XXII 22nd Century Group Inc.

1.59
0  0%
Previous Close 1.59
Open 1.62
52 Week Low 0.55
52 Week High 1.8
Market Cap $220,786,117
Shares 138,859,193
Float 124,095,863
Enterprise Value $197,743,708
Volume 1,603,535
Av. Daily Volume 1,929,353
Stock charts supplied by TradingView

Drug Pipeline

Drug Stage Notes
VLN cigarettes
MRTP application
NDA Filing
NDA Filing
FDA Tobacco Products Scientific Advisory Committee (TPSAC) to met February 14, 2020, regarding MRTP application.

Latest News

  1. WILLIAMSVILLE, N.Y., Nov. 24, 2020 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE:XXII), a leading plant-based, biotechnology company that is focused on tobacco harm reduction, very low nicotine content tobacco, and hemp/cannabis research, announced today that Morning Consult, a global data intelligence company with an editorial division that issues an influential newsletter reaching more than 300,000 audience members on the Hill and within federal agencies, published a powerful op-ed article penned by John Pritchard, 22nd Century's vice president of regulatory science.

    In the article, Pritchard calls for the U.S. Food and Drug Administration (FDA) to accelerate implementation of its Comprehensive Plan on Tobacco and Nicotine Regulation…

    WILLIAMSVILLE, N.Y., Nov. 24, 2020 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE:XXII), a leading plant-based, biotechnology company that is focused on tobacco harm reduction, very low nicotine content tobacco, and hemp/cannabis research, announced today that Morning Consult, a global data intelligence company with an editorial division that issues an influential newsletter reaching more than 300,000 audience members on the Hill and within federal agencies, published a powerful op-ed article penned by John Pritchard, 22nd Century's vice president of regulatory science.

    In the article, Pritchard calls for the U.S. Food and Drug Administration (FDA) to accelerate implementation of its Comprehensive Plan on Tobacco and Nicotine Regulation, in particular to impose the mandate requiring all cigarettes sold in the United States to contain minimally or non-addictive levels of nicotine. The proposed rule was removed abruptly from the agency's agenda late last year without warning or significant explanation. Yet, smoking remains the number one preventable cause of death in America, killing near half a million people a year or, 1,300 deaths per day. The serious direct and indirect harm caused by cigarette addiction is irrefutable. Furthermore, the COVID-19 pandemic has further accelerated the need to promote and protect respiratory health.

    "Despite the obvious harm of smoking, the staggering public health costs, and the millions of lives lost, we have never mustered the fortitude to enact policies that would make cigarettes less addictive and end this public health disaster. This is the perfect time to take that step," wrote John Pritchard, vice president of regulatory science of 22nd Century Group.

    Pritchard stressed the importance of a timely decision by the FDA, "Companies like the one where I work have developed technology to decrease the chances that future generations become addicted to cigarettes and to provide alternatives for smokers of highly addictive cigarettes…Yet we continue to wait almost a year for a further authorization to allow us to communicate this breakthrough to adult smokers. The faster this can be achieved, the sooner and greater the public health benefit in the United States."

    The article is reprinted below in its entirety:

    It's Time for the Government to Refocus on Respiratory Health

    BY JOHN PRITCHARD

    Published November 19, 2020

    Americans have historically applied science and technology to advance the nation and its public health. We developed advanced diagnostic tools, removed lead from gasoline, limited harmful substances in our food and drink and countless other examples. There is, however, one tragic exception to such success: cigarettes.

    Despite the obvious harm of smoking, the staggering public health costs and the millions of lives lost, we have never mustered the fortitude to enact policies that would make cigarettes less addictive and end this public health disaster. This is the perfect time to take that step.

    The COVID-19 pandemic has brought into sharp focus the importance of respiratory health: We all need air that is not harmful. For people addicted to the nicotine in cigarettes, this pandemic brings yet another specter related to their already compromised respiratory health.

    The serious direct and indirect harm caused by cigarette addiction is irrefutable. Smoking causes almost half a million deaths a year or 1,300 deaths per day. Compare that to COVID-19, which tragically takes about 1,200 lives per day, and there's little doubt that smoking is a never-ending pandemic.

    Further, 16 million Americans are currently living with smoking-related disease, leading to about $300 billion in annual economic costs. The outlook remains truly horrific; the Centers for Disease Control and Prevention estimates 5.6 million children alive today will die from smoking-related diseases.

    The U.S. Food and Drug Administration responded to these alarming statistics by developing the landmark Comprehensive Plan for Tobacco and Nicotine Regulation in 2017. The plan was straightforward: create a roadmap to better protect youth and help addicted adult smokers quit, significantly reducing tobacco-related disease and death in the United States in the years to come.

    At the time, then-FDA Commissioner Dr. Scott Gottlieb called it an opportunity to save millions of lives. "The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes – the only legal product that, when used as intended, will kill half of all long-term users," Gottlieb said at the time.

    Then, late last year, without warning or significant explanation, the FDA abruptly removed the proposed rule-making to reduce nicotine levels in cigarettes from its regulatory agenda. Even before the COVID-19 pandemic struck, policymakers decided there were more immediate priorities than cigarette addiction and the roughly half-million Americans who die from it each year.

    And so, here we are still; the cycle continues. The tobacco industry promotes an addictive product and gains financially from smokers' life-long compulsive consumption, the costs of which are largely borne (like COVID-19) by individuals and families in lower socio-economic communities and regions. Deaths are offset by "replacement smokers" – our children.

    But the facts remain. There are approximately 34 million smokers in the United States, 70 percent of whom have expressed a desire to quit. In fact, a recent survey found that 8 in 10 adult smokers favor requiring cigarette makers to lower nicotine levels in cigarettes so that they are less addictive.

    By mandating the reduction of nicotine levels in cigarettes to minimally or non-addictive levels and by introducing a pragmatic regulatory approach to alternative methods of nicotine delivery, we have the opportunity to reduce the harm caused by addiction and to save millions of lives. But we continue to delay the steps needed to make that a reality.

    This is where science comes in. Companies like the one where I work have developed technology to decrease the chances that future generations become addicted to cigarettes and to provide alternatives for smokers of highly addictive cigarettes. Our product, based on years of research by the FDA, the National Institutes of Health and the CDC, dramatically reduces the amount of nicotine in tobacco. The FDA has already authorized our product for sale as "appropriate for the protection of public health" in 2019. Yet we continue to wait almost a year for a further authorization to allow us to communicate this breakthrough to adult smokers. The faster this can be achieved, the sooner and greater the public health benefit in the United States.

    Too many Americans pay a fatal price for cigarette addiction and for too long; the global pandemic has accelerated the need to promote and protect respiratory health. The FDA's comprehensive plan on tobacco and nicotine deserves and demands to be a national priority. The FDA should revisit their plan and accelerate its own actions. But even before that, the agency should provide authorizations to those products that can begin to change the trajectory of disease and death in the United States. The impact of these actions will go a long way towards protecting public health and the lives of individual Americans now and for generations to come.

    We have the science. Now, we just need the will.

    About Morning Consult

    Morning Consult is a global data intelligence company established in 2014. The company provides global survey research tools, data services and news to organizations in business, marketing, economics, and politics. Morning Consult's editorial division covers various subject areas including, Washington, Brands, Tech, Energy, Finance, Health, Sports, and Entertainment. The company produces original reporting, as well as daily email newsletter briefings that reach 300,000 subscribers.

    About 22nd Century Group, Inc.

    22nd Century Group, Inc. (NYSE:XXII) is a leading plant biotechnology company focused on technologies that alter the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering, gene-editing, and modern plant breeding. 22nd Century's primary mission in tobacco is to reduce the harm caused by smoking through the Company's proprietary reduced nicotine content tobacco cigarettes – containing 95% less nicotine than conventional cigarettes. The Company's primary mission in hemp/cannabis is to develop and commercialize proprietary hemp/cannabis plants with valuable cannabinoid profiles and desirable agronomic traits.

    Learn more at xxiicentury.com, on Twitter @_xxiicentury and on LinkedIn.

    Cautionary Note Regarding Forward-Looking Statements

    Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements typically contain terms such as "anticipate," "believe," "consider," "continue," "could," "estimate," "expect," "explore," "foresee," "goal," "guidance," "intend," "likely," "may," "plan," "potential," "predict," "preliminary," "probable," "project," "promising," "seek," "should," "will," "would," and similar expressions. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in "Risk Factors" in the Company's Annual Report on Form 10-K filed on March 11, 2020 and in its subsequently filed Quarterly Report on Form 10-1. 22nd Century undertakes no obligation to publicly update or revise any forward-looking statement as a result of new information, future events, or otherwise, except as otherwise required by law.

    All information provided in this release is as of the date hereof, and the Company assumes no obligation to and does not intend to update these forward-looking statements, except as required by law.

    Investor Relations & Media Contact:

    Mei Kuo

    Director, Communications & Investor Relations

    22nd Century Group, Inc.

    (716) 300-1221



    Primary Logo

    View Full Article Hide Full Article
  2. WILLIAMSVILLE, N.Y., Nov. 18, 2020 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE:XXII), a leading plant-based, biotechnology company that is focused on tobacco harm reduction, very low nicotine content tobacco, and hemp/cannabis research, announced today that Chief Executive Officer, James A. Mish, will speak on a panel at the Cowen 2020 Boston Cannabis Conference on Wednesday, December 2, 2020 at 11:50 a.m. EST. The virtual conference is a forum for objective first-hand updates on both marketed and emerging products across the spectrum of the cannabis industry focusing on consumer, technology, and healthcare.

    The panel, "Tobacco and Cannabis," moderated by Vivien Azer, managing director and senior research analyst specializing in tobacco…

    WILLIAMSVILLE, N.Y., Nov. 18, 2020 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE:XXII), a leading plant-based, biotechnology company that is focused on tobacco harm reduction, very low nicotine content tobacco, and hemp/cannabis research, announced today that Chief Executive Officer, James A. Mish, will speak on a panel at the Cowen 2020 Boston Cannabis Conference on Wednesday, December 2, 2020 at 11:50 a.m. EST. The virtual conference is a forum for objective first-hand updates on both marketed and emerging products across the spectrum of the cannabis industry focusing on consumer, technology, and healthcare.

    The panel, "Tobacco and Cannabis," moderated by Vivien Azer, managing director and senior research analyst specializing in tobacco, cannabis, and beverages sectors at Cowen, will feature executives of U.S. cannabis and tobacco operators sharing their on-the-ground reactions to the election, COVID-19, and industry trends.

    22nd Century's management team will also participate in one-on-one meetings with investors during the course of the conference from Monday, November 30, 2020 to Wednesday, December 2, 2020. For more information regarding the Cowen 2020 Boston Cannabis Conference, please visit: https://www.cowen.com/conferences-and-events/3rd-annual-boston-cannabis-conference/.

    About 22nd Century Group, Inc.

    22nd Century Group, Inc. (NYSE:XXII) is a leading plant biotechnology company focused on technologies that alter the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering, gene-editing, and modern plant breeding. 22nd Century's primary mission in tobacco is to reduce the harm caused by smoking through the Company's proprietary reduced nicotine content tobacco cigarettes – containing 95% less nicotine than conventional cigarettes. The Company's primary mission in hemp/cannabis is to develop and commercialize proprietary hemp/cannabis plants with valuable cannabinoid profiles and desirable agronomic traits.

    Learn more at xxiicentury.com, on Twitter @_xxiicentury and on LinkedIn.

    Investor Relations & Media Contact:

    Mei Kuo

    Director, Communications & Investor Relations

    22nd Century Group, Inc.

    (716) 300-1221

     



    Primary Logo

    View Full Article Hide Full Article
  3. WILLIAMSVILLE, N.Y., Nov. 16, 2020 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE:XXII), a leading plant-based, biotechnology company that is focused on tobacco harm reduction, very low nicotine content tobacco, and hemp/cannabis research, announced today that the Company will present and meet with investors at the Virtual Fall Investor Summit. The conference is being held virtually November 16 -18, 2020.

    22nd Century is scheduled to present on Tuesday, November 17, 2020 at 4:30 p.m. ET. The live webcast and presentation will be accessible in the Investors section of 22nd Century's website under Events. An archived replay of the webcast will be available shortly after the live event.

    Please visit https://investorsummitgroup.com/ to register…

    WILLIAMSVILLE, N.Y., Nov. 16, 2020 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE:XXII), a leading plant-based, biotechnology company that is focused on tobacco harm reduction, very low nicotine content tobacco, and hemp/cannabis research, announced today that the Company will present and meet with investors at the Virtual Fall Investor Summit. The conference is being held virtually November 16 -18, 2020.

    22nd Century is scheduled to present on Tuesday, November 17, 2020 at 4:30 p.m. ET. The live webcast and presentation will be accessible in the Investors section of 22nd Century's website under Events. An archived replay of the webcast will be available shortly after the live event.

    Please visit https://investorsummitgroup.com/ to register for the conference and schedule one-on-one meeting with 22nd Century.

    About 22nd Century Group, Inc.

    22nd Century Group, Inc. (NYSE:XXII) is a leading plant biotechnology company focused on technologies that alter the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering, gene-editing, and modern plant breeding. 22nd Century's primary mission in tobacco is to reduce the harm caused by smoking through the Company's proprietary reduced nicotine content tobacco cigarettes – containing 95% less nicotine than conventional cigarettes. The Company's primary mission in hemp/cannabis is to develop and commercialize proprietary hemp/cannabis plants with valuable cannabinoid profiles and desirable agronomic traits.

    Learn more at xxiicentury.com, on Twitter @_xxiicentury and on LinkedIn.

    Investor Relations & Media Contact:

    Mei Kuo

    Director, Communications & Investor Relations

    22nd Century Group, Inc.

    (716) 300-1221

     



    Primary Logo

    View Full Article Hide Full Article
  4. Key Highlights:

    • 22nd Century remains focused on its primary mission of reducing the harm caused by smoking. To this end, in recent weeks the Company has intensified its proactive efforts to secure a Modified Risk Tobacco Product (MRTP) authorization from the U.S. Food and Drug Administration (FDA) for VLN®. With 95% less nicotine than leading brands - or any other cigarette in the U.S. - VLN® will make 22nd Century the first, and only company in the world to achieve a MRTP designation for a combustible cigarette.

    • The Company has plans in place to commercialize VLN® in the U.S. 90 days after receiving MRTP authorization. These plans include a rollout through large, well-recognized retail chains in the U.S. and a marketing campaign to introduce…

    Key Highlights:

    • 22nd Century remains focused on its primary mission of reducing the harm caused by smoking. To this end, in recent weeks the Company has intensified its proactive efforts to secure a Modified Risk Tobacco Product (MRTP) authorization from the U.S. Food and Drug Administration (FDA) for VLN®. With 95% less nicotine than leading brands - or any other cigarette in the U.S. - VLN® will make 22nd Century the first, and only company in the world to achieve a MRTP designation for a combustible cigarette.



    • The Company has plans in place to commercialize VLN® in the U.S. 90 days after receiving MRTP authorization. These plans include a rollout through large, well-recognized retail chains in the U.S. and a marketing campaign to introduce adult smokers to the world's lowest nicotine content cigarette.



    • 22nd Century was recently granted a new, highly valuable U.S. patent which provides the Company with precise genetic control over nicotine levels in virtually any variety of the tobacco plant. The breakthrough technology will enable the Company to rapidly introduce very low nicotine traits into all varieties of tobacco currently used in the production of cigarettes and other tobacco products.



    • The Company has refocused its hemp/cannabis strategy to prioritize the upstream value chain segments of plant/seed biotechnology, breeding, cultivation, and purification of disruptive, proprietary plant lines over cannabidiol (CBD) and hemp-based consumer products in the U.S.



    • Net sales revenue increased approximately 13.1% from the third quarter of 2019 to $7.3 million.



    • Year-to-date, gross profit improved by $1.1 million year-over-year and continues to show improvement as a result of increased contract manufacturing operation (CMO) sales volume and pricing as well as targeted actions to improve production costs.



    • Quarter-to-date, total operating expenses improved by $3.2 million and operating loss improved by $3.6 million over the prior-year quarter.



    • Net loss improved by $6.0 million over the same quarter in the prior year.



    • The Company's financial position remains strong with cash, cash equivalents, and short-term investment securities totaling approximately $26.8 million at the end of the third quarter 2020.



    • Adjusted EBITDA improved by 26.4% compared to the third quarter of 2019.



    WILLIAMSVILLE, N.Y., Nov. 05, 2020 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE:XXII), a leading plant-based, biotechnology company that is focused on tobacco harm reduction, very low nicotine content tobacco, and hemp/cannabis research, announced today that the Company filed its 2020 Third Quarter Report on Form 10-Q with the U.S. Securities and Exchange Commission. The Company will provide a business update for investors on a live audio webcast to be held today at 8:00 a.m. ET.

    James A. Mish, chief executive officer of 22nd Century Group, together with Michael Zercher, chief operating officer, and John Franzino, chief financial officer, will host the webcast. Interested parties are invited to participate by visiting the Events section on the Company's Investor Relations website at www.xxiicentury.com/investors/events. Following prepared remarks, the Company will host a Q&A session during which management will accept questions from industry analysts. Investors, shareholders, and members of the media will also have the opportunity to submit their questions through the interactive webcast.

    "In my first few months as CEO of 22nd Century, I met with scientists, public health officials, national cigarette retailers, farmers, and 22nd Century shareholders. What I heard, from each of these groups, is that 22nd Century's VLN® cigarettes have the potential to disrupt and redefine the entire tobacco industry and, in doing so, prevent millions of our nation's youth from becoming addicted to the only legal consumer product that, when used as intended, will kill half of all long-term users," said James A. Mish, chief executive officer of 22nd Century Group. "Understanding these facts has helped me to truly appreciate the Company's primary mission of reducing the harm caused by smoking and to reaffirm the Company's strategic priorities."

    After conducting a comprehensive review of 22nd Century's existing business, extensive intellectual property portfolio, and the regulatory climate in which the Company operates, management has identified near-term milestones and medium/long-term opportunities:

    1. Securing a MRTP authorization from the FDA for VLN® remains the Company's number one priority. Separately, but at the same time, 22nd Century has made product launch plans that include a national roll-out with large, well-recognized retail chains in the U.S. and a marketing campaign that has been designed to introduce adult smokers to the world's lowest nicotine content cigarette. Commercial product launch and licensing discussion with potential strategic partners in the U.S. and globally will commence within 90 days of MRTP authorization.



    2. An equally important first priority initiative is supporting and advancing the FDA's plan to require that all cigarettes sold in the U.S. be made "minimally or non-addictive" by limiting their nicotine content to just 0.5 milligrams of nicotine per gram of tobacco (a level already achieved by 22nd Century's proprietary VLN® cigarettes). When the FDA mandate ultimately goes into effect, 22nd Century plans to make the Company's proprietary reduced nicotine content tobacco and related intellectual property available to every cigarette manufacturer in the U.S.



    3. 22nd Century's near- and medium-term commercial prospects have never been brighter. Since reporting second quarter earnings, the Company has refocused its hemp/cannabis strategy to target the upstream segments of the value chain such as plant biotechnology research, gene modification and engineering, and modern plant breeding. This renewed emphasis on intellectual property and high-value genetic traits is a shift away from CBD and hemp-based consumer products in the already saturated U.S. market. Accordingly, 22nd Century will concentrate its hemp/cannabis efforts on initiatives related to the Company's current (and exclusive) KeyGene collaboration and on the existing worldwide license agreement with Anandia Laboratories.



    4. 22nd Century has also identified a third plant-based franchise that has similarities in its genome to the hemp/cannabis plant. The Company plans to turn attention to this franchise after execution of its tobacco and hemp/cannabis strategies. 22nd Century is in the process of securing valuable and necessary intellectual property and pursuing strategic partnerships to support the development of this franchise. The Company will provide additional information as the competitive situation allows.



    5. Additionally, 22nd Century's operating results for the third quarter were strong, driven by year-over-year revenue growth and continued gross margin improvement. The Company's balance sheet is healthy and has excellent prospects to establish strategic partnerships upon its MRTP authorization. 22nd Century is fully prepared to launch its historic VLN® product.

    Business Highlights and Key Events

    • On September 17, 2020, 22nd Century announced the appointment of Michael Koganov, Sc.D., Ph.D., to its Board of Directors. Dr. Koganov will serve as Chair of the Company's Scientific Advisory Board and as a member of the Board of Director's Finance Committee. Recognized as a leading expert in the development of plant-derived, natural products and solutions for pharmaceutical, consumer packaged goods, and life science companies, Dr. Koganov brings a valuable scientific perspective to 22nd Century's business and research and development strategies.



    • On October 14, 2020, the Company announced that it was granted U.S. Patent No. 10,669,552 entitled "Up-regulation of auxin response factor NbTF7 to decrease nicotine in a plant." This crucial patent covers methods of manipulating plant metabolism and alkaloid levels by controlling transcription factor NbTF7, which regulates the nicotine alkaloid biosynthetic pathway. This breakthrough technology provides the Company with a rapid pathway to introduce very low nicotine traits into virtually any variety of tobacco, including bright, burley, oriental, and cigar tobacco varieties. This achievement further demonstrates that the FDA's Comprehensive Plan for Tobacco and Nicotine Regulation to limit the nicotine content for all cigarettes sold in the U.S. is technically feasible and at the same time definitively disproves the "Big Tobacco" claim that such low nicotine levels cannot be achieved in all tobacco varieties.



    • On October 19, 2020, the Company announced its participation in the Food and Drug Law Institute's Tobacco and Nicotine Products Regulation and Policy Conference. John Pritchard, 22nd Century's vice president of regulatory science, presented as a member of the conference's "Nicotine and Harm Reduction" panel on Thursday, October 22. During the conference, 22nd Century expressed strong support for the FDA's landmark 2017 Comprehensive Plan for Tobacco and Nicotine Regulation, in particular the FDA's plan to require all cigarettes sold in the U.S. to be made "minimally or non-addictive" by limiting their nicotine content to just 0.5 milligrams of nicotine per gram of tobacco, a level already achieved by 22nd Century's proprietary VLN® cigarettes. The Company gained significant exposure with the 300 participants attending the conference, including members of the FDA's Center for Tobacco Products (CTP), advocates of public health and regulation, and key members of the media. 22nd Century continues to advocate for common-sense tobacco and nicotine regulation and urges public health officials to unite against the tragic toll of cigarette addiction.



    • Since reporting second quarter earnings in August, the Company has finalized its strategic plans, set near-term milestones, and identified exciting medium and long-term opportunities. 22nd Century's primary mission and highest, near-term priority is on reducing the harm caused by smoking. The Company will achieve its mission by bringing to market its proprietary, reduced nicotine content tobacco cigarettes – containing 95% less nicotine than conventional cigarettes – under the brand name VLN® upon the FDA's authorization of its MRTP application. The Company continues to maintain its dialogue with the FDA, and believes the Agency is in the final stages of the review process related to its application. In addition to its ongoing contact with the FDA, 22nd Century is also working with various legal counsel, advisors, and government affairs specialists to highlight the public health importance of its MRTP application to encourage a near-term authorization of its application.



      With more than 34 million smokers in the U.S. and more than 1 billion worldwide, the FDA's authorization of the VLN® MRTP application will serve as a catalyst for 22nd Century's commercial sales. The Company believes that achieving just one-quarter of one percent (0.25%) market share of the U.S. cigarette market, could result in revenues that may over time, based on the disruptive nature of VLN®, drive the Company's market capitalization more than 10 times higher. In addition, the Company believes the FDA's authorization of 22nd Century's MRTP with modified exposure claims would open multiple licensing opportunities for 22nd Century's proprietary reduced nicotine content tobacco in the U.S. and globally.



    • The Company will make VLN® available to adult smokers in the U.S. through its planned distribution in pharmacies, convenience stores, and other tobacco retail outlets within 90 days of receiving MRTP authorization from the FDA. 22nd Century has received extremely positive feedback on its reduced nicotine content cigarettes from many potential partners in the independent, regional, and national retail trade, and the Company is in the process of finalizing its distribution plans and agreements. The Company is also in the final stages of completing its marketing plans for VLN® and currently anticipates a phased roll out in select geographies within 90 days of MRTP authorization. 22nd Century plans to position VLN® in the premium pricing segment of the cigarette market and expects it to deliver corresponding margins. The Company's consumer market research indicates that 60% of adult smokers have an interest in using VLN®. Discussions with potential tobacco retailers have indicated strong support from trade channel partners.



    • 22nd Century has also made considerable progress in the development of its non-GMO (genetically modified organisms) technology and has successfully applied the next generation methodology of reducing nicotine levels in tobacco plants to several varieties of tobacco. The non-GMO technology has shown to consistently achieve reductions in nicotine levels by as much as 99% compared to conventional tobacco. The Company believes that non-GMO technology is key to commercializing global opportunities where non-GMO products are preferred by consumers or where GMO products are banned. The Company will begin to execute on commercial opportunities overseas once it secures MRTP authorization from the FDA, as the Agency is viewed as the gold standard in public health. The Company has already harvested non-GMO crops from field trials conducted earlier this year and is already developing a non-GMO very low nicotine content cigarette prototype.



    • The Company's genesis in hemp/cannabis research was established in 2014 through a worldwide license agreement with Anandia Laboratories. The Company maintains its exclusive sublicense in the U.S. and co-exclusive sublicense in the remainder of the world, excluding Canada, for 23 patent and patent applications relating to the hemp/cannabis plant. The licenses for these valuable patents survive Aurora Cannabis's acquisition of Anandia. The Company believes that it can accelerate its research in hemp/cannabis through selective partnerships.



      Through its partnership with KeyGene, the Company has recently completed building its proprietary bioinformatics platform. Armed with this encyclopedia of information on the hemp/cannabis genome, 22nd Century looks now to begin monetizing the vast knowledge foundation and intellectual property it has developed over the past year. The Company believes that its collaborative efforts with KeyGene enables the Company to modify and improve the hemp/cannabis plant using the fastest and most cost-effective methods available. 22nd Century continues to target and develop hemp/cannabis lines with select agronomic traits including lines with stable, ultra-high tetrahydrocannabinol (THC) levels, lines with higher levels of rare cannabinoids, and lines with ultra-low terpene levels.



    • 22nd Century has refocused its hemp/cannabis strategy to target the upstream segments of the cannabinoid value chain, in particular, in the areas of plant biotechnology research, gene modification and engineering, modern plant breeding and development, and extraction. The Company intends to build upon its core strengths in the plant science and ingredient value chain and seek to form operational partnerships that will enable it to offer comprehensive commercial breeding, cultivation, and extract purification services utilizing its proprietary hemp/cannabis plants in development. With the progress that 22nd Century has made over the past year in its partnership with Panacea, the Company will focus on and ensure the accelerated delivery of valuable, commercial plant lines and technology, and intellectual property for the life science, consumer product, and pharmaceutical markets over finished consumer goods.



    • 22nd Century has also identified a third plant-based franchise that has similarities in its genome to the hemp/cannabis plant. The Company plans to turn attention to this franchise after execution of its tobacco and hemp/cannabis strategies. 22nd Century is in the process of securing valuable intellectual property and pursuing strategic partnerships to support the development of this franchise and will provide additional information over the coming months as the competitive situation allows.

    2020 Third Quarter and Year-to-Date Financial Results

    • Net sales revenue for the third quarter of 2020 was $7.3 million, an increase of 13.1% over net sales revenue of $6.5 million during the third quarter of 2019. Net sales revenue year-to-date was $20.8 million, an increase of 12.0% from net sales revenue of $18.6 million for the first nine months of 2019. The increase in sales for both periods was primarily driven by higher volume and pricing in its contract manufacturing business.



    • Gross profit improved by $383 thousand in the third quarter of 2020 compared to prior year and improved $1.1 million year-to-date compared to the first nine months of 2019. The improved gross margin was primarily the result of higher volume, price increases, and lower labor and overhead costs driven by factory efficiencies implemented over the last nine months.



    • Total operating expenses improved by $3.2 million for the third quarter and improved by $4.0 million year-to-date, driven by the following:



      • Research and development expenses decreased by $1.0 million quarter-to-date and $2.2 million year-to-date. This was primarily driven by a reduction in personnel expense, lower license and contract costs, and the absence of a one-time impairment charge taken on research tobacco leaf inventory in the prior year.



      • Research and development expenses related to the MRTP application was favorable in the third quarter by $65 thousand and $1.4 million year-to-date. The expenses in the prior year were primarily related to preparation for the Company's Tobacco Products Scientific Advisory Committee (TPSAC) hearing which occurred on February 14, 2020.



      • Sales, general and administrative expense was favorable by $890 thousand in the third quarter. The favorability was driven primarily by lower one-time severance expenses and decreased equity compensation that occurred in the third quarter of 2019 as a result of management changes.



      • Sales, general and administrative expense was $690 thousand higher year-to-date compared to the first nine months of 2019. This was driven primarily by an increase in expenses related to consulting and professional services and personnel and insurance costs and was partially offset primarily by lower equity compensation and a decrease in one-time severance expense.



      • Impairment of intangible assets decreased by $1.1 million in the third quarter and by $997 thousand year-to-date. The decrease year-over year was related to an intellectual property portfolio rationalization that resulted in higher impairment in the prior year.
    • Operating loss improved by $3.6 million in the third quarter of 2020 to ($4.0) million. The improvement in the quarter was driven by higher gross profit which increased by $384 thousand and lower total operating expenses of $3.2 million, primarily driven by the aforementioned impairment of intangible assets recorded in the prior year, lower sales, general and administrative expenses, and lower research and development spend.



    • Operating loss year-to-date improved by $5.1 million to ($12.9) million driven by the combination of higher gross profit which increased by $1.1 million and a $4.0 million reduction in operating expenses. The decrease in operating expenses were primarily driven by a decrease in research and development expenses and the aforementioned impairment of intangible assets recorded in the prior year.



    • Net loss for the third quarter of 2020 improved by $6.0 million to ($4.2) million, representing a net loss per share of ($0.03) as compared to a net loss of ($10.3) million, or a net loss per share of ($0.08) for third quarter of 2019. In addition to the improvement in operating loss of $3.6 million, other income and expense improved by $2.5 million primarily due to a reduction in the unrealized loss on Aurora warrants of ($3.0) million in the quarter.



    • Net loss for the first nine months of 2020 improved by $7.1 million to ($13.3) million, representing a net loss per share of ($0.10) as compared to a net loss of ($20.4) million, or a net loss per share of ($0.16). In addition to the improvement in operating loss of $5.1 million, other income and expense improved by $2.0 million primary due to a $1.9 million litigation expense recorded in the prior year. This was partially offset in the current year by an impairment charge of $1.1 million related to the Panacea stock warrant investment.



    • Adjusted EBITDA was ($3.4) million for the third quarter of 2020, an improvement of $1.2 million, or 26.4% compared to Adjusted EBITDA of ($4.6) million for the third quarter of 2019.



    • Adjusted EBITDA was ($10.2) million for the first nine months of 2020, an improvement of $3.1 million, or 23.3% compared to Adjusted EBITDA of ($13.4) million for the first nine months of 2019.

    Balance Sheet and Liquidity

    • For the first nine months of 2020, net cash used in operating activities was approximately $12.6 million, compared to approximately $11.7 million in the first nine months of 2019.



    • The Company's liquidity remains strong with cash, cash equivalents, and short-term investment securities totaling approximately $26.8 million as of September 30, 2020.



    • The Company does not have any plans or need to raise capital at this time. It believes the continued improvement in quarterly cash burn rate, an ongoing reduction in costs, and a healthy cash position should provide the Company with ample ability to execute for the foreseeable future.

    Third Quarter Earnings Conference Call

    22nd Century will host a live audio webcast today at 8:00 a.m. ET to discuss its third quarter 2020 financial results. Following prepared remarks, the Company will host a Q&A session during which management will accept questions from interested analysts. Investors, shareholders, and members of the media will also have the opportunity to pose questions to management by submitting questions through the interactive webcast during the event.

    The live audio webcast, interactive Q&A, and investor presentation will be accessible in the Events section on the Company's Investor Relations website at www.xxiicentury.com/investors/events. An archived replay of the webcast and the event transcript will also be available shortly after the live event has concluded.

    About 22nd Century Group, Inc.

    22nd Century Group, Inc. (NYSE:XXII) is a leading plant biotechnology company focused on technologies that alter the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering, gene-editing, and modern plant breeding. 22nd Century's primary mission in tobacco is to reduce the harm caused by smoking through the Company's proprietary reduced nicotine content tobacco cigarettes – containing 95% less nicotine than conventional cigarettes. The Company's primary mission in hemp/cannabis is to develop and commercialize proprietary hemp/cannabis plants with valuable cannabinoid profiles and desirable agronomic traits.

    Learn more at xxiicentury.com, on Twitter @_xxiicentury and on LinkedIn.

    Cautionary Note Regarding Forward Looking Statements

    Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements typically contain terms such as "anticipate," "believe," "consider," "continue," "could," "estimate," "expect," "explore," "foresee," "goal," "guidance," "intend," "likely," "may," "plan," "potential," "predict," "preliminary," "probable," "project," "promising," "seek," "should," "will," "would," and similar expressions. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in "Risk Factors" in the Company's Annual Report on Form 10-K filed on March 11, 2020 and in its subsequently filed Quarterly Report on Form 10-Q. 22nd Century undertakes no obligation to publicly update or revise any forward-looking statement as a result of new information, future events, or otherwise, except as otherwise required by law.

    All information provided in this release is as of the date hereof, and the Company assumes no obligation to and does not intend to update these forward-looking statements, except as required by law.

    Below is a table containing information relating to the Company's Adjusted EBITDA for the three and nine months ended September 31, 2020 and 2019, including a reconciliation of net (loss) income to Adjusted EBITDA for such periods.

      Quarter Ended
      September 30, 
      Dollar Amounts in Thousands ($000's)
                     $ Change 
      2020  2019  fav / (unfav)
    Net loss $ (4,221) $ (10,245) $ 6,024 
    Adjustments:         
    Impairment of intangible assets   —    1,142    (1,142)
    Amortization and depreciation   323    390    (67)
    Unrealized loss (gain) on investment   429    2,959    (2,530)
    Realized (gain) loss on short-term investment securities   —    (90)   90 
    Gain on the sale of machinery and equipment   (1)   —    (1)
    Accretion of non-cash interest expense   4    12    (8)
    Equity-based employee compensation expense   306    1,440    (1,134)
    Interest Income   (270)   (242)   (28)
    Interest Expense   19    —    19 
    Adjusted EBITDA $ (3,412) $ (4,634) $ 1,222 

    1Fav = Favorable variance, which increases Adjusted EBITDA; Unfav = unfavorable variance, which reduces Adjusted EBITDA



              
      Year-to-date Ended
      September 30, 
      Dollar Amounts in Thousands ($000's)
                     $ Change 
      2020  2019  fav / (unfav)
    Net loss $ (13,307) $ (20,360) $ 7,053 
    Adjustments:         
    Impairment of intangible assets   146    1,142    (996)
    Impairment of Panacea warrant   1,062    —    1,062 
    Amortization and depreciation   997    1,111    (114)
    Unrealized loss (gain) on investment   562    1,410    (848)
    Realized (gain) loss on short-term investment securities   —    (146)   146 
    Litigation Settlement   —    1,891    (1,891)
    Gain on the sale of machinery and equipment   (1)   (87)   86 
    Accretion of non-cash interest expense   34    33    1 
    Equity-based employee compensation expense   1,162    2,406    (1,244)
    Executive and board search fees   430    —    430 
    Interest Income   (1,344)   (757)   (587)
    Interest Expense   19    3    16 
    Adjusted EBITDA $ (10,240) $ (13,354) $ 3,114 

    1Fav = Favorable variance, which increases Adjusted EBITDA; Unfav = unfavorable variance, which reduces Adjusted EBITDA

    Adjusted EBITDA, which the Company defines as earnings before interest, taxes, depreciation and amortization, as adjusted by the Company for certain non-cash and non-operating expenses, as well as certain one-time expenses, is a financial measure not prepared in accordance with generally accepted accounting principles ("GAAP"). In order to calculate Adjusted EBITDA, the Company adjusts the net (loss) income for certain non-cash and non-operating income and expense items listed in the table above in order to measure the Company's operating performance. The Company believes that Adjusted EBITDA is an important measure that supplements discussions and analysis of its operations and enhances an understanding of its operating performance. While management considers Adjusted EBITDA to be important, it should be considered in addition to, but not as a substitute for or superior to, other measures of financial performance prepared in accordance with GAAP, such as operating loss, net (loss) income and cash flows from operations. Adjusted EBITDA is susceptible to varying calculations and the Company's measurement of Adjusted EBITDA may not be comparable to those of other companies.

    Investor Relations & Media Contact:

    Mei Kuo

    Director, Communications & Investor Relations

    22nd Century Group, Inc.

    (716) 300-1221

    Primary Logo

    View Full Article Hide Full Article
  5. WILLIAMSVILLE, N.Y., Oct. 22, 2020 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE:XXII), a leading plant-based, life science company driven by next generation biotechnology, will host a live audio webcast on Thursday, November 5, 2020 at 8:00 a.m. Eastern Standard Time to discuss its 2020 third quarter results. 22nd Century will report the Company's third quarter 2020 results in a press release at 7:00 a.m. Eastern Standard Time the same day.

    During the webcast, James A. Mish, chief executive officer; Michael Zercher, chief operating officer; and John Franzino, chief financial officer, will review the Company's 2020 third quarter results and provide details on a new strategic plan that includes near-term milestones and exciting medium…

    WILLIAMSVILLE, N.Y., Oct. 22, 2020 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE:XXII), a leading plant-based, life science company driven by next generation biotechnology, will host a live audio webcast on Thursday, November 5, 2020 at 8:00 a.m. Eastern Standard Time to discuss its 2020 third quarter results. 22nd Century will report the Company's third quarter 2020 results in a press release at 7:00 a.m. Eastern Standard Time the same day.

    During the webcast, James A. Mish, chief executive officer; Michael Zercher, chief operating officer; and John Franzino, chief financial officer, will review the Company's 2020 third quarter results and provide details on a new strategic plan that includes near-term milestones and exciting medium and long-term opportunities to drive innovation and growth. The management team will also discuss the re-alignment of the Company to support this new strategy. Following prepared remarks, the Company will host a Q&A session during which management will accept questions from interested analysts. Investors, shareholders, and members of the media will also have the opportunity to pose questions to management by submitting questions through the interactive webcast during the event.

    The live audio webcast and interactive Q&A will be accessible on the Events web page in the Company's Investor Relations section of the website, at www.xxiicentury.com/investors/events. An archived replay of the webcast and the event transcript will also be available shortly after the live event has concluded.

    About 22nd Century Group, Inc.

    22nd Century Group, Inc. (NYSE:XXII) is a leading biotechnology company developing disruptive, plant-based solutions for the life science, consumer product, and pharmaceutical markets. In its work with the tobacco plant, 22nd Century is dedicated to its founding mission of reducing the harm caused by smoking. The Company's proprietary reduced nicotine content tobacco cigarettes – containing 95% less nicotine than conventional cigarette brands – are poised to disrupt the $800 billion global tobacco market. In its work with the hemp/cannabis plant, 22nd Century is utilizing modern genetic engineering technologies and proprietary plant breeding methods to develop novel cannabis plants and plant extracts. 22nd Century owns or controls more than 200 issued and pending patents related to the tobacco and hemp/cannabis plants.

    Learn more at xxiicentury.com, on Twitter @_xxiicentury and on LinkedIn.

    Investor Relations and Media Contact:

    Mei Kuo

    Director, 22nd Century Group

    22nd Century Group

    716-300-1221

    Primary Logo

    View Full Article Hide Full Article
View All 22nd Century Group Inc. News