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
Date of Report (Date of earliest event reported):
(Exact Name of Registrant as Specified in Charter)
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer |
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(Address of Principal Executive Office) | (Zip Code) | |
Registrant’s telephone number, including area code: ( | ||
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading symbol | Name of each exchange on which registered |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 | Disclosure of Results of Operations and Financial Condition |
On March 1, 2022, 22nd Century Group, Inc. (the “Company”) issued an earnings release for the quarter and year ended December 31, 2021. 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 |
Supplemental financial information for earnings release dated March 1, 2022 |
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 1, 2022 | 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 2021
| ● | Secured FDA MRTP Authorization for VLN® King and VLN® Menthol King Reduced Nicotine Content Cigarettes |
| ● | Advancing to U.S. Pilot Market Launch in Chicago |
| ● | Announced Circle K as First VLN® Retail Trade Partner |
| ● | Announced South Korea as the First International VLN® Launch |
| ● | Commenced Hemp/Cannabis Revenue in the Fourth Quarter of 2021 |
| ● | Full Year Net Sales Up 10.1% Year-Over-Year |
BUFFALO, N.Y., March 1, 2022 (Globe Newswire) — 22nd Century Group, Inc. (Nasdaq: XXII), a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco, and improving health and wellness through modern plant science, today reported results for the fourth quarter and full year ended December 31, 2021, and provided an update on recent business highlights. The Company will host a live audio webcast today at 10:00 a.m. ET.
“The past several months were incredible as 22nd Century transforms from a pure science and contract manufacturing company into a company selling branded VLN® cigarettes, licensing valuable biotechnology IP, and supplying highly specialized plant lines in large and dynamic global end markets,” said James A. Mish, chief executive officer of 22nd Century Group. “We secured our highly-anticipated FDA MRTP designation on December 23, and immediately moved to launch our VLN® pilot program by the end of March. The first VLN® cigarettes packaged with the FDA’s added claim of ‘Helps You Smoke Less’ rolled off our manufacturing lines in late January. Additionally, we have finalized our point-of-sale materials to educate adult smokers about how to use VLN® to change their relationship with highly addictive nicotine cigarettes, and we have worked alongside Circle K to prepare for our first launch in more than 150 metro Chicago stores before rolling VLN® out nationwide. Our mission is to get this product as quickly as possible into the hands of adult smokers, 70% of whom want to quit and are looking for new and innovative products to help them smoke less.
“We remain committed to making VLN® products readily available to as broad a market as possible, including both U.S. and international markets,” Mish added. “We expect our first global market shipment and revenue to South Korea will commence by the end of March, and we are dedicated to exploring licensing of our VLN® tobacco and IP as well as partnerships that can help expand the availability of VLN® and reduced nicotine content products across all markets.”
“Rather than creating or sustaining nicotine addiction like every other product in the tobacco category, VLN® is a combustible tobacco cigarette designed to help adult smokers smoke less, which makes it the most potentially disruptive product to hit the tobacco industry in decades,” said Michael Zercher, Chief Operating Officer. “With over 70% of adult smokers wanting to quit and 60% of adult smokers in our studies telling us they are likely to use VLN®, we look forward to bringing VLN® to market and doing our part to reduce the harm caused by smoking.”
Recent Key Financial and Business Highlights
Tobacco Franchise
| ● | Secured the world’s first and only MRTP designation for a combustible cigarette for VLN® King and VLN® Menthol King 95% reduced nicotine content cigarettes, announced December 23, 2021 by the FDA. |
| o | FDA proactively added “Helps You Smoke Less” evidence-based headline claim to Company’s requested claims |
| ● | Announced Circle K will be the VLN® pilot launch partner, initially selling in more than 150 Chicago retail stores to optimize 22nd Century’s marketing mix ahead of full national launch. |
| o | VLN® will be positioned in the premium pricing segment of the cigarette market, with corresponding margins. |
| o | State regulatory approval process is underway for tobacco sales authorizations. |
| o | Advancing discussions with multiple additional retail trade partners to expand the regional and national sales reach of VLN®. |
| ● | The Company continued the international launch process for VLN®, identifying South Korea as the initial launch market. |
| o | First shipment expected by the end of March. |
| o | The South Korean market includes a well-developed interest in alternative tobacco products, an ideal market in which to test VLN®’s global appeal. |
| o | Continuing launch process in additional markets in Asia and Europe with limited regulatory barriers while also leveraging VLN®’s MRTP authorization toward seeking approval in additional markets with higher regulatory barriers. |
| ● | Advancing discussions with tobacco and pharmaceutical companies toward licensing and strategic partnerships to scale VLN®’s market penetration. |
| ● | 22nd Century Group continued its support of transformative public health policies to ban menthol in cigarettes and mandate reduced nicotine content in all tobacco products. |
| o | The Company could have the only combustible menthol cigarette exempt from the FDA’s proposed menthol cigarette ban, providing a critical off-ramp to help current menthol smokers smoke less. |
| o | 22nd Century would have the only cigarette able to meet the reduced nicotine content product standard on day one under the FDA’s Comprehensive Plan requiring that all cigarettes be made “minimally or non-addictive.” |
| o | Applauds the confirmation of Dr. Robert Califf, a long-time proponent of the reduced nicotine mandate and menthol ban, as FDA commissioner. |
| o | Received a new purchase order for 3 million research cigarettes, including menthol, to be delivered in March 2022 for use in studies underpinning FDA’s proposed reduced nicotine content and menthol ban proposals. |
| ● | Reported record full-year tobacco contract manufacturing revenue of $30.9 million, up 10.1% year-over year, and record full year manufacturing gross margin of approximately 7.0%. |
| o | Increased sales to the new export customer secured in July 2021. |
| o | Secured an additional new contract manufacturing customer in October 2021, now in full production for 2022. |
| o | Began investment of $1.6 million into expansion of the Company’s existing manufacturing operations, currently representing 1% of the cigarette market, with the ability to expand to 3% of the market. |
| o | Commenced production of VLN® reduced nicotine content cigarettes for commercial sale in 2022. |
| ● | Readying for the largest VLN® tobacco growing year ever contracted to support expansion in both the U.S. and international markets, including launch of the Company’s new southern hemisphere capabilities to facilitate year-round growing of VLN® tobacco. The growing program will include our proprietary, non-GMO VLN® varieties grown at commercial scale, including bright and burley varieties, to enable production of our VLN® 2.0 American blend cigarettes beginning in 2023. |
Hemp/Cannabis Franchise
| ● | The Company generated the first revenue from its hemp/cannabis IP and plant lines beginning in the fourth quarter of 2021. |
| o | Announced a three-way non-exclusive license of the Anandia biosynthesis IP jointly owned with Aurora Cannabis Inc. to Cronos Group Inc., intended to assist in the advancement of biosynthetic cannabinoids. |
| o | Sold the first hemp biomass from the proprietary 22nd Century crop harvested at Needle Rock Farms. Additional biomass was sent for refinement into distillates for sale in the first quarter 2022. |
| ● | 22nd Century Group received USDA Organic Certification under 7 CFR Part 205 for its hemp production at Needle Rock Farms. USDA Organic Certification will allow 22nd Century to command a premium in price and margins for its raw materials. |
| ● | The Company is now preparing plant lines for a considerably expanded growing program in 2022 aligned to specific buyer interest in each plant line placed into the field. |
| ● | Announced an industry-first breakthrough in hemp/cannabis plant transformation with our partner KeyGene, expanding the Company’s capabilities in modifying the principal genes controlling cannabinoid synthesis. |
| ● | Moved into a new lab facility located in Maryland, which will enhance the Company’s relationship with its partners and key governmental agencies such as the NIH, NIST and FDA. |
Hops Franchise
| ● | The Company continued to advance its entry into the $500 billion per year global specialty hops market, its third and newest alkaloid plant franchise and closely related to hemp/cannabis. |
| ● | 22nd Century is targeting monetization of hop plant varieties and IP with upfront license fees expected to begin in late 2022 to early-2023. |
| ● | The Company is advancing discussions with multiple significant hops growers and consumer product partners to develop specific desired traits in leading hops strains using the Company’s extensive alkaloid experience and proprietary technologies. |
Corporate Business Highlights
| ● | Richard Fitzgerald joined the Company as its Chief Financial Officer, effective November 15, 2021, expanding the Company’s financial and strategic capabilities as it works to rapidly scale the business across all three of its plant franchises. |
| ● | Company CEO James A. Mish was appointed to 22nd Century Group’s Board of Directors, enhancing the Board’s depth of experience in the commercialization of science-driven consumer products as the Company prepares to launch its first reduced nicotine content tobacco products and commercially modified hemp/cannabis plant lines. |
Full Year 2021 Financial Results
| ● | Net sales for 2021 were $30.9 million, an increase of 10.1% from 2020. The increase was due to an increase in contract manufacturing sales. |
| ● | Gross profit for 2021 was $2.1 million, compared to $1.4 million in the prior year. Gross margin in 2021 increased to 6.7%, from 5.1% in the prior year. |
| ● | Total operating expenses for 2021 increased to $30.5 million compared to $20.6 million in the prior year, driven by: |
| o | Sales, general and administrative expenses increased by $10.9 million compared to the prior year period. This was driven primarily by higher personnel, insurance, investor relations and corporate communications expense, strategic consulting expense, intellectual property license fees, and marketing costs. These investments were deployed to support, evaluate, and prepare for future opportunities as the Company moves quickly to market readiness in both tobacco and hemp/cannabis. |
| o | Research and development expense for 2021 declined by $0.9 million compared to the prior year. This favorability was primarily driven by a tobacco leaf inventory impairment in the prior year period which did not reoccur in the current year period, and lower personnel costs and contract costs partially offset by patent fees. The Company’s R&D investments are |
| expected to grow in future quarters as the Company continues to accelerate the development of new, highly-differentiated hemp/cannabis plants and expand its R&D efforts in hops. |
| ● | Operating loss for 2021 was $(28.4) million, compared to $(19.2) million in the prior year period. This was primarily driven by an increase in SG&A, offset by higher gross profit and lower research and development expense. |
| ● | Net loss in 2021 was $(32.6) million, an increase of $12.9 million, representing a net loss per share of $(0.21). This compares to 2020 net loss of $(19.7) million, or $(0.14) per share. |
| ● | Of the $12.9 million increase in net loss, $6.6 million of the change was due to a non-cash unrealized loss related to fair value adjustments for investments in Aurora Cannabis stock warrants and Panacea Holdings common stock. |
2021 Fourth Quarter Financial Results
| ● | Net sales for the fourth quarter of 2021 were $8.0 million, an increase of 8.9% from $7.3 million in the prior year period. The increase was due to an increase in contract manufacturing sales. |
| ● | Gross profit for the fourth quarter of 2021 was $387 thousand, compared to $588 thousand in the prior year period, due to the favorable effect of a large customer order that benefitted last year’s fourth quarter. |
| ● | Total operating expenses for the fourth quarter of 2021 increased to $9.4 million compared to $6.8 million in the prior year period. This was driven by the following: |
| o | Sales, general and administrative expenses increased by $2.9 million compared to the prior year period. |
| o | Research and development expense for the fourth quarter of 2021 was favorably lower by $323 thousand compared to the prior year period. |
| ● | Operating loss for the fourth quarter of 2021 was $(9.0) million, compared to $(6.2) million in the prior year period. This was primarily driven by an increase in SG&A and reduction in gross profit, offset by lower research and development expense. |
| ● | Of the $7.6 million increase in net loss, $5.1 million of the change was due to a non-cash unrealized loss related to fair value adjustments for investments in Aurora Cannabis stock warrants and Panacea Holdings common stock. |
Balance Sheet and Liquidity
| ● | For the full year 2021, net cash used in operating activities was $22.8 million, compared to $15.6 million in the prior year period. |
| ● | The Company ended the year with a cash position of $48.7 million as of December 31, 2021, and the Company’s continued initiatives to manage expenses relative to net sales revenue should provide the Company with additional runway to execute for the foreseeable future. |
Fourth Quarter Earnings Conference Call
22nd Century will host a live webcast today at 10:00 a.m. ET to discuss its fourth quarter and full year 2021 financial results and business highlights. During the webcast, James A. Mish, chief executive officer of 22nd Century Group, together with Michael Zercher, president and chief operating officer, and Richard Fitzgerald, chief financial officer, will review the Company’s 2021 financial results and provide an update on progress made in each of the Company’s three franchises.
Following prepared remarks, including an accompanying slide presentation, 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 and archived webcast, interactive Q&A, and slide presentation will be accessible on the Events web page in the Company's Investor Relations section of the website, at https://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. (Nasdaq: XXII) is a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco and improving health and wellness through plant science. With dozens of patents allowing it to control nicotine biosynthesis in the tobacco plant, the Company has developed proprietary reduced nicotine content (RNC) tobacco plants and cigarettes, which have become the cornerstone of the FDA’s Comprehensive Plan to address the widespread death and disease caused by smoking. The Company received the first and only FDA MRTP authorization of a combustible cigarette in December 2021. In tobacco, hemp/cannabis, and hop plants, 22nd Century uses modern plant breeding technologies, including genetic engineering, gene-editing, and molecular breeding to deliver solutions for the life science and consumer products industries by creating new, proprietary plants with optimized alkaloid and flavonoid profiles as well as improved yields and valuable agronomic traits.
Learn more at xxiicentury.com, on Twitter @_xxiicentury, and on LinkedIn.
Learn more about VLN® at tryvln.com.
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, 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.
Investor Relations & Media Contact
Mei Kuo
Director, Communications & Investor Relations
22nd Century Group, Inc.
(716) 300-1221
[email protected]
Darrow Associates Investor Relations
Matt Kreps
T: 214-597-8200
22nd CENTURY GROUP, INC.
CONSOLIDATED BALANCE SHEETS
($ in thousands, except per-share data)
| | December 31, | | December 31, | ||
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| 2021 |
| 2020 | ||
ASSETS |
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Current assets: |
| |
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Cash and cash equivalents | | $ | 1,336 | | $ | 1,029 |
Short-term investment securities | |
| 47,400 | |
| 21,313 |
Accounts receivable, net | |
| 585 | |
| 2,159 |
Inventory, net | |
| 2,881 | |
| 2,034 |
Prepaid expenses and other assets | |
| 2,183 | |
| 1,806 |
Total current assets | |
| 54,385 | |
| 28,341 |
Property, plant and equipment, net | |
| 5,841 | |
| 2,483 |
Operating leases right-of-use assets, net | |
| 1,723 | |
| 247 |
Intangible assets, net | |
| 7,919 | |
| 8,211 |
Investments | |
| 2,345 | |
| 6,536 |
Other assets | | | 3,741 | | | 5,876 |
Total assets | | $ | 75,954 | | $ | 51,694 |
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LIABILITIES AND SHAREHOLDERS' EQUITY | |
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Current liabilities: | |
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Notes payable | | $ | 596 | | $ | 539 |
Operating lease obligations | |
| 308 | |
| 247 |
Accounts payable | |
| 2,173 | |
| 1,116 |
Accrued expenses | |
| 1,489 | |
| 931 |
Accrued payroll | |
| 2,255 | |
| 2,208 |
Accrued excise taxes and fees | |
| 1,270 | |
| 1,691 |
Accrued severance | |
| 217 | |
| 339 |
Deferred income | |
| 119 | |
| 272 |
Total current liabilities | |
| 8,427 | |
| 7,343 |
Long-term liabilities: | |
|
| |
|
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Operating lease obligations | |
| 1,432 | |
| — |
Severance obligations | | | 21 | | | 241 |
Total liabilities | | | 9,880 | | | 7,584 |
Commitments and contingencies (Note 12) | |
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Shareholders' equity | |
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Preferred stock, $.00001 par value, 10,000,000 shares authorized | |
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Common stock, $.00001 par value, 300,000,000 shares authorized | |
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Capital stock issued and outstanding: | |
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162,872,875 common shares (139,061,690 at December 31, 2020) | |
| | |
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Common stock, par value | | | 2 | | | 1 |
Capital in excess of par value | |
| 244,247 | |
| 189,439 |
Accumulated other comprehensive (loss) income | |
| (162) | |
| 74 |
Accumulated deficit | |
| (178,013) | |
| (145,404) |
Total shareholders' equity | |
| 66,074 | |
| 44,110 |
Total liabilities and shareholders’ equity | | $ | 75,954 | | $ | 51,694 |
22nd CENTURY GROUP, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
($ in thousands, except per-share data)
| | Three Months Ended | | Year Ended | ||||||||
| | December 31, | | December 31, | ||||||||
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| 2021 |
| 2020 |
| 2021 |
| 2020 | ||||
| | (unaudited) | | | | | | | ||||
Revenue: | | |
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| | | | | | |
Sale of products, net | | $ | 7,960 | | $ | 7,308 | | $ | 30,948 | | $ | 28,111 |
Cost of goods sold (exclusive of depreciation shown separately below): | |
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Products | |
| 7,573 | |
| 6,720 | |
| 28,879 | |
| 26,673 |
Gross profit (loss) | |
| 387 | |
| 588 | |
| 2,069 | |
| 1,438 |
Operating expenses: | |
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| |
|
| |
| | |
| |
Research and development | |
| 972 | |
| 1,416 | |
| 3,256 | |
| 4,090 |
Research and development - MRTP | | | 2 | | | (119) | | | 18 | | | 38 |
Sales, general and administrative | |
| 8,050 | |
| 5,160 | |
| 25,881 | |
| 14,971 |
Impairment of intangible assets | | | 78 | |
| 30 | |
| 78 | |
| 176 |
Depreciation | |
| 172 | |
| 215 | |
| 633 | |
| 688 |
Amortization | |
| 145 | |
| 134 | |
| 615 | |
| 658 |
Total operating expenses | |
| 9,419 | |
| 6,836 | |
| 30,481 | |
| 20,621 |
Operating loss | |
| (9,032) | |
| (6,248) | |
| (28,412) | |
| (19,183) |
Other income (expense): | |
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| |
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| |
| | |
| |
Unrealized gain (loss) on investments | |
| (4,954) | |
| 128 | |
| (6,994) | |
| (434) |
Impairment of Panacea investment | | | — | | | (679) | | | — | | | (1,741) |
Gain on Panacea investment conversion | | | — | | | — | | | 2,548 | | | — |
Realized gain (loss) on short-term investment securities | |
| — | |
| 5 | |
| — | |
| 5 |
Gain on the sale of property, plant and equipment | |
| — | |
| — | |
| — | |
| 1 |
Interest income, net | |
| 49 | |
| 407 | |
| 321 | |
| 1,751 |
Interest expense | |
| (14) | |
| (18) | |
| (58) | |
| (72) |
Total other income (expense) | |
| (4,919) | |
| (157) | |
| (4,183) | |
| (490) |
Loss before income taxes | |
| (13,951) | | | (6,405) | |
| (32,595) | | | (19,673) |
Income taxes | |
| 14 | | | — | |
| 14 | |
| 38 |
Net loss | | $ | (13,965) | | $ | (6,405) | | $ | (32,609) | | $ | (19,711) |
Other comprehensive income (loss): | |
|
| |
|
| |
| | |
| |
Unrealized gain (loss) on short-term investment securities | |
| (135) | |
| (59) | |
| (236) | |
| 72 |
Reclassification of (gain) loss to net loss | |
| — | |
| (6) | |
| — | |
| (5) |
Other comprehensive income (loss) | | | (135) | | | (65) | | | (236) | | | 67 |
Comprehensive loss | | $ | (14,100) | | $ | (6,470) | | $ | (32,845) | | $ | (19,644) |
| | | | | | | | | | | | |
Net loss per common share - basic and diluted | | $ | (0.09) | | $ | (0.05) | | $ | (0.21) | | $ | (0.14) |
Weighted average common shares outstanding - basic and diluted (in thousands) | |
| 162,768 | |
| 138,813 | |
| 156,208 | |
| 138,813 |
Below is a table containing information relating to the Company’s Adjusted EBITDA for the three months and year-to-date ended December 31, 2021 and 2020, including a reconciliation of net (loss) income to Adjusted EBITDA for such periods.
| | Quarter Ended | |||||||
| | December 31, | |||||||
| | Dollar Amounts in Thousands ($000's) | |||||||
| | (unaudited) | |||||||
|
| | |
| | |
| | $ Change |
| | 2021 | | 2020 | | | fav / (unfav) | ||
Net loss | | $ | (13,965) | | $ | (6,405) |
| $ | (7,560) |
Adjustments: | | | | | | | | | |
Impairment of intangible assets | | | 78 | | | 30 | | | 48 |
Impairment of Panacea investment | | | — | | | 679 | | | (679) |
Unrealized loss (gain) on investment | | | 4,954 | | | (128) |
| | 5,082 |
Amortization and depreciation | | | 317 | | | 349 | | | (32) |
Equity-based employee compensation expense | | | 1,111 | | | 491 |
| | 620 |
Interest (income)/expense, net | | | (35) | | | (389) |
| | 354 |
Adjusted EBITDA | | $ | (7,540) | | $ | (5,373) |
| $ | (2,167) |
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 |
| | 2021 | | 2020 | | | fav / (unfav) | ||
Net loss | | $ | (32,609) | | $ | (19,711) |
| $ | (12,898) |
Adjustments: | | | | | | | | | |
Impairment of intangible assets | | | 78 | | | 176 | | | (98) |
Impairment of Panacea investment | | | — | | | 1,741 | | | (1,741) |
Unrealized loss (gain) on investment | | | 6,994 | | | 434 |
| | 6,560 |
Gain on Panacea investment conversion | | | (2,548) | | | — |
| | (2,548) |
Amortization and depreciation | | | 1,248 | | | 1,345 | | | (97) |
Equity-based employee compensation expense | | | 3,983 | | | 1,654 |
| | 2,329 |
Interest (income)/expense, net | | | (263) | | | (1,680) |
| | 1,417 |
Adjusted EBITDA | | $ | (23,117) | | $ | (16,041) |
| $ | (7,076) |
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.
Exhibit 99.2
| FOURTH QUARTER AND FULL YEAR 2021 EARNINGS PRESENTATION March 1 , 2022 XXII |
| 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. 2 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. |
| Financial 3 VLN® HELPS YOU SMOKE LESS *Trade dress subject to change. Launching VLN® in the U.S. pilot market and select international markets ▪ Secured VLN® MTRP authorization December 23 , 2021 ▪ FDA mandated additional data - driven claim ‘ Helps You Smoke Less ’ on every package ▪ Pilot launch in 150 + Chicago metro Circle K stores in March 2022 ; readying for full national launch ▪ Expanding retail channel with additional regional and national partners ▪ Opened licensing discussions to expand market access to RNC tobacco products ▪ Preparing first international VLN® shipment to South Korea for late 1 Q 2022 |
| Tobacco Hemp/Cannabis Hops Financials |
| THE FIRST AND ONL Y COMBUSTIBLE CIGARETTE MRTP 5 ▪ FDA authorized VLN® King and VLN® Menthol King MRTPs on December 23, 2021 ▪ FDA added the data - driven claim “Helps You Smoke Less” and authorized all requested claims ▪ Rather than just shifting smokers to another highly addictive, nicotine - laden product, we are focused on helping smokers reduce their nicotine consumption and smoke less .. *Trade dress subject to change. “ We know that three out of four adult smokers want to quit and the data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes. ” - Mitch Zeller, FDA Center for Tobacco Products. |
| READYING FOR U.S. PILOT MARKET LAUNCH Pilot launch leading to national rollout with current and additional retail partners ▪ 62,000 sq. ft. manufacturing facility in NC producing and shipping VLN® cigarettes; ready to increase production ▪ Circle K is pilot retail partner, which has more than 7,000 locations ▪ Chicago metro pilot program at 150+ Circle K sites will test, measure, and refine marketing materials to maximize VLN®’s broad commercial success ▪ Additional partners in discussion that add regional and national distribution access 6 |
| 22 ND CENTURY'S VLN® PILOT WILL EMPHASIZE TRIAL, REPEAT PURCHASE, AND ADVOCACY BY ADULT SMOKERS. PILOT MARKET: CHICAGO Pilot launch leading to national rollout with current and additional retail partners 7 ▪ 3rd largest U.S. City ▪ Illinois is the 2nd most expensive cigarette market in the U.S. ▪ Diverse population ▪ Smoking rate of 12.7% ▪ 335,000+ metro smokers ▪ 1.2M+ Chicagoland smokers ▪ VLN® King and VLN® Menthol King will both be sold in the pilot |
| READY TO ADVANCE TO FULL NATIONAL ROLL - OUT AFTER PILOT PROGRAM PILOT PARTNER: CIRCLE K Pilot launch leading to national rollout with current and additional retail partners 8 ▪ 2 nd largest national C - store chain, 7,000 + stores ▪ 150 + identified Chicago metro pilot stores currently sell in excess of 10 million packs of cigarettes annually ▪ VLN® will have a premium shelf position, immediately below Marlboro ▪ Pilot program will include hundreds of thousands of direct marketing impressions in - store, full advertising support and more |
| 9 ▪ First shipment to South Korea by end of March ▪ High smoking rate – 1 in 3 adult men are smokers ▪ Large alternative cigarette market channels ▪ Strong government support for its “tobacco endgame” plan ▪ Launch partner in place ▪ Targeting additional key markets in Asia and Europe where regulations require minimal interaction with regulators 9 GLOBAL MARKETS: LAUNCH IN SOUTH KOREA |
| SUPPORTING A MENTHOL BAN & NICOTINE CAP ▪ FDA continues to advance its menthol and reduced nicotine content mandates. The Agency has sent their proposed rule to prohibit menthol cigarettes to the Office of Management and Budget. ▪ By banning menthol and reducing nicotine in all cigarettes, the science shows that smokers will more easily quit smoking nicotine or migrate to less toxic products. ▪ With our MRTP in hand, 22 nd Century could have the only combustible menthol cigarette on the market exempt from the menthol ban, providing a critical off - ramp for menthol smokers. ▪ Shipping an additional 3 million research cigarettes, including menthol, this month for studies underpinning FDA ’ s reduced nicotine content and menthol ban proposals. 10 |
| Tobacco Hemp/Cannabis Hops Financials |
| First Hamp/Cannabis Revenue in Q4 2021 ▪ First biomass sales in Q4 2021 ▪ Three - party IP agreement for Anandia biosynthetic IP ▪ Follow - on distillate/isolate sales Q1 2022 ▪ USDA Organic Certification under 7 CFR Part 205 2022+ Commercial Accelerant Opportunities ▪ Readying next - generation plant lines and IP tailored to customer needs in 2022/2023 ▪ Line of sight to monetization across medical, recreational, and consumer product applications MOVING TO REVENUE IN HEMP/CANNABIS 12 22 nd Century has established a leadership position in genetic IP critical to hemp/cannabis achieving its full commercial potential. |
| BREAKTHROUGH IN FUNCTIONAL TRANSFORMATION 13 ▪ Breakthrough in proprietary plant transformation leading to clear protein expression by the introduced genes ▪ Allows 22 nd Century Group to target specific hemp/cannabis biosynthesis pathways and engineer the modification of cannabinoids ▪ Typically only used by the largest plant science companies such as Bayer/Monsanto, Corteva and Syngenta ▪ Unlocks additional revenue opportunities from new plant lines with higher commercial value at accelerated rates, lower cost and lower risk |
| Tobacco Hemp/Cannabis Hops Financials |
| Introduce new agronomic traits to improve disease/pest resistance and plant architecture to increase crop yields in leading hop strains that are already well - accepted by the brewing industry. Increase hops content of hops active molecules that drive the beer industry, such as alpha and beta acids, plus new compounds like terpenoids and flavonoids not generally associated with hops to produce new, disruptive, unique, and proprietary aromatic hop flavor profiles. Increase hops content of active molecules with health and wellness applications as extracts/distillates in functional foods and beverages, nutraceuticals, and pharmaceuticals ( xanthohumol and 8 - prenylnaringenin). 1 2 3 15 22ND CENTURY’S HOPS VALUE PROPOSITION Hops Growers Industry Leadership Consumer Goods and Nutraceutical Companies 22 nd Century is leveraging its experience with tobacco and hemp/cannabis, a close hop relative, to accelerate the development of proprietary specialty hop varieties or valuable traits. |
| Tobacco Hemp/Cannabis Hops Financials |
| FOURTH QUARTER 2021 FINANCIAL HIGHLIGHTS Net Sales Gross Profit Gross Profit Margin Operating Loss Cash and Cash Equivalents 4Q 2021 $8.0M $387K 4.9 % $(9.0)M $48.7M 4Q 2020 $7.3M $588K 8.1% $(6.2)M $22.3M 17 CMO activities fund the cost of facilities needed to manufacture VLN® reduced nicotine tobacco products for the U.S. and global launch. |
| FULL YEAR 2021 FINANCIAL HIGHLIGHTS Net Sales Gross Profit Gross Profit Margin Operating Loss Cash and Cash Equivalents FY 2021 $30.9M $2.1M 6.7 % $(28.4)M $48.7M FY 2020 $28.1M $1.4M 5.1% $(19.2)M $22.3M 18 CMO activities fund the cost of facilities needed to manufacture VLN® reduced nicotine tobacco products for the U.S. and global launch. |
| FULL YEAR 2021 FINANCIAL HIGHLIGHTS Quarter Ended Dollar amounts in millions December 31, 2021 December 31, 2020 Cash and cash equivalents 1 $ 48.7 $ 22.3 Total assets 2 $ 76.0 $ 51.7 Total liabilities 3 $ 9.9 $ 7.6 Total shareholders' equity 4 $ 66.1 $ 44.1 19 Balance sheet aligned to partner - focused VLN® launch and continued R&D activity across all three franchises. 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 inta ngi ble 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. |
| 2022 PRIORITIES & AREAS OF FOCUS 20 Tobacco Franchise Hemp/Cannabis & Hops Franchises Financial Launching VLN® in U.S. and International Markets ▪ Launching VLN® Chicago pilot with Circle K ▪ Engaging with multiple retail trade partners to support national launch capabilities post - pilot ▪ First VLN® international launch in South Korea ▪ Ramping manufacturing capabilities 01 Expanding upstream hemp/cannabis revenue ▪ Initiated hemp/cannabis biomass sales and IP licensing activities ▪ Expanding available plant lines for 2022 and 2023 ▪ Achieved hemp/cannabis breakthrough in plant transformation 03 04 Positioning for launch in hops market ▪ Building out commercial partnerships ▪ Targeting specific applications and benefits of interest to key hops growers ▪ Faster route to commercialization than first two franchises Balance sheet strength to fuel partner - focused commercialization strategy ▪ $49 million in growth capital to support VLN® national launch ▪ Leveraging partner footprint and marketing capabilities for low - cost, high - impact approach ▪ Deploying capital to fuel U.S. VLN® launch, commence international sales of VLN®, accelerate cannabis commercialization, and launch hops franchise 05 02 Advocating for proposed menthol ban and nicotine cap policies ▪ FDA progress on menthol ban ▪ MRTP positions VLN® as possibly the only menthol cigarette still available ▪ Favorable political climate |
| 21 Q&A |
| CONTACT INFORMATION INVESTOR RELATIONS & MEDIA CONTACT Mei Kuo 22nd Century Group, Inc. Director, Communications & Investor Relations T: 716 - 300 - 1221 [email protected] Matt Kreps Darrow Associates Investor Relations T: 214 - 597 - 8200 [email protected] |
| Application Targeted Benefit Zero/Undetectable THC and High CBD Zero/Undetectable THC and High CBG Crop loss due to hemp going “hot” (exceeding 0.3% THC content) is a common industry issue. Zero THC helps growers stay under the allowed threshold, reduce crop losses, and reduce processing cost while high CBD and CBG increase yields. Consumers and CPG brands get zero THC content. Stable High THC Targeting disruptive lines with 30 - 40% stable yield of pure THC, well above unpredictable yields in current strains Yield Enhancement Increase in cannabinoid content in the flower and the rest of the plant for overall increased plant yields Powdery Mildew Resistance Crop loss can be as much as 25% of the crop yield depending on the region, growth method and year. Divaric Acid (CBDV) – A non psychoactive minor cannabinoid with demonstrated anti - epileptic and anti - convulsive action ( Epidiolex ) Increase of yields of CBDV to a stable 4 - 8%, making it more accessible for use in medical research and commercialization. Low Terpene and New Terpenes Profiles Reduce the terpenes responsible for undesirable aromas and the development of new combinations of terpenes desirable to consumers 23 KEY INITIAL HEMP/CANNABIS PROGRAMS 22nd Century is advancing a broad funnel of hemp/cannabis plant lines & IP designed to address specific industry needs. |
| Application Targeted Benefit Agronomic traits/powdery mildew, downey mildew, fusarium, and wireworm (disease resistance/pest resistance) Crop loss can be as much as 30% of the yield depending on region and year Architecture traits/ratio cone/biomass and lupulin density Success can generate 20 - 60% increase in yield Consumer traits/Alpha and Beta acids in beer are industry drivers Stabilize the content and tailor to meet specific requirements from brewers Terpenoids/flavonoids (oils) are new flavor drivers Creating new disruptive, unique and proprietary aromatic hops flavor profiles for the brewing industry. Xanthohumol and 8 - prenylnaringenin potential nutraceuticals and pharmaceuticals Addressing a broad range of opportunities including managing anxiety, inducing calm, addressing sleeping disorders, resolving stomach problems, and other wellness applications 22nd Century is actively engaged in discussions with multiple hops growers and consumer product partners to develop specific desired traits. 24 KEY INITIAL HOPS OPPORTUNITIES |