Tobacco harm reduction
Search documents
Research Study Demonstrates Significantly Reduced Secondhand Toxicant Exposure from Charcoal Free Shisha Devices and Electronic Vaping Products
Businesswire· 2026-01-28 13:00
customary conditions to closing.The foregoing list of risk factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors†section of the final prospectus of CAEP dated as of June 25, 2025 and filed by CAEP with the SEC on June 26, 2025, CAEP's Quarterly Reports on Form 10-Q, CAEP's Annual Report on Form 10-K and the Registration Statement that will be filed by AIR Global and AIR and the proxy statement/prospectus containe ...
22nd Century Files VLN® MRTP Renewal – Only Combustible Tobacco Product Authorized by the FDA Specifically to Help Smokers Smoke Less
Globenewswire· 2026-01-06 11:10
Core Viewpoint - 22nd Century Group, Inc. is advancing the fight against smoking-related health harms through its VLN reduced nicotine content products, which have been authorized by the FDA as a Modified Risk Tobacco Product [1][4]. Group 1: Product and Market Impact - The VLN reduced nicotine content cigarettes have been shown to lower daily nicotine consumption by 40% over 12 weeks in a study with over 400 participants, indicating their potential to reduce smoking rates and increase quit attempts [2]. - Approximately 28.8 million smokers in the U.S. contribute to over $600 billion in annual healthcare costs related to tobacco harm, highlighting the significant market opportunity for VLN products [2]. - VLN cigarettes contain 95% less nicotine than conventional cigarettes, providing a non-addictive alternative for smokers [3][10]. Group 2: Regulatory and Strategic Developments - The FDA originally authorized VLN combustible cigarettes in December 2021 for a five-year period, with a renewal application filed for December 2026 [3]. - The company is expanding its range of VLN branded products and tobacco plant varieties to offer smokers more low-nicotine alternatives, aligning with the FDA's proposed guidelines for low nicotine [5]. - The renewal process is part of the company's ongoing research and development efforts to advance reduced nicotine content in tobacco and introduce additional VLN products [5]. Group 3: Company Vision and Leadership - The CEO of 22nd Century Group emphasized that the FDA's MRTP authorization for VLN cigarettes represents a forward-thinking approach to reducing smoking-related health harms, focusing on behavioral and social aspects of nicotine addiction [4]. - The company aims to empower smokers to take control of their nicotine consumption through its innovative VLN products, positioning itself as a leader in the tobacco harm reduction movement [8][9].
22nd Century Group (NasdaqCM:XXII) Conference Transcript
2025-12-10 21:57
Summary of 22nd Century Group Conference Call Company Overview - **Company**: 22nd Century Group (Ticker: XXII) - **Industry**: Tobacco harm reduction - **Focus**: Pioneering nicotine harm reduction products, specifically VLN (Very Low Nicotine) branded products aimed at reducing nicotine addiction among smokers [1][2] Core Points and Arguments - **Transition Phase**: The company is moving from a debt-laden turnaround phase to a product launch and growth phase, indicating a positive shift in business strategy [2] - **Nicotine Epidemic**: The CEO highlighted a global nicotine epidemic, comparing its scale to the COVID pandemic, emphasizing the need for effective nicotine reduction solutions [2][4] - **Product Offering**: The VLN cigarette is presented as a solution to nicotine addiction, allowing smokers to reduce their nicotine intake while maintaining the smoking ritual [4][6] - **Target Market**: The company targets the 70% of the 28.8 million U.S. smokers who wish to quit, equating to approximately 20.5 million potential customers [5][8] - **Unique Selling Proposition**: Unlike traditional nicotine replacement therapies (NRTs), VLN products allow smokers to adjust their nicotine consumption without losing the smoking experience, which is crucial for habit change [6][8] Business Developments - **Inventory and Distribution**: Initial store inventories are being loaded, with some stores already reordering products. The company is also exploring cross-marketing opportunities [7][8] - **Financial Position**: The company is now debt-free and has received a $9.5 million insurance settlement, providing sufficient cash to sustain operations into 2026 [9][12] - **Growth Strategy**: The focus is on moving away from low-margin contract manufacturing operations to more profitable branded products [9] International Expansion - **South Korea Market**: Plans for a rollout in South Korea are currently on hold until the U.S. market is fully optimized [10] Marketing and Customer Acquisition - **Cost Efficiency**: Customer acquisition costs are low, primarily involving retail placement and minimal marketing expenses. The company is implementing promotional strategies to encourage product trials [13] Future Outlook - **Break-even Target**: The company aims to break even in the first half of 2026, with expectations of covering cash flow by that time [12] Additional Notes - **Website Functionality**: The company’s website (tryvln.com) is operational and provides updated information on product availability [11] - **CEO's Closing Remarks**: The CEO expressed optimism for the future and gratitude towards shareholders, indicating a positive outlook for 2026 [15]
22nd Century to Participate in the Emerging Growth Conference on December 10, 2025
Globenewswire· 2025-12-09 14:29
Core Insights - 22nd Century Group, Inc. is a leader in the tobacco harm reduction movement, focusing on reducing nicotine addiction through innovative products [3][4]. Company Announcement - The CEO, Larry Firestone, will present at the Emerging Growth Virtual Investor Conference on December 10, 2025, at 3:55 PM Eastern Time [1]. Technology and Products - The company has developed proprietary non-GMO reduced nicotine tobacco plants that contain 95% less nicotine than traditional tobacco [4]. - The flagship product, VLN cigarette, is designed to provide traditional smokers with a familiar alternative while significantly reducing nicotine consumption [5]. - VLN cigarettes are the only low nicotine combustible cigarettes authorized by the FDA in the United States [6]. Investor Engagement - Investors can register for the conference online and submit questions in advance for consideration during the event [2]. - An archived webcast will be available for those unable to attend live [2]. Contact Information - Investor relations contact is Matt Kreps, reachable at investorrelations@xxiicentury.com or by phone at 214-597-8200 [8][9].
22nd Century (XXII) - 2025 Q3 - Earnings Call Transcript
2025-11-04 14:00
Financial Data and Key Metrics Changes - The company reported a net revenue of $4 million in Q3 2025, a slight decrease from $4.1 million in Q2 2025, with total cartons sold dropping to 517,000 from 779,000 [34] - Gross profit was a loss of $1.1 million in Q3 2025, compared to a loss of $0.6 million in Q2 2025, reflecting lower volume and a transition to higher margin products [34] - The company ended the quarter with $4.8 million in cash and a $9.5 million receivable from an insurance recovery, increasing total assets to $32.4 million from $21.7 million at the end of 2024 [33] Business Line Data and Key Metrics Changes - The company is transitioning from a low-margin CMO business to higher-margin branded products, with shipments of newly branded VLN and partner VLN products totaling approximately 6,000 cartons year-to-date [30] - Natural style cigarettes contributed an additional 14,000 cartons to the total shipments, indicating a shift in product mix towards higher-margin offerings [30] Market Data and Key Metrics Changes - VLN and partner VLN products are now available in approximately 1,500 stores across 21 states, with authorization in about 40 states, which is crucial for expanding distribution [31] - The company expects to see rate of sale metrics in early 2026, which will provide insights into marketing effectiveness and consumer adoption [31] Company Strategy and Development Direction - The company aims to support the FDA's low nicotine mandate by positioning its VLN products as a solution for tobacco harm reduction, emphasizing the importance of both full nicotine and low nicotine offerings [22][26] - Future plans include licensing arrangements to allow other tobacco companies to adopt VLN products, thereby expanding market reach and supporting public health initiatives [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving EBITDA break-even by the second quarter of 2026, despite current challenges in sales metrics [39] - The company has successfully restructured its operations and is now focused on growth, with a well-funded balance sheet to support future initiatives [27][28] Other Important Information - The company has become debt-free and improved its balance sheet significantly, allowing for growth capital to be directed towards advancing VLN products in the market [27] - The management team has entered into customary employment agreements with key executives to support the company's growth trajectory [38] Q&A Session Summary Question: What are the plans for the $14 million in cash going forward? - The company plans to use the cash for operations, advancing VLN in the market, and initiating R&D and CapEx in early 2026 [36] Question: What is the current share equivalent of outstanding warrants? - There are just under 7 million shares outstanding, with a fully diluted basis of 23.7 million shares [37] Question: What is the impact of the Needham sales agreement on SG&A going forward? - The sales agent agreement will not change the current G&A level, as it is just formalizing terms for executive officers [37] Question: Is the company still targeting EBITDA break-even by the second quarter of 2026? - The company is still driving for that target and remains optimistic about achieving it [39]
Altria(MO) - 2025 Q3 - Earnings Call Transcript
2025-10-30 14:02
Financial Data and Key Metrics Changes - Adjusted diluted earnings per share increased by 3.6% in Q3 and by 5.9% for the first nine months [20] - Adjusted operating companies income (OCI) for smokeable products grew by 0.7% to nearly $3 billion in Q3 and by 2.5% to $8.4 billion for the first nine months [20] - Adjusted OCI margins expanded to 64.4% for both Q3 and the first nine months, representing margin growth of 1.3 percentage points and 2.7 percentage points respectively [20] Business Line Data and Key Metrics Changes - Domestic cigarette volumes declined by 8.2% in Q3 and 10.6% for the first nine months when adjusted for trade inventory movements [21] - The oral tobacco products segment saw adjusted OCI decline by less than 1% in Q3, but adjusted OCI increased by 3.3% with margin expansion of 1.8 percentage points to 69% [24][25] - Helix's reported shipment volume for on! increased by nearly 1% in Q3 and approximately 15% for the first nine months [8] Market Data and Key Metrics Changes - The nicotine pouch category grew to 55.7 share points, an increase of 11.1 share points year-over-year [7] - The e-vapor category included approximately 21 million vapers, up nearly 2 million versus a year ago [13] - The discount segment of the industry expanded by 2.4 share points year-over-year, with Basic capturing over half of that growth [23] Company Strategy and Development Direction - The company is focusing on expanding its smoke-free portfolio and exploring international opportunities through a collaboration with KT&G [5][18] - The launch of on! PLUS is seen as a premium product aimed at appealing to both adults who dip and competitive nicotine pouch consumers [10] - The company is committed to returning value to shareholders, as evidenced by a recent dividend increase and an expansion of the share repurchase program [5][27] Management Comments on Operating Environment and Future Outlook - Management noted that consumers are under pressure but are seeing some consistency in gas prices and inflation [33] - The company is optimistic about the regulatory environment, particularly with recent FDA actions that may streamline product authorizations [16] - The company raised the lower end of its 2025 guidance range, expecting adjusted diluted EPS in the range of $5.37-$5.45, representing a growth rate of 3.5%-5% from a base of $5.19 in 2024 [26] Other Important Information - The company returned nearly $6 billion to shareholders in the first nine months, including $5.2 billion in dividends and $712 million in share repurchases [27] - The balance sheet remains strong, with a debt to EBITDA ratio of 2x as of September 30 [28] Q&A Session Summary Question: Insights on fourth quarter earnings growth and smokeable OCI - Management acknowledged the impact of share repurchase and MSA legal fund expiration on earnings growth, while monitoring consumer spending in a dynamic marketplace [31] Question: Drivers behind the moderation in cigarette industry decline - Management indicated that consistency in consumer pressures and stepped-up enforcement in e-vapor are influencing market dynamics [34] Question: Performance and positioning of on! in a competitive environment - Management expressed satisfaction with on!'s performance despite competitive pressures, highlighting steady retail takeaway volume [37] Question: Opportunities from the KT&G partnership - Management outlined three prongs of the partnership: expanding modern oral initiatives, exploring non-nicotine opportunities, and improving operational efficiencies [40] Question: Pricing strategy for on! PLUS - Management confirmed that on! PLUS is positioned as a premium product, with introductory price promotions planned for its launch [48] Question: Impact of FDA pilot program on product launches - Management emphasized the importance of a functioning regulatory system and indicated that decisions will be made in the long-term best interest of the company [57]
Why Did 22nd Century Group Shares Surge 39% In After-Hours Trading? - 22nd Century Group (NASDAQ:XXII)
Benzinga· 2025-10-29 06:31
Core Insights - 22nd Century Group Inc. shares surged 39.07% to $2.10 after receiving a $9.5 million insurance settlement related to a business interruption claim from the November 2022 Grass Valley incident [1] Financial Position - CEO Larry Firestone stated that the settlement marks a transition for the company from a cleanup phase to a growth phase, enhancing its balance sheet with significant cash resources to support strategic execution [2] Product Focus - The company is dedicated to expanding its core business, particularly through its VLN product line, which aims to strengthen its position in tobacco harm reduction [2] - 22nd Century Group utilizes proprietary VLN tobacco, which contains 95% less nicotine than traditional tobacco, in its VLN and Partner VLN reduced-nicotine cigarettes [3] Regulatory Compliance - The VLN products are the first and only combusted tobacco products to comply with the FDA's proposed standard for nicotine yield in cigarettes [4] Earnings and Stock Performance - In the second quarter, the company reported a loss of $13.16 per share, significantly higher than the estimated loss of $6.21 per share [5] - The company is set to report third-quarter earnings on November 4 [5] - The stock has fluctuated between $1.43 and $394.02 over the past year, with a current market capitalization of $5.71 million [5] - At the close of trading on Tuesday, shares fell 0.66% to $1.51 [5] Stock Trends - Benzinga Edge Stock Rankings indicate that XXII is trending downward across all time frames [6]
22nd Century Announces Receipt of $9.5 Million from Settlement of Insurance Claim
Globenewswire· 2025-10-28 21:07
Core Insights - 22nd Century Group, Inc. has received $9.5 million in cash from a settlement agreement with its insurer related to business interruption from the Grass Valley incident in November 2022 [1][2] - The settlement marks a transition for the company from a cleanup phase to a growth phase, providing meaningful cash resources to execute its strategy [2] - The company aims to expand its position in the tobacco harm reduction movement with its VLN products, which contain 95% less nicotine [2][4] Company Overview - 22nd Century Group is focused on pioneering the tobacco harm reduction movement, enabling smokers to control their nicotine consumption [3] - The company has developed proprietary non-GMO reduced nicotine tobacco plants using patented technologies, resulting in a product with 95% less nicotine than traditional tobacco [4] Product Information - The flagship product, VLNcigarette, is designed to provide traditional cigarette smokers with a familiar alternative that helps them manage their nicotine intake [5] - VLNcigarettes are the only low nicotine combustible cigarettes authorized by the FDA in the United States [6]
22nd Century Launches VLN® with Major C-Store Chain, New Marketing Collateral, Continues to Expand State Authorizations
Globenewswire· 2025-10-23 11:45
Core Insights - 22nd Century Group, Inc. has launched VLN reduced nicotine content cigarettes at approximately 140 Circle K locations in Illinois, expanding its market presence as VLN is now authorized for sale in 45 states with 5 states pending [1][3] - The company aims to achieve distribution in all 50 states to demonstrate the feasibility of its VLN products and align with the FDA's low nicotine mandate published in January 2025 [4] - VLN cigarettes contain 95% less nicotine than traditional cigarettes, which has been shown in clinical studies to reduce smoking rates [5][9] Company Strategy - The CEO of 22nd Century Group expressed excitement about expanding VLN's presence and emphasized the importance of state authorizations and distribution partnerships [3] - The company is focused on increasing the availability of VLN products through new stores, chains, and geographical areas [3] Product Information - VLN and Partner VLN reduced nicotine content cigarettes are the first combusted tobacco products to comply with the FDA's proposed new Tobacco Product Standard for Nicotine Yield [5][10] - The proprietary non-GMO reduced nicotine tobacco plants developed by the company result in a product that contains 95% less nicotine than traditional tobacco [8]
22nd Century Group to Announce Third Quarter 2025 Results on November 4, 2025
Globenewswire· 2025-10-21 12:00
Core Viewpoint - 22nd Century Group, Inc. is set to host a webcast on November 4, 2025, to discuss its third quarter results for 2025, highlighting its ongoing leadership in tobacco harm reduction and nicotine consumption control [1][2]. Company Overview - 22nd Century Group is a pioneer in the tobacco harm reduction movement, focusing on enabling smokers to manage their nicotine consumption [4]. - The company has developed proprietary non-GMO reduced nicotine tobacco plants that contain 95% less nicotine than traditional tobacco plants, supported by an extensive patent portfolio [5]. Products - The flagship product, VLN cigarette, utilizes low nicotine tobacco, providing traditional smokers with a familiar alternative that helps reduce nicotine consumption by 95% compared to regular cigarettes [6]. - VLN cigarettes are the only low nicotine combustible cigarettes authorized by the FDA in the United States [7]. Webcast Details - The webcast will feature Larry Firestone, CEO, and Dan Otto, CFO, who will review financial results and discuss recent progress and future plans for 2025 [2][3].