UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
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Item 2.02 | Disclosure of Results of Operations and Financial Condition |
On March 11, 2021, 22nd Century Group, Inc. (the “Company”) issued an earnings release for the quarter and full year ended December 31, 2020. A copy of the earnings release is furnished as Exhibit 99.1 to this report.
The information in this item shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liabilities of Section 18, nor shall it be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent, if any, expressly set forth by specific reference in such filing.
Item 9.01(d) | Financial Statements and Exhibits |
Earnings release dated March 11, 2021 |
Supplemental financial information for earnings release dated March 11, 2021 |
104 | Cover Page Interactive Data File - The cover page XBRL tags are embedded within the inline XBRL document |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| 22nd Century Group, Inc. |
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| /s/ James A. Mish |
Date: March 11, 2021 | James A. Mish |
| Chief Executive Officer |
Exhibit 99.1
22nd Century Group Reports Business Highlights and Financial Results for the Fourth Quarter and Full-Year 2020
Key Business and Financial Highlights
| ● | 22nd Century has a tremendous global commercial opportunity in the more than $800 billion markets across the tobacco and hemp/cannabis industry. |
| ● | Securing Modified Risk Tobacco Product (MRTP) authorization for VLN® remains 22nd Century’s number one priority. The Company is highly confident that the FDA is in the final stages of the review process related to its application. |
| ● | 22nd Century is fully prepared and eager to launch VLN® King and VLN® Menthol King within 90 days of receiving MRTP designation. MRTP designation is a catalyst for the VLN® brand and tobacco franchise via partnerships and licensing agreements in the U.S. and internationally. |
| ● | 22nd Century believes that recent political changes will likely be highly favorable to its business prospects from a policy priority and regulatory standpoint. The Company believes that, under the new administration, the FDA will now be re-energized in implementing its ground-breaking Comprehensive Plan for Tobacco and Nicotine Regulation, in particular the Agency’s plan to cap the amount of nicotine in combustible cigarettes to a “minimally or non-addictive” level. |
| ● | The Company has now secured four out of the five key partnerships needed to maximize each component in the upstream segment of the hemp/cannabis value chain. The partnerships will enable 22nd Century to accelerate the new development of valuable, commercial hemp/cannabis lines and intellectual property to market in two years while it monetizes a portion of the Company’s current portfolio of intellectual property (IP) from its previous license agreement with Anandia Laboratories. 22nd Century is also in final discussions with top-tier plant breeders that will be announced soon. |
| ● | Net sales revenue of $7.3 million for the fourth quarter was consistent over the prior-year period and improved by 8.8% to $28.1 million for the full-year. |
| ● | Gross profit for the fourth quarter improved by $364 thousand and by $1.4 million for the full-year; gross profit margin improved by 500 basis points for both periods. |
| ● | Net loss increased by $207 thousand for the fourth quarter. For the full-year, net loss improved by $6.8 million. |
| ● | Adjusted EBITDA was unfavorable by $1.3 million for the fourth quarter. For the full-year Adjusted EBITDA improved by $1.8 million. |
| ● | The Company’s balance sheet is well funded with $22.3 million at the end of full-year 2020. Additional cash of $11.8 million received from warrants exercised in February and March 2021 will provide the Company with additional runway to fuel current operations, strategy, and growth initiatives. 22nd Century does not have any outstanding warrants following these transactions. |
Note: All financials referenced in this release are in conformity with U.S. Generally Accepted Accounting Principles (“GAAP”) and comparisons in this release are to the same period in the prior year unless otherwise noted.
WILLIAMSVILLE, N.Y., March 11, 2021 (Globe Newswire) — 22nd Century Group, Inc. (NYSE American: 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 Annual Report on Form 10-K 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, president and 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.
“Since joining 22nd Century Group in June, we have communicated our strategic plan and go forth strategy. Our stock price has increased significantly since reporting third quarter earnings demonstrating our commitment to our shareholders,” said James A. Mish, chief executive officer of 22nd Century Group. “As we look to 2021, we see tremendous commercial opportunity for our tobacco and hemp/cannabis franchises. Our focus remains on our primary mission: to reduce the harm caused by smoking. Once we secure MRTP designation, we will capitalize on our VLN® brand and begin to build our tobacco franchise through licensing and partnership opportunities in the U.S. and internationally. We have made significant progress in our hemp/cannabis research and look forward to monetizing a portion of our hemp/cannabis IP this year. With the majority of our hemp/cannabis operational partnerships now in place, we believe we will be able to commercialize our new disruptive, commercially valuable hemp/cannabis plants in development in two years.”
Tobacco Franchise Highlights and Recent Key Events
| ● | Over the past several months, 22nd Century has been executing on the strategic plan that it announced on its third quarter earnings call in November 2020. The Company continues to focus on its primary mission and highest, near-term priority of securing MRTP authorization for its proprietary, reduced nicotine content tobacco cigarettes, VLN®. The Company is maintaining its dialogue with the FDA and is highly confident that 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 has been and continues working with various legal advisers, regulatory consultants, and government affairs specialists to highlight the public health importance of its MRTP application to encourage a near-term authorization of its application. |
| ● | 22nd Century is fully prepared to make VLN® available to adult smokers in the U.S. within 90 days of receiving MRTP authorization from the FDA and is in advanced discussions with potential partners in the independent, regional, and national retail trade. The Company anticipates a phased roll out of VLN® in select geographies and plans to position VLN® in the premium pricing segment of the cigarette market and, therefore, expects it to deliver corresponding margins. On January 11, 2021, 22nd Century announced that it will significantly expand its growing program and an increase in planting in the 2021 crop year for VLN® based on the Company’s latest sales projections. This new planting is in addition to the Company’s sizeable inventory of VLN® tobacco, which is earmarked for the launch and initial sales of VLN® cigarettes. |
| ● | The Company believes that recent political changes will likely be highly favorable to its business prospects from a policy priority and regulatory standpoint. It also believes that the new administration will likely have an impact on the timing of its MRTP application based on the Company’s positive and relentless approach with the FDA through multiple channels. 22nd Century has already begun work to align with the new administration and to encourage their support. |
| ● | Additionally, the Company believes that under the new administration, the FDA will now be re-energized in implementing its ground-breaking Comprehensive Plan for Tobacco and Nicotine Regulation, in particular the Agency’s plan to cap the amount of nicotine in combustible cigarettes to a “minimally or non-addictive” level. 22nd Century believes that the MRTP authorization and the launch of VLN® will serve as a vanguard for the FDA’s proposed mandate and maintains its bullish outlook on the implementation of a nicotine cap for combustible cigarettes. |
| ● | The Company's research cigarettes, SPECTRUM®, continue to fuel numerous independent, scientific studies to validate the enormous public health benefit identified by the FDA and others of implementing a national standard requiring all cigarettes to contain “minimally or non-addictive” levels of nicotine. On December 8, 2020, 22nd Century announced that the FDA in coordination with the National Institute on Drug Abuse (NIDA) and others, submitted an order to 22nd Century for 3.6 million variable nicotine research cigarettes. In March 2021, the Company will fulfill the order bringing the total number of research cigarettes provided for public health research to more than 31 million cigarettes. |
| ● | 22nd Century believes that its next-generation, non-GMO, plant research is the key to commercializing its reduced nicotine content tobacco and technology in international markets where non-GMO products are preferred, or GMO products are banned. It continues to make significant progress in its non-GMO tobacco research. During the fourth quarter of 2020, 22nd Century confirmed that it has successfully applied its non-GMO technology to Bright and Burley varieties of tobacco and has developed a VLN® 2.0 prototype cigarette. The Company is also using its non-GMO technology to introduce reduced nicotine traits into Oriental varieties of tobacco. 22nd Century believes that decades of experience with the tobacco plant will provide it with the ability to accelerate the development of additional tobacco-based technologies for multiple applications across various end-use markets beyond reduced nicotine content tobacco products. |
Hemp/Cannabis Franchise Highlights and Recent Key Events
| ● | Since reporting third quarter earnings, 22nd Century continues to place a renewed emphasis on 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 believes that it can differentiate itself in the hemp/cannabis industry by building upon its core strength and expertise in plant science and in the ingredient value chain and through its operational partnerships; including the addition of its new operational partner, CannaMetrix. 22nd Century continues to shift its focus away from the already saturated U.S. consumer market of cannabidiol (CBD) and hemp-based products and has refocused its partnership with Panacea, through a non-binding agreement, to provide ingredient cultivation capabilities and extraction and purification services. The agreement will provide the Company with operational assets, including Needle Rock Farms and various extraction and distillation equipment. |
| ● | Over the past year, the Company has made tremendous progress with KeyGene in its hemp/cannabis research. In March 2020, the Company announced that it has built its proprietary bioinformatics platform and can begin monetizing a portion the vast knowledge foundation and intellectual property it has developed over the past year. 22nd Century believes that its collaborative efforts with KeyGene enable the Company to modify and improve the hemp/cannabis plant using the fastest and most cost-effective methods available. The Company 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. |
| ● | On February 10, 2021, 22nd Century Group announced that it has developed and launched a new, cutting-edge technology platform that will enable the Company and its strategic partners to quickly identify and incorporate commercially valuable traits of hemp/cannabis plants to create new, stable hemp/cannabis lines. The platform, developed in collaboration with researchers at KeyGene, incorporates a suite of proprietary molecular tools and a large library of genomic markers and gene-trait correlations. 22nd Century has already characterized millions of high-value single nucleotide polymorphisms (SNPs). By targeting these newly identified SNPs, the Company has been able to locate and isolate specific sections of genetic code from genome assemblies present in the Company’s state-of-the-art hemp/cannabis bioinformatics database. This major breakthrough enables 22nd Century Group to quickly and easily identify the genes responsible for specific traits in a plant and is a powerful tool for the Company and the hemp/cannabis industry. The Company has already begun discussions to license this platform to strategic partners to help them improve their plant breeding techniques and optimize their hemp/cannabis lines. |
| ● | The Company continues to secure commercially, valuable patents and intellectual property through its internal research capabilities and external research partnerships. On December 17, 2020, the Company announced that it was granted a new U.S. Patent No. 10,787,674 B2 entitled “Trichome specific promoters for the manipulation of cannabinoids and other compounds in glandular trichomes”. This new intellectual property enables 22nd Century to develop and deliver new hemp/cannabis plants that are designed to produce cannabinoids more efficiently by activating the molecular promoters, “on/off switches,” specifically and only in the plant’s trichomes where the majority of cannabinoids are produced. The patent application describes eight promoters covering all of the major steps in the cannabinoid biosynthesis pathway and is related to the control of cannabinoid and terpene production. The Company believes it can monetize a portion of its existing hemp/cannabis intellectual property in 2021 and will continue to bring new, disruptive technology forward. |
| ● | On March 3, 2021, 22nd Century announced that it has secured an exclusive agreement with CannaMetrix, LLC for the use of their proprietary, human cell-based testing CannaMetrix EC50Array™ technology that will enable it to accelerate the commercialization of new, disruptive hemp/cannabis plant lines and intellectual property. CannaMetrix’s proprietary CannaMetrix EC50Array™ technology serves as a high-throughput roadmap for developing new hemp/cannabis plant lines with tailor-made cannabinoid and terpenoid profiles for use in the life science, consumer product, and pharmaceutical markets. The human cell-based assay has the ability to measure and validate the potency and efficacy of cannabinoids and/or terpenoids through defined biomarkers and receptor activity, and can rapidly identify optimum plant profiles by measuring the potency and effect on the human cell system. |
| ● | 22nd Century believes that it can accelerate the development of commercially, valuable hemp/cannabis lines and related intellectual property through selective partnerships and has now secured four out of the five key partnerships needed to maximize each component in the upstream segment of the cannabinoid value chain: plant profiling (CannaMetrix), plant biotechnology (KeyGene), plant cultivation (Panacea-Needle Rock Farms), and ingredient extraction/purification (Panacea). The Company is also in final discussions with top-tier, plant breeders that will be announced soon. The new partnership with CannaMetrix combined with 22nd Century’s worldwide, exclusive agreement with KeyGene, and the refocused strategy with its partnership with Panacea will enable the Company to bring new commercially valuable hemp/cannabis plant lines to market in as quickly as two years. |
2021 Priorities and Areas of Focus
| 1. | 22nd Century remains focused on securing FDA authorization for VLN®, the only reduced nicotine content combustible cigarette in the world that will receive a MRTP designation from FDA. The Company plans to execute a commercial product launch and will seek licensing and partnership initiatives within 90 days of authorization. |
| 2. | The Company believes that an equally important first priority initiative is to support and advance the FDA’s plan to require 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. |
| 3. | 22nd Century continues to target the upstream segment of the cannabinoid value chain by creating proprietary, commercially valuable new plant lines and related intellectual property with stabilized genetics to harness and optimize hemp/cannabis plant potential. The Company expects to monetize a portion of its existing hemp/cannabis IP in 2021 and will continue to bring disruptive technology forward. |
| 4. | The Company will turn attention to the development of a third, plant-based franchise after securing MRTP authorization for VLN®. 22nd Century will leverage its plant science expertise to develop and secure valuable intellectual property and sign lucrative strategic partnerships to support the development of this franchise. |
| 5. | 22nd Century will maintain diligent financial execution, efficient operating structure, and balance sheet strength to support its growth initiatives. |
Fourth Quarter and Full-Year 2020 Financial Results
| ● | Net sales revenue for the fourth quarter of 2020 increased $46 thousand, or 0.6% to $7.3 million compared to the prior-year period. For full-year 2020, net sales revenue increased $2.3 million, or 8.8% to $28.1 million compared to the prior-year. The increase for both periods was primarily driven by higher volume and increased pricing in the Company’s contract manufacturing business. |
| ● | Gross profit for the fourth quarter improved by $364 thousand, or 161.8% to $588 thousand compared to the prior-year period. For full-year 2020, gross profit improved by $1.4 million, or 9,413% to $1.4 million. The improvement in gross margin was primarily the result of higher volume, price increases, and lower labor and overhead costs driven by factory efficiencies implemented in 2020. |
| ● | Total operating expenses for the fourth quarter of 2020 increased by $1.1 million compared to the prior-year period. For full-year 2020, operating expenses decreased by $3.0 million compared to the prior-year. This was driven by the following: |
| ● | Research and development expense for the fourth quarter of 2020 was favorable by $127 thousand compared to the prior year period. For full-year 2020, research and development expense was also favorable by $2.3 million compared to the prior year. 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 expense related to the MRTP application was favorable by $205 thousand for the fourth quarter compared to the prior year period. For full-year 2020, research and development expense related to the MRTP application was favorable by $1.6 million compared to the prior year. The favorability was primarily the result of expenses incurred in 2019 that were associated with the preparation for the Company’s Tobacco Products Scientific Advisory Committee (TPSAC) hearing which occurred on February 14, 2020. |
| ● | For the fourth quarter of 2020, sales, general and administrative expense increased by $1.3 million compared to the prior year period. This was driven primarily by higher insurance, consulting, and personnel expense which were partially offset by lower legal fees. |
| ● | For the full-year 2020, sales, general and administrative expense increased by $2.0 million compared to the prior year. This was driven primarily by insurance expenses, consulting and professional services, and the addition of new members to the Company's management team, including its newly appointed Chief Executive Officer and Chief Financial Officer. The increase was partially offset by a decrease in one-time severance and equity compensation expenses that occurred in 2019, legal fees, and travel and entertainment savings as a result of the COVID-19 pandemic. |
| ● | Impairment of intangible assets for the fourth quarter of 2020 increased by $30 thousand compared to the prior year period. For full-year 2020, impairment of intangible assets decreased by $966 thousand compared to the prior year. The decrease year-over-year was related to an intellectual property portfolio rationalization that resulted in higher impairment in 2019. |
| ● | For the fourth quarter of 2020, operating loss was unfavorable by $696 thousand compared to the prior year period. This was primarily driven by an increase in SG&A and was partially offset by higher gross profit and lower research and development spend related to the MRTP application in 2019. |
| ● | For full-year 2020, operating loss improved by $4.4 million to $(19.2) million compared to the prior year driven by the combination of higher gross profit of $1.4 million and lower total operating expenses of $20.6 million. The decrease in operating expenses were primarily driven by a decrease in research and development expenses related to the MRTP application in 2019, a reduction in personnel expense, and an intellectual property portfolio rationalization that resulted in higher impairment in the prior year. |
| ● | Net loss for the fourth quarter of 2020 was $(6.4) million, representing a net loss per share of $(0.05) as compared to a net loss of $(6.2) million, or a net loss per share of $(0.05) for the fourth quarter of 2019. |
| ● | Net loss for full-year 2020 improved by $6.8 million to $(19.7) million, representing a net loss per share of $(0.14) as compared to a net loss of $(26.6) million, or a net loss per share of $(0.21). In addition to the improvement in operating loss of $4.4 million, other income and expense improved by $2.5 million primary due to a $1.9 million litigation expense and a reduction in the unrealized loss on Aurora warrants of $2.4 million recorded in the prior year. This was partially offset in the current year by an impairment charge of $1.7 million related to the Panacea stock investment. |
| ● | Adjusted EBITDA was $(5.4) million for the fourth quarter of 2020 compared to Adjusted EBITDA of $(4.1) million for the fourth quarter 2019. |
| ● | Adjusted EBITDA was $(15.6) million for full-year 2020, an improvement of $1.8 million compared to Adjusted EBITDA of $(17.5) million for full-year 2019. |
Balance Sheet and Liquidity
| ● | For twelve months 2020, net cash used in operating activities was approximately $15.6 million, compared to approximately $14.6 million for the twelve months in 2019. |
| ● | The Company’s liquidity remains strong with cash, cash equivalents, and short-term investment securities totaling approximately $22.3 million as of December 31, 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, a healthy cash position, and the addition of $11.8 million to its balance sheet from an exercise on previously issued stock warrants should provide the Company with additional runway to execute for the foreseeable future. |
Fourth Quarter Earnings Conference Call
22nd Century will host a live audio webcast today at 8:00 a.m. ET to discuss its full-year 2020 financial results and business highlights. 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.
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. 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 American: 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 Form 10-K filed on March 11, 2021. 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 twelve months ended December 31, 2020 and 2019, including a reconciliation of net (loss) income to Adjusted EBITDA for such periods.
| | Quarter Ended | |||||||
| | December 31, | |||||||
| | Dollar Amounts in Thousands ($000's) | |||||||
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| | |
| | $ Change |
| | 2020 | | 2019 | | | fav / (unfav) | ||
Net loss | | $ | (6,405) | | $ | (6,198) |
| $ | (207) |
Adjustments: | | | | | | | | | |
Impairment of intangible assets | | | 30 | | | — | | | 30 |
Impairment of Panacea investment | | | 679 | | | — | | | 679 |
Amortization and depreciation | | | 349 | | | 313 | | | 36 |
Unrealized loss (gain) on investment | | | (128) | | | 1,010 |
| | (1,138) |
Realized (gain) loss on short-term investment securities | | | (5) | | | (75) |
| | 70 |
Accretion of non cash interest expense | | | 9 | | | 20 |
| | (11) |
Equity-based employee compensation expense | | | 491 | | | 1,134 |
| | (643) |
Interest income, net | | | (407) | | | (309) |
| | (98) |
Interest expense | | | 9 | | | — |
| | 9 |
Adjusted EBITDA | | $ | (5,378) | | $ | (4,105) |
| $ | (1,273) |
1Fav = Favorable variance, which increases Adjusted EBITDA; Unfav = unfavorable variance, which reduces Adjusted EBITDA
| | Year-to-date Ended | |||||||
| | December 31, | |||||||
| | Dollar Amounts in Thousands ($000's) | |||||||
|
| | |
| | |
| | $ Change |
| | 2020 | | 2019 | | | fav / (unfav) | ||
Net loss | | $ | (19,711) | | $ | (26,558) |
| $ | 6,847 |
Adjustments: | | | | | | | | | |
Impairment of intangible assets | | | 176 | | | 1,142 | | | (966) |
Impairment of Panacea investment | | | 1,741 | | | — | | | 1,741 |
Amortization and depreciation | | | 1,345 | | | 1,425 | | | (80) |
Unrealized loss (gain) on investment | | | 434 | | | 2,419 |
| | (1,985) |
Realized (gain) loss on short-term investment securities | | | (5) | | | (221) |
| | 216 |
Litigation settlement | | | — | | | 1,891 |
| | (1,891) |
Gain on the sale of machinery and equipment | | | (1) | | | (87) |
| | 86 |
Accretion of non cash interest expense | | | 43 | | | 53 |
| | (10) |
Equity-based employee compensation expense | | | 1,654 | | | 3,540 |
| | (1,886) |
Executive and board search fees | | | 430 | | | — |
| | 430 |
Interest income, net | | | (1,751) | | | (1,066) |
| | (685) |
Interest expense | | | 29 | | | 3 |
| | 26 |
Adjusted EBITDA | | $ | (15,616) | | $ | (17,459) |
| $ | 1,843 |
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
Exhibit 99.2
| FOURTH QUARTER 2020 EARNINGS PRESENTATION MARCH 11, 2021 |
| CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements concerning our business operations, and financial performance and conditions, as well as our plans, objectives, and expectations for our business operations and financial performance and conditions that are subject to risks and uncertainties. All statements other than those of historical fact are forward-looking statements. These types of statements typically contain 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. Forward-looking statements are based on current expectations, estimates, forecasts, and projections about our business, 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 that could cause actual results to differ materially from those estimated. The contents of this presentation should be considered in conjunction with the risk factors, warnings, and cautionary statements contained in the Company’s annual, quarterly, and other reports filed with the U.S. Securities and Exchange Commission. 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 required by law. 2 |
| Q4 2020 & RECENT HIGHLIGHTS 3 DISRUPTING THE +$800 BILLION GLOBAL TOBACCO AND HEMP/CANNABIS MARKETS WITH PROPRIETARY, COMMERCIALLY VALUABLE TECHNOLOGY AND RELATED INTELLECTUAL PROPERTY 1. On 3/4/2021, President Biden issued a proclamation as part of National Colorectal Cancer Awareness Month, 2021, strongly committing the administration to improving the prevention and treatment of colorectal cancer. The proclamation states that “people with increased risk for developing diseases include certain racial and ethnic minority populations, as well as individuals with IBS, a family history of colorectal cancer, or other risk factors such as tobacco use.” 2. The Company has received total net proceeds of $8.1 million and will receive an additional $3.7 million from warrants exercised on 3/10/21. Tobacco Franchise Hemp/Cannabis Franchise Favorable Political Climate Recent Financials • Continued proactive efforts to secure U.S. Food and Drug Administration’s (FDA) Modified Risk Tobacco Product (MRTP) designation of VLN® • Fully prepared for commercial launch of VLN® within 90 days of receiving MRTP designation • Expanded VLN® growing program to support anticipated demand • MRTP designation opens multiple licensing and partnership opportunities for reduced nicotine content tobacco technology and intellectual property (IP) • Successful field trial evaluations have confirmed application of non-GMO technology to Bright and Burley varieties of tobacco; testing VLN® 2.0 prototype • Executing refocused hemp/cannabis strategy to target the upstream segment of cannabinoid value chain by creating disruptive, valuable plant lines and IP • Secured 4 of 5 key partnerships needed to maximize and support each component of the upstream segment of the cannabinoid value chain; partnerships will help accelerate commercialization of next-gen hemp/cannabis plant lines and IP in 2 years • Restructured partnership with Panacea to support refocused strategy in hemp/cannabis; operational assets, including Needle Rock Farms and plant extraction and distillation equipment • New administration and political changes likely to be highly favorable and influence: • Timing of MRTP authorization; VLN® brand and tobacco franchise opportunities in the U.S. and internationally • Enactment of mandate to require all combustibles to be made “minimally or non-addictive” • Federal legalization of cannabis • New administration is already showing a focus on improving public health as a priority1 • Continue to deploy positive and relentless approach that aligns with new administration and encourage enactment of a nicotine cap • Diligent financial execution and efficient operating structure produced strong operating results • 9% increase in net sales to $28.1M for FY 2020 • $4.4M YOY improvement in operating loss for FY 2020 • 500bps YOY improvement in gross profit margin % in 4Q & FY 2020 • Balance sheet is well funded to support current operations and strategy • $11.8M additional cash received from warrants exercised in Feb/March 20212 provides additional runway |
| 2021 PRIORITIES & AREAS OF FOCUS 4 Tobacco Franchise Hemp/Cannabis & Third Plant-based Franchise Financial Secure MRTP Authorization from FDA; fully prepared for commercial launch of VLN® within 90 days of receiving FDA authorization and execute on licensing and partnership initiatives 01 Target upstream segment of cannabinoid value chain; creating disruptive, commercially valuable plant lines and related intellectual property with stabilized genetics to harness and optimize hemp/cannabis plant potential. Monetize a portion of our hemp/cannabis IP beginning in 2021 and continue to bring disruptive technology forward 03 04 Turn attention to development of a third, plant-based franchise after securing MRTP authorization for VLN®. Leverage know-how in plant science and secure valuable intellectual property, and pursue strategic partnerships to support development of this franchise Maintain diligent financial execution, efficient operating structure, and balance sheet strength to support growth initiatives 05 02 Support, advance, and advocate for FDA to enact its proposed mandate to cap nicotine content of all combustibles to just 0.5 milligrams of nicotine per gram of tobacco – a “minimally or non-addictive” level of nicotine |
| CONTINUOUS PIPELINE OF REVENUE OPPORTUNITY 5 Leverage core strength and know-how in plant science to create an extensive pipeline of high-value, commercial opportunities beyond near-term prospects across all franchises Tobacco Franchise 2021 & Beyond • Commercial launch of VLN® within 90 days of receiving MRTP designation • MRTP designation is catalyst for the VLN® brand and tobacco franchise; secure licensing and partnership opportunities in U.S. and internationally Favorable Political Climate • Believe under new administration, FDA will be re-energized on implementing reduced nicotine mandate in combustibles; enactment would multiply revenue opportunities tremendously 2022 & Beyond • Apply non-GMO technology to multiple varietals of the tobacco plant and monetize VLN® 2.0 Beyond VLN® • Decades of research with tobacco plant will provide ability to accelerate the development of additional tobacco-based technologies for multiple applications across various end-use markets beyond reduced nicotine content tobacco products • FDA’s proposed reduced nicotine cap would be the grand slam for public health Hemp/Cannabis Franchise 2021 & Beyond • Monetize a portion of our hemp/cannabis IP beginning in 2021 2022 & Beyond • Begin monetizing our next-gen hemp/cannabis plant lines Federal Legalization of Cannabis • Will open enormous whitespace revenue opportunity for hemp/cannabis plant lines, technology, and IP Third Plant-Based Franchise • Leverage expertise in plant science and genetic engineering and pursue strategic partnerships to support the development of third franchise • Third-franchise plant species has a similar genome to the hemp/cannabis plant. • Operates in industry that is not as highly regulated and legislated; faster route to commercialization than first two franchises. $714B1 +$100B2 +$500B3 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. Prohibition Partners; “The Global Cannabis Report – November 2019” 3. Addressable market of third plant-based franchise is based on a global estimate in 2019. +$1.3 TRILLION GLOBAL ADDRESSABLE MARKET OPPORTUNITY NATURAL INTERSECTION OF ADJACENCIES ACROSS 22ND CENTURY’S PLANT-BASED FRANCHISES |
| VLN® HAS MASSIVE GLOBAL MARKET OPPORTUNITY 6 2/3 of adult smokers want to quit 6 <10% of adult smokers successfully quit in 2018 6 1B global adult smokers 4 34M U.S. adult smokers 5 $714B1 cigarettes account for 90% of the global tobacco market 60% of adult smokers indicate likelihood to use VLN®3, based on our consumer perception studies 87% 13% Global Tobacco Market 20181 Combustible Cigarettes Other5 $817B SMOKERS ARE ACTIVELY SEEKING ALTERNATIVES TO ADDICTIVE COMBUSTIBLE CIGARETTES 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. Other tobacco includes cigars and cigarillos 4%, smoking tobacco 4%, vaping systems & heated tobacco products 3%, smokeless tobacco 2%, and NRT smoking cessation aids 0.3% 3. 22nd Century Group Perception Study (n=3,018) 2 4. World Health Organization; https://www.who.int/news-room/fact-sheets/detail/tobacco 5. Centers for Disease Control and Prevention; https://www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_smoking/index.htm 6. Centers for Disease Control and Prevention; https://www.cdc.gov/tobacco/data_statistics/fact_sheets/cessation/smoking-cessation-fast-facts/index.html 6 |
| VLN® IS IN FINAL STAGES OF REVIEW WITH THE FDA 7 • Securing MRTP designation for VLN® is number one priority • Highly confident that FDA is in the final stages of the review process • Continue working with various legal advisers, regulatory consultants, and government affairs specialists to highlight the public health importance of MRTP application and encourage near-term authorization • Work with new administration will likely have an impact on timing of MRTP application based on positive and relentless approach through multiple channels • MRTP authorization and the launch of VLN® will serve as a vanguard for the FDA’s proposed reduced nicotine mandate *For descriptive purposes only. Final trade dress subject to the FDA review and authorization. |
| FULLY PREPARED FOR COMMERCIAL LAUNCH OF VLN® 8 • Company-owned and operated manufacturing facility has ample capacity to manufacture approximately 1% of the U.S. tobacco market share; ability to triple manufacturing capacity with minimal investment • Expect initial roll-out of VLN® in select markets within 90 days of receiving MRTP authorization from FDA; plan to position VLN® in the premium pricing segment of the cigarette market with corresponding margins • VLN® continues to be received positively by the trade; advanced discussions with a number of independent, regional and national tobacco retailers • Launch will be accompanied by a strong marketing campaign to generate brand and product awareness; deploying a thoughtful approach to maximize success in the marketplace • Plan to build and scale VLN® brand and tobacco franchise through licensing opportunities and strategic partnerships *For descriptive purposes only. Final trade dress subject to the FDA review and authorization. |
| MRTP DESIGNATION IS A CATALYST FOR VLN® BRAND & TOBACCO FRANCHISE 9 *For descriptive purposes only. Final trade dress subject to the FDA review and authorization. • MRTP designation opens multiple licensing and partnership opportunities for reduced nicotine content tobacco technology and IP in the U.S. and internationally • FDA authorization is considered by regulators around the world to be the gold standard in public health; MRTP designation will be helpful in navigating regulatory pathways in international markets • Next-generation, non-GMO, plant research is key to commercializing reduced nicotine content tobacco technology in international markets where non-GMO products are preferred, or GMO products are banned • Successfully applied non-GMO technology to Bright and Burley varieties of tobacco and developed VLN® 2.0 cigarette prototype • Introducing reduced nicotine traits into Oriental varieties of tobacco |
| Industry Problem: Existing plant genetics result in low quality and unreliable yield for large-scale, commercial production of hemp/cannabis plants Market demand for hemp/cannabis • Global legal cannabis market is projected to be worth +$100B by 20241 • North America held the largest legal, cannabis revenue share at 90% in 20192 • Federal legalization will transform the U.S. cannabis market OPTIMIZING HEMP/CANNABIS PLANTS 10 • Decades-long experience and know-how in plant biotechnology and genetic engineering; demonstrated strong track record in developing disruptive, valuable plant lines • Ability to increase value of hemp/cannabis crops by improving genetics to optimize desired traits; generate stable, higher yield plants lines, and de-risk planting 22nd Century will enable large, commercial-scale growers to improve hemp/cannabis crop yield and improve stability, achieving artisanal quality hemp/cannabis plants in high-volume production 22nd Century Group Solution: Optimize hemp/cannabis plant genetics and create disruptive, proprietary plant lines that are stable and deliver higher crop yield for commercial use The 22nd Century Advantage 1. Prohibition Partners; “The Global Cannabis Report – November 2019” 2. Grandview Research; “Legal Marijuana Market Size Worth $73.6 Billion by 2027 | CAGR 18.1%” |
| 22ND CENTURY HAS SECURED FOUR OF THE FIVE KEY PARTNERSHIPS NEEDED TO MAXIMIZE AND SUPPORT EACH COMPONENT IN UPSTREAM SEGMENT OF THE CANNABINOID VALUE CHAIN BUILDING NETWORK OF KEY PARTNERSHIPS TO ACCELERATE COMMERCIALIZATION OF NEW, DISRUPTIVE HEMP/CANNABIS PLANTS 11 Plant Biotechnology Established proprietary bioinformatics platform and cutting-edge molecular breeding platform in partnership with KeyGene; capabilities include genetic engineering and plant line development Plant Profile/ Roadmap CannaMetrix’s high-throughput proprietary, human cell-based cannabinoid assay technology serves as a roadmap for developing new hemp/cannabis plant lines with tailor-made cannabinoid & terpenoid profiles Ingredient Extraction & Purification Panacea provides 22nd Century with extraction and purification services utilizing proprietary plant lines in development Plant Breeding & Trials Currently in advance discussions with various partners that will provide 22nd Century with plant breeding and trial capability Plant Cultivation Needle Rock Farms provides 22nd Century with operational assets including plant cultivation capabilities Strategic partnerships enable 22nd Century to capitalize on core strength in plant science and deliver valuable, commercial-scale plant lines and IP in two years |
| FOURTH QUARTER & FULL YEAR 2020 FINANCIAL HIGHLIGHTS 12 1. Gross profit margin is calculated by dividing net sales revenue by gross profit. 2. 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 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. Net sales Operating loss YOY Improvement in gross profit margin1 YOY Adjusted EBITDA2 YOY 4Q 2020 $7.3M Consistent YOY $(696)K +500BPS $(1.3)M FY 2020 $28.1M +9% YOY +$4.4M +500BPS +$1.8M |
| FINANCIAL SNAPSHOT 13 $ in millions Select Financials Three Months Ended December 31, Twelve Months Ended December 31, 2020 2019 2020 2019 Net sales revenue $ 7.3 $ 7.3 $ 28.1 $ 25.8 Operating loss $ (6.2) $ (5.6) $ (19.1) $ (23.6) Net loss $ (6.4) $ (6.2) $ (19.7) $ (26.6) Net loss per common share - basic and diluted $ (0.05) $ (0.05) $ (0.14) $ (0.21) Weighted average common shares outstanding – basic and diluted (in thousands) 138,927 128,778 138,813 125,883 Adjusted EBITDA $ (5.4) $ (4.1) $ (15.6) $ (17.5) Summary Balance Sheet Items Year Ended Year Ended December 31, 2020 December 31, 2019 Cash and cash equivalents1 $ 22.3* $ 39.0 Total assets2 $ 51.7 $ 69.0 Total liabilities3 $ 7.6 $ 6.9 Total shareholders' equity4 $ 44.1 $ 62.1 1. Cash and cash equivalents includes short-term investment securities. 2. Total assets is the sum of total current assets, total property, plant and equipment, and total other assets including intangible assets, net, investments and convertible note. 3. Total liabilities includes current liabilities and long-term liabilities and excludes shareholders’ equity. 4. Total shareholders’ equity excludes any liabilities. As per press release issued on March 10, 2021. 5. The Company has received total net proceeds of $8.1 million and will receive an additional $3.7 million from warrants exercised on 3/10/21. *Additional $11.8M cash received from warrants exercised in Feb/March 20215 |
| 22ND CENTURY INVESTMENT HIGHLIGHTS 14 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. Prohibition Partners; “The Global Cannabis Report – November 2019” 3. Modified Risk Tobacco Product; https://www.fda.gov/tobacco-products/advertising-and-promotion/modified-risk-tobacco-products 4. The Company has received total net proceeds of $8.1 million and will receive an additional $3.7 million from warrants exercised on 3/10/21. • VLN® is the first, and only reduced nicotine content cigarette anticipating FDA’s Modified Risk Tobacco Product (MRTP)3 designation • Fully prepared to launch VLN® within 90 days of authorization; designation is a catalyst for VLN® brand and tobacco franchise opportunities • Developing new disruptive, proprietary hemp/cannabis plant lines with stable, higher yields, and other commercially desirable traits through accelerated breeding processes • Potential legislative tailwinds including enactment of reduced nicotine mandate and legalization of cannabis would open tremendous revenue opportunity • Exclusive, pure-play plant biotechnology core competencies • Creating disruptive, proprietary commercial plant lines and new intellectual property in tobacco, hemp/cannabis, and other large adjacent market • Over 200 issued and pending patents in plant- based biotechnology applications supports entry into adjacent high-value markets. • 20+ years of expertise in developing new, disruptive technologies +$1.3T global addressable market across tobaccco1, hemp/cannabis2, & third plant-based franchise • Efficient operating model with multiple routes to market – commercialization, licensing, and partnership opportunities • Clear path to profitability through existing platforms, cultivating large adjacent markets to leverage core technologies for additional growth • Healthy balance sheet with more than $22M in cash on 12/31/20; $11.8M additional cash received from warrants exercised in Feb/March 20214 Financial strength Clear growth strategy with continuous, rich pipeline of revenue opportunities |
| 15 Q&A |
| FINANCIAL INFO |
| ADJUSTED EBITDA DEFINITION 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 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. 17 |
| ADJUSTED EBITDA 18 2020 2019 % Change fav / (unfav)1 2020 2019 % Change fav / (unfav)1 Net loss (6,405) $ (6,198) $ (207) $ (19,711) $ (26,558) $ 6,847 $ Adjustments: Impairment of intangible assets 30 $ - $ 30 $ 176 $ 1,142 $ (966) $ Impairment of Panacea warrant 679 $ - $ 679 $ 1,741 $ - $ 1,741 $ Amortization and depreciation 349 $ 313 $ 36 $ 1,345 $ 1,425 $ (80) $ Unrealized loss (gain) on investment (128) $ 1,010 $ (1,138) $ 434 $ 2,419 $ (1,985) $ Realized (gain) loss on short-term investment securities (5) $ (75) $ 71 $ (5) $ (221) $ 216 $ Litigation Settlement - $ - $ - $ - $ 1,891 $ (1,891) $ Gain on the sale of machinery and equipment - $ - $ - $ (1) $ (87) $ 87 $ Accretion of non cash interest expense 9 $ 20 $ (11) $ 43 $ 53 $ (10) $ Equity-based employee compensation expense 491 $ 1,134 $ (643) $ 1,654 $ 3,540 $ (1,885) $ Executive and board search fees - $ - $ - $ 430 $ - $ 430 $ Interest Income (407) $ (309) $ (98) $ (1,751) $ (1,066) $ (685) $ Interest Expense 9 $ - $ 9 $ 29 $ 3 $ 26 $ Adjusted EBITDA (5,378) $ (4,105) $ (1,273) $ (15,616) $ (17,459) $ 1,843 $ Quarter Ended Year-to-date Ended December 31, December 31, Dollar Amounts in Thousand ($000's) Dollar Amounts in Thousand ($000's) |
| CONTACT INFORMATION INVESTOR RELATIONS & MEDIA CONTACT Mei Kuo Director, Communications & Investor Relations 22nd Century Group, Inc. (716) 300-1221 [email protected] |