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22nd Century (XXII) - 2020 Q1 - Quarterly Report
2020-05-07 16:03
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2020 ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period From ________ to ________ Commission File Number: 001-36338 22nd Century Group, Inc. (Exact name of registrant as specified in its charter) of incorporation) Identification No.) ...
22nd Century (XXII) - 2020 Q1 - Earnings Call Transcript
2020-05-07 13:43
Financial Data and Key Metrics Changes - First quarter revenue increased by 12% year-over-year, reaching $7.1 million, driven by steady sales and contract manufacturing cigarettes [11][27] - Operating loss improved by 23% to $4.1 million compared to a loss of $5.4 million in the prior year, primarily due to reduced operating expenses [11][28] - Net loss for the first quarter was $4 million, or a loss per share of $0.03, compared to a net loss of $2.1 million or a loss per share of $0.02 for Q1 2019 [28] - Adjusted EBITDA improved by approximately 30% to negative $3.2 million, or negative $0.02 per share, compared to negative $4.6 million, or negative $0.04 per share in Q1 2019 [29] - Cash used in operating activities was approximately $4.7 million, flat year-on-year, with liquidity remaining strong at approximately $34 million [30] Business Line Data and Key Metrics Changes - The company’s focus is on VLN cigarettes and the MRTP application, with significant progress made in the FDA review process [12][17] - The company has successfully completed research field trials validating new non-GMO methodologies for reducing nicotine in tobacco plants, with potential to reduce nicotine levels by up to 99% [18][19] Market Data and Key Metrics Changes - The company is exploring international markets for VLN, where non-GMO products are preferred by consumers [20] - The legal hemp/cannabis space is a growing focus, with strategic partnerships established to enhance R&D capabilities [21][25] Company Strategy and Development Direction - The company is in the final action stage of its MRTP application with the FDA, which is crucial for marketing and advertising claims [12][17] - Continued emphasis on R&D in both tobacco and hemp/cannabis sectors, aiming to create strong shareholder returns [25] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the impact of COVID-19 but emphasizes minimal disruption to operations and a strong financial position [8][30] - The FDA's recent announcement regarding the public comment period for the MRTP application is viewed as a positive sign for future outcomes [15] Other Important Information - The company has maintained a work-from-home policy for corporate employees while ensuring the production facility remains operational [9][10] - The partnership with KeyGene and investment in Panacea are expected to accelerate growth in the legal hemp/cannabis market [21][25] Q&A Session Summary - The call concluded without a Q&A session, as indicated by the operator's closing remarks [34]
22nd Century (XXII) - 2019 Q4 - Annual Report
2020-03-11 20:12
or UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K x Annual Report under Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2019 (716) 270-1523 ¨ Transitional Report under Section 13 or 15(d) of the Securities Exchange Act of 1934 (Registrant's telephone number, including area code) Commission File Number: 001-36338 22nd Century Group, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction (IRS ...
22nd Century (XXII) - 2019 Q3 - Quarterly Report
2019-11-07 21:11
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2019 ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period From ________ to ________ Commission File Number: 001-36338 22nd Century Group, Inc. (Exact name of registrant as specified in its charter) of incorporation) Identification ...
22nd Century (XXII) - 2019 Q2 - Earnings Call Transcript
2019-08-09 00:40
Financial Data and Key Metrics Changes - For Q2 2019, net sales revenue decreased by 15.9% to $5.8 million compared to the prior year period [46] - For the first half of 2019, net sales revenue decreased by 7.1% to $12.1 million [46] - The company experienced a gross loss on sales during both the second quarter and the first half, contrasting with a slight gross profit in the same periods last year [47] - Net losses for Q2 2019 were greater than the losses experienced in the comparable year-ago period, primarily due to a non-cash expense of $1.9 million related to a lawsuit settlement and an unrealized loss of $1.4 million on investment in Aurora Cannabis stock warrants [52] Business Line Data and Key Metrics Changes - The decrease in net sales revenue was principally driven by a decrease in production volume in the contract manufacturing business, in line with industry trends [46] - Research and development expenses decreased in both time periods, while expenses related to hemp cannabis increased, reflecting a shift in strategic priorities [49] Market Data and Key Metrics Changes - The legal hemp cannabis market in the US is estimated to be valued between $1 billion to $2 billion annually, with rapid growth expected due to the legalization of hemp products [29] - The hemp cannabis market is believed to be growing faster than the marijuana industry, with potential to surpass the combined value of medical and adult-use marijuana markets in the coming years [30] Company Strategy and Development Direction - The company aims to leverage its strong foundations in both tobacco and hemp cannabis to create future shareholder value [17] - The pursuit of reduced nicotine product standards and the approval of VLN branded products are central to the company's mission to reduce smoking harm and create shareholder value [25] - The company is actively engaged in building awareness of its proprietary very low nicotine content cigarettes and plans to bring these to market [27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's movement towards adopting a reduced nicotine product standard, which is seen as critical for public health [18] - The company believes that its tobacco harm reduction efforts and the development of hemp cannabis products will create substantial value for shareholders [28] - Management highlighted the importance of executing the business plan to achieve positive cash flows and strengthen the company's position in both tobacco and hemp cannabis [54] Other Important Information - The company has made significant investments in research and development for hemp cannabis, including a new research lab and a growing facility in Oregon [34] - An exclusive worldwide multi-year agreement was signed with KeyGene NV to develop hemp cannabis plants with valuable cannabinoid profiles [35] Summary of Q&A Session - The Q&A session concluded without specific questions being addressed during the call, with listeners directed to contact the Investor Relations department for further inquiries [57][58]
22nd Century (XXII) - 2019 Q2 - Quarterly Report
2019-08-07 20:11
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2019 ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period From ________ to ________ Commission File Number: 001-36338 22nd Century Group, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction (IRS Empl ...
22nd Century (XXII) - 2019 Q1 - Quarterly Report
2019-05-07 20:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2019 ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period From ________ to ________ Commission File Number: 001-36338 22nd Century Group, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction (IRS Emp ...
22nd Century (XXII) - 2018 Q4 - Earnings Call Transcript
2019-03-08 03:56
Financial Data and Key Metrics Changes - Net sales revenues for the year ended December 31, 2018, were $26,426,000, a 59.2% increase from $16,600,000 in 2017, marking the highest annual net sales revenue in the company's history [12][13] - Gross profit on product sales for 2018 was $899,000, a positive change of $1,607,000 from a gross loss of $708,000 in 2017, primarily due to increased factory utilization [14] - Net loss for 2018 was $7,967,000, or a negative $0.06 per share, compared to a net loss of $13,029,000, or a negative $0.13 per share in 2017, reflecting a decrease in net loss of 38.9% [16] - Adjusted EBITDA for 2018 was a negative $19,489,000, worsening from a negative $11,411,000 in 2017, primarily due to increased operating expenses [20] - Cash position at December 31, 2018, was $56.4 million, sufficient to cover normal monthly operating expenses of approximately $850,000 for several years [21] Business Line Data and Key Metrics Changes - The increase in net sales revenue was primarily attributed to additional revenue from contract manufacturing of cigarettes and filtered cigars [13] - Operating expenses for 2018 were $20,388,000, an increase of 90.5% from $10,703,000 in 2017, largely due to expenses related to the Modified Risk Tobacco Product (MRTP) application with the FDA [15] Market Data and Key Metrics Changes - The company is actively engaged in the hemp cannabis market, which has seen significant legislative changes, including the 2018 Farm Bill that legalized hemp [33][34] - The FDA's plan to reduce nicotine content in cigarettes is expected to complement the company's MRTP initiative, which seeks to commercialize very low nicotine content cigarettes [29][31] Company Strategy and Development Direction - The company aims to advance its MRTP application for very low nicotine content cigarettes while simultaneously increasing investment in hemp cannabis research and development [37][49] - The strategic vision includes forming partnerships and alliances to enhance its biotechnology efforts in the hemp cannabis industry [38][41] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's commitment to nicotine reduction and the progress of the MRTP application, noting more than 20 conversations with the FDA in recent months [30][46] - The company believes it is well-positioned to capitalize on opportunities in the hemp cannabis market, with a strong cash position and ongoing research initiatives [49] Other Important Information - The company is facing frivolous class action lawsuits, which management believes are without merit and intends to defend vigorously [42][44] - The company has a unique competitive advantage in producing very low nicotine tobacco, which is distinct from other low nicotine products in the market [72] Q&A Session Summary Question: Can you provide clarity on expenses for 2019? - Management indicated that expenses related to the MRTP application would decrease significantly, with an anticipated $1.5 million in additional expenses for the application [52][56] Question: What are the top priorities for the company moving forward? - The top priorities include advancing the MRTP and PMTA applications and building out the hemp franchise [57][58] Question: How does the company plan to address the potential delays in the MRTP timeline? - Management expressed confidence in the cash position, stating there is more than four years of cash available, and noted that the MRTP process is progressing smoothly [65][66] Question: What is the competitive landscape in the hemp business? - Management acknowledged that while there are competitors, the company believes it has a significant head start in developing unique hemp strains with zero THC [95][96]
22nd Century (XXII) - 2018 Q4 - Annual Report
2019-03-06 21:12
FORM 10-K x Annual Report under Section 13 or 15(d) of the Securities Exchange Act of 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the fiscal year ended December 31, 2018 or ¨ Transitional Report under Section 13 or 15(d) of the Securities Exchange Act of 1934 Commission File Number: 001-36338 22nd Century Group, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction (IRS Employer of incorporation) Identification No.) Nevada 98-0468420 85 ...