22nd Century Group Reports Business Highlights and Financial Results for the Third Quarter 2021
11/04/2021 - 06:00 AM
Meeting Held October 14 with Senior Level Staff at FDA Company’s Confidence in a Positive MRTP Application Outcome and Timing at Its Highest Level Monetizing Hemp/Cannabis Plant Lines and IP Beginning in the Fourth Quarter of 2021 Introduced Hops as the Third Plant-Based Franchise, Expanding Total Addressable Markets to $1.3 Trillion Record Year-to-Date Net Sales of $23.0 Million , Up 11% From Year-To-Date of 2020 Executing From a Strong Financial Position with Cash and Cash Equivalents of $55.2 Million as of September 30, 2021 Uplisted Common Shares to the Nasdaq Capital Market (“Nasdaq”) Under the Symbol, “XXII” BUFFALO, N.Y., Nov. 04, 2021 (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 plant science, today reported results for the third quarter ended September 30, 2021, and provided an update on recent business highlights. The Company will host a live audio webcast today at 10:00 a.m. ET.
“I am proud of the tremendous progress we have made during 2021 as we complete the final step to MRTP authorization of our VLN® reduced nicotine tobacco cigarettes and begin to monetize our highly disruptive hemp/cannabis plant lines and IP,” said James A. Mish, chief executive officer of 22nd Century Group.
Mish added, “We are closer than ever to accomplishing our mission to reduce the harm caused by smoking. Our decision to maintain a collaborative approach with the FDA is moving our MRTP application forward. Based on our recent positive discussion with senior-level staff at FDA on October 14, our confidence in our MRTP application outcome and timing is at its highest level. We are ready to immediately scale production of our VLN® products for launch in both the U.S. and international markets, and we are eager to bring VLN® to adult smokers in the U.S. and globally to help address the overwhelming amount of death and disease caused by smoking.”
Key Financial and Business Highlights
Tobacco Franchise
Securing MRTP designation for VLN® remains 22nd Century’s number one priority. 22nd Century possesses the expertise to navigate the MRTP application process to a successful conclusion as evidenced by the positive and collaborative exchanges with FDA and throughout the process. The Company held a successful meeting with the FDA on October 14, 2021, regarding its MRTP application. Following the meeting, and in conjunction with recent Center for Tobacco Products (CTP) activity, the Company’s confidence in a positive outcome for its MRTP application and timing is at its highest level to date. Evidenced by the Agency’s recent authorization of e-cigarettes and other nicotine products, the FDA continues to demonstrate its ongoing commitment to advance its Comprehensive Plan for Tobacco and Nicotine Regulation ® will serve as a vanguard for the FDA’s proposed mandate to cap the levels of nicotine in combustible cigarettes. Under these product standards, 22nd Century would have the only cigarette able to meet the reduced nicotine mandate on day one and, with the FDA’s determination that the Company’s reduced nicotine content cigarettes are “appropriate for the protection of health” under the PMTA pathway, the Company could have the only combustible menthol cigarette exempt from the FDA’s proposed menthol cigarette ban 22nd Century Group applauds the potential nomination of Dr. Robert Califf for FDA commissioner. Califf participated in an event VLN® is market-ready. The Company’s U.S. pilot program and manufacturing capabilities are in place to launch VLN® in the U.S. within 90 days of receiving MRTP designation. The Company plans to position VLN® in the premium pricing segment of the cigarette market and, therefore, expects it to deliver corresponding margins. The Company continued its international launch process for VLN® . The Company is focusing on several of the leading markets in Asia and a test market in Europe. These markets have a strong affinity for new, modified risk tobacco products and will likely require minimal interaction with regulators to launch VLN®. Sales to local partners in one or more markets are expected to begin in the first quarter of 2022. The Company also plans to establish a company branch in New Zealand. The Company has expanded its strategic discussions to include pharmaceutical partnership opportunities where reduced nicotine cigarettes may provide synergistic benefits to other products already marketed to address tobacco harm reduction. 22nd Century’s growth in tobacco contract manufacturing volumes and disciplined operations continued in the third quarter and confirms readiness of the Company’s operations ahead of VLN® launching: In July 2021, the Company announced that it had secured a substantial new agreement with a tobacco industry partner that specializes in exporting cigarettes to countries outside the United States. In October 2021, the Company secured an additional new contract manufacturing customer. The Company has completed the expansion of its in-house nicotine content testing capabilities, which allows for rapid, in-house analysis of its tobacco. This initiative improves the cost per VLN® sample by more than 90% while significantly reducing the lead time to uncover key data. Internal testing of the Company’s current crop of VLN® leaf commenced in August using the newly installed testing equipment. The assets needed to manufacture research cigarettes and VLN® are generating profits and cash flow ahead of the MRTP authorization. The Company’s record VLN® tobacco growing program in the U.S. is driven by the Company’s latest sales projections. The new crop and the Company’s existing inventory of VLN® tobacco are earmarked for the launch and sales of VLN® cigarettes. 22nd Century Group has signed a partnership agreement to grow VLN® in the southern hemisphere providing the Company with year-round growing capabilities. 22nd Century Group continues to leverage its non-GMO technology to rapidly introduce reduced nicotine traits into virtually any variety of tobacco. The Company will begin planting its non-GMO VLN® varieties at commercial scale, including Bright and Burley varieties, in 2022. The Company submitted its formal response to the New Zealand Ministry of Health’s Smokefree Aotearoa 2025 Action Plan. This follows the release of a new proposal by the New Zealand Ministry of Health Manatū Hauora that calls for reducing the amount of nicotine allowed in smoked tobacco products to “minimal levels.” Hemp/Cannabis Franchise
The Company expects to monetize its hemp/cannabis plant lines and IP beginning in the fourth quarter of 2021 with upfront license fees plus revenue from sale of its hemp biomass and extract from the current crop harvested at Needle Rock Farms. Next-generation, disruptive plant lines and IP are being accelerated for 2022 and 2023 revenue programs. During the quarter, 22nd Century Group and KeyGene reached a collaborative agreement with the National Institute of Science and Technology The Company is nearing agreements with Aurora relating to both plant development and licensing of shared Anandia IP for biosynthetic cannabinoids. 22nd Century added strategic partnerships with the world’s leading alkaloid plant producer-breeders, including Extractas Bioscience, Sawatch Agriculture, and Folium Botanical for next-generation commercial hemp/cannabis plant breeding and commercial scale-up. The partnerships facilitate year-round growing capabilities at locations in both the southern and northern hemispheres. The Company now controls the most comprehensive and innovative upstream cannabinoid value chain in the industry, an asset critical to unlocking commercial success for large-scale cultivation and extraction as this emerging industry continues to scale with the continuing success of global legalization and commercialization efforts and the entrants of new players from adjacent industries including tobacco, pharmaceutical, and other consumer products companies. 22nd Century Group is in the process of applying for its USDA Organic Certification for its hemp farm, Needle Rock Farms. USDA Organic Certification will allow 22nd Century to command a premium in price and margins for its raw materials. Hops Franchise
The Company announced entry into the global specialty hops market, its third and newest plant franchise, on August 30, 2021. Hops is a large global addressable market estimated at more than $500 billion annually that includes well-established hops providers and consumer brands. 22nd Century is approximately eight months into its initial hops two-year development cycle and expects monetization of hop plant varieties and IP with upfront license fees beginning in late 2022 to mid-2023. 22nd Century is actively engaged in discussions with multiple significant hops grower and consumer product partners to develop specific desired traits in leading hops strains. The Company is securing hop plant germplasm for use in breeding, and it is advancing valuable IP on those plants. The Company is advancing its hop genome sequencing efforts through its partnership with KeyGene, which has been accelerated by its knowledge of genome sequencing in hemp/cannabis, which is closely related to the hop plant. 22nd Century is in the process of establishing a new subsidiary in the Netherlands, 22nd Century Group Europe B.V., to open new revenue opportunities in hops, as well as serve its tobacco and hemp/cannabis plant franchises through an expanded global footprint. Corporate Business Highlights
22nd Century began trading on Nasdaq Capital Markets on August 16, 2021. Uplisting to the Nasdaq aligns the Company with other high-achieving, innovative, and growth-oriented global science and technology companies and enhances the Company’s visibility to a wide audience of institutional investors. 22nd Century appointed accomplished life sciences and biotechnology executive Anthony Johnson to its Board of Directors. New research coverage of the Company was initiated by Vivien Azer on July 23, 2021. Azer is a leading beverages, tobacco, and cannabis senior analyst at Cowen & Company, LLC. 2021 Third Quarter Financial Results
Net sales for the third quarter of 2021 were $7.8 million , an increase of 6.9% from $7.3 million in the prior year period. The increase was due to an increase in contract manufacturing sales. Gross profit for the third quarter of 2021 improved by $87 thousand , or 24% to $449 thousand compared to the prior year period – a seventh consecutive quarter of year-over-year improvement in gross profit. The improvement in gross margin was primarily the result of increased filtered cigar sales mix due to new customer contracts and price increases on the Company’s contract manufactured cigarettes. Total operating expenses for the third quarter of 2021 increased by $3.5 million compared to the prior year period. This was driven by the following: Sales, general and administrative expenses increased by $3.6 million compared to the prior year period. This was driven primarily by higher personnel, insurance, financial and strategic consulting costs, and marketing costs. These investments deployed to support, evaluate, and prepare for future opportunities are critical as the Company moves quickly to market readiness in both tobacco and hemp/cannabis. Research and development expense for the third quarter of 2021 was favorably lower by $52 thousand compared to the prior year period. 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 higher license and contract costs for field trials and 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 to hops. Operating loss for the third quarter of 2021 was $(7.9) million , an increase of $3.4 million 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 in the third quarter of 2021. Net loss in the third quarter of 2021 was $(9.4) million , an increase of $5.1 million compared to the prior year period primarily due to an increase in non-cash charges off-set by benefits to other income and expenses, and representing a net loss per share of $(0.06). This compares to the third quarter of 2020 net loss of $(4.2) million , or $(0.03) per share. The Company recorded a non-cash unrealized loss of $1.9 million related to its fair value adjustments for investment in Aurora Cannabis stock warrants and investment in Exactus common stock. Balance Sheet and Liquidity
For the first nine months of 2021, net cash used in operating activities was $18.2 million , compared to $12.6 million in the prior year period. The Company ended the quarter with a cash position of $55.2 million as of September 30, 2021, and the Company’s continued initiatives to manage expenses relative to net sales revenue should provide the Company with additional runway to execute for the foreseeable future Third Quarter Earnings Conference Call
Following prepared remarks, including an accompanying slide presentation, the Company will host a Q&A session, during which management will accept questions from interested analysts. Investors, shareholders, and members of the media will also have the opportunity to pose questions to management by submitting questions through the interactive webcast during the event.
The live and archived webcast, interactive Q&A, and slide presentation will be accessible on the Events web page in the Company's Investor Relations section of the website, at https://www.xxiicentury.com/investors/events
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22nd CENTURY GROUP, INC. CONSOLIDATED BALANCE SHEETS (Unaudited) ($ in thousands, except per-share data)
September 30, December 31, 2021 2020 ASSETS Current assets: Cash and cash equivalents $ 1,629 $ 1,029 Short-term investment securities 53,532 21,313 Accounts receivable, net 1,179 2,159 Inventory, net 2,703 2,034 Prepaid expenses and other assets 3,131 1,806 Total current assets 62,174 28,341 Property, plant and equipment, net 4,754 2,483 Operating leases right-of-use assets, net 478 247 Intangible assets, net 8,036 8,211 Investments 7,300 6,536 Other assets 3,713 5,876 Total assets $ 86,455 $ 51,694 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Notes payable $ 1,782 $ 539 Operating lease obligations 74 247 Accounts payable 1,443 1,116 Accrued expenses 3,440 4,830 Accrued severance 223 339 Deferred income — 272 Total current liabilities 6,962 7,343 Long-term liabilities: Operating lease obligations 407 — Severance obligations 72 241 Total liabilities 7,441 7,584 Commitments and contingencies (Note 11) Shareholders' equity 10,000,000 preferred shares, $.00001 par value 300,000,000 common shares, $.00001 par value Capital stock issued and outstanding: 162,735,483 common shares (139,061,690 at December 31, 2020) Common stock value 2 1 Capital in excess of par value 243,087 189,439 Accumulated other comprehensive (loss) income (27 ) 74 Accumulated deficit (164,048 ) (145,404 ) Total shareholders' equity 79,014 44,110 Total liabilities and shareholders’ equity $ 86,455 $ 51,694
22nd CENTURY GROUP, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) ($ in thousands, except per-share data)
Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Revenue: Sale of products, net $ 7,811 $ 7,310 $ 22,988 $ 20,803 Cost of goods sold (exclusive of depreciation shown separately below): Products 7,362 6,948 21,306 19,953 Gross profit (loss) 449 362 1,682 850 Operating expenses: Research and development 854 906 2,287 2,676 Research and development - MRTP 2 4 16 158 Sales, general and administrative 6,821 3,169 17,827 9,809 Impairment of intangible assets — — — 146 Depreciation 173 160 461 473 Amortization 168 163 471 524 Total operating expenses 8,018 4,402 21,062 13,786 Operating loss (7,569 ) (4,040 ) (19,380 ) (12,936 ) Other income (expense): Unrealized gain (loss) on investments (1,900 ) (429 ) (2,040 ) (562 ) Impairment of Panacea investment — — — (1,062 ) Gain on Panacea investment conversion — — 2,548 — Gain on the sale of property, plant and equipment — 1 — 1 Interest income, net 52 270 272 1,344 Interest expense (23 ) (23 ) (44 ) (54 ) Total other income (expense) (1,871 ) (181 ) 736 (333 ) Loss before income taxes (9,440 ) (4,221 ) (18,644 ) (13,269 ) Income taxes — — — 38 Net loss $ (9,440 ) $ (4,221 ) $ (18,644 ) $ (13,307 ) Other comprehensive income (loss): Unrealized gain (loss) on short-term investment securities (28 ) 87 (101 ) 132 Other comprehensive income (loss) (28 ) 87 (101 ) 132 Comprehensive loss $ (9,468 ) $ (4,134 ) $ (18,745 ) $ (13,175 ) Net loss per common share - basic and diluted $ (0.06 ) $ (0.03 ) $ (0.12 ) $ (0.10 ) Weighted average common shares outstanding - basic and diluted (in thousands) 162,721 138,857 153,998 138,774
Below is a table containing information relating to the Company’s Adjusted EBITDA for the three months and year-to-date ended September 30, 2021 and 2020, including a reconciliation of net (loss) income to Adjusted EBITDA for such periods.
Quarter Ended September 30, Dollar Amounts in Thousands ($000's) $ Change 2021 2020 fav / (unfav) Net loss $ (9,440 ) $ (4,221 ) $ (5,219 ) Adjustments: Amortization and depreciation 341 323 18 Unrealized loss (gain) on investment 1,900 429 1,471 Gain on the sale of machinery and equipment — (1 ) 1 Accretion of non cash interest expense 2 4 (2 ) Equity-based employee compensation expense 1,119 306 813 Interest income, net (52 ) (270 ) 218 Interest expense 21 19 2 Adjusted EBITDA $ (6,109 ) $ (3,411 ) $ (2,698 )
1 Fav = Favorable variance, which increases Adjusted EBITDA; Unfav = unfavorable variance, which reduces Adjusted EBITDA
Year-to-date Ended September 30, Dollar Amounts in Thousands ($000's) $ Change 2021 2020 fav / (unfav) Net loss $ (18,644 ) $ (13,307 ) $ (5,337 ) Adjustments: Impairment of intangible assets — 146 (146 ) Impairment of Panacea investment — 1,062 (1,062 ) Amortization and depreciation 931 997 (66 ) Unrealized loss (gain) on investment 2,040 562 1,478 Gain on the sale of machinery and equipment — (1 ) 1 Gain on Panacea investment conversion (2,548 ) — (2,548 ) Accretion of non cash interest expense 6 34 (28 ) Equity-based employee compensation expense 2,871 1,162 1,709 Executive and board search fees — 430 (430 ) Interest income, net (272 ) (1,344 ) 1,072 Interest expense 38 20 18 Adjusted EBITDA $ (15,578 ) $ (10,239 ) $ (5,339 )
1 Fav = 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.
