Edited Transcript of XXII earnings conference call or presentation 8-May-19 8:00pm GMT

Thomson Reuters StreetEvents - finance.yahoo.com Posted 6 years ago
. Without being addicted to the product, the smoker can smoke fewer cigarettes, the smoker might make more quit attempts. But in general, by smoking less or perhaps by quitting, that smoker will lessen their exposure to tar and to smoke and to the cancer causing agents in cigarettes by simply smoking less or quitting altogether. So that's our claim. Our modified risk claim is actually a reduced exposure claim, a reduced exposure to nicotine and only nicotine. Does that make sense?" data-reactid="175">Yes, that's an excellent question and a very important question. Our product does not, and let me be very clearly, it does not reduce tar carcinogens and we are not seeking anything from the FDA to say otherwise. What we are seeking from the FDA is a very simple claim. The right to make the claim that our cigarettes have 95% less nicotine, period. That's all we're asking. It's reduced exposure. So there are sort of 2 different branches to the modified risk program, one is exactly what you've outlined is a modified risk branch, I guess. The other is a modified or reduced exposure. And so what we are looking for, a reduced exposure marketing authorization where we can expose consumers to less nicotine to hopefully a minimally or nonaddictive amount of nicotine. And the idea is when you expose consumers to only a minimally or nonaddictive amount of nicotine, than the smoker can smoke as much as he or she sees fit. Without being addicted to the product, the smoker can smoke fewer cigarettes, the smoker might make more quit attempts. But in general, by smoking less or perhaps by quitting, that smoker will lessen their exposure to tar and to smoke and to the cancer causing agents in cigarettes by simply smoking less or quitting altogether. So that's our claim. Our modified risk claim is actually a reduced exposure claim, a reduced exposure to nicotine and only nicotine. Does that make sense?

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Unidentified Analyst, [20]

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Thank you for clarifying that. And to follow up, if a cigarette, let's say, talk about IQOS, again the same company has their own combustible products, if you look at let's say the Marlboro Ones it looks to be 0.01 milligrams of nicotine in the Marlboro Plus One, 0.1 milligrams of nicotine per cigarette. The question is, of course, how much tobacco is in each cigarette? Consumers don't look at nicotine per gram of tobacco. They look at nicotine per cigarette. So I'm very curious with VLN, what is the nicotine content per cigarette?

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Henry Sicignano, 22nd Century Group, Inc. - President, CEO & Director [21]

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Okay. I'm not exactly sure what you're looking at with Marlboro, but let's also make this very clear because you're making some very excellent points. The old way that nicotine exposure was measured was nicotine yield as measured by a smoking machine. And the FDA said, I don't know 10 years ago, that that's really not a valid way to measure nicotine exposure because smokers alter their smoking behavior when given a light product or an ultralight product or a low tar product. They takes more puffs per cigarette, they inhale more or less deeply. They alter their breath behavior and basically defeat the filter and the ventilation holes in order to get the nicotine that they are seeking. So nicotine yields are not looked at as an accurate measure of nicotine that consumers are actually inhaling into their bodies. But we've measured our nicotine exposure by cigarette, by content in the tobacco and by yield, okay? So it's important to say by each of those metrics, we've measured the nicotine tobacco content, the yield and the nicotine per cigarette. in all 3 cases, we're at least 95% less than each and every one of the 100 top-selling brands in the United States. So I can say that definitively. Any way you want to look at it, we're 95% less. The most accurate way to look at it, scientists believe is by nicotine content.

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Unidentified Analyst, [22]

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In this case then what would be your nicotine content per VLN cigarette?

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Henry Sicignano, 22nd Century Group, Inc. - President, CEO & Director [23]

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The range that we target is exactly the range that we believe the FDA will mandate which is between 0.3 and 0.7 milligrams per gram nicotine per gram of tobacco.

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Unidentified Analyst, [24]

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So that's between 0.3 and 0.7? So if I took a Marlboro...

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Henry Sicignano, 22nd Century Group, Inc. - President, CEO & Director [25]

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The target is 0.5. That's the ideal.

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Unidentified Analyst, [26]

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If I took a Marlboro Plus One and cut the filter off and just weighed the tobacco, I'm going to get 0.62 maybe 0.65 grams. And they're advertising that as 0.1 milligrams of nicotine. If I do the math, that means their tobacco is coming in at 0.16 milligrams per gram?

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Henry Sicignano, 22nd Century Group, Inc. - President, CEO & Director [27]

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You know what, I don't have a chart so I don't want to start giving you exact numbers in front of me. I just was looking at a chart a couple of hours ago with literally the 100 brands all marked down there. But whatever they're talking about right now is likely yield, is I think what you're talking about. I don't think that very many folks are publishing anything about content. But if you want to get into this more deeply, you can certainly e-mail us and we'll share with you a chart of all the numbers. As a matter of fact, they're all included in our MRTP application and our PMT application. So we'll be happy to share that data with you. It's all publicly available or will be.

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Operator [28]

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The next question comes from [Marian Gray].

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Unidentified Analyst, [29]

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I want to make $10, so I'm just going to say show me the money and I'll tell you later what that means. How close are we to other countries going VLN? Because I know about a year ago or less, Canada was looking for VLN cigarettes.

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Henry Sicignano, 22nd Century Group, Inc. - President, CEO & Director [30]

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Well, we haven't publicly announced any strategic partnership with another country, but I have disclosed publicly that we've talked to about half a dozen countries. And I mentioned earlier in my prepared remarks that John Pritchard is going to be sort of instrumental in talking with some of the folks in the regulatory and the public health world about doing exactly that, about bringing very low nicotine cigarettes to international markets. Mike, Zercher, our head of business development, is talking with major tobacco companies in international markets. But John Pritchard will be working with public health officials and regulatory experts in these international markets. I guess I'll just say we're certainly talking to folks in North America, in Europe and in Asia, frankly. But I can't really make any announcement yet. We don't have something to announce.

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Unidentified Analyst, [31]

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Have we sent VLN cigarettes to Canada?

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Henry Sicignano, 22nd Century Group, Inc. - President, CEO & Director [32]

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We've sent VLN cigarettes to dozens of countries. So that's all I can say.

We'll take one last call because it's approaching the 5:00 hour.

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Operator [33]

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We'll take the question from Ivan (inaudible).

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Unidentified Shareholder, [34]

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Henry, could you please tell me, I'm a longtime shareholder and I'll be honest with you. I've been listening to these conference calls for years. It seems to me like you're saying the same old stuff here, and I'm learning nothing new on this conference call. Can you speak a little bit about what you're doing with the University of Virginia and Anandia as far as research? Are we going to renew some of these contracts? And if not, what are we doing? When are we going to start making revenue off some of these research partners that we are partnering with?

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Henry Sicignano, 22nd Century Group, Inc. - President, CEO & Director [35]

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That's an excellent question. I'm going to let Tom address some of our strategic partnerships with research institutions. But let me just say broadly, 22nd Century, I understand what you're saying and I sympathize with you. 22nd Century, though we are growing our revenues each year, and that's important to demonstrate that we're capable of doing that, we're capable of running a factory and we're capable of growing our contract manufacturing business, that's not how we're going to build substantial shareholder value here. That's generally -- what that's doing is it's growing a little part of our business, it's enabling us to have a factory, to support the 50-plus people who work there so that when we do supply research cigarettes to the government or when we do need a factory inspection from the FDA for a modified risk product that we have that factory up and ready and available at a moment's notice. So that's why we're selling whatever we're selling, $25 million worth of product a year simply to pay the overhead there and to keep the lights on. What you're going to see, I believe, is you're going to see one day a regulatory approval or you're going to see a licensing announcement and you're going -- that's going to be an on/off switch. We're not going to get there incrementally. It's not going to be in 1 year we did $25 million, the next year we did $45 million and then the share price went up 10% and then it went up 15% and then it went up 20%. It's not going to be like that. We're going to achieve success. You've been a shareholder for several years, well then obviously you realize our first application that we submitted for our modified risk tobacco product was a strong one. But we invested, I don't know, $2 million I guess in that application because that's the resources that our company had.

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Unidentified Shareholder, [36]

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If that's the case, why did you waste the time in submitting it? The whole thing is you submitted that application, and at the very end of the year, if I'm not mistaken, it was December 2 or December 31st, you let your shareholders know that you're giving no choice. You waited 1 whole year without any word throughout the process like you're doing this year. This is what I'm upset about. I've heard you, Henry, since the first...

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Henry Sicignano, 22nd Century Group, Inc. - President, CEO & Director [37]

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Sir, let me correct you, sir. We didn't wait a year to let you know. The FDA waited a year to respond to us. So let's just be very, very clear about that. The FDA responded literally 350 days after we submitted our application. We had an initial meeting early on which we reported. Let me finish. Not on the first application, sir. On the first application, we had a preliminary -- sir, I'm not going to argue with you. I'm telling you the facts. The facts are we submitted the application, we had some early discussion with the FDA and we didn't hear anything from the FDA for the better part of the year, okay? This second application.

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Unidentified Shareholder, [38]

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What happened to this application?

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Henry Sicignano, 22nd Century Group, Inc. - President, CEO & Director [39]

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It's already different, sir. I've already publicly announced that we've had some 20 conversations with the FDA. I publicly announced that we spent more than $10 million on this application, and that we've used all of the guidance that the FDA gave us on our first application in the second application. I've also told you that I -- let's count how many companies in the world, how many multinational tobacco companies have been granted this amount of tobacco products.

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Unidentified Shareholder, [40]

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Henry, I'm only worried about 22nd Century which I've been invested in for 7 years and I've heard all the things that you discussed, all of this, Henry. From the hemp side, I don't hear anything about Virginia or University of Virginia, I don't hear about anything from Anandia. I haven't heard when you guys announced about -- even the -- what is that? You guys are going to start something in North Carolina and Virginia. I think it was iHemp Platform that 2 of your executives were in. You guys don't even mention anything like that anymore. I'm interested in new things. I'm not interested in the same baloney that I hear every conference call. Everyone takes a global risk, anyone can just understand that. I'm not learning anything new.

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Henry Sicignano, 22nd Century Group, Inc. - President, CEO & Director [41]

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Okay, well, you're learning as much new things as I'm allowed to publicly disclose, sir. But the first thing I suggest you do is you read that 10-K very carefully because I think we've done a pretty good job of disclosing a lot. Pay a lot of attention to our press releases and understand that we spend as much money and as much time as Reynolds did on their modified risk application. And I'm very, very proud of it and optimistic that we might be the first one authorized in the world. Now I wish you would pay...

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Unidentified Shareholder, [42]

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You should not be proud of you guys getting raises without our share price going up. That's ridiculous.

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Henry Sicignano, 22nd Century Group, Inc. - President, CEO & Director [43]

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Well, I understand your sentiment. And if you feel that way, maybe you want to sell your shares.

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Unidentified Shareholder, [44]

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You shouldn't say that to a shareholder that has a lot of family in your company that's listening to us, Henry. That's ridiculous. Because if I lived in New York, I definitely would have went to your shareholders' meeting.

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Henry Sicignano, 22nd Century Group, Inc. - President, CEO & Director [45]

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You'd be welcome to attend, sir. You'd be welcome to attend.

I think I'm very proud of what we've accomplished. I believe that our application is a very strong one and could be the first MRTP approved by the FDA. So that's our focus. We've worked very hard on that. I'm very proud of the application. And I think that's where you should focus as well. In terms of hemp and cannabis, we've done quite a bit of work there. Our IP status is widely regarded as a world-leading status. The Keygene relationship that we've announced, the partnership with Keygene, I think will bring us to a place with cannabinoids, much faster than we were able to get to that place with nicotine in terms of controlling that genetic pathway. So those are the thoughts, and that's what we're very proud of, that's what we're focused on. I think our successes will lead and the share price will follow. So that's the best I can tell you. And my family and friends are also invested in this company. So we're in it for the long haul, and I hope you'll be satisfied when we do achieve some successes with the FDA and with our IP and cannabis.

So with that, I think I'll say thank you very much, and we look forward to talking to you next quarter. Good night.

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Operator [46]

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Thank you, ladies and gentlemen. This concludes today's teleconference. You may now disconnect.