22nd Century Group Inc (XXII) 2022 Q1 法說會逐字稿

Welcome to the 22nd Century Group's First Quarter 2022 Earnings Conference Call. (Operator Instructions) 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. Thank you. Please go ahead.

Thank you, Donna. 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 Rich Fitzgerald, our Chief Financial Officer.

Earlier today, we issued a press release announcing our results for the first quarter of 2022. We'll start today's call with prepared remarks from Jim, Mike and Rich before moving into a Q&A session. During our prepared remarks, we will be referring to slides, which are available for viewing in the webcast and posted in the Investors section of our website at xxiicentury.com, under the events subheading. We hope these slides will serve as a framework for management's prepared remarks, reinforce key takeaways and provide additional transparency and insight into our business, strategy and objectives. Also, those of you joining by webcast can submit questions through the online interface, which we may include during the Q&A session of today's call, time permitting.

Before we begin, some of the statements made today are forward-looking. Forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those contemplated by these statements. Additional information regarding these factors can be found in our annual, quarterly and other reports filed with the SEC. During this call, we may also discuss non-GAAP financial measures, including adjusted EBITDA, which we define as earnings before interest, taxes, depreciation and amortization as adjusted for certain noncash and nonoperating expenses. For more details on these measures, please refer to our press release issued earlier today.

And with that, I'll turn the call over to Jim beginning from Slide 3.

Thanks, Mei. Good morning, everyone, and happy Cinco de Mayo. As you know, 22nd Century is focused on advanced plant biotechnology to improve human health. This morning, we'll provide an update across our 3 franchises: reduced nicotine tobacco, hemp cannabis and hops. Based on recent activity, we will focus on tobacco, but we remain highly confident of the significant opportunities in all 3 of these franchises that will generate substantial growth and value for the company.

Of course, let's begin with an update on the pilot launch of VLN, the first and only modified risk tobacco product approved by the FDA. It's still early, but the pilot is going extremely well. We're absolutely thrilled that VLN is on the shelves at our Circle K pilot locations in Chicago, giving smokers for the first time ever, an FDA-authorized tobacco cigarette with 95% less nicotine designed specifically to help them smoke less. Our Circle K pilot is designed to refine our marketing to maximize trial, repeat purchase and advocacy as we ready for national launch. But bear in mind, we very well may accelerate and expand to additional markets prior to completion of a pilot. This is even more compelling now that the FDA has advanced its proposed rulemaking banning menthol as the characterizing flavor in cigarettes.

The rule includes a process that specifically highlights reduced nicotine menthol cigarettes as an example of a product that would be exempted from the role. We believe that VLN Menthol King would be the only menthol cigarette left on the market under this role and a cornerstone of the FDA's policy providing menthol smokers a critical off ramp as the rule takes effect. This is a $24 billion total addressable market and exactly as the FDA indicated in our MRTP authorization in December. All this is favorably impacting our strategic partner discussions.

Further, we do not expect to wait for the rule to take full effect to see the benefit. VLN Menthol King is already selling very well in our Chicago pilot as menthol smokers are showing strong interest. The FDA's addition of the helps you smoke less claim to our MRTP authorization has been a significant win as it helps smokers immediately understand why VLN is important. Having that direct science-based claim on our packaging means that every time a smoker goes to the store to buy a pack of cigarettes, our VLN signage and the VLN packs on the shelf prominently remind them exactly why they should buy our product instead of the highly addictive alternatives. And this is an audience looking for solutions. 70% of adult smokers want equipped, but haven't succeeded with current products even after 6, 10 or even more quite temps. That's the norm today, and we will change it.

The VLN science shows they can help smokers to take control of their nicotine consumption and help to break the addiction cycle that so many smokers have found impossible to escape. Smokers now have a choice that will help them to smoke less rather than reinforcing their nicotine addiction as every other tobacco product does.

Shifting to Slide 4, the launch of VLN opens up the doors to growth in strategic partnerships, the 22nd Century has never seen before. We now have a premium priced, highly disruptive FDA-authorized products on store shelves, whether we are talking about the $80 billion U.S. tobacco market, a $24 billion menthol market or the $800 billion global market, capturing even a very small part of these markets will be transformative to 22nd Century. It's important to remember that this process is not new to our team. Our VLN team has successfully executed this type of branded specialty launch before, most notably with Natural American Spirit garnering significant market share and created an extraordinary value worldwide. Of course, we will always implement ways to accelerate this growth. Billing from our Chicago pilot in 150 Circle K stores we will then roll out to their 7,000 stores nationwide as well as other regional and national channel partners and even additional international markets beyond South Korea, where we made our first shipment in Q1.

I'll stop there and let Mike fill in some of the details of our pilot program and launch market, then I'll briefly discuss our hemp cannabis and hops franchise actions with you. But sincerely, I could not be more excited about 22nd Century, 2022 and the future of the company. Mike?

Thanks, Jim, and good morning, everyone. As of April 11, we officially entered the market with our VLN King and VLN Menthol King reduced nicotine content cigarettes and in so doing, passed another major milestone for 22nd Century and our shareholders. Immediately following the FDA's authorization of our MRTP 2 days before Christmas, we put our pilot launch plan into action with Circle K and our other marketing and distribution partners.

The final piece of the puzzle was the Illinois State Attorney General registration that is required for every cigarette brand sold in the state. While this mandatory state level process took some time to complete, once we had it in hand on April 4, we began stamping and distributing VLN immediately with the very first retail sale of VLN coming just a week later. Our team on the ground has done an excellent job in the few weeks since then, creating high visibility for VLN with the posting of our point-of-sale advertising in the more than 150 Chicago Lynch Circle K stores selected for the pilot.

During the weeks leading up to the launch, we also secured both a feature story in the Chicago Tribune about VLN, about how VLN can help people to smoke less and support from the Chicago Medical Society, a group of 7,000 medical professionals in Chicago affirming the very exciting opportunity that medical professionals have with VLN to help their patients who are smokers.

While we have been in market for just a few weeks now, initial sales results have been very good and are exceeding expectations. So far, this has been driven primarily by media exposure, support from the health care community and in-store visibility. We'll be hitting our full stride in the coming weeks with our remaining marketing and promotional programs, which include direct mail and e-mail, digital and print advertising, store clerk training and incentives, promotions delivered in-store and through mobile, a branded website, including store locator and other powerful programs, all designed to generate trial, drive repeat purchase and build word-of-mouth amongst adult smokers.

We believe the economic environment with consumer inflation running high will also be helpful to the VLN launch as smokers see the health and financial benefits of a cigarette that helps them smoke less. We look forward to providing you with more details about our pilot results in our future communications.

Turning to Slide 7. The pilot is important to optimizing our marketing programs and mix so that we can maximize our investments as we look to a national launch. To date, we have already secured permission from state-level regulators in 9 states and filed applications in all of the remaining states. We expect to be permitted to sell VLN in most and very likely all states by the end of third quarter this year.

In addition to expanding our geographic scope, we are working already to expand the retail footprint of VLN beyond Chicago. Circle K is an ideal partner for this given their 7,000-plus stores across the country as well as thousands of stores outside the U.S. They're poised to work with us here and abroad to help us make VLN widely available to adult smokers.

We have also advanced our discussions with other potential channel partners, including mass merchandise, pharmacy and dollar stores as well as wholesalers and strategic partners as part of this national launch planning. Underlying our planning is the belief that VLN is poised to become the most disruptive product to hit the tobacco industry in decades. And we'll capture the attention and interest of the hundreds of millions of adult smokers around the world who want to smoke less. We look forward to discussing our plans for the next phase of the VLN launch in future calls.

Turning to Slide 8. Our manufacturing facility is a key strategic asset where we have built the capabilities needed to produce high-quality reduced nicotine content cigarettes, including the tens of millions of research cigarettes used in independent clinical studies that underlie our FDA-mandated helps you smoke less claim and FDA's larger plans to ban menthol and require all cigarettes to be nonaddictive. We will be shipping another order for an additional 3 million research cigarettes, including menthols in the coming months to support this continuing federal research program.

Given these capabilities, our factory team was able to begin manufacturing VLN quickly despite the global supply chain constraints impacting every industry due to COVID, and we are ready to further scale our manufacturing as we move into additional markets. As noted in today's press release, we are now installing an additional $1.5 million cigarette making and packing lines and making other improvements to expand our manufacturing capacity by 25%. We are also making a multimillion-dollar investment in growing our largest crop of VLN tobacco ever based on the interest in VLN we have seen from the retail trade, strategic partners and most importantly, adult smokers in our market research and pilot market.

With this year's VLN crop, we will literally be harvesting the results of the work done in the past few years by our stellar science team, and our world-class plant research partners to create our non-GMO VLN tobacco varieties and much of the IP that makes up our deep moat in this area, which will enable us to bring to market a non-GMO American blend version of VLN made with bright and burley varieties of tobacco. We have also expanded our growing program to the Southern Hemisphere, providing us with year-round growing capabilities to meet future demand for VLN.

We continue to believe that VLN's appeal goes beyond the U.S. market, as noted on Slide 9. Even before the FDA authorized our MRTP, we committed to you that we would begin VLN sales outside the U.S. in the first quarter. And we did that with our first shipment to South Korea in March, with more to follow as our commercial partner proceeds with the retail launch there.

We are excited about the commercial and public health opportunity for VLN in South Korea. We chose South Korea is our first international market because of its high smoking rates, especially among men where approximately 1 in 3 are smokers. The country also has a large premium market, and there is strong interest among adult smokers in low-yield cigarettes and innovative tobacco products.

Our partner is a new company formed specifically to bring VLN to market. The company's leadership team brings a wealth of professional knowledge and senior executive leadership experience, highly relevant to the venture, including the successful introduction of several new foreign products to the Korean market, the management of multi-location retail outlets, including in the convenience store channel, which is where most cigarettes are sold in Korea and experience with the branding and marketing of high-end premium priced consumer products.

Our partners' professional backgrounds are as impressive as their passion for introducing PLN to their country to help adult smokers there. We believe this is a winning combination of mission and experience, and we look forward to sharing more information about our progress with VLN in South Korea as the business develops in the coming months. Elsewhere, we are advancing discussions with prospective partners in several other markets outside the U.S., where like South Korea, regulations allow us to go to market today with claims with little or none of the regulatory complexity of the U.S. With the first and only MRTP designation for a combustible cigarette from FDA, the enormous body of scientific evidence supporting that positions VLN very well for international expansion.

Advancing to Slide 10. We applaud FDA's announcement last week of its plan to ban menthol in highly addictive combustible cigarettes. In authorizing VLN, FDA has given adult smokers, including menthol smokers, a tool to satisfy the urge to smoke while allowing them to reduce their consumption of highly addictive nicotine. We are already seeing, as Jim mentioned, increased interest in VLN from menthol smokers who are looking to get ahead of the ban with a cigarette that will help them to smoke less. Menthol smokers are figuring out what the independent science clearly shows about reducing nicotine to nonaddictive levels in cigarettes.

Our products provide a critical off-ramp for adult smokers by helping them to smoke less. We believe this type of bold, evidence-based public health policy will continue to be the direction FDA heads in advancing its mission to reduce the harm caused by tobacco. In several public statements, including most recently when announcing the menthol ban, Dr. Califf, the recently appointed Head of FDA, has been clear about the critical role that reducing nicotine in cigarettes can play in tobacco harm reduction, which has even greater potential than a menthol ban to reduce the harm caused by smoking.

Obviously, we recognize these policies will not happen overnight, but FDA knows, as do we, that having our VLN products on the market now provides an opportunity for adult smokers to choose a cigarette that helps them to smoke less, while also showcasing how effective these policies can be. Wrapping up, we're incredibly excited to finally bring VLN in the market. Our goal is to make VLN available to as many adult smokers around the world as quickly as possible. We're highly confident in its appeal to adult smokers its ability to help them to smoke less and ultimately, in its potential to change the tobacco industry for good.

I thank you for your time today and for your confidence in 22nd Century. I'll now pass you back to Jim for an update on our hemp/cannabis and ops franchises. Jim?

Thanks, Mike. It's really been an incredible first quarter in tobacco, and we're excited for the path ahead, especially with the national rollout of VLN and working to support the FDA and their comprehensive plan. In fact, every catalyst that we could have asked for has worked and is working in our favor and it's positioning us for substantial growth. So we're very excited about that.

Let's now turn to Slide 12 as we focus for a few minutes on our other 2 growth franchises, starting with hemp/cannabis. This is a transformative year for hemp/cannabis, and we continue to deliver as promised. We remain absolutely committed to this franchise to maximizing the consumer experience and confidence with hemp/cannabis products by developing superior plant lines to provide the inputs going into those products. We do this by developing proprietary scalable plant lines that exhibit stable genetic profiles, predictable agronomic traits and highly valuable yield profiles necessary to fully commercialize the industry.

We completed our first harvest of high CBD and high CBG, low THC plants at needle rock farms in the fourth quarter, selling biomass at that time and holding a portion of the harvest for potential of a high-purity distillate utilizing a new purification technology that we sold in this quarter. We're also able to generate revenue since Q4 from our first IP agreement, a 3-party deal with Aurora Cannabis and Cronos Group for use of our shared and NDIIP that addresses the production of biosynthetic cannabinoids.

Looking at 2022, we're excited to continue scaling and developing our proprietary plant technologies as we work to revolutionize the industry as much as was done a decade ago with other major crops like corn, wheat and soybeans. We're now preparing hemp plant lines for an expanded 2022 growing program at our USDA organic-certified needle rock farms, all of which is presold. We're also advancing our science as we move new plant lines forward, having achieved an industry-first breakthrough in hemp/cannabis plant transformation with our partner, Keygene, expanding the company's capabilities in modifying the principal genes controlling cannabinoid biosynthesis in the plant. We have also shipped our transformative next-generation seeds to extract this for breeding and scale up. There's more big news to come in this franchise.

In the global hops market on Slide 14, we continue to leverage our alkaloid plant expertise and IP to apply our capabilities in is closely related alkaloid plant family. While hops is a $500 billion a year global market, the industry still relies mainly on costly, multiyear and high-risk traditional breeding techniques. We believe our unique know-how and IP can bring exciting improvements to this industry, transforming the hops plant development cycle to reduce cost, risk and time required to create a tailored plant variety as we are doing with hemp and cannabis. We can dramatically cut the current decades-plus development cycle through our advanced breeding capabilities giving a major competitive advantage to hope companies that work with us.

Finally, I'm very excited to note that Dr. Calvin Treat will join the company as its Chief Scientific Officer, starting in late May. This further enhances our deep expertise in plant-based technology and intellectual property across all 3 plant franchises. Dr. Treat has led global plant biotechnology programs at Bayer and Monsanto, including corn, soybean and cotton crop technologies and is now joining 22nd Century to do the same in key alkaloid plant families.

I'll now pass you over to Rich to review our financial performance.

Thanks, Jim, and good morning to everyone. Starting off with Slide 16 and our quarterly results. Net sales increased by 33% year-over-year to $9 million through a combination of higher volume and price increases within our contract manufacturing cigar and cigarette business. We continue to generate new business and orders with additional customers and are also now manufacturing VLN cigarettes for our pilot launch in both the U.S. and international markets.

We continue to closely monitor certain supply shortages that are affecting our industry. But our team in North Carolina is managing through those quite effectively. Gross profit margin for the first quarter declined year-over-year to 5% due to product mix, supply chain delays and an MSA settlement assessment. The largest factor of this margin impact was that in the prior year first quarter, we completed a notable research cigarette order at higher margin, whereas in the current year, a comparable research cigarette order was deferred by the customer into the second quarter of 2022.

It's important to note that our investment in the CMO business is now paying dividends as we were well positioned to promptly commence VLN manufacturing as part of our 90-day pilot market launch effort. As VLN exits the pilot phase and begins to scale, its positioning as a premium brand will command higher revenue and margins when compared to our third-party CMO manufacturing business. This is a net positive to our revenue and gross margin profile as we progress national and OUS launches of VLN. Some of the early enhanced margin benefit will be reinvested to initially fund launch activities. But in the midterm, it will generate much greater revenue and margin per carton than our legacy CMO third-party business.

Turning to total operating expenses for the first quarter. They increased by $2.8 million as we continue to advance our go-to-market plans and scale the business to support our VLN launch. The increase in operating costs was driven by a $0.3 million increase in R&D spending versus the prior year and an increased SG&A spending of $2.5 million. Increases in SG&A spending were driven by higher strategic consulting costs, stock-based compensation, legal and insurance costs.

Operating loss for the quarter was $8.1 million compared to an operating loss of $5.2 million in the prior year. Net loss for the quarter was $8.9 million compared to $5 million in the prior year's first quarter. Our press release earlier this morning provides an adjusted EBITDA measure that we believe is a useful tool in evaluating the operating performance of the business on an ongoing basis, removing the effect of onetime and noncash expenses. On an adjusted EBITDA basis, we reported a loss of $6.6 million in the first quarter of 2022 compared to a $4.4 million loss in the same period a year ago.

Now going to Slide 17 and reviewing our strengthened balance sheet. We had $38.6 million of cash at the quarter end, and we have the resources to fund a runway for the commercial launch and growth of our reduced nicotine tobacco business and our hemp/cannabis franchises. I want to highlight that our launch strategies emphasize using current resources and leveraging our partnership opportunities to drive scale rather than focusing on a high-cost launch strategy that would require additional capital from the outset. It's important to note that our balance sheet is adequate for the launch plans and -- where we will continue to emphasize partner-driven marketing rather than costly time-consuming organizational scale-out. This is tailored to the unique product claims of VLN as well as the unique regulatory environment our product enjoys.

With that, I'll now pass you back to Jim.

Thanks, Rich. It's an exciting time for us as we go to market in the U.S. with Circle K as our pilot partner, which will ultimately lead to the several major national C-store and pharmacy change, placing our VLN products in front of customers. With the proposed menthol ban gaining traction, as it should, we may well be the only combustible menthol cigarette in the market as a tool to help smokers transition away from traditional menthol products targeted by the proposed FDA ban. And we're moving ahead with our first international launches as well. We're ready to go.

Every catalyst, as I indicated before, has worked in our favor and is in our pockets and have positioned us for strong growth. And so we're ready to go not just on our innovation tobacco products, but also in our hemp/cannabis products and with our emerging research and global hops market. We really look forward to the year ahead and talking again soon. And with that, operator, please open the call for our questions.

(Operator Instructions) The first audio question today is coming from Vivien Azer of Cowen.

This is Harrison Vivas on for Vivien. So just to start off, can you try and -- can you just dimensionalize the dollar benefit you got from your shipments to South Korea in the quarter?

Yes. Again, this like the pilot in Chicago is a small initial order to go through regulatory clearance there and it did not rise to the level where we would separately disclose it.

Okay. Understood. So kind of transitioning to Chicago, can you just talk about initial sell-through trends relative to your initial expectations? And maybe comment on retail inventory days on hand versus the initial launch.

Yes, Harris, this is Mike. I can respond to that question. We've been in the market for about 3 weeks now. We've got, so far, 2 weeks of reporting data. So the sales data so far does exceed our expectations, but it's still very early days. Two data points do not make a trend line. So -- but the anecdotal evidence on the ground is all very positive, and we look forward to reporting more details about the sales results and inventories on hand as we -- through the coming weeks as the sales state develops.

Okay. That's helpful. Last one for me. Just as it relates to the 9 new states, can you sort of provide maybe some line of sight into the timing that you're expecting? Are there key milestones that you're looking to hit in Chicago before expanding? And if so, what are those milestones? If you can provide any color on those 9 additional states that would be helpful.

Yes, our key metric will be essentially share of market in the stores where we're selling. And that will be one of the key decision points as the pilot develops the geographic scope and the timing of the next phase of the launch still in planning, and we'll be happy to provide more details about that as we firm up those plans.

The next question is coming from Brian Wright of ROTH Capital Partners.

Good morning. Happy Cinco de Mayo, and congrats on all the progress. My first question is, did you give us the exact numbers for us in the Chicago pilot other than over 150? I just wanted to make sure I might have missed that.

It's up 159 stores, to be exact.

Okay. Great. And then are you willing to -- you did mention that the menthol sales in Chicago were outpacing the non-menthol sales. Is there -- I know it's early, but is it like a meaningful difference? Is it like 55-45, 60-70 or any color on that to just out of curiosity?

Yes. So I don't know if they're outpacing menthol is outpacing non-menthol, but certainly methods over-indexing relative to share of market across other brands. So we think that's a positive sign, non-menthol smokers' interest in this.

Great. Great. And then just last one. You mentioned that the -- that there's a $3 million R&D shipment, and that's going to come in the second quarter then. As far as revenue record (inaudible)

Yes, 3 million. Yes, there are 3 million research cigarettes being manufactured and shipped that I don't know the exact timing that it likely is second quarter but could slide in the third quarter depending on the delivery processes, basically.

Okay. And it's all or nothing. So it's either second quarter or third quarter, it wouldn't be like a mix of both?

It depends on the manufacturing schedule. Sometimes we ship them in parts.

The next question is coming from Jim McIlree of Dawson James.

Jim, in your opening comments, you talked about possibly expanding to additional markets while the trial is underway. Would that be with Circle K or would that be with somebody else? Or can you say?

It could be a combination. We're watching this every day and making sure that we're doing everything we can to simultaneously refine our marketing collateral, yet at the same time, accelerate revenue and growth. And we're letting that play out. But that very well, as I said, may open up opportunities to move into these other markets prior to the end of the pilot. That could be in part with Circle K, that could be in part with others as well. So we're watching that very carefully.

And as I said before as well, the -- it becomes that much more compelling, and we're paying that much more attention to it based on the FDA's activity and how the menthol mandate is progressing. So it could be -- to answer your question, though, Jim, it could be with Circle K and others.

Got it. Got it. And Mike, you've mentioned some of the factors that you're evaluating as this trial progresses. I was hoping you could prioritize what you think, let's say, the 2 or 3 most important metrics that you are looking at as this trial goes forward.

Yes. I mean, ultimately, the biggest question in the pilot is share of store sales. And the reason that's important is primarily because that's the key variable in planning for a national launch. And so the size of the revenue in the national launch will drive all of our planning from there. And so the share of store sales is the key metric in developing that plan. That's what determines what revenue we can expect, what margin we can expect as a result of that or profit we can expect as a result of that. And what size the marketing programs need to be to drive that. So we're looking at share of market and then secondarily, cost of acquisition consumer acquisition and the key variables in that national plan.

Got it. And it's -- so I'm assuming that you have some expectation or range of expectations about market share over the life of the trial and you're just tracking that relative to the actual results. Is that a good way to look at it?

That's right. Yes.

Okay. Great. And Mike...

As I said before, it's a relatively low bar any premium -- new premium offering in the cigarette category is a new thing. We think we're well positioned to succeed as a premium offering. And so it's a relatively low bar for us to be profitable here, even capturing relatively small numbers in terms of market share. But our objective is to, obviously, capture as much share as we can as quickly as we can.

Okay. Okay. And Mike, for you again. I think that you mentioned during your commentary, 2 sources of spending coming up and I didn't write it down fast enough. But I thought one of them was an expansion of capacity. And then the second was planting a new crop. Can you just repeat that and maybe expand on that in terms of the total amount of dollars required and the time frame for spending those dollars?

Yes. So I did mention we're spending $1.5 million on installing an additional making and packing line at the manufacturing facility. So that will allow us to expand the VLN sales as well as maintain and grow the contract manufacturing business at the same time. And then the other investment I mentioned was a multimillion-dollar investment in our new -- in our -- in this year's VLN crop. We haven't publicly -- we haven't disclosed the amount that we're investing there for competitive reasons, but it is the largest crop of VLN that we've ever planted by a sizable margin. And we're doing that with the confidence that the demand for VLN will be significantly as we head into a national launch and build out the international markets.

Okay. And so both of those are a 2022 events?

That's correct.

All right. And you said on the second one on the VLN crop, is that crop going to be harvested this year as well?

Yes, that would be harvested, yes, this year, late summer, early fall. So it's going into the ground as we speak.

At this time, we will address submitted questions from the web.

Thank you. First question is what barriers would keep big tobacco companies from copying XXII low nicotine technology as soon as regulations demand it.

Jim, do you want to take that?

Yes. Go ahead, I can chime in.

Yes. So we've been working for a number of years on creating these varieties of reduced nicotine tobacco plants. There are dozens of patents that we own or control related to nicotine biosynthesis in the tobacco plant. In recent years, our research has been focused on using non-GMO methods of creating these plants, which have allowed us to produce different varieties of tobacco, basically introducing reduced nicotine concentrates into different varieties of tobacco, which we think are important for a number of reasons.

One, the non-GMO approach allows us to access many international markets where GMOs are not allowed or not accepted by consumers. It also allows us to create -- is it basically make any variety of tobacco, non-GMO, and that allows us to work closely with any number of manufacturers who may be making combustible tobacco products, including cigars to convert their proprietary lines into reduced nicotine line. So that opens up a number of strategic opportunities.

So all of this is protected by a very wide and deep moat, as a dimension of dozens of patents. And the big tobacco companies have in the process of the rulemaking around the reduced nicotine mandate plumply commented about the strength of our IP and how difficult it would be for them to develop these plants themselves over time that it would take 10 or 20 years and multibillions of dollars for them to do this research. So that's where our confidence lies.

And in addition, just to add on to that. In addition, you have double protection because not only would they have to do that, but they would have to seek PMTA and MRTP authorization, which would take quite some time. So we've got a deep and wide IP moat now across all these varietals at the low nicotine levels and then doubly protected with the timeliness of getting PMTAs and MRTPs through the system.

Thanks, Jim. Our next question is does variable nicotine research cigarettes mean that the future levels of nicotine may be variable that the FDA will allow.

It's a good question. The -- that remains to be seen. But based on the current independent clinical science, it's unlikely that the levels will be variable. So we make the variable research cigarettes so that FDA and the researchers can answer that very question. There have been a number of studies done already by independent researchers to address that question, one of the largest being essentially the equivalent of Phase III study with over 1,000 patients.

So what that clearly showed was that a sort of a variable approach or a step-down approach is not the best way to address it because in those middle levels of nicotine, you actually see increased consumption. And it's a phenomenon similar to what has been seen with light and ultra-light cigarettes, low-tar cigarettes in the past when our smokers end up smoking more.

In the case of very low levels of nicotine like we have in VLN, you don't see that compensatory smoking. You don't see an increase in smoking, but of course, rather a decrease of smoking, which is why we have the claim on the path that VLN helps you smoke class. And so what we would expect based on science is that the FDA will mandate an immediate reduction in nicotine levels to very low levels, basically to the level that our product is today.

Thanks, Mike. Our next question is, given the very large market for menthol cigarettes in the U.S., will the company be able to satisfy this market once the FDA bans all other menthol cigarettes.

Yes, 2 questions. Go ahead, Rich.

Go ahead. Well, Mike, I was just pointing out that with the expansion, we'll be able to satisfy 1% of the U.S. market. That's an $80 billion market, and we have the capacity to expand that up to 3%. So clearly, we've -- with the North Carolina facility and the ability to modularly expand it, we can step up to 1%, 2%, 3% of the U.S. market, which would be a very good penetration given that it's an $80 billion market. Mike, do you have anything?

Yes. Yes, those are great points that -- and those are -- that increase 2%, 3% of market is an investment with minimal investments and can be done very quickly. As we approach a final rule or as FDA approaches a final rule, of course, we do have a bit of time to plan for that. We're looking at manufacturing alternatives there to be able to address the larger market. But one of the key assumptions in any kind of analysis is like this is where do menthol -- what do menthol smokers do. And so FDA's expectations, of course, is that some smokers will quit.

And that's one of the reasons why FDA looks favorably upon reduced nicotine cigarettes and VLN as well is because this is something that helps them not only to smoke less, but potentially helps them to wean themselves from combustible cigarettes. And so some menthol smokers will quit. Some menthol smokers will switch to less harmful forms of nicotine delivery like vape and e-cigarettes. That's fully expected in a menthol rule. And then some smokers may decide that they want to continue to consume cigarettes with high levels of nicotine but without menthol so they might migrate away from menthol addictive menthol, our high nicotine menthol cigarettes.

So the entire menthol market is not what we need to supply. It will be something -- some subset of that, but we're well positioned to be able to do that. We have the time to increase our supplies and our manufacturing capacity to be able to do that. We would also expect to be working with strategic partners who are already in the industry to be able to provide -- meet the demand from their customers as well.

Thanks, Mike. And we have time for 2 more questions. A few investors are asking if mail order or online sales of VLN will be available.

Mail order sales are not current -- are basically prohibited by federal law. Although in time, we think there's a good case to be made to make an exception to that rule for VLN, but that's not something that we can do today. But if that's something that you'd like to see, I'd encourage you to contact your federal Congress people and U.S. senators, encourage them to look at a change like that in federal well.

Thanks, Mike. And our last question is, is VLN currently exempt or expected to be exempt from any state or federal excise tax and/or MSA payments?

Yes. There are a handful of states already where VLN has a reduced state excise tax rate being that it is an MRTP product, and those states are high on our list when we look at rolling out the national launch. We think there's some benefit there potentially to smokers as well as to our bottom line. And we are looking at the possibilities of that sort of benefit expanding to other states as well as to the federal excise tax.

MSA payments is an interesting question. That's something that's set by an industry agreement with the various states who are parties to that settlement agreement. So it's unlikely that we could renegotiate a 20-plus year old settlement agreement like that. But certainly, the reduced excise taxes go a long way towards helping the cost.

Thanks, Mike. I'll turn it over to Jim for closing comments.

Thank you, Mei. I appreciate all the great questions and look forward to reconnecting again in the next quarter, whereas Mike indicated, we'll have much more data to share and trend information as well. So thank you for all your time and attention to 22nd Century. As I said before, we're excited across all 3 franchises. We've got all the catalysts in our pocket, and we're poised for growth, and we're finally focused on execution across these 3 franchises, obviously, with the nearest term focus on our tobacco franchise and VLN. So thank you for your time, and we'll talk soon.

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