Welcome to the 22nd Century Group’s Fourth Quarter 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode and the floor will be opened for questions following management’s prepared remarks. As a reminder, today’s conference is being recorded. At this time, I would like to turn the call over to Mei Kuo, Director of Communications and Investor Relations. Please begin.

Thank you, Brock. Good morning and welcome to 22nd Century’s fourth quarter earnings conference call. Joining me today are; Jim Mish, our Chief Executive Officer; Mike Zercher, our President and Chief Operating Officer; and John Franzino, our Chief Financial Officer.

Thanks, Mei and good morning, everyone and thanks for joining 22nd Century’s conference call today. 2020 was a tremendous year for the 22nd Century Group. Since joining the company in June, we’ve really stressed communicating our strategic and tactical plan. The significant increase in our stocks since reporting third quarter earnings is a testament to our commitment to our shareholders. Despite the recent volatility and it’s been driven by the positive impact of all of our remaining warrants being exercised and sold off, plus general market conditions, we’ve done nothing, but consistently communicate news regularly to our shareholders to build confidence and credibility. Today’s call is a continuation of Morgan News and what’s to come in 2021. If you turn to Slide 3 on the presentation, I’ll touch on a few key highlights. We’ve never been more excited about our tobacco franchise and our prospects remain extremely high securing MRTP authorization for VLN and reducing the harm caused by smoking remains our number one priority. We are highly confident that we are in the final stages of the application process with the FDA. As Mike, John, and I continue to defer any variable pay until such time, our confident level has only gone up based on the proactive efforts we have deployed over the last several months, and other strong signals, including the recent change of administration at the White House.

Thanks, Jim and good morning, everyone. Turning to Slide 6, it’s important for us to remind everyone of the massive global market opportunity there is for VLN, our proprietary reduced nicotine cigarettes, which contained 95%, less nicotine than conventional cigarettes. In 2018, global tobacco market was worth over $800 billion with 90% of that being sales of highly addictive conventional cigarettes. There were more than one billion smokers around the world with 34 million of those in the U.S. We know that more than two thirds of adult smokers want to quit and 50% attempt to quit each year, yet less than 10% of those quit attempts actually succeed. We know that smokers are actively seeking alternatives to addictive conventional cigarettes, and we are encouraged by data from our own consumer perception studies showing that 60% of current adult smokers are likely to use VLN. Despite vape and many other potential modified risk tobacco product alternatives coming to market in recent years, the CBC recently reported that the smoking rate appears to be up year-over-year. New research shows that more Americans have turned cigarette smoking as they’ve struggled with broader leaf and the disruption of regular routines, another tragic outcome of the COVID-19 pandemic. Now is the time to address the enormous amount of death and disease caused by cigarette addiction by offering adult smokers, a new and different alternative with tobacco cigarette with drastically reduced nicotine levels. Because VLN is a cigarette made from tobacco; it tastes, smells and smokes like a conventional cigarette, but it contains just 0.5 mg of nicotine per gram of tobacco, an amount that FDA has said based on clinical studies is likely to be minimally are non-addictive. This is the form factor adult smokers prefer while also being a tobacco product intentionally designed to not create or sustain addiction. The first FDA Commissioner to take on the tobacco industry, Dr. David Kessler said in 2010, that “if we reduce the level of the stimulus, meaning nicotine, we reduce the craving” and he called reducing nicotine in cigarettes, “the ultimate harm reduction strategy.” Since 2011, 22nd Century has supplied millions of reduced nicotine content cigarettes to independent scientists and researchers around the world to conduct dozens of clinical studies that have shown over and over again, that Dr. Kessler was right. Reducing the nicotine content of cigarettes is indeed the ultimate harm reduction strategy. We believe that commercially VLN has near-term blockbuster potential while authorization of our application and the launch of VLN will serve as a Vanguard for the FDA’s proposed reduced nicotine mandate. A positive response to our MRTP application is one of the most important decisions FDA can make right now for public health. We are eager and fully prepared to launch VLN post MRTP authorization. And so offer adult smokers a new alternative to highly addictive conventional cigarettes.

thanks, Mike. let’s turn to Slide 10. I want to remind everyone of the size of the prize of our hemp/cannabis franchise. The global legal cannabis market is projected to be more than $100 billion in just a few years. 90% of the legal cannabis market share is held in North America with more and more States considering cannabis reform legislation will transform the U.S. cannabis market. We believe that the existing hemp/cannabis plant lines have poor genetics resulting in a low quality and unreliable plant yield for large scale commercial production. This is a common and widespread problem that is prevalent throughout the entire industry. leveraging our decade long experience and know-how in plant biotechnology, including genetic engineering, gene editing and modern plant breeding, we’ll be able to create new hemp/cannabis plant lines that have optimized plant profiles with stable genetics and higher yield for commercial use. We believe our technology will have broad-based appeal for various end-use markets. on slide 11, we’ve provided an illustration of the upstream segment of the cannabinoid value chain and visualize how our partnerships will maximize and support each component, now that we secured four of the five key partnerships. we are well on our way to vertically integrating our hemp/cannabis capabilities. The combination of our core strength and plant science in our network of key partnerships will enable us to drive differentiation and value by delivering new valuable plant lines and IP in two years. our solutions for the hemp/cannabis industry will be tailored to the unique needs across a wide range of end-use markets, including, but not limited to the life science, consumer product, and pharmaceutical industry. We look forward to sharing more good news once we have secured the fifth component. I’ll now pass it over to John to review our financial performance. John?

Thanks, Jim and good morning to everyone. In summary, on slide 12, we had a great quarter and an excellent year. The actions we took in 2020 to optimize our contract manufacturing operations have been successful. Net sales and gross profit margin have improved year-over-year for the fourth consecutive quarter, demonstrating our ability to execute on the objectives and strategies we set for the business. We provided a snapshot of our financials for the quarter and the year on slide 13. I’ll now walk you through in a bit more detail. Net sales revenue for the fourth quarter increased by $46,000 to $7.3 million. for the year, net sales revenue increased by $2.3 million to $28.1 million. The increase in 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 $364,000 to $588,000; for the year, gross profit improved by $1.4 million 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 increased by $1.1 million; for the year, operating expenses improved by $3 million, driven by the following: R&D expense was favorable by $127,000 and by $2.3 million for the quarter and year respectively. 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 and leaf inventory in the prior year. R&D expense related to our MRTP application is favorable by $205,000 and $1.6 million in the quarter and year respectively. This favoribility is primarily the result of expenses incurred in 2019 that were associated with the preparation of our…

Thanks, John. Now, turning to slide 14. In summary, we have a tremendous global market opportunity of more than $1.3 trillion across our three franchises. In fact, we give a bit more of a hint on the third franchise valuing it at $500 billion. We will continue to take a relentless approach to securing MRTP authorization and truly believe we are on the verge of a home run and possibly a grand slam of our tobacco franchise. My confidence in the MRTP authorization is absolute. We are eager and fully prepared to launch VLN within 90 days of receiving authorization. Our MRTP designation will serve as a catalyst for licensing and partnership opportunities in the U.S. and internationally. Our research and tobacco extends beyond just VLN and our reduced nicotine content technology. We look forward to developing more tobacco-based technologies for various high value end-use markets. In addition, we are well positioned to capitalize on the various opportunities in the upstream segment of the cannabinoid value chain. In 2021, we’ll begin to monetize a portion of our hemp/cannabis IP and we look forward to a network of partnerships working in concert to accelerate the development of new disruptive hemp/cannabis plants and IP for the life science, consumer product, and pharmaceutical industry. And lastly, we believe there are potential legislative tailwinds, including the enactment of a reduced nicotine mandate and the legalization of cannabis that would open up even greater revenue opportunity for 22nd Century. It’s truly an exciting time for our company and our shareholders, and I truly hope that you share in our enthusiasm. We will continue to work hard to execute on the strategic plans we’ve laid out. We will continue to communicate regularly and frequently, and provide as much transparency as we can. We will bring more good news as we advance on all fronts. And with that, operator, please open up the call for questions.

Thank you, sir. Our first question today comes from Jim McIlree of Bradley Woods. Please proceed with your questions.

Thank you and good morning, everyone.

Good morning, Jim.

John, a couple of questions for you. I just want to verify the share count as of today or after the warrant exchange is somewhere around $146 million. Is that right, $146 million, $147 million?

Yes, that’s correct.

Okay, great. And then the G&A increase is fairly large, is that – is there a lot of non-cash in there or one-time? So, I guess two questions on the increase, one is that a permanently higher level? And then second, how much of the increase was non-cash?

well, in response to that, the quarter-over-quarter increase in G&A; in this quarter, we did accrue approximately $2 million for cash benefits, cash bonuses, which would be paid out over the course of next year, of course, major part of our accounting requires us to accrue even the bonuses for myself, Jim and Mike, even though they are at this point, now deferred until such time as the payments would be deferred until such time as we would have the MRTP in place. The other piece that was included in there, it was about $500,000 through the year of additional costs that we had pertaining to readiness for VLN. This included some development of our advertising and commercial areas and this advertising commercial strategies that we would have in there as well as some consulting costs and bringing on consultants to help us with the marketing efforts, anticipate that X that amount the balance would probably continue as we go forward at the rate of what we had booked in the past year, although if timing, of course, it gets to where the bonuses recruit at year-end. So that’s where you see the large lift in the fourth quarter.

Great. That’s helpful. Thank you. You also mentioned an impairment charge for the Panacea warrants. Are those – do those now have a positive value or are those written down to zero?

We actually wrote those down to zero predominantly, because at this point, we – it was part of wrapped into an exchange of assets that we have in place with our note receivable with Panacea and at this stage, we don’t have the intention to exercise those warrants moving forward. And we still – excuse me, we still maintain on our books, the value of our preferred stock, which we strongly believe is of that value and marking it to, we didn’t have to take any provisions on that. but at this stage and we’ve reflected in our books, the value of the warrants, it’s well explained in our form 10-K, reflecting the value of our panacea investment, which would be a post the intent that we have with our non-binding letter of intent that we have in place right now.

All right. And just one last one for you, John, when’s the K getting filed? I’m not seeing it yet. Is that coming soon?

I believe it was filed this morning at 7:00 AM.

All right. Well, my services – obviously…

Just a correction there, the K will be filed shortly.

Okay, great. Thank you. Mike, can you talk about the MRTP timing relative to other MRTPs and relative to what FDA guidelines are that is you’ve gone this many months, and this is the number of months it took for a prior MRTP, or this is the number of months that the FDA suggested should take. Can you just refresh us on that timeline?

Yes, Jim. Thanks for the question. So, FDA guides that MRTP review will take 360 days, although that is not binding on FDA. There have been just two other MRTPs authorized. Those – there were varying time periods there. There are several milestones in the process that we look at, including TPSAC meeting and closing a public comment period. So, we’re within the window there based on those other products. There of course, are some unusual circumstances given COVID-19 and the impact that that has had on the FDA. And so we do know that FDA has acknowledged publicly that some of their folks have been assigned to other federal agencies to help with COVID-19. We don’t know if that’s affected the center for tobacco products at FDA, which is the center that reviews MRTP applications, but we have seen that they continue to work on other applications. We know that they continue to work on ours, given our dialogue with them. But clearly, COVID-19 has had some impact on FDA overall. And we fully expect now that with the election behind us – the presidential election behind us and the transition well underway that FDA is paying close attention to our application and all of their work around tobacco.

And remind me when was your application submitted and I think you amended it. So, when was the amended application submitted?

Well, there have been several amendments over time. Those don’t necessarily reset the clock in fact. I think we would begin really, the key timing point is the closing of the public comment period, but the application itself was filed in December of 2019. And then there were some applications in the first part of or some amendments in the first part of 2020 – or I’m sorry.

Okay.

Yes, yes. I might be confusing the timing with the PMTA, so.

right. But I just wanted to make sure I’m looking at the same timeline and that’s what I kind of have to. So, we’re at that sort of 365 days plus or minus, but we have to remember, like you said, COVID has an – could have and probably have an impact and who knows what that is?

Yes.

Okay, okay. That’s great.

And I’ll note that there are other MRTP applications for other products that are still under review. It’s not just VLN.

Yes, yes. Got it.

So, there’s no hard and fast timeline. It’s the bottom line.

right. I understand that the FDA is not obligated to stick to that 365 days. And Jim, on the hemp/cannabis, I guess two questions here. one, in your final comments; you talked about commercialization or revenue generation. I’m not sure which phrase you used for hemp this year. I think you said that and I just wanted to verify that that’s the case. And then secondly, on cannabis, my assumption is that you’re really not going to get any revenue generated from your cannabis work until you get a federal change of cannabis on the DEA schedule. So, the first part hemp this year, yes; and then the second part no cannabis until we get that action. Is that correct?

So, yes, the – let me address the first part. We expect revenue from the existing library of work that has been done over the past two years. So, the company, with their working KeyGene and other partnerships, developed advanced technology, it’s not the optimum technology that we have targeted for later generations. but it’s certainly further down the road than existing plant lines and we’re in discussions with strategic partners to license that technology – that hemp-based technology out there has – they’re more stable lines, higher cannabinoid content, et cetera. So, we anticipate revenue stream from that work that’s been done over the past two years. And then we have additional plant lines coming through in the pipeline as well that will start to see revenue generation as early as next year as the license work goes on and people want to capture a piece of that upfront with upfront payments et cetera. So, we have a good pipeline of that moving ahead. on the cannabis marijuana front, let’s say the – that component of it, we’re conducting R&D off shore in the Netherlands on next generation plant lines that are much more stable, higher levels of cannabinoids. And we want to be positioned for the legalization of that in order to generate licensing opportunities there. So, that will come with the legislative actions, but based on what the Biden administration has said in the past and based on just the momentum going legalization across federal lines, we believe is going to happen. They may need to work on that before the midterms, in order to get that push through. So that’s – that potentially is a timeline there and when it happens, we’ll be ready with those plant lines that have gone way down the value chain and development, and then can be transferred and licensed pretty quickly. There may be some early opportunities, but it all really ties down to how fast these things can move through legislation. Does that answer your question?

It does. Thanks a lot. Appreciate it and thanks for taking my questions. Good luck with everything.

Thank you. And I just – I did want to make a point there just to add onto Mike’s commentary. And I think it’s important for people to understand on the MRTP timing, that our connectivity and our dialog with FDA has gone up, certainly since the last earnings call other touch points, other data points that we get connected to the FDA have also gone up, and we have a multitude of additional data points that has raised our confidence in the timing of the MRTP that Mike’s alluded to answer your question, Jim. So again, the confidence level has gone up and we’re focusing our attention to the launch sequence to make sure we’ve got that ready to go and we’re confident in that as well. So, I just wanted to put my $0.02 in there on the MRTP time. But thank you, Jim, for the questions. And Mei, if we have time gives certainly open it up for additional?

Yes. So Jim, your first question that we have is would VLN 2.0 prototype be subject to a new MRTP application process, or would it still fall under the current MRTP application?

I’ll ask Mike to address that, please.

Sure. we – again, there’s only been two MRTP applications for other products authorized by FDA. So, there’s not a lot of precedents here. but based on the precedent that exists, we believe that it would not require a new MRTP that it would fall under the current MRTP application, although perhaps requiring an additional submission within that application. So, we think it will be a relatively straightforward process to bring that to market.

Thanks, Mike. our second question is, does VLN 2.0 give smokers the same taste and smell they’re accustomed to what is the difference between 1.0 and 2.0?

So yes, I’ll take that. So, the 2.0 is meaningful, because it’s using a blend of tobacco varieties. So typically, most cigarettes sold in the United States and in many parts of the world are referred to as American blend cigarettes and they constitute, usually made of three types of tobacco Bright, Burley and Oriental. And it is that blended tobacco is that gives that the typical American blend flavor characteristics. And so that is what we’re targeting in the development of VLN 2.0. Mostly, that’s important because it’s a non-GMO technology, which is a key to opening up international markets for us. We don’t think that based on our sensory studies with smokers that there’s a significant difference between 1.0 and 2.0. but it is an important point for international markets that being the non-GMO status.

All right. Our next question is, does the company have a backup plan in the event that the MRTP application is denied or delayed?

Well, I’ll start off and maybe, ask Mike to join in as well. I mean we’re absolutely committed and collaborating with the FDA to get this MRTP done. We’re just not going to concede anything less than that – the reduced harm and the impact that this could make is just too important. So, plan A, B and C is to use whatever means necessary to drive this to completion. There are different levels of that. But right now, we believe we’re in a very good position, very collaborative position, and we need to let the process run its course, but there’s to make a clear VLN is the brand. the 95% less nicotine is the claim and we’re focusing our entire attention to that and driving that forward. And I’ll let Mike comment on it as well or ask him to comment on as well.

Sure. Thanks, Jim. Yes, I think it’s important to point out that the product itself has already been authorized by FDA. FDA has basically already decided that the product itself meets the standard to put a new product onto market. So basically, there’s a good standard. It is that the product must be appropriate for the protection of public health and our PMTA application, which was authorized sometime ago, was basically FDA’s decision agreeing that the product is appropriate for the protection of public health. So, the only question that remains with the MRTP is, Jim alluded to is the name VLN for the product and the headline claim 95% less nicotine also appropriate for the protection of public health. We believe that it is. We believe there’s no reason the FDA would find otherwise. And I’d add, we believe that it’s actually smokers have a right to know that there’s a product available to them that has 95% less nicotine in it, which is the addictive chemical in tobacco that keeps people addicts, first-time smokers initially and keeps smokers coming back to smoking. And so we believe that very firmly that smokers have a right to know about this and that once they do know about it, that many of them will choose to smoke a cigarette without nicotine and find ways to help them – find ways to use that to help them to reduce their exposure to nicotine. So again, we’re extremely confident that we’ll have a positive decision on this, and we’ll continue to push this very hard until we get that.

Thanks, Mike. Our next question is how will VLN be successful when big tobacco has the most to lose from it?

Sure. I can take that question. The – so certainly, big tobacco’s reliance on the profits that they generate from the sale of addictive conventional cigarettes, but we also see that the same companies are moving as quickly as they can in many cases to transition their business to less harmful non-combustible products like vape and IQOS and so on. We think there’s an enormous opportunity in that in all of these companies aligning with FDA’s plan to make all cigarettes non-addictive. And in doing so, actively migrate smokers to less harmful forms of nicotine consumption or to quit smoking entirely. So clearly, yes, I think Commissioner Gottlieb, when he first announced the comprehensive plan for nicotine called reduced – reducing nicotine in cigarettes, the cornerstone of the plan. And so we believe that our interests and the industry’s interests are aligned. the entire industry embraces the concept of harm reduction and the continuum of risk when it comes to smoking and nicotine products.

Thanks, Mike. Jim, this is the question for you. Did the new partnership like CannaMetrix and new breeders mentioned require additional capital.

Thanks for the question. Very minimal capital. And let me take the time to explain what CannaMetrix release all about. So, I’ve seen and heard some questions around that. In essence, when you take a look at bringing disruptive plant lines to bear, the first thing you want to do is identify what consumer benefit that you want to have? What patient benefit do you want to have? You talk with large pharmaceutical companies. You talk with large consumer product companies. You get an understanding of what’s the benefit that you want to create. What’s the consumer benefit from the finished product? And once you understand that CannaMetrix technology allows you to very quickly profile the plant composition that will give you just that benefit. They’ve been utilizing this technology and pharmaceutical, very sophisticated pharmaceuticals and dermatological products for years. And that’s why we targeted it. And that’s why we wanted to get access to it and to control it. In essence, that’s what it does. So now, we can profile the plant very quickly and use that roadmap to feed it into KeyGene for them to create it at the small scale. The capital requirement for CannaMetrix is relatively very small and already accounted for. And the partnerships that we’re in dialogue with are true strategic partnerships, where they’re putting skin in the game as well as us in either resources or actual dollars. So, from a capital perspective from our side, we can execute on a strategy with minimal investment and John’s already accounted for that in our plans for 2021, and what we’ve already put into it.

Thanks, Jim. And then as a follow-up to that question. Can you speak to how our partnership with Panacea has evolved?

Yes. And I think it’s a worthwhile drilling into. So, the original strategy was more based on a role up of finished products, finished goods into the hemp/cannabis industry. And although the choice of Panacea was not a bad choice, that strategy is extremely challenging to implement, because of the market landscape, the fractured landscape, the competitive landscape, and we’ve turned our attention of course, to the upstream value chain. There were gyms within Panacea’s network that we saw as and continue to see as high value; specifically, the farm, the needle rock farm asset is a state-of-the-art, it can be a showpiece for the cannabis world. That location happens to be voted as the – or identified as the best place to grow cannabis in the United States. And we saw that as a big value and under our management, under our ownership, and under our drive of getting new disruptive plant lines into that farm to act as a showpiece and then demonstrate the scale up on the outside on a farming basis. We viewed as a high strategic fit. So, we’ve moved under the LOI to control and own that farm. The other component in Tennessee, was their extraction and purification technology and techniques, asset and techniques. Those, as well, are included in the LOI and to fit within the upstream value chain. So, you saw on the presentation, those five components now, takes us to an original concept. So, identifying a profile of a plant through CannaMetrix, feeding that into KeyGene to bring out a small scale clone and see technology scaling that up with the breeders that we’ll be announcing shortly with strategic partnerships. and then taking that to the Panacea assets that we’ve now turned our attention to and a state-of-the-art showpiece farm that could demonstrate, where it can be grown and then transferred all around the world as necessary, and also utilized purification techniques to get isolates out of it as necessary and gives us the option of either selling as seeds, clones, finished ingredients, not finished products, but finished ingredients or licensing the entire dose CA out to strategic partners to run.

Thanks, Jim. And our last question is why are you licensing VLN through strategic partner as your primary business model?

Mike, could you take that?

Yes, yes. So, our plans are to initially to launch VLN into test market. during the test market phase, we’ll be looking to essentially refine our messaging and communication tools, essentially learning how to optimize the investments that we make in VLN as we scale it. Scaling any product on a national basis, any CPG product on a national basis requires a lot of resources to build out a route to market. There are a number of companies that already have established routes to market for cigarettes, their tobacco companies. and so to minimize risk and chances of success and ROI, it makes sense to partner with one or more existing tobacco companies that have routes to market to – and globally. So that is a – it’s a typical strategy for a new CPG product launch, it makes sense for VLN as well. And so those are the reasons we’re pursuing it.

Thanks, Mike. And just one last question. Jim, this one for you. How will you be able to convince hemp/cannabis growers and manufacturers to license 22nd Century’s technology?

Yes. Great question and thank you. And we already are in the process of doing this. We’re having discussions with strategic partners that are strong players in this industry. They recognize that as they have tried to scale up high-quality lines that have been successfully grown at smaller scale that as they scale it up, the quality drops down dramatically. The yields dropped down dramatically. They know that they’ve got an issue and they’re open to these kinds of discussions and understanding the technology and moving in that direction. So, the timing is perfect and their recognition of an industry issue is absolute. So, it’s not a matter of convincing them to get interested in the technology. It’s a matter of identifying the exact strains that they want to optimize and make sure that it’s valuable for 22nd Century to focus on that, and putting that through the newly established network, that’s already demonstrated the capability of modulating the plants. So, the objective is all the same and that is to bring high quality, our seasonal type of lines that can be grown now at small scale and greenhouses, and small farms to the large scale. So, you can have large brands out there that have high quality, and then it could be dominant from a consumer benefit perspective. So, we’re already in discussions with them. They’re already convinced that this is all workable. It’s just a matter of identifying the exact plant lines and that’s what we’re in the process of doing that.

Thanks, Jim.

Is that it, Mei?

That’s it.

I think we’re out of time.

So, to just wrap up, as always, thanks everyone for your time and really, the thoughtful questions. And most importantly, your continued support of 22nd Century and we’re all on this mission together. We believe in it, ultimately, on the tobacco side, it – the reduction of harm will save lives. And it’s a – that’s what’s of most criticality to us as we go through this together. So, thank you for everything and if you have any further questions following the call, please reach out to Mei at investorrelations@xxiicentury.com and we’ll be sure to try to answer them as quickly as we can. Thank you and have a great day.

Thank you. This does conclude today’s call. you may now disconnect.