More Than 16 Million Americans Attempt To Quit Smoking Each Year without the Use of Drugs or Therapies–And Only 2-5% Successfully Quit In A Given Year; 22nd Century Group (NYSE MKT: XXII) Is Developing the Most Effective Solution to Date for These “Marooned” Consumers
The Wealthy Biotech Trader (or “WBT”), an investment newsletter focused on showing everyday investors new opportunities in rapidly growing, little-known biotech, pharmaceutical and medical device stocks releasing impressive news and making market moves, would like to highlight the massive paradigm shift in the word of smoking cessation (quitting).
After being shunned by investors for the past couple of years, the tobacco sector has been slowly proving that it’s set for a meteoric rise and investors should pay more attention to it. Previous headwinds which had plagued the sector such as a declining smoking population and increased regulation have now fully played out, leaving a couple of stocks dealing a tobacco recipe that is ripe for investors’ picking.
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22nd Century Group (NYSE MKT: XXII) is a plant biotechnology company whose 200 patents worth of technology allows it to decrease or increase the level of nicotine in tobacco plants through plant breeding and genetic engineering. The Company’s main focus, although counter intuitive as a cigarette marketer, is to reduce harm from smoking when compared to traditional big brands such as Marlboro (NYSE: PM).
Currently, the company’s products include high nicotine cigarettes marketed under the RED SUN brand name, very low nicotine cigarettes marketed under the MAGIC brand name and SPECTRUM research cigarettes with varying levels of nicotine for the U.S. government and accredited research organizations around the world–the company actually sells cigarettes to the National Institute of Health (NIH) for studies proving how low nicotine tobacco is the most effective way to reduce smoking rates and addictiveness of cigarettes. The U.S. Food and Drug Association (FDA) funded a landmark study that showed 22nd Century’s proprietary Very Low Nicotine cigarettes were “associated with reductions in smoking, nicotine exposure, and nicotine dependence, with minimal evidence of nicotine withdrawal, compensatory smoking, or serious adverse events.” See study here:http://www.nejm.org/doi/full/10.1056/NEJMsa1502403.
22nd Century is also in the process of developing a Very Low Nicotine cigarette as a novel and remarkably effective prescription smoking cessation aid–yes a prescription cigarette. Code named “X-22” the product reportedly causes no new side effects and yet seems to demonstrate higher efficacy rates than Pfizer’s (NYSE: PFE) market-leading, side effect-laden Chantix drug (which logs in excess of $600 million in sales each year). Pfizer must think XXII is on to something with this approach as they actually funded a study on smoking cessation where patients were treated with Chantix in combination with 22nd Century’s ultralow nicotine cigarettes, also with remarkable results.
With a US smoking cessation market size in excess of $1 Billion, and another $3 billion outside the States, one of the other mega-player in the smoking cessation space is the $100 Billion British Behemoth, GlaxoSmithKline Plc (NYSE: GSK). GSK is the maker of the prescription quit smoking pill Zyban which strangely is also used to treat depression and is also rife with extreme side effects. There is no doubt a need for a simpler, safer more effective solution and, with XXII recently announcing the active search for a strategic pharma partner for a phase III FDA study, commercialization of a blockbuster new product could be just around the corner pending approval.
In the ground-breaking 2015 clinical study funded by the FDA, independent researchers found that smokers who used 22nd Century’s (NYSE MKT: XXII) patented very low nicotine cigarettes (which contain approximately 95 percent less nicotine than ordinary cigarettes),smoked far fewer cigarettes per day, had minimal withdrawal symptoms and doubled their attempts to quit. This study was published in the highly-respected New England Journal of Medicine. And, currently, the FDA is funding an additional $20+ million smoking cessation study using the company’s very low nicotine cigarettes. Results of this study are only months away… and when this study is published, investors can expect the 22nd Century’s share price to move dramatically.
22nd Century Group has quite a bit going for it beyond tobacco as well. The company owns the exclusive patent rights in the U.S. which allow it to increase or decrease concentrations of the most important cannabinoids (the active ingredients) in cannabis. With this technology, 22nd Century is developing low-THC, high-CBD strains for the rapidly growing medical marijuana markets. With federal marijuana legalization nearing reality, the company is poised to capitalize on its impressive cannabis patent portfolio and growing cannabis technology.
With current share prices under $1, XXII is ripe for the picking based on a couple of other drivers as well. Having focused for years purely on research and development, the company is now turning its focus to monetizing its extensive patent portfolio. 2014 revenues were only $530,000 but, under a new CEO, 22nd Century earned more than $8.5 million in 2015. Furthermore, the Company just released Q1 2016 financials with the main highlight being a 400% revenue jump compared to the same quarter in 2015.
Not including licensing deals or international sales, publicly disclosed projections call for at least $12 million this year. Though not yet profitable, 22nd Century’s commercial expansion in Europe, Southeast Asia, and elsewhere should add significantly to the company’s bottom line in 2016, and with the FDA set to approve the world’s first ever Modified Risk Tobacco Products application for 22nd Century’s patented very low nicotine cigarettes (Brand A) before the end of this year, investors are looking at massive growth potential–these are similar to the Company’s X-22 smoking cessation aid, but may, upon clearance be marketed to retail customers as a “safer” or “reduced risk” cigarette. There are so many catalysts and binary moves this company can make over the next 6-12 months, it is difficult to believe this NYSE micro-cap still trades under $1. Undoubtedly, 22nd Century will not remain “under the radar” for much longer.
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