipartisan support for smoking harm reduction [7] - 22nd Century Group's VLN products have demonstrated commercial viability and effectiveness in controlling nicotine intake, countering skepticism from major tobacco companies [1][7] Market Positioning and Competitive Advantage - The company's extensive patent portfolio ensures it is the sole provider of low nicotine combustible cigarettes in the U.S. and key international markets [6] - 22nd Century Group collaborates with retailers to stock VLN products and other reduced nicotine cigarette brands, creating a new market category [1]

Core Viewpoint - The FDA's proposal to mandate reduced nicotine content in cigarettes has cleared the OMB review, which could significantly impact public health by reducing smoking-related harms [1][2]. Group 1: FDA Proposal and Company Position - The FDA's proposed tobacco product standard aims for a drastic reduction in nicotine levels in cigarettes, aligning with public health goals and the mission of 22nd Century Group [1][2]. - 22nd Century Group supports the FDA's initiative and emphasizes its role in research and development of reduced nicotine products, including the VLN brand [2][3]. Group 2: Product and Market Strategy - The VLN cigarette contains 95% less nicotine than traditional cigarettes, providing smokers with a familiar alternative that helps control nicotine consumption [3]. - The company plans to expand its product line with additional reduced nicotine content products and increase consumer awareness of low nicotine cigarettes as a distinct market category [2][3]. Group 3: Company Overview - 22nd Century Group is a pioneering company in nicotine harm reduction, with a manufacturing facility in Mocksville, North Carolina, capable of producing over 45 million cartons of tobacco products annually [3]. - The company holds a comprehensive patent portfolio that ensures it is the only provider of low nicotine combustible cigarettes in the U.S. and key international markets [3].