Back, everyone. Next, we have 22nd Century Group. It trades on the NASDAQ under the symbol XXII and is the pioneering nicotine harm reduction company in the tobacco industry, enabling smokers to take control of their nicotine consumption. Please welcome Chairman and CEO Larry Firestone. Welcome back to the conference, Larry. It's been a while. Nice to see you again.
Yeah, thanks, Anna. I think we've been doing this now for a little over a year, so it's nice to be back, and thanks for hosting us.
Wonderful. The floor is yours.
Okay, so welcome to 22nd Century. As Anna mentioned, we're on the NASDAQ under the ticker symbol XXII, and we are a pure-play tobacco company with a unique portfolio of brands. Really, the portfolio of brands that we have are focused on nicotine harm reduction. We have our own proprietary VLN, and we have our Flanker VLN. We'll go into those as we get further into the presentation. We are the only FDA-authorized low-nicotine combustible cigarette on the market, and our company is driving to create a disruptive new VLNC, which would stand for very low-nicotine cigarette category, so that we can carve out the low-nicotine category in the market.
We're poised for growth and value creation. We're in a very exciting spot. We've got a nice new platform that we're launching from in 2025, and we're fully aligned with the FDA's low-nicotine mandate that came out in January 2025. You know, we offer a choice. We actually are the only ones who offer a choice with nicotine consumption. Let's talk about where we've come from and where we're going. In 2024, our team rallied around a turnaround strategy. We laid out our plan. We've been tracking to our plan, and our team really, really stepped up. We took our costs way down and adopted a lean operating model.
We've right-sized the company, and we put a focus on VLN. We really refocused on VLN, and then we developed not only our own VLN but our Flanker strategy as well. You know, in doing so and working through 2024, we also solidified our balance sheet. We've restructured it, and we've got it in a good place right now and ready to grow. In 2025, here we are, six, seven weeks into the year. We've got a lot going on at our company, and again, to the same plan that we've had really starting in 2024. We're relaunching VLN with new branding and also with the Flanker brands that we've been talking about.
What that does for us is that builds a portfolio of brands for us to go to the market. Instead of going to the market with, you know, two SKUs of cigarette packs and selling that into corporate retail, we're going with a portfolio of products that we can sell and really make a difference in the presentation of how VLN sits on the shelf. We're driving to cash positive. After we get through 2025, this initiation of growth, where are we going? It is really a couple of angles of approach, but one is expanding retail distribution. There are about 273,000 retail outlets that sell tobacco products.
We are in a very small segment of those. We have a long way to grow with points of distribution. More importantly, we are focused on driving rate of sale. Once we implement, rate of sale is the name of the game. We are looking with our R&D team to launch companion VLN-based products. We believe VLN low nicotine plays in every one of the tobacco areas that you see out there in the market, which will drive increased revenue, profitability, and cash flow. We have been moving very fast in 2025. I call it action to traction. So far, we have signed Smoker Friendly.
Smoker Friendly is a very large and well-known retailer in the tobacco space. We signed a five-year contract manufacturing agreement with Smoker Friendly that includes their standard brands, which is about 22 SKUs. There's Smoker Friendly Black Label, which is about eight SKUs, and they're the first to adopt the Flanker VLN. We are very excited to have Smoker Friendly, you know, adopt a Flanker VLN and tuck it into their portfolio of products. That is very important for us, and that is very important to the strategy that we put together.
We have our own VLN. It is going to grow into their 300 Smoker Friendly stores. We have a lot going on at Smoker Friendly. They're kind of the architect, if you will, or they're kind of the chassis that we want to build with other retailers as well. Not only are we talking with Smoker Friendly and really moving the ball with Smoker Friendly, but we're having similar discussions with other major retailers. VLN penetration across the US is the target, and Flanker VLN SKUs and our VLN SKUs are really the key to doing that. As we talked mid-last year, I think mid-last year, we talked about new branding.
We talked about new messaging. We talked about integrated marketing. All of that is now coming to fruition here as we enact this with the VLN strategy with Smoker Friendly. That's our first test drive there. We are expanding the state approvals. We've been at around 26 states approved, and we're now expecting to be approved in all 50 states by the regulators by July of 2025. With that, as we run into a retailer that's in a state that we're not in, after July of 2025, we'll be in that state so we can go penetrate that state and penetrate that market.
The FDA did a nice job of coming out with a refresh of, I think, what was started in 2017 under the first Trump administration for a low nicotine harm reduction proposal. They reinitiated that in January of this year, and we're out in the comment section, and we're the only company that fully is aligned with the FDA for a low nicotine mandate. Our growth strategies are pretty straightforward, and in fact, I've already talked about just about all of them. We're relaunching VLN and Flanker VLN in the market with our updated branding, and we're building what I call a portfolio of VLN, which is going to be VLN and Flanker VLN. I'll show you a picture here in a couple of slides.
You know, I'd say the big initiative, the big new initiative that we haven't talked about before is to drive a new VLNC category and shelf space in the market. We think that VLN on its own, or low nicotine tobacco, has got to be carved away from the regular cigarette space so that when people are looking for a choice or they realize that they have a choice, they can find it all in one spot. We're looking at developing non-combustible VLN products to widen the portfolio, and this will just help us grow not only in a VLNC category but in other VLN products that involve tobacco going forward.
VLN, here's our new branding. We're very excited about it. We're getting a lot of positive response from the market as they look at what we're bringing forward. There's the three SKUs: gold, green, and red. Really, as I've talked before, nicotine equals addiction. You know, we are the tip of the spear. We're leading the harm reduction movement by offering a choice. We're the only one who's got a choice that's approved by the FDA. As many of you know, we've got our MRTP and our PMTA, and that's very hard to come by.
Anyone who's at a standing start today is going to have a long road ahead to move that through the FDA. This has been in development for 26 years, and we're pretty proud that we're the ones that are taking the lead on this. Literally, billions are being spent on nicotine harm reduction awareness campaigns and governance. Not only did the FDA come out with its low nicotine initiative, but you've got TV, radio, commercials, associations, societies, conferences, healthcare restrictions, and of course, the famous court-ordered warnings that are on every retail door and every place that sells tobacco products.
We provide the choice for control with VLN for our consumers. The interesting thing for me, and I'm just going to throw this in here, is that we're keeping a very close eye on this because we think VLN aligns very closely with zero and low proof spirits. You know, consumers are breaking the paradigm, and what I'm talking about here is mocktails, and you see them in restaurants, and you see them, you know, in the liquor store shelves, and you see them in the supermarkets. It's really positioning in the same way we want to position VLN, which is a better-for-you position. It's at an above premium price.
It's not going out at a discount. It's domestic and international. There's a lot of movement going on there, and it's an emotional and a lifestyle-driven change to break that paradigm. This is a rapidly growing space in the US a lcohol spirits market, and we think VLN has a shot to actually catch the wind of that, which means that the consumers' minds are changing. As we go through the VLN plan, we think VLN is shifting now from maybe when this started, and this predates me, from a novel idea to a category in the market.
That category in the market is a big deal for our company. We are going to be really, really focused on that. As I mentioned, we are the first and only low nicotine combustible product authorized by the FDA. It is shifting from a novelty to a category in the market, and we have got our proprietary brand and our Flanker brands, which are comprising the portfolio. Over time, we will add other VLN products to that. Our newly branded VLN is ready to ship in March of 2025. In the next month, we'll be ready. We'll have all the packaging. We'll have all the pieces of the components together.
The same with the Smoker Friendly VLN. That'll be ready to ship in March of 2025. The new collateral approach, and you see some of it over to the right there, but I'll walk you through. I'll show you some of the other collateral that we've put together, and we'll be developing model stores as we go. Flanker VLN, let me explain Flanker VLN real quick. Flanker VLN, you know, you see our VLNs on the right, and those are the 3 SKUs that we have now in the VLN category. On the left, the far left is Smoker Friendly VLN. To have Smoker Friendly, a brand that's well-known in the market, adopt a VLN skew and tuck it into its portfolio not only means, you know, movement and adoption from them, but also it gives them another set of SKUs and profit opportunity.
We manufacture that for Smoker Friendly. We've got a Pinnacle VLN example here as we manufacture our Pinnacle product for Murphy Oil. We have other companies out there that we're talking to about adopting a VLN skew. A lot of these customers have, you know, what I would call tier four, which is high volume, low margin opportunities. VLN allows them to kick it up and take a piece of a higher piece of the market. We're very excited about this. This creates our portfolio, and again, this drives us towards a VLNC category.
What you see on the left here is the VLNC category. You see our VLN on the top, Smoker Friendly in the middle, and Pinnacle on the bottom. That is our vision of, and it does not, it will not stop there, but that is our vision of what you would see in retail around a VLNC category. The consumers can find that segment like if they found non-alcoholic beer, if they found non-alcoholic spirits, and wanted to change the paradigm for their personal lives. Along with that, we have got countertop mats. You see here an example of a garbage can stick-on and a floor mat.
We are going to lift the VLN idea and crusade, if you will, so that it is right there in the consumer's view. Distribution-wise, we have got a diverse distribution throughout the US. We've got, we've had, and we have, you know, about 5,100 retail stores across 26 states that carry VLN, and we're talking to all of them. The reception that we've gotten around the new packaging and the new approach and the new marketing and how we're bringing this to market has been nothing but positive. We've actually created some excitement around VLN in these retail outlets.
As I mentioned, there's 273,000 resellers of tobacco. We're in about 5,100. That's about 2% of the market. When I talk about action to traction, what you'll see is you'll see us sign a contract. As you think about the long walk-up that has to happen, we've got state approvals that need to happen. We've got store adoption that needs to happen, and then corporate resets that need to happen, which happen on a calendar. Just because we announce a contract, for example, Smoker Friendly, there is a lag time to see it turn into revenue. When I talk about traction, I'm talking about revenue.
You'll see a contract, you'll see a little bit of a quiet period, and then you'll start to see some revenue, and you'll see those reported in our numbers. We're less than 2% of the way there, and now we're on our way to marching forward as we go. I will point out, rate of sale is key to us. We could go a mile wide very quickly, and unless we're focused on capturing rate of sale, then we'll have a challenge. That's our big deal. Once we get in, we got to make sure it's selling and moving and consumers are aware of it. Now, a year ago, I turned off all the R&D initiatives as we were trying to right-size the company.
We shut down everything. We said, "Everybody stop, everybody out of the pool." We spent the year 2024 getting ourselves together and understanding what initiatives we should drive. We've got R&D awake again, and I'm very excited about the initiatives that we're driving here. Right now, our VLN product is an 85 millimeter. It's known as a king-sized product. We're going to be adding a 100 millimeter VLN to the lineup, which will double our skew set no matter how many SKUs we have out there. That will come to fruition in 2026.
We're very excited about that as that's another segment of the market, if you will. We're looking at and already working on non-combustible low nicotine product extensions. There is a lot of noise, a lot of activity, a lot of energy around high nicotine products and non-combustibles. We think we're the ones to bring the low nicotine piece to that equation. Our partnership with North Carolina State University is on various low nicotine tobacco issues and improvements. That also feeds our intellectual property portfolio. We're very, very excited about what we're doing in R&D now.
On the P&L financially, 2024 was the reconstruction year. You see what you see here, what my eyes see here is negative gross profit, negative gross margin. We've gone to our customers and we've restructured contracts. This is really core to changing the angle of approach on that. We've got, I think we've got, I know we've got all of our customers now in a profitable state, all of our customers, all of our SKUs. Operating expenses, we brought those down significantly as well. I think we're now at a runtime state.
With the advent of traction in VLN and revenue growth as we go forward and revenue growth in CMO business as well, which tags along with that and positive gross margins that will run with that revenue growth and keeping our OpEx in line, we'll be crossing the line to break even very soon here and then going and making money. In summary, you know, I talked about action to traction, but you know, we've got a lot going on in the company. Every piece of the company we've turned over and we've got set. We've initiated profitable growth as we, you know, after our turnaround, everything that we're doing, we're looking at making money.
We've got our VLN strategy is solidified and launched, and we've got action in that realm, not yet traction. That's bringing forward the, now with the Flanker VLN, with Smoker Friendly and others that we're talking to, here comes the portfolio, which is very exciting. That'll give us some growth through 2025. We are fully aligned with the FDA's low nicotine mandate and the potential, I can't say this one enough, the potential of the VLNC category that would separate VLN from the rest of the market and really give us a highlight, a highlight reel to show the consumer.
Then continued development through our R&D of low nicotine strains and low nicotine products, our improved balance sheet. We've taken our debt down to $4.6 million, and it was, I don't have the number off the top of my head, but it was sizable. Our new target to achieve EBITDA break-even is now Q4. We had that targeted at Q1, but now that we're getting our hands around the lag time between contract signing and actual revenues, we've pushed that out to Q4, and I'm very comfortable with that. Our keys to success, as I mentioned, is increasing our points of distribution.
Those are contracts with retail and also with Flanker VLN partners. More importantly, and probably most importantly, is rate of sale. With that, Anna, I'll turn it back to you. All right. Fantastic. Thank you, Larry. Okay. Your presentation today does have a lot of information about this new launch and packaging, but can you share more about how it's different from the initial launch and why do you think this approach will yield better results? Yeah. The initial launch was, we had 2 SKUs. We went to the market with two SKUs. We got some traction with some retailers, but it was very, it was a very personnel-heavy launch as opposed to a consumer education, a consumer attachment launch.
With the new marketing that we have, you know, you can kind of, and I'm not picking on anything or anybody, but we had, you know, two packs on the shelf and no material really in front of the consumer at all. It was just two additional packs on the shelf. You wouldn't, if it was, if I go to my alcohol spirits analogy, if you put another bottle of gin and it just says no alcohol on it, but you don't let the consumer know it's there, you're not going to, you're really not going to get a lot of traction. We leveraged, you know, some of the relationships we had to get 5,200, 5,100 points of distribution, but we really lost the rate of sale.
We didn't focus on that. We're on that here, and our customers and our retailers are also excited to see what we're doing to drive rate of sale as well.
Wonderful. If you can give us a little bit more insight into the low nicotine mandate that's been proposed by the FDA back in January, and does it go into effect? Does it benefit your consumers?
Yeah. The FDA came out with a reinforcement, if you will, of the mandate that they put forth in 2017. It's been bantered back and forth. It's, you know, gone through a lot of comments, a lot of pressure. Of course, big tobacco would like this not to happen. You know, our company and our product, our VLN product is actually mentioned throughout the FDA mandate. You know, we're pretty excited about that. The FDA put it back out there. We're right now in a comment period that'll go till the, till I think the beginning of the fourth quarter. Once the comments are all in, there's going to be a bunch of lobbying and there's going to be a bunch of activity around that because obviously the impact that it would have on the tobacco market.
They are going to make a decision and rule and see if this is something they are going to put forward. It would be very exciting for us on one hand. On the other hand, we are not depending, we are not waiting to depend on any governmental action or the FDA to move our business forward. We are very excited in the position that we are in. If the FDA, if we have got the traction that we want to have, the action and the traction, and the FDA gets the approval and everything moves forward in 2026 and beyond, that is just good news for us. That would just help us.
Absolutely. What has the response been? What have you heard from your retail partners on this new packaging, marketing plans, all these updates?
They are all, you know, it has been everything from, you know, this is very exciting to we are blown away. This is the way it should be done. We're told that, you know, the market is pretty, I would say the market is pretty regular. It just sort of is in a replenishment mode. As we're selling in this new product and this new concept in the way that we're selling it in, the retailers like it. I mean, let's face it, retailers like to make money on every slot in every retail store. If we put VLN in many slots, let's just say three Smoker Friendlys and three of ours, that's six slots. Each of those slots has to make money.
It really, when they look at how we're going to bring it to market and how we're going to educate the customers and how we're going to do our area gate marketing and social media and things like that, they get very excited about that. There hasn't been this kind of, we've been told there hasn't been this kind of excitement in the tobacco market in a long time in the cigarette side.
Wonderful. Larry, your presentation announced an update to your cash positive outlook to now Q4 this year. Can you give us some more
insight on that? Yeah. We're, you know, as I mentioned, the kind of action to traction, we now appreciate the lag time that goes with signing a contract, to getting state approvals, to getting store adoption, to getting the corporate resets. I'm going to say that's what we've normalized around is a six to seven month timeline from when it's very exciting that we sign the contract to when we start to see revenues and walk up. In our original forecast, I'll take the blame on that. I didn't have that kind of a lag time built into the forecast. I think we're a little more in alignment with our market and what it takes to move the product through.
It's a little bit of a delay, but we've also come through a very tumultuous turnaround and I'm very patient. This is going to happen and we don't need to really push anybody too hard so that we turn them off and go into market.
Wonderful. Larry, do you have any closing remarks for our viewers today?
I'd just like to thank everyone for joining 22nd Century's presentation, sticking with us, keeping an eye on us. I think we're really up to some big stuff here and look forward to giving you updates in the future, Anna. I always appreciate you.
Wonderful. Thank you so much. Great update and we look forward to seeing you again real soon.