Conference Presentation

Made public by

sourced by PitchSend

14 of 19

Creator

Tscti logo
Tscti

Category

Healthcare

Published

2020

Slides

Transcriptions

#1文 22nd Century Group, Inc. A Life Science Company Driven By Next Generation Plant Biotechnology LD Micro 500 Virtual Conference Presentation September 2020 (NYSE American: XXII)#2Disclaimer Ž 22nd Century Group, Inc. Forward-Looking Statements This presentation contains forward-looking statements concerning our business, operations and financial performance and condition as well as our plans, objectives and expectations for our business operations and financial performance and condition that are subject to risks and uncertainties. All statements other than statements of historical fact included in this press release are forward-looking statements. You can identify these statements by words such as "aim," "anticipate," "assume," "believe," "could," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "potential," "positioned," "predict," "should," "target," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends. These forward-looking statements are based on current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our management's beliefs and assumptions. These statements are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. All forward-looking statements are subject to risks and uncertainties and others that could cause actual results to differ materially from those contained in our forward-looking statements. Please refer to the "Risk Factors" in our Annual Report on Form 10-K filed on March 11, 2020 and in our subsequently filed Quarterly Report on Form 10-Q. We undertake 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 2#3We Are: A plant-based, life science company Vision A plant-based biotechnology leader applying next generation science to create proprietary technology and intellectual property solutions Mission Develop and provide unique, plant-derived commercial solutions that enhance and broaden the consumer experience to the life science, consumer products, and pharmaceutical markets 3#4Accomplished Leadership Team James A. Mish Chief Executive Officer 23 Purisys™ NORAMCO INC Ashland Pfizer always solving Global executive leadership experience at science- driven organizations operating in the consumer products, pharmaceutical, and cannabinoid spaces Former Chief Executive Officer at Purisys and Noramco 30+ years industry experience Nora B. Sullivan Director & Chairperson of the Board Rand Capital Corporation citi 20+ years of investment management experience John Franzino Chief Financial Officer SANTA FE NATURAL TOBACCO COMPANY Extensive financial leadership experience in tobacco and alcoholic beverage industries Clifford B. Fleet Director Altria Former Chief Executive Officer at 22nd Century and Philip Morris 25+ years of industry experience Former Chief Financial Officer at Santa Fe Natural Tobacco and Labatt USA 25+ years industry experience Labatt R.J. REYNOLDS TOBACCO Richard M. Sanders Director SANTA FE NATURAL TOBACCO COMPANY * Michael Zercher President & Chief Operating Officer SANTA FE NATURAL 25+ years industry experience Former President / Chief Executive Officer at Santa Fe Natural Tobacco 20+ years of industry experience TOBACCO COMPANY 20+ years in the tobacco industry in global marketing, sales, operations, and business development 22nd Century Group, Inc. Former Vice President at Reynolds USA and Santa Fe Natural Tobacco R.J. REYNOLDS TOBACCO Roger D. O'Brien Director O'Brien Associates sun microsystems 40+ years of executive leadership and management consulting experience 4#5What's New at XXII A new blueprint and 180-day workplan ● Embracing our roots in plant-based, life science biotechnology Exploring global expansion in our tobacco and hemp/cannabis franchises Re-focusing on our disruptive, proprietary IP creation ● ● ● ● Focused on reduced nicotine tobacco plus new tobacco opportunities Enhancing cannabis franchise Looking to serve broader end markets across the life science, CPG (food, beverage, nutrition, personal care), recreational cannabis, and pharmaceutical space Identifying a third franchise specifically serving life science markets LO 5#6A Life Science Company Driven By Next Generation Plant Biotechnology KK 02 01 Massive Market Opportunity in tobacco, hemp/cannabis, and other botanically driven life science categories Substantial R&D Platform with cutting edge technology applications and deep intellectual property moat 03 Established & Developing Strategic Partnerships to bring commercial solutions to market 04 * 22nd Century Group, Inc. Financial Strength including NYSE American listing and healthy balance sheet 6#7Massive, established market Capture market share through disruptive technology We Compete in Industries Ripe for Disruption 22nd Century's core competencies in plant-based research provides solutions across highly-regulated end markets Tobacco Industry Category Attributes Hemp/Cannabis Industry 20+ years of deep, established R&D technologies First and only combustible tobacco product anticipating MRTP approval $817B Market (2018)¹ Demonstrated Strength Commercial Launch Plant-Based Highly-Regulated Consumer-Facing Licensing Opportunities R&D Innovation $85B+ Market (2024E)² 1) Foundation for a Smoke Free World; https://www.smokefreeworld.org/wp-content/uploads/2019/08/FSFW Global-Trends-in-Nicotine 6.22.2020.pdf 2) PR Newswire; https://www.prnewswire.com/news-releases/global-cannabis-market-now-projected-to-exceed-89-billion-by-2024-300904306.html Emerging Presence Ž Commercial Whitespace 22nd Century Group, Inc. Nascent, fast-growing market Highly fragmented industry Opportunity to seize leadership through a differentiated product offering Category entry through impactful partnerships 22ND CENTURY HAS FIRST MOVER ADVANTAGE IN VERY LOW NICOTINE TOBACCO TECHNOLOGY AND ITS FAMILY OF PATENTS IN PLANT-BASED BIOTECHNOLOGY APPLICATIONS ENABLES ENTRY INTO ADJACENT MARKETS 7#8Our Playbook for Developing Plant Biotechnology Extensive in-house R&D capabilities in combination with selective partnerships yield disruptive plant-based technologies, ingredient solutions, and formulated products In-House Capabilities Select Partnerships 1) As of August 27, 2020 Plant-Based Research & Development • 200+ issued and pending applications for tobacco and hemp/cannabis plants ¹ 1 • GMO & Non-GMO tobacco lines NC STATE UNIVERSITY University of K Kentucky ● ● Plant Biotechnology Applications Molecular breeding, genetic modification, and transformation technologies Ability to create new, high value plant lines and valuable intellectual property KeyGene Ÿ 22nd Century Group, Inc. 8#9na Our Tobacco Franchise We are setting the stage for a successful launch of VLNⓇ, our proprietary reduced nicotine cigarettes containing 95% less nicotine than conventional counterparts X The FDA has authorized 22nd Century to sell its reduced nicotine content tobacco cigarettes in the U.S. 22nd Century Group, Inc. Develop and commercialize GMO and non-GMO varieties of 95% reduced nicotine tobacco Premarket Tobacco Product Application (PMTA) Modified Risk Tobacco Product Application (MRTPA) An MRTP authorization would allow 22nd Century to make powerful marketing and advertising claims, in the U.S. under the brand name VLNⓇ, distinguishing the product from conventional cigarettes CONTINUE TO SUPPORT THE FDA'S PROPOSED PLAN FOR THE ADOPTION OF A REDUCED NICOTINE PRODUCT STANDARD FOR ALL COMBUSTIBLE CIGARETTES#10Tobacco Is A Massive Market Opportunity 4% 3% 4% 2% 0.3% Global Tobacco Market 2018 ¹ $817B $714B¹ 87% Cigarettes Cigars & Cigarillos Smoking Tobacco ↑ Smokeless Tobacco Vaping Systems & Heated Tobacco Products NRT Smoking Cessation Aids 60% of current adult smokers indicated likelihood to use VLNⓇ 1B Global Adult Smokers 2 2/3 of Adult Smokers Want to Quit 4 <10% of Adult Smokers Successfully Quit in 2018 4 1) Foundation for a Smoke Free World; https://www.smokefreeworld.org/wp-content/uploads/2019/08/FSFW Global-Trends-in-Nicotine 6.22.2020.pdf 2) World Health Organization; https://www.who.int/gho/tobacco/use/en/#:~:text=In%202015%2C%20over%201.1%20billion, Region%20and%20the%20African%20Region. 3) Centers for Disease Control and Prevention; https://www.cdc.gov/tobacco/data statistics/fact sheets/adult data/cig smoking/index.htm 4) Centers for Disease Control and Prevention; https://www.cdc.gov/tobacco/data statistics/fact sheets/cessation/smoking-cessation-fast-facts/index.html 5) U.S. News; https://health.usnews.com/health-conditions/allergy-asthma-respiratory/smoking-cessation/overview Ž 34M U.S. Adult Smokers 3 SMOKERS ARE ACTIVELY SEEKING ALTERNATIVES TO ADDICTIVE COMBUSTIBLE CIGARETTES 22nd Century Group, Inc. 1/2 of Adult Smokers Made an Attempt to Quit in the Past Year 4 95% of smokers Who Do Not Participate in a Smoking Cessation Program Fail 5 10#11Features and Benefits of Reduced Nicotine Cigarettes Proprietary Technology in Reduced Nicotine Content Science-Backed Research from Clinical Trials VLNⓇ cigarettes contain 95% less nicotine than conventional cigarette alternatives We own or control over 200 issued and pending patents and other intellectual property related to nicotine biosynthesis in tobacco plants Since 2011, our reduced nicotine tobacco has been used in more than 50 independent scientific clinical studies conducted by researchers at universities and institutes These studies have been largely funded by U.S. government agencies and are estimated to have cost over $100 million ● ● ● Ž Discernable Adult Smoker Benefits Reduce nicotine exposure and dependence Smoke fewer cigarettes per day Experience reduced withdrawal symptoms Increase number of smoke-free days Double quit attempts STUDIES SUPPORT 22ND CENTURY'S PMTA & MRTP APPLICATIONS AS WELL AS THE FDA'S PROPOSED PLAN TO REDUCE NICOTINE LEVELS IN ALL COMBUSTIBLE CIGARETTES Sources: Eric C. Donny, Ph.D., Rachel L. Denlinger, B.S., et al. "Randomized Trial of Reduced-Nicotine Standards for Cigarettes." Oct. 2015. Dorothy K. Hatsukami, PhD; Xianghua Luo, PhD, et al., "Effect of Immediate vs Gradual Reduction in Nicotine Content of Cigarettes on Biomarkers of Smoke Exposure." Sept. 2018. Dorothy K Hatsukami, Michael Kotlyar, et al., "Reduced nicotine content cigarettes: effects on toxicant exposure, dependence and cessation." Feb. 2010. 22nd Century Group, Inc. 11#12VLNⓇ Path to Commercialization The FDA Pathway to MRTP Commercial Readiness Submit Premarket Tobacco Product Application (PMTA) to the FDA December 4, 2018 ✓ Submit Modified Risk Tobacco Product Application (MRTPA) to the FDA May 17, 2019 ✓ The FDA accepted and filed MRTPA for substantive scientific review July 19, 2019 PMTA authorized by the FDA December 17, 2019 "Authorizing these reduced nicotine products for sale in the U.S. is appropriate for the protection of public health" - The FDA press release on 12/17/19 MRTPA public comment period close May 18, 2020 MRTP Authorization by the FDA IN "FINAL ACTION" STAGE *These advertisements were submitted to the FDA as an exhibit to the Company's MRTP application for VLN. ● ✓ The FDA's Tobacco Products Scientific Advisory Committee (TPSAC) review of MRTPA February 14, 2020 Go-to-Market Strategy After the FDA authorizes 22nd Century's MRTP application, VLNⓇ will be registered with each state to enable national commercialization • 22nd Century will initially launch VLN® though a targeted pilot rollout program across select U.S. geographies • 22nd Century manufactures its reduced nicotine content cigarettes in a 62,000 sq. ft. manufacturing facility, which also contract manufactures third-party brands Contains 95% less nicotine than conventional cigarettes* VLN VLN 95% LESS NICOTINE Helps dace your cumption VLN Nicotine is addictive, Less nicolare does NOT mean safer. All cigaretten can cause disease and death. 95% LESS NICOTINE If you smoke, consider VLN™ VLN™ smells, burns, and tastes like a conventional cigarette, but greatly reduces your nicotine consumption Learn more at vincigarettes.com 95% LESS NICOTINE nicotine consump * VLN Helps reduce nicotine consumption SURGEON GENERAL'S WARNING: Cigarette Smoke Contains Carbon Monoxide. 22nd Century Group, Inc. MAKE THE SWITCH to 95% Less Nicotine REAL TOBACCO VLN smells, burns, and tastes like a conventional cigarette, but greatly reduces your nicotine consumption For the nearest retailer, visit vincigarettes.com/stores or call: 800-225-1838 ext. 221 % LESS NICOTINE VLN Nicotie is addictive as nicotina does NOT safer A ciganes can cause disease and death SURGEON GENERAL'S WARNING: Cigarette Smoke Contains Carbon Monoxide. Smells, burns, and tastes like a conventional cigarette * 12#13Our Hemp/Cannabis Strategy Develop a hemp/cannabis franchise with both internal investments and external relationships focused on key cannabinoids and terpenes and the associated genetic markers that will allow us to create proprietary plant lines for commercial use Develop proprietary plant varieties with valuable cannabinoid and terpene profiles and agronomic traits Develop new technologies to facilitate production of distinctive, high value plant lines with desirable traits Develop high-resolution genomic database to enable characterization of hemp/cannabis lines Conduct greenhouse and field trials to certify plant genetics * 22nd Century Group, Inc. Develop commercial partnerships through investments and other strategic relationships Develop strategic partnerships focused on high-value segments of the hemp/cannabis value chain to generate profitable revenue Commercialize our proprietary plants through these strategic partnerships ESTABLISH A LEADERSHIP POSITION IN THE LEGAL HEMP/CANNABIS INDUSTRY BUILT ON SCIENCE-DRIVEN DIFFERENTIATION 13#14XXX Our Science-to-Sale Hemp/Cannabis Platform We are leveraging our leading technology to develop proprietary ingredient solutions for disruptive end use products Seed/Plant Biotechnology Unique Cannabinoid Profile Current Focus: Ingredient Solutions Ke Gene Plant Breeding & Engineering Select Terpene Traits Ingredient Cultivation Beneficial Agronomic Characteristics Ž Future Opportunity: Formulated Products Product Formulation Superior User Experience 22nd Century Group, Inc. Product Sale OUR CURRENT FOCUS ON SUPPLYING UNIQUE INGREDIENT SOLUTIONS ENABLES DIFFERENTIATED PRODUCT OFFERINGS 14#15Financial Snapshot 22nd Century maintains a healthy balance sheet and an asset light model $ in millions Summary Income Statement & Cash Flow Items Net revenue Operating loss Capital expenditures Summary Balance Sheet Items 2 6 Months Ended June 30, 2020 2019 $13.5 $ (8.9) $ (0.4) Most Recent Quarter June 30, 2020 $28.9 $61.1 $7.3 $ 53.9 $ 12.1 $ (10.4) $ (0.6) 2019 Year Ended December $25.8 $ (23.6) $(1.1) Cash and cash equivalents Total assets Total liabilities Total shareholders' equity Source: Company filings 1) Capital expenditures includes acquisition of patents and trademarks, acquisition of machinery and equipment and acquisition of license 2) Cash and cash equivalents includes short-term investment securities. At 06/30/20 and 12/31/19 the short-term investment securities consisted of money market funds and corporate bonds Ž 2019 22nd Century Group, Inc. Year Ended December $39.0 $69.0 $6.9 $ 62.1 2018 $26.4 $ (24.0) $(1.1) 15#16Gaining Momentum Across End Markets Corporate Initiatives Tobacco Milestones Hemp/Cannabis Milestones 2018 Pursued opportunity from the FDA's Advance Notice of Proposed Rulemaking (ANPRM) to reduce nicotine in cigarettes Premarket Tobacco Product Application (PMTA) submitted to the FDA seeking authorization to commercialize reduced nicotine content tobacco cigarettes Modified Risk Tobacco Product Application (MRTPA) submitted to the FDA for authorization to market VLNⓇ reduced nicotine content cigarettes with pack and advertising claims | 2019 Expanded R&D capabilities into adjacent hemp/cannabis applications The FDA applications for VLNⓇ cigarettes advanced with completion of the FDA's inspection of manufacturing facility The FDA accepted and filed for substantive scientific review MRTPA The FDA determined that sale of 22nd Century's proprietary reduced nicotine content cigarettes is 'appropriate for the protection of public health' Worldwide and exclusive strategic R&D partnership formed with KeyGene Initial investment in Panacea Life Sciences, Inc., a hemp CBD company * 2020+ 22nd Century Group, Inc. Further strengthened the executive leadership team with the addition of James A. Mish, CEO and John Franzino, CFO bringing deep industry experience The FDA's Tobacco Products Scientific Advisory Committee (TPSAC) reviewed MRTPA MRTPA public comment period closed Prepare and execute VLNⓇ commercial launch Advanced non-GMO plant lines and product development Announced high-quality genome sequence assembly with KeyGene of two hemp/cannabis lines and established new, proprietary bioinformatics platform 16#17Strategic Spotlight: Priorities & Objectives 01 Develop and provide proprietary, plant-based commercial solutions to the life science, consumer products, and pharmaceutical end use markets 02 Bring VLN® brand reduced nicotine content tobacco cigarettes to market Ž 22nd Century Group, Inc. 03 Optimize spending and allocate resources to execute path towards revenue growth and profitability#18FOR MORE INFO: [email protected] xxiicentury.com/investors Ž 22nd Century Group, Inc.

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Fiscal 3Q Investor Presentation image

Fiscal 3Q Investor Presentation

Healthcare

FY23 Full-Year Results Presentation image

FY23 Full-Year Results Presentation

Healthcare

Healthcare Network P&L Statement and Expansion Projects image

Healthcare Network P&L Statement and Expansion Projects

Healthcare

Accreditation and Quality Assurance Overview image

Accreditation and Quality Assurance Overview

Healthcare

Investment Highlights image

Investment Highlights

Healthcare

Investor Presentation image

Investor Presentation

Healthcare

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update image

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update

Healthcare

BioAtla Investor Presentation Deck image

BioAtla Investor Presentation Deck

Healthcare