Welcome to the 22nd Century Group's First Quarter 2021 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, Diego. Good morning and welcome to 22nd Century's first 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. Earlier today, we issued a press release announcing our results for the first quarter 2021. We'll start today's call with prepared remarks from Jim, Mike and John before moving into a Q&A session.

Thanks, Mei. Good morning, everyone. And thanks for joining 22nd Century's call today. Before turning to the slides, let me start by saying that my energy level and excitement is really the highest it's been in my 35-year career based on what's happened for 22nd Century since our last earnings call, and what's on our doorstep. 2021 is off to an extremely exciting start. First, let me again confirm that I remain absolutely confident in our MRTP authorization and that we are in the final stage. I also continue to believe that our stock and market cap are still tremendously undervalued, regardless of the significant increase that we've seen in the past quarter and especially with the recent pullback. Based only on extremely favorable news. Every turn of macro events that we could have possibly hoped for have gone in our favor. And they'll dramatically accelerate and expand the commercial opportunities for both our tobacco and hemp cannabis franchises. I'll speak more detail as the day goes on. But this includes Federal and state administration changes, continued dialogue and signals from FDA regarding our MRTP authorization, new emphasis placed on nicotine ban mandate in both the U.S. and New Zealand. FDA's commitment to advancing to new product standards, administration support for cannabis legalization and safe banking, not to mention our pending rejoining the Russell and eliminating all warrants in exchange for $11.8 million onto our balance sheet. In fact, it's been quite a quarter.

Thanks, Jim. And good morning, everyone. On Slide 6, it's important to understand how critical combustible cigarette products are to the global tobacco market. This slide illustrates that while vaping and other alternative tobacco products may capture a lot of media attention, combustible cigarettes make up the lion's share of the market, with 90% of the $800 billion global tobacco industry. Any public health strategy addressing the enormous amount of death and illness caused by tobacco must address combustible cigarettes head on. Two thirds of smokers are trying to quit, but less than 10% are succeeding. It's clear that products available today simply do not get the job done. With 60% of smokers in our research telling us they'll use our product, we believe VLN will change the face of the tobacco industry forever. We see the need for VLN and an enormous body of independent clinical research tells us what the benefits will be for smokers, reduced nicotine exposure and dependence, fewer cigarettes smoked per day, an increased number of days of smoke-free days, and all with minimal to no withdrawal symptoms or compensatory smoking. It's clear that removing nicotine from the equation will be a winning proposition for public health and most importantly, for smokers looking to take back control. Turning to Slide 7, every indication is that our application is in the final stages of review with the FDA. And there are no outstanding requests for information. We believe that a positive response to our MRTP application is one of the most important decisions FDA can make right now for public health. To that end, we continue to ramp up our outreach activity at the highest levels of the administration, Congress and the FDA about VLN and a reduced nicotine mandate. We will continue to increased pressure as needed until we achieve success and will then advance to launching VLN within 90 days of securing our MRTP.

Thanks, Mike. Let's turn to slide 10. We believe the Biden administration will be more open to updating hemp and cannabis regulations at the Federal level, including both medical and recreational uses as more and more states have done across the country. We are now having 36 states that have legalized medical use of cannabis and 15 states so far that have approved recreational use, including announcement by New York State a few weeks ago. Momentum is coming from both sides of the aisle and across the country as this slide illustrates. Legalization will increase competition, which will increase capital flowing into the market, which increases the need for highly differentiated products grown at scale. Exactly where 22nd Century is uniquely focused. Moving to Slide 11. Our vision about what we've been building and the fact that we believe that we are now positioned as the Monsanto of cannabis. Deepened plant science and genetic IP critical to quickly transform the cannabis plant into a high quality, large scale and stable commercial asset. As this plant science focused that will serve as the critical link to create the specific characteristics needed to optimize consumer products and generate the financial returns, consistency and quality necessary for success in highly competitive markets? We also believe that companies are able to closely control the traits and consistency of the plants will be the all-time winners. And will be able to command a premium price and margin in the markets. On slide 12. Position 22nd Century in this Monsanto-like position. We have built an outstanding chain of partnerships to maximize our value in each component of the upstream hemp cannabis market. The growing demand for hemp and cannabis products means the industry will increasingly face a key fundamental challenge. Growers require stable, consistent and predictable…

Thanks, Jim. And good morning to everyone. The summary of our Q1 financial results are depicted on Slide 14. And overall, as Jim and Mike have stated we've had a great quarter - solid quarter. And that is essentially evidenced by the improved gross margin performance. Some of the actions that we took in 2020 to optimize our contract manufacturing operations have been successful. While sales volume from the contract manufacturing business was impacted at the beginning of the quarter. In March, we fulfilled a large spectrum order that had dramatically higher margins. This demonstrates our ability to manage costs and meet our obligations to fulfill that order. The SPECTRUM cigarette order is similar to reduced nicotine VLN cigarettes, and for which we are ready begin commercial scale production immediately upon MRTP authorization. A higher gross profit margin realized from the combination SPECTRUM sales and cost containment measures was more than offset by costs incurred this quarter over the first quarter of last year due to higher SG&A costs associated with building a strong management team and the branding and launch readiness for VLN. Net sales revenue for the first quarter decreased by $252,000 to $6.8 million. The decrease was primarily driven by lower volume in the earlier part of the quarter in our contract manufacturing cigarette sales. And was partially offset by the increase in volume in March driven by successfully completing the order for the SPECTRUM cigarettes and increasing pricing during the quarter in the company's contract manufacturing business. Gross profit margin improved year-over-year for the fifth consecutive quarter demonstrating our ability to execute on the objectives and strategies we set to the business. Gross profit for the first quarter increased by 540 basis points over $360,000 to $647,000. The improvement in gross margin was primarily the result…

Thanks, john. Now turning to Slide 16. Our investment summary has not changed since the year-end report. But we now have even stronger tailwinds propelling us forward. Our market opportunities more than $1.3 trillion across three exciting franchises and well-established growth opportunities layered in from now and for the next several years. We continue our relentless approach to securing MRTP authorization and truly believe we are on the verge of a transformative tobacco franchise for both product sales and licensing on a global scale. The recent and significant move on reduced nicotine mandate makes our reduced nicotine contact technology even more important positioning 22nd Century to become a clear leader in this category. Our research in 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 the potential linchpin technology provider in the upstream segment of the cannabinoid value chain as that industry makes the turn to mass production. We will begin to monetize a portion of our hemp cannabis IP this year, and have built a network of partnerships giving us a unique and disruptive capability to accelerate the development of new disruptive hemp, cannabis plants and IP on a highly accelerated basis. As always, we will continue to work hard to execute on the strategic plans we've laid out. And continue to communicate regularly on our successes. And with that operator, please open the call for questions.

Thank you. And at this time, we'll be conducting a question-and-answer session. Our first question comes from Vivien Azer with Cowen. Please state your question.

Hi. Good morning.

Good morning, Vivien.

Good morning. So my first question is, is on the tobacco side, please. So appreciate the conversation around VLN is certainly encouraging from your perspective. But I'm just curious to understand how much capacity you really think there is at the agency, given that they are going to be pursuing menthol? And there's a pretty heavy lift on the PMTA process on e-cigarettes as well?

Good morning, Vivien. This is Mike. It's great question. Clearly, those are all major undertakings, when you're talking about two product standards and the PMTA applications that they're processing. Our understanding is that FDA geared up ahead of time on the PMTAs staffed up in anticipation of that. And all of our indications are that that's not impacting the work that's being done to move the nicotine mandate forward. Nor the work being done on our MRTP application. So we believe FDA's got the capabilities to manage all of those.

Okay, that's helpful. Thank you for that perspective. And then just on the cannabis side, I think I heard the word likely, in terms of regulatory change - that will from regulatory change. And certainly, the commentary from Majority Leader Schumer is encouraging. But can you just be a little bit more specific about how you guys are kind of thinking about the timing? I think we're - at Cowen, we're taking a slightly more conservative approach, given that the democrats don't seem inclined to get rid of the filibuster.

Yeah, so the way - great question, Vivien. And the way we look at it is, there's two compartments. There's the hemp component, which even with the Farm Bill, there's still some uncertainty and confusion out there. And we believe that at the very least, that will be clarified in the relatively short term, certainly this year. That will help at least on the consumer product side. And I think we'll set the stage for advancements on the consumer product side in the U.S. The legalization on a recreational and medical use, that will go through a process. But that's where we're focusing store attention offshore, to get the new strains into countries where it has legalization in the appropriate manner. So our initial strains, we've got a combination of the new strains. We've got a combination of such things as high CBG level strains, higher cannabinoid level strains in general. That even with the clarification and the movement on the hemp side in the U.S., we think we can move quickly. And we're in dialogue with several strategic partners in the U.S. to advance that that are encountering these quality issues. And then right behind that, we do think legalization on the recreational side federally, we think will take place. That's going to take some more time to play out. But in that meantime, we're active on higher quality THC strains offshore and getting those into the hands of strategic partners, where the legalization has occurred on a country basis. So for example, the Canadian region. So that's the way we're looking at it. But we will be fully prepared when the U.S. moves on the recreational side to have these strains available. And there's no doubt and the more we have these dialogues with the strategics, the combination of quality and scale really everywhere around the world on the recreational side is becoming more and more of a problem with the strains that they're growing out there.

Understood. That's very helpful. Thank you.

Our next question comes from James McIlree with Dawson. James. Please state your question.

Thank you. Good morning. John, is the G&A has had a new good level going forward or was there some unusual things, onetime things in there that would suggest it's too high or too low for the rest of the year.

Thank you for the question, Jim. Essentially, we did pull forward some expenses related to developing brand strategies around VLN, anticipate that for the balance of the year, we have - we have it budgeted well out. And that's discretionary, some of the expenses are discretionary as we would pursue it. But overall, we've been focusing on cash burn, and to maintain our cash burn rate, which was similar to the first quarter of about $1.3 million a month, which was - which given our cash resources which sustain us over a period of time. There may be some shifting around with the G&A expenses. But overall, we anticipate that we'll manage them accordingly with the cash burn, and with the margin we gained from contract manufacturing, at this point.

Okay, that's great. Thank you. Jim, you talked about revenue in the second half from the hemp business. And I was wondering if you could put ranges around that? Is that - are we talking small amounts, like less than a million for the second half? And then in 2022, are you thinking it's $1 million to $5 million? Or is it larger than that?

Yeah, thanks for the question, Jim. There's two components. There's monetization of the existing library of IP through an upfront license fee that we're in advanced dialogue with. That will come as I said in Q3 to Q4. And it's tough to put an exact figure around it. But it's substantive I'd say in the $2 million to $3 million range. But that all drops to the bottom - obviously drops to the bottom line. But in addition to that, based on how we've been resetting things in our network, and this is what I announced earlier, we are starting our first growth of hemp cannabis, with our higher strain, plant line strain of CBG, and CBD-CBG combination. So we're putting about five separate lines in the ground. As we speak, the seedlings are on route. And we're beginning that growing process. It'll all depend on the exact yields as we get into the October timeframe and harvest. And you try to push that time period as far as you can, because the later you harvest, the higher these cannabinoid levels go. So we're going to push that to the optimum levels. And then harvest and we have off-take agreements for that biomass, as biomass for the most part in Q4. That range, again is going to be depend on yields. But could be in that $2 million to $3 million range in that time period. Some of it could spill into Q1 of 2022, based on the needs of perhaps a distillates or isolates if we need to process at that farm. But that's, you know, putting a framework around it. It's just modest, but it's our first grow. And these are highly profitable, high margin strains, and off take commitments that we've got put in place.

Okay, and those licenses you're talking about - but those are onetime fees. Those are not annual fees. Is that correct?

Yeah. The first bucket that I was talking about is a onetime with that product of a strategic partner. Now that could be expanded because it's not exclusive. But that particular one is a onetime for that strategic partner.

Okay. And, Mike, I was hoping you could help me understand what you think the implications of the menthol ban would have on your VLN application as it relates to menthol. I mean, it seems like it's possible that the FDA says, wait until - they said to you wait until menthol is figured out or --?

Yeah, Jim, it's a great question--

Leave it or -

Yeah sorry. I didn't mean to interrupt you there. We don't believe it's, it will impact our application for a couple of reasons. One, the FDA has been working on this issue of a menthol banned for many years going back to the Tobacco Control Act, when they were first granted authority to regulate tobacco. So it's not a new issue for them. Despite that, they did authorize our PMTA application, as you know, for both the menthol and non-menthol versions of our reduced nicotine cigarette. So the product - the PMTA product is exactly the same product as the MRPT product. So we don't expect - they've already decided that a menthol - very low nicotine cigarette is appropriate for the protection of public health. That's the regulatory standard that a PMTA product has to meet. And we don't see that equation or that analysis changing, simply because they've announced their intention to put a menthol ban into place. And then secondarily, there is a solid body of science, using menthol reduced nicotine cigarettes to understand what differences there might be between menthol and non-menthol reduced nicotine cigarettes. And the results are consistent across both products, whether menthol or non-menthol, that smoking consumption is reduced, increased, it doesn't change the compensatory smoking or withdrawal symptoms. So the public health benefit is there based on the science. And so, clearly a rule, or even a proposed rule hasn't been published yet around menthol we would expect ultimately for our product. Our menthol VLN cigarettes to be included in the MRTP approval and for it to be accepted from any menthol ban that might come in the future.

And similar to the prior question, or asking about capacity at the FDA. Is it the same group that the FDA that's tasked with the menthol ban as it is with evaluating or approving the MRTP?

So my understanding - again, this is based for multiple pieces of information. But my understanding based on that body of information is, that the group's responsible for drafting product standards, reviewing comments that are submitted in response to the proposed rules is a different group than the group that handled - that does the bulk of the work on an MRTP application? So I don't I don't think there's any overlap. There aren't any significant overlap, I should say, as it relates to our application. I don't think it slows things down.

And then my last one. Kuo talks about the restructuring of your agreement with Panacea? If you can just say, is there anything that has occurred since the end of the quarter? That is useful to know, or where are you on that restructuring?

Yeah, we continue down the same path that we've been working towards has been very collaborative, and really a win-win approach with Panacea. We're turning our attention to the farm. And we've talked through that already. And then also kind of working with them on the extraction and isolation equipment. So we continue to work on really papering that up. And at the same time, working with them to help promote their finished products into the marketplace with the concept of these higher strains are more valuable strains coming through. So we're in the process really, heading down the same path. We've been talking about just matter of papering everything up. But it continues to be a great relationship, and it's very much going in the right direction. And the end result is also Panacea will undoubtedly have stronger channels to market. And it will be able to truly get their finished products moving in the right directions or helping to coordinate that as well. So I would think that, sometime in the next - this quarter, current quarter, we hope to button everything down, and we'll communicate when that's all complete. But it's still heading down the same path we've been talking about Jim.

Okay, fantastic. Thanks a lot. And good luck with everything.

Thank you.

I'll now pass it to Mei Kuo to go through some web questions. Thank you.

Thanks, Diego. Our first question is, can you elaborate on the genetic modifications you're making to the cannabis plants? And how and why there would be incentive for growers and dispensaries to be using your product? What is preventing you from bringing some of your current developed hemp cannabis strains to market in the U.S. or elsewhere?

Yeah. Thanks Mei, I'll take that. It's a great question. Let me just create the foundation again, that the real critical challenge in the entire industry right now. And you can go talk with major Canadian LPs, you can talk with MSOs or everywhere around the world is that as they go into mass production the quality and the stability of the plant strains that they are growing, basically are implode. They're very problematic. The level of cannabinoids are not consistent. They fluctuate from batch to batch. And it just yields a poor consumer experience. So this Monsanto approach we've been talking about. I give Monsanto the gold standard is being able to modulate plants in work in these strategic partnerships in a rapid basis at scale are high quality. We're a boutique version of that. We're only focused on three plant lines or alkaloid in fact. We've talked about tobacco, hemp, and a third plant line that will soon announce. That's really our specialty. So the opportunity is to address that large scale production. Now we have several new strains. One of which is ultra-high end THC, one of which is ultra-high end cannabinoids in general, in particular to CBG. And one of which is modulated terpenes lower to impact the fragrance profile on the flavor profile. And we're continuing to move those move those forward. In fact, the CBG line is one of the ones we're putting in the in the ground over the next several weeks. Because CBG in particular - in plant strains with CBG stable plant strains are kind of a hot property going into the second half of this year and into beginning of next year. So we are in fact moving forward with existing plant lines. Will then turn our attention as the next generation as I've, always said that this existing plant lines, although was a great proof of concept, and better than what's on the marketplace today, is still not anywhere near optimized. So we will continue to do that with the next strains coming through and hopefully growing in this roughly two-year cycle that we've talked about.

Thanks, Jim. Our next question is, do you have any fear that big tobacco has a solution for if when nicotine mandate is implemented? They stated publicly that they are decades away? But what if they are just saying this to prevent the government from taking action? And they have actually identified a way to produce the nicotine tobacco?

Yeah, me. Thanks for the questions. Great question for all of our listeners here. So the-- we do know - so we're not afraid here that there's an - that there are alternative technologies. We do know that one other way that they produce nicotine cigarettes could be produced would be simply by extracting the nicotine from tobacco plants using well-known extraction processes. In fact, there was a product cigarette on the market back in the 80s called Next. It was referred to as a de-necotinized cigarette. And it was launched by Philip Morris. It achieved about 1% market share before they yanked it from the market realizing that that wasn't a path that made sense for them to go down as a company that profits from nicotine addiction. But they did - they built a $250 million extraction facility to produce that tobacco. Now one of the problems that they also had with the product was that the smokers didn't really like the taste of it. And the reason for that is because when you extract nicotine, you extract a lot of other things from the plant, including flavor and aroma compounds. And so really what you end up with in that process is something that's more akin to paper or shell dust then it is tobacco, because you've taken out all of the flavor alongside the nicotine. And so we believe our technology where we're growing tobacco without nicotine, as opposed to extracting the nicotine is a far superior technology, simply because it'll be more acceptable to smokers. And we do believe it's true that it'll take years for big tobacco to try to duplicate what we've done this, if they were to use a genetic editing technology. But we have very strong intellectual property portfolio, really a…

Thanks, Mike. And speaking of the FDA, was the new equipment to measure nicotine levels in-house a strong suggestion by the agency was installing testing and calibrating it a factor in the slow action on the MRTP?

It was not a suggestion at all from the FDA. This was a decision - an idea that was brought forward by our team, our operations team. And we made the decision to make this investment based simply on the fact that it reduces our costs quite significantly 90%, approximately around testing and also really speeds things up when it comes to testing. So we want to and need to test tobacco, when it comes in from the farms to make sure that it's the right nicotine levels and to know what we have in our inventory. And then we tested at every step of the processing manufacturing chain. And so there's a lot of testing that's involved in that. We want to ensure that every product that leaves our factory is compliant with what we've said it would be. And so we tested every step along the way. That's a lot of testing. It has been costly, when we do the SPECTRUM, the research cigarette manufacturing orders. And so this simply reduces our costs and allows us to do all of this much more quickly, which will become of critical importance when we go to market with VLN. And so we made this investment in anticipation of that positive decision on the MRTP coming soon.

Thanks, Mike. And we have time left for a couple of questions here. There have recently been some news reports about possible IP waiver for COVID-19 vaccines. Are there any similar concerns for 22nd Century or VLN IP protection?

Yeah. Go ahead, Mike.

Yeah, sure. I think, obviously, this is big news this morning with COVID-19 IP. There are really no similarities between these two bad situations and our IP related to tobacco. COVID is a global pandemic that is raging in other parts of the world, while tobacco is certainly an epidemic. There are - it's a well-studied thing, and we have the solution. And we've made it clear to the FDA and other regulatory bodies around the world. We're willing to license this technology. So unlike some of the COVID vaccine manufacturers, who have fought against licensing. So there's really no comparison there. And ultimately, growing our tobacco and making it into reduced nicotine cigarettes is virtually the same process, as it would be for conventional tobacco and conventional cigarettes. So unlike vaccines, with specialized processes, there's no concerns around that, either. So at the end of the day, we're willing to license our IP. And we will do that, at any point in time when the government asks us to do it.

Thanks, Mike. And just one last question. I want to make sure we touch on the cannabis side of the business. You raise this idea of a Monsanto of cannabis? Are there other companies with similar approaches? What about large growers? Why can't they move faster than 22nd Century to achieve this?

Yeah, there are really just a few pathways to get to improve product lines. There's a purely synthetic approach, which helped develop prior to coming in 22nd Century. But that's very expensive and really targeted towards the clinical pharmaceutical use. There's a biosynthetic approach to fermentation. But there's been a lot of fluff in substance and without substance on that approach. And I would continue to believe that at least five to seven years just in development. And what you get out is a single cannabinoid, CBD or CBG. So they are - those companies have not been hitting their milestones. Then there's the standard breeding approach, which is like shooting in the dark. And it's clear that - you get strains that are high quality, high scale and quick, is at least a seven to 10-year adventure. That's been documented very much. I just had a call with KeyGene yesterday, again. I continue to be amazed with what they can really do and the speed at which they can work. And we apply a different type of science. It's very much like what Monsanto does and the more commodity products like soy and corn, they do not participate in this cannabis hemp space or the alkaloid plants that were honed in on. But we are certainly learning off of that gold standard type of approach. And our technology approach is very unique with KeyGene and itself. Then when you combine that with Cannametrics and these specific alkaloid specialist breeders we're going to be using in this particular area. Plant-based biotechnology that is alkaloid based into large end use markets. I can assure you there was no one else doing it this way. And where we have a two-year cycle, the closest nearest competitor is in the standard breeding approach, which is realistically seven to 10 years.

Thanks, Jim. I think we ran out of time for questions. But if you have any closing remarks,

I just wanted to thank everybody for their time. We continue to have high levels of optimism across all three of our franchises. And we look forward to communicating more and moving things forward. So thank you all for your time, and we'll be talking soon.

Thank you. This concludes today's conference. All party may disconnect. Have a great day.