Summary of 22nd Century Group (XXII) Conference Call - August 20, 2025 Company Overview - **Company Name**: 22nd Century Group Inc. - **Ticker Symbol**: XXII - **Industry**: Tobacco, specifically focused on nicotine harm reduction - **Market Position**: Leader in the tobacco harm reduction movement since 1998, aligned with FDA's low nicotine mandate [1][2][3] Key Industry Insights - **Tobacco Market Size**: - Global market: $1.1 trillion in annual sales, with $873 billion from cigarette sales [4] - U.S. market: $109 billion in annual sales, with $83 billion from cigarette sales [4] - **Smoker Statistics**: - 1.1 billion smokers globally, with 28.8 million in the U.S. [4] - 8 million annual deaths globally due to smoking-related health conditions [4] - U.S. smoking-related deaths: approximately 480,000 annually [4] - **Market Growth**: U.S. tobacco industry projected to grow to $180 billion by 2030, representing an 8.15% CAGR [5] Core Company Strategies - **Product Focus**: - Emphasis on low nicotine (VLN) products, which are positioned to compete with traditional combustible cigarettes and other nicotine delivery systems [11][12] - Development of a diverse portfolio including VLN cigarettes, moist snuff, and other tobacco products [26] - **Regulatory Alignment**: - Fully compliant with FDA's proposed rule for low nicotine content (0.7 mg/g), which is expected to significantly reduce nicotine addiction [14][42] - **Research and Development**: - Ongoing research into non-GMO low nicotine tobacco and its potential to lower harmful nitrosamines [16][30] - Independent studies showing that 40% of participants reduced their smoking habits using VLN products [17] Financial Strategy and Performance - **Shift in Business Model**: - Transitioning away from high-volume, low-margin contract manufacturing to focus on branded products [25][31] - Anticipated lower revenues in the short term as the company prioritizes gross profit and margins [25] - **Future Financial Goals**: - Targeting cash flow breakeven by 2026 [48] - Maintaining operating expenses around $2 million per quarter [31] Market Launch and Distribution - **Product Launch**: - VLN products are set to launch in 2,000 retail outlets across 30 states, with plans for nationwide distribution [27][39] - Marketing strategies include extensive consumer communication and in-store promotions [22] - **Retail Partnerships**: - Engaging with major retailers for broader distribution once state approvals are secured [39][28] Additional Insights - **Public Health Concerns**: - Addressing issues of nicotine addiction and the impact of smoking on public health, particularly among youth [6][8] - **Industry Dynamics**: - The company positions itself as a leader in the transition towards reduced nicotine products, similar to the shift from leaded to unleaded gasoline [47] - **Government Support**: - No direct government funding anticipated; the company relies on independent research to validate its products [37][38] Conclusion - **Outlook**: - The company is optimistic about its future, focusing on growth in the VLN segment and aligning with regulatory changes to capture market share [32][50]

Financial Data and Key Metrics Changes - Net revenue for Q2 2025 was $4 million, a decrease from $6 million in Q1 2025, with total cartons sold increasing to 779,000 from 478,000 in the previous quarter [33] - Gross margin remained consistent at a loss of $600,000, with total operating expenses rising to $2.3 million from $2 million in the previous quarter [34] - Net loss from continuing operations was approximately $3.3 million, consistent with Q1 2025, while adjusted EBITDA was a loss of $2.6 million compared to a loss of $2.3 million in Q1 2025 [35] Business Line Data and Key Metrics Changes - The company is shifting focus from low-margin CMO business to high-margin branded products, which is expected to improve gross margins despite a potential decline in top-line revenue in the near term [23][31] - The introduction of VLN products is anticipated to drive revenue growth and gross margin expansion, although initial financial results may not reflect this until Q3 2025 [31] Market Data and Key Metrics Changes - The company has begun shipping Pinnacle VLN products in August 2025, with initial stocking orders exceeding 3,000 cartons, indicating a positive market entry for the new product line [32] - The FDA's proposed low nicotine mandate is expected to create a competitive environment for VLN products, positioning the company favorably against traditional combustible cigarettes [24][28] Company Strategy and Development Direction - The company aims to lead the tobacco harm reduction movement by leveraging its proprietary low nicotine tobacco technology, which is compliant with the FDA's new standards [25][26] - A strategic shift towards higher-margin products is underway, with plans to phase out low-margin CMO products to enhance profitability [23][31] Management's Comments on Operating Environment and Future Outlook - Management acknowledges challenges in achieving profitability due to delays in launching high-margin products, projecting a timeline into 2026 for breakeven on EBITDA [32] - The company is optimistic about the market potential for VLN products, emphasizing the importance of scaling and rate of sale as key metrics for future success [49] Other Important Information - The company is actively pursuing a lawsuit against Dorchester Insurance Company for $9 million in business interruption insurance, with a trial date set for November 2025 [35] - The company has reduced debt by approximately $1 million and improved working capital by tightening inventory [33] Q&A Session Summary Question: When might the company achieve breakeven on a quarterly basis for EBITDA? - Management indicated that they are looking at the first half of 2026, with a focus on the timing of branded product launches and sales rates to determine if breakeven can be achieved in Q1 or Q2 [41] Question: Is the current cash position sufficient to reach breakeven, or will additional share issuance be necessary? - Management noted that while the current cash of $3 million is being managed carefully, there may be a need for additional fundraising, though it would be less than previous amounts [42][43] Question: What are the plans regarding the outstanding debt rolling over in March 2026? - Management is in discussions with creditors about paying off the debt and plans to allocate part of any new fundraising towards extinguishing it [44] Question: Is there a chance that the MRTP for VLN would not be renewed? - Management expressed confidence that the MRTP would be renewed, given compliance with the FDA's recent mandates [45]

Financial Data and Key Metrics Changes - Adjusted diluted earnings per share increased by 8.3% to $1.44 in the second quarter and by 7.2% for the first half [19] - Adjusted operating companies income in the Smokable Products segment grew by 4.2% to $2.9 billion in the second quarter and by 3.5% to $5.5 billion in the first half [19] - Adjusted OCI margins expanded to 64.5% for both the second quarter and the first half [20] Business Line Data and Key Metrics Changes - In the Smokable Products segment, domestic cigarette volumes declined by 10.2% in the second quarter and 11.9% for the first half [20] - Oral nicotine pouches, particularly ON!, reported a shipment volume increase of 26.5% to 52.1 million cans in the second quarter [11] - Adjusted OCI for the Oral Tobacco Products segment grew by 10.9% in the second quarter and 5.5% in the first half [23] Market Data and Key Metrics Changes - The e-vapor category included over 20.5 million vapers, up by over 1.9 million year over year [14] - Disposable vapers increased by an estimated 2.7 million to approximately 14.4 million, representing over 60% of the e-vapor category [14] - Domestic cigarette volumes at the industry level declined by an estimated 8.5% in the second quarter [20] Company Strategy and Development Direction - The company aims to shape a fully regulated industry and provide expanded product choices for adult nicotine consumers [8] - Continued focus on driving trial, building long-term equity, and increasing profitability in the ON! brand [12] - The company is actively exploring potential next steps regarding the nJoy e-vapor product line, including an appeal against patent disputes [13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong performance of operating companies despite challenging market conditions [18] - The macroeconomic environment remains dynamic, with inflation and consumer confidence being key factors to monitor [32] - The company raised the lower end of its 2025 guidance range, expecting adjusted diluted EPS in the range of $5.35 to $5.45 [25] Other Important Information - The company returned over $4 billion to shareholders through dividends and share repurchases in the first half of the year [8] - The total debt to EBITDA ratio as of June 30 was 2.0 times, in line with the target [26] - The company is advocating for more coordinated actions against illicit e-vapor products to clean up the marketplace [16] Q&A Session Summary Question: Insights on the raised guidance range and consumer environment - Management highlighted the dynamic market and the need to monitor adult tobacco consumer behaviors due to inflationary pressures [31] Question: Update on nJoy e-vapor product development - Management confirmed that product development for the nJoy ACE device is progressing, with plans to file for FDA approval [35] Question: Long-term EPS growth outlook - Management remains confident in achieving mid-single-digit EPS growth through FY 2028, despite economic strains on consumers [44] Question: Strategy for the Basic brand - The company is using targeted analytics to maintain consumer loyalty and expand the Basic brand's presence in discount segments [49] Question: Impact of illicit vape crackdowns - Management noted that while enforcement actions are increasing, it is too early to determine their overall impact on the market [58] Question: Tariff impacts on business - Tariffs have had some impact on costs, particularly in supply chain materials, but are not viewed as material to overall business performance [98]

Financial Data and Key Metrics Changes - Adjusted diluted earnings per share increased by 8.3% to $1.44 in Q2 2025 and by 7.2% for the first half, driven by robust adjusted operating companies income growth and share repurchases [19][25] - Adjusted operating companies income for the Smokable Products segment grew by 4.2% to $2.9 billion in Q2 and by 3.5% to $5.5 billion in the first half [19][20] - Adjusted OCI margins expanded to 64.5% for both Q2 and the first half [20] Business Line Data and Key Metrics Changes - Oral nicotine pouches, particularly ON!, were the primary growth driver, with reported shipment volume increasing by 26.5% to 52.1 million cans year-over-year [9][23] - Domestic cigarette volumes in the Smokable Products segment declined by 10.2% in Q2 and 11.9% for the first half, with adjusted estimates showing declines of approximately 10.5% [20][21] - The Oral Tobacco Products segment saw adjusted OCI grow by 10.9% in Q2, primarily driven by ON!'s strong performance [23] Market Data and Key Metrics Changes - The e-vapor category included over 20.5 million vapers, up by 1.9 million year-over-year, with disposable vapers increasing to approximately 14.4 million [14][15] - The flavored disposable market continues to drive e-vapor category growth, representing over 60% of the category [15][16] Company Strategy and Development Direction - The company is focused on shaping a fully regulated industry and expanding product choices for adult nicotine consumers, while also advocating for enforcement against unregulated products [7][14] - The strategy includes targeted launches and promotions for the Basic brand to retain consumers in the portfolio while addressing macroeconomic pressures [21][49] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong performance of operating companies despite challenging market conditions and inflationary pressures [18][32] - The company raised the lower end of its 2025 guidance range, expecting adjusted diluted EPS to be in the range of $5.35 to $5.45, reflecting a growth rate of 3% to 5% from 2024 [25][26] Other Important Information - The company returned significant value to shareholders, paying approximately $3.5 billion in dividends and repurchasing 10.4 million shares for $600 million in the first half of the year [26][27] - The total debt to EBITDA ratio as of June 30 was 2.0 times, in line with the target [27] Q&A Session Summary Question: Discussion on the raised guidance range and expectations for the second half - Management acknowledged the strong first half results and the dynamic market conditions, emphasizing the need to monitor consumer behavior amid inflation [30][32] Question: Update on nJoy e-vapor product development - Management confirmed that product development for the new nJoy device is progressing, with plans to file for FDA approval once ready [34][36] Question: Long-term EPS growth outlook - Management remains confident in achieving mid-single-digit EPS growth through FY 2028, despite current economic strains on consumers [43][44] Question: Strategy for the Basic brand and discount share - The company is strategically repositioning Basic as a discount brand while using data analytics to target consumers effectively [49][50] Question: Impact of enforcement on illicit vapes and cigarette volumes - Management noted that while enforcement actions are increasing, it is too early to determine their full impact on the market [55][58] Question: Clarification on tariff impacts - Management indicated that while tariffs have affected costs, they do not view them as material to overall business performance [96][97]

Core Insights - 22nd Century Group, Inc. has announced a significant increase in state authorizations for the sale of its VLN® reduced nicotine content cigarettes and other products, enabling new sales activities and product launches [1][2][3] - The company aims to achieve nationwide availability of VLN® products across all 50 states, demonstrating compliance with the FDA's Low Nicotine Mandate [3][4] - The company has over 2,000 partner VLN® retailers preparing to implement sales, with expectations for further growth in the second half of 2025 [3][4] Product and Market Expansion - The increase in state authorizations allows for the launch of new partner brands and private label VLN® products in large, untapped markets across the U.S. [4] - There are over 272,000 retail outlets in the U.S. selling tobacco products, presenting a substantial market opportunity for both VLN® and conventional products [4] - Key state authorizations include VLN® Gold and Green in 41 states, VLN® Red in 21 states, and various Smoker Friendly and Pinnacle® products across multiple states [8] Harm Reduction and Innovation - 22nd Century Group has been a leader in the tobacco harm reduction movement for 27 years, focusing on reducing smoking rates and health harms through its VLN® products [5][6] - VLN® cigarettes contain 95% less nicotine than traditional cigarettes, supported by decades of peer-reviewed studies indicating reduced smoking rates and health risks [5][7][10] - The company utilizes proprietary technologies to create reduced nicotine tobacco blends, ensuring a unique position in the market with its patented products [10]