Good afternoon, and thank you all for joining us for our next Midwest IDEAS Conference presentation. Presenting next is Niagen Bioscience, which trades on Nasdaq under the ticker symbol NAGE. Representing the company today is their Chief Financial Officer, Ozan Pamir.
Hi, everyone. Nice to see everyone. Thanks for joining today. I want to first ask the group who is familiar with NAD, what NAD is, other than Bill? Just one person. NAD is a coenzyme that exists in every living cell of every living being. It is vital for DNA repair, cellular defense, and energy production. It declines as we age. Between the ages of 30 and 70, your NAD levels are shown to decline by 65%. What does this mean? This means that if you think about how you used to recover when you were younger from sports, when you sprain your ankle or hurt your wrist, then you are able to get back to playing whatever sport you were playing.
As you age, that can turn from weeks to months, and it can increase over time, and sometimes you may never play the sport that you are playing again.
That is because the NAD levels in your tissue have declined, and they are unable to repair themselves. There is one problem with NAD. NAD is a large molecule that if it is outside of your cell, it cannot enter your cell. It has a phosphate group around it, and the only way that you can elevate your NAD levels is by taking a precursor. If you are taking an NAD product as a dietary supplement or injecting yourself with an NAD or IV product, it is not going to elevate your NAD levels in the tissue and in the cell. That is what we sell. We have patented nicotinamide riboside. We sell it under the brand name of Niagen as an ingredient, and we have commercialized it as a supplement ourselves as our consumer product. Niagen Bioscience is the world's leading NAD company.
We tackle aging, and we do that by selling Niagen. We sell Niagen as an ingredient to other supplement companies. We sell our own consumer product through Niagen through various e-commerce channels and retail. We sell Niagen Plus, which is our IV and injection product, and we have entered into the skincare business. These are some of the highlights of our business. We have a cash-generating business, which provides strategic optionality to our company. I will talk a bit more about this a little bit later about our core business and how we are approaching our business model. We have strategic partnerships with blue-chip companies like Nestlé, who is also a shareholder in the company, just under 5%, and Watsons, which is one of our largest distribution partners. We have accomplished all this by growing profitably and maintaining a very healthy and strong balance sheet.
In the last 12 months, we had $127 million of revenues. We had $16 million of net income, and we finished last quarter with just under $67 million in cash and no debt. We also have an incredibly clean cap table. We have 79 million shares outstanding. We have no warrants in the company, and we continue to operate the business very conservatively. Our business is backed by our very strong patent portfolio. We have over 100 patents covering many different precursors, not just NR. Probably one of our largest opportunities is our drug development pipeline. We have done over 500 published studies on NR, and we have done more than 46 now clinical trials on NR.
Some of these were in rare genetic diseases and accelerated aging diseases, and we have seen remarkable results in those. We are developing a new molecule that is similar to NR, but it is significantly more bioavailable and it has a different safety profile. We are purposing that molecule for drug development in the rare disease space. When I talk about our core business, it is our branded product of Tru Niagen. I have some samples here that you guys can grab after the presentation. We have our ingredient partners like Nestlé, Life Extension, H&H, where we sell the ingredient. We have entered into the injectable and telehealth space. Injectables in the IV space, we entered into 2024, and we recently launched our telehealth business. We entered into the skincare business with our first product. We are going to have another launch of that later this year.
As I mentioned earlier, our drug development pipeline. Niagen has an incredibly impressive scientific advisory board. We have Charles Brenner, who is the world's foremost authority on NAD metabolism. He is the one who discovered NR and the NR kinase pathway, the way that NR can enter your cells. We have a Nobel Prize winner with Roger Kornberg. We have Rudy Tanzi, who is a leading researcher in Alzheimer's. We have the world's leading authority on milk. NR is actually found in milk, the elixir of life. We have an aging expert, Hassy Cohen, who is also an expert in peptides and has patented various very popular peptides in the past.
We have one of the world's leading breast cancer researchers who has studied NAD supplementation and cancer. We have Dr. Will Bohr, who is helping us also with our rare disease drug development, and is one of the world's most published researchers on aging. NAD has become incredibly popular over the years, and especially recently, we have had many celebrities talk about NAD. They take NAD products, and super majority of them take Tru Niagen. I will not get into the details of the market, but as you can imagine, anti-aging market is incredibly large, and it remains to be captured by us. I will get into the consumer business and with our Tru Niagen product. This is our flagship product, Tru Niagen, at 1,000 mg. It is the most tested NAD booster out there. It is the most efficient and effective way to elevate NAD levels.
Our studies have shown that after 8 weeks, your NAD levels increase by 40% - 50%. This is only one of our pieces of research. We have, as I said earlier, over 45 human clinical studies, over 500 published scientific studies, and many more research collaborations. The skincare opportunity is very interesting to us. We did a pilot launch of Niagen NanoCloud. One of the problems with NR is that it's not stable in water. The way to get around that is to change the format of how you apply your skincare product. This is a product that we developed that has hyaluronic acid and Niagen inside. You apply it to your face or your skin right at the time of use by mixing with a serum of your choice.
Our studies have shown really meaningful benefits for customers, and we did a pilot launch of this earlier this year. We sold out very quickly, and we expect to do a second launch of it later this year in October. You can find our products in many distribution channels. We recently launched at GNC and Sam's Club. We've been at Sprouts nationwide. We are in The Vitamin Shoppe, and internationally, you can find us in Watsons in Hong Kong, Singapore, Malaysia, and Philippines. We're in Australia and New Zealand through our partnership with Matakana Health, and we're on iHerb as well. This is in addition to our own website and our other e-commerce channels. The IV market for NAD, we think is a very meaningful market for us to go after.
It has been around for a little bit, and we estimate that it's about a $500 million market between the IV and injection market. We developed a pharmaceutical-grade version of Niagen. We got on the 503B Category 1 list, and we have launched an IV product through Compound Pharmacy Partners in 2024. We've been working on this ever since. The NAD IV gives us a very important benchmark of why Niagen is superior to NAD. The molecular difference that I described earlier between NAD and Niagen is very visible when you're looking at the IV product. NAD IV, because of that large molecule structure and the phosphate group, NAD molecule cannot enter your cells as you take an IV.
What happens is that it has to break down into different molecules, and it causes inflammation in the body, and it causes a lot of headaches and sweats and stomach pains. Because of that, you have to dial it down, and it ends up taking you 3, 4 hours to do an NAD IV. On the flip side, Niagen IV takes about 30 minutes, and there are no side effects. That is because of that molecular structure that I described earlier. We are now in over 1,700 clinics nationwide. Some of our largest partners are Restore Hyper Wellness and Drip Hydration. We continue to grow this network. Going to the drug development side. We recently made some announcements around our new molecule, NB4168. This is a differentiated molecule that we have, and we think it's better suited for pharmaceutical development.
It has a significantly improved bioavailability and a superior PK profile and a safety profile, which leads us to believe that it will have a higher therapeutic index. This is a very de-risked clinical development opportunity for us, we think. We have done two clinical trials to date on ataxia-telangiectasia using Tru Niagen, the supplement product, and they have had remarkable results. We have many other trials that were done on different diseases like Werner syndrome, citrin deficiency, and Cockayne and Friedreich's ataxia, and all of them have showed meaningful benefit to the patients. We think that ataxia is just the beginning of this program, and we are developing a new formulation for pediatric patients for NB4168. Essentially what the molecule does is that it releases significantly more active moiety into the bloodstream. It is not present in nature. It is not available as a supplement.
We have a much stronger patent portfolio around this molecule, including composition of matter patent. Some of the preclinical work we have done is shown on the right-hand side here. You can see the bioavailability of NR CL versus NB4168. It is significantly higher. It is designed to have superior efficacy. It avoids the gut microbiome, and it essentially is a delayed release of the product. What is ataxia-telangiectasia? This is the first indication that we are going after. Ataxia-telangiectasia is a rare disease. It is a genetic disease where the ATM gene is knocked out in these patients. ATM gene is a very busy gene. It has many different functions. When it doesn't work, it causes many issues in the body, and one of which is NAD depletion. These kids have non-detectable levels of NAD, and because of that, their cells are unable to repair themselves.
They have a lifespan of about 20, and they get into wheelchairs by age of 12, most of the time. It is an incredibly terrible disease, and what we have seen in our studies with using the supplement product was significant improvement in motor functions, and other benefits. These are the two trials that we did. One of them was in 2021, the other one was in 2024. Both designed as phase II, but they are investigator-initiated trials. They have given us an incredible knowledge base in how this disease works and the effects of NR, and the links to NAD depletion. As I said earlier, ataxia is just the beginning. We see this as a platform, and it can definitely lead to different diseases and treatments for them. That is a quick summary of our business.
On our financial update, as I said earlier, we are at $127 million of revenue, $16 million of net income. We generated $17 million of Adjusted EBITDA, and $6 million of operating cash flow. We do have $67 million of cash, no debt, and very clean cap table. Our core business has really attractive gross margins. We are looking at anywhere between 63%-65% gross margin, give or take, in any given quarter, depending on our business mix. E-commerce represents more than 50% of our business. We have experienced 66% CAGR since Tru Niagen was launched in 2017. We also are seeing strong Adjusted EBITDA numbers across the board. We are very focused on our profitability and cash flow. It is a priority for the company. That is all I have. I am happy to take some of your questions.
What are you doing to increase awareness of the product? When you asked at the beginning, wanting to because of new market for announcement.
The question was what are we doing to increase awareness of our product? Our marketing to date has been very much focused on word of mouth and performance marketing. We do have plans to expand the education of our customers. We see marketing in twofold. One of them is the studies that we have done to date. We see that as a very important marketing tool in educating customers in what NAD is, and why NAD is important, and why Niagen is the most effective precursor to elevate NAD levels. We think that is an incredible tool that we have. The second one is trying different approaches of marketing. We have not done a brand campaign in the past. We have not done anything other than what I described, word of mouth marketing and performance marketing. That is something that we have plans to accomplish in the near future.
So we have patents. We have composition of matter patents. The question was, can you elaborate on the patents? We have composition of matter patents, method of use patents, crystal form patents, and most of them run out 2036 and 2037. We have, across the board, over 100 of them on a variety of different molecules, and our chloride is only one of them that we have commercialized yet.
Ozan, would you please expand on that new molecule that you have not quite commercialized, and the roadmap taking that forward?
Are you asking about the NB4168
You were asking about
Didn't you just say you had a new molecule that you have not capitalized or commercialized yet that was different than the pharmaceutical?
Oh, yes. We do have three other molecules that we have patented. We are exploring ways to commercialize that, but we have not put together a plan for that yet.
Relative to the NB4168, walk us through the milestones and the steps along the way, and the timing that you'd anticipate each of those to
For the NB4168, what the milestones are. With NB4168, we're right now going through some preclinical development. We're doing some preclinical efficacy in worms and mouse models and so on. Once that's completed, we just announced recently a deal with a CRO called Evotec. We are working through with them on the other preclinical work we need to do on safety, toxicology, PK, PD studies. We expect those to be done early 2027, and we would expect to be in first-in-human studies in healthy volunteers in 2027. We don't expect that to be a very long study. It will be a safety study, and then following that, we are looking at designing a phase II. Overall, the full timeline is you're looking at about 2030 for a drug approval. We do think that there are multiple pathways we can get there.
We do have the capital to fund this, but it would be our preference not to fund the clinical trials. We think that a spin-out transaction or a licensing transaction or partnership would be the most beneficial for our shareholders.
I have three questions. First of all, one question about the studies that you were doing with those patients that unfortunately were suffering. You said that there was a little bit of a recovery that you were able to see happen. How much of a recovery exactly were you able to see? I mean, was it like a full recovery, just a little bit, or what exactly is that recovery?
You're asking about the ataxia trials that were done in the past, and what were the results like. For the first one, the Netherlands open label trial, we've used two different These are all standard scales that are used to measure progression of ataxia. One of them is called ICARS, the other one is SARA. Both of these showed statistically significant improvements on both of these rating scales. The second one also, it was a longer trial of two years, but only 13 patients. This one used more testing scores like the A-T NEST, ICARS, and SARA, and gait scale, and three of these have showed improvement in neuromotor function. It's not a cure, but it is a way to manage symptoms and improve the symptoms.
Okay. The effect tapers off
Correct. In these open label trials, it was like on and off treatment. Once they got off of the product, their symptoms worsened.
Okay, great. Now for the other two questions. I know that there's a certain ratio for the body surface area that different animals go through when you give them doses, and the human's ratio is a little bit less than a mouse's, and a lot of those initial studies were on mice. But even accounting for that, the promising studies in mouse health, that initially caused a lot of excitement there. They were taking much higher relative doses than what this product is. I'm assuming that you got to be safe, maybe start off with a small dose. But do you think that having, it seems like, I mean, this is targeted by roughly 88%. Do you think that that high of a deviation from what the initial studies had in terms of potency, might change the math of if it's actually beneficial?
Are you thinking like the preclinical studies that were done for ataxia-telangiectasia, like the mouse studies that were done in 2016, they had a much higher dose, essentially? It's a very good question, and that is one of the reasons why we have switched our molecule from Niagen to NB4168. Because NB4168, it exposes the bloodstream to significantly more NR than what you would take as a dietary supplement. It bypasses the gut microbiome, and because of that, our current thesis is that it will have that therapeutic benefit that we're looking for.
Awesome. Then just the last question that I have. Just like a year and a month ago, 16th of July in 2025, there was a study done, where it found that this substance also might cause anxiety symptoms within small mammals like mice. Is that something that you see at this level of the dosage, or that's not really something you see?
Yeah, we have not seen that elsewhere.
Fantastic.
All right.
How long of a horizon is on the marketing campaign, and in between that time, is there a risk there where someone sees what you are doing and that it is a great idea, that they just market that guideline and kind of push you guys out even though you have a better promise?
Are you asking about like for our consumer product, if we are delayed on the marketing campaign, can someone come in and do a marketing campaign? So there is competition out there. There are other NAD products available out there. One thing to remember is that we have built our business around NAD. There is no other company that operates the way we do in that sense. There are supplement companies that sell NAD products, but they have not built a brand around NAD. So it is very normal for other supplement companies to do a brand campaign and come in as competition, but it is not going to be targeting what we are targeting. We are the leading company in the NAD space, and I think a brand campaign or a larger marketing campaign would really solidify that.
I don't think that there is a risk of someone else cutting in front of the line and replicating the marketing campaign, for example.
Ozan would you please differentiate between these two trials, for A-T versus the trials which you're going to be embarking upon between here and 2030?
Yeah. The question was to differentiate between the trials that were done with A-T and what we plan to do. The first difference is that they use Tru Niagen as the supplement. That is nicotinamide riboside chloride. It's a different molecule. It is available as a supplement. The second difference is that these are open label trials, which means that they were not placebo-controlled. So for FDA standards, for the trial to be accepted by the FDA, it has to be done as a placebo-controlled, double-blind study. We plan to differentiate through that as well. Yeah. All right. I think that's all the questions there is. Thank you, everyone, for your time. I'm happy to answer any other questions after this.