Frank Jaksch
Analyst · Harburn Enterprises. Your line is open
Thanks, Tom. We accomplished a number of important milestones in 2015. 2015 is the first year that the ingredients segment has accounted for the majority of the company’s revenue. The $20 million revenue mark is also a significant milestone for any growth company, not just our industry, but companies in just about any industry and we are now comfortably above that annual revenue run rate. Two years ago, our entire business was $10 million and this year the ingredient business alone was over $12 million led by our lead ingredient, NIAGEN. We reported our first human clinical trial deal in 2015 for NIAGEN, which demonstrated that even a single dose of NIAGEN can raise NAD substantially. We received NDI status for NIAGEN in November, which is a very important regulatory milestone for the company. We also reported our first significant licensing agreement for NIAGEN with the joint development agreement we signed with P&G. Activity in the new business development area remains robust and we expect strong revenue growth in 2016. As I mentioned earlier, Q1 2016 revenue is tracking towards another record quarter. On the business development front, activity for NIAGEN up to now has been largely – or the customer base has been largely focused on a narrow group of what I will call direct-to-consumer supplement companies. And importantly, with our recently announced deal with BPI Sports, we expect in 2016 nutritional supplement products featuring NIAGEN will for the first time populate the shelves of tens of thousands of major branded retail locations throughout the U.S. BPI has plans to introduce dietary supplement products featuring NIAGEN in a large number of retail outlets, including Costco, Wal-Mart, Walgreens, Target, Meijer, and a host of others as well. As we signed in our deal with BPI in January, we expect to see BPI-related revenues starting in earnest in Q2 as they begin preparing for initial stocking orders from these retailers. Also on the retail front, in January we announced that Specialty Nutrition Group had launched NIAGEN in GNC stores nationwide. It is worth noting that Greg Horn, CEO of SNG, is a former CEO of GNC and he selected NIAGEN as one of the first products SNG would market through GNC. Also, in the second half of 2015, both Jarrow Formulas and CVS Health launched retail products featuring NIAGEN. In November, ChromaDex announced that we received NDI status or new dietary ingredient status from the FDA. NDI status is very important regulatory milestone for the company and for several different reasons, and one of the primary reasons is that getting this status from the FDA allows for – it is basically a sign-off for the FDA that this ingredient is safe, which is very important for us for a lot of different reasons, especially in light of some activity that happened last year with the New York Attorney General targeting several large big-box retailers like Walgreens, Wal-Mart, GNC. And a lot of those companies now are – not only them, but also the brand stakeholders that put products on those shelves are being held to a higher standard and it is important for us to have this status because, one, it is very difficult to get NDI status from the FDA. As a matter of fact, it is like an 88% -- somewhere in the region of about an 88% failure rate for applications in that space. So, actually, getting this status is important for us because it derisks an ingredient going into that channel, so it makes it a lot easier to have a discussion regarding bringing a new and innovative ingredient into that space. We also received or announced self-affirmation of GRAS, and GRAS is generally recognized as safe. And that status allows us for – to include this ingredient or ingredients into food products. Why that is important is because we currently don't have NIAGEN in food products, and obviously this is a very new development that we have achieved GRAS status. We still are going to be pushing forward as well with the FDA to get a formal GRAS recognition from the FDA, but self-affirmation is the first step in moving in that direction and it allows us, at least at this point, to move forward with business development activities in the food and beverage space for NIAGEN, which previously we really couldn't pursue. In November 2015, we announced a joint development agreement with Procter & Gamble. That was a very big deal for us. ChromaDex will provide P&G exclusivity to NIAGEN for use in P&G-branded products, and P&G is one of a number of discussions we have ongoing with multiple Fortune 500 companies. And it is worth noting that it took us about two years before we were able to even secure this joint development agreement with P&G, so it took a while just to get to that point and I'm just using that as a point to highlight that although we are working with other Fortune 500 companies, it does take time to get to structured relationships like we have already announced with this P&G relationship. This P&G relationship is an enormous opportunity for ChromaDex as they have the right to incorporate NIAGEN to a number of P&G products, some of which are the highest volume consumer products in the world. So NIAGEN continues to be our primary revenue growth driver. We began 2015 with just five NIAGEN customers and by the start of 2016, our customer account had risen to 13, so we are more than double the amount of customers. So if you take a look at if we only had five and we generated the revenue that we did last year, we expect those same customers that we had last year to continue to grow, but we have eight additional clients coming into this year, which is a good sign for what the revenue growth potential for NIAGEN might be. Although we may not give guidance, at least it will give you some indication of what effect that could have on our revenue. One better way to look at this might be that we actually have one client that we had last year and that one client we expect to actually do the same amount of revenue, just that one client, the same amount of revenue that we did with all of NIAGEN sales for last year. In addition to these new clients, we’re proud to say that NIAGEN will soon populate the shelves of tens of thousands of major brand retail locations throughout the U.S. I think it’s also very important to note that we were in the very early stages or the very early innings of commercialization and business development for NIAGEN. And with the recent regulatory qualifications, the NDIN status, the GRAS status that we have now achieved, we have opened doors for NIAGEN to be included as a featured ingredient in a growing number of food, beverage, supplement markets that we haven’t really even had previously had the opportunity to penetrate. And we expect that further developments that we are working on right now will also lead to future penetration to other markets that we haven’t even discussed today. I hope all of you had a chance to read the shareholder letter that I wrote in January. It is very exciting to witness the ever-growing excitement that we see surrounding published research and the commentary on NR’s potential health benefits as an NAD precursor. In fact, our commercialization of NIAGEN in mid-2013 may one day be looked upon as a seminal event in the advancement of healthy aging. Even with all of our early success, I firmly believe that we are in the bottom of the first inning with respect to the commercial potential of NIAGEN as the vitamin of healthy aging. To the general population, NIAGEN may still be largely unknown and with respect to the investment community, it is both relatively unknown and in my opinion, underappreciated and consequently I believe our company is significantly undervalued. Published research has shown that NR is perhaps the most effective precursor to boost NAD in the cell and we believe this is a key point to keep in mind when considering the potential value of NIAGEN. An abundance of published studies from esteemed researchers and institutions have demonstrated the potential health and therapeutic benefits of NR as a precursor to NAD. NAD is arguably the most important cellular cofactor required for improvement of mitochondrial performance and the function of every cell in the human body. As we age, NAD levels decline, which in turn leads to mitochondrial dysfunction and poor cellular energy metabolism. Scientists have now shown that depletion of NAD results in numerous age-related health issues. Our vision for NIAGEN is that it will become part of an important nutrient deficiency story, similar to vitamin C, vitamin D, folic acid, or even the omega-3 fatty acid story. Ingredients that address significant nutrient deficiencies are always amongst the largest ingredient markets and they are often fortified into the food supply in everyday products, such as milk, bread, juices, cereal, and even baby formula. Perhaps the most unrealized value for ChromaDex shareholders may lie in NR's pharmaceutical applications. We have been working closely with NIH now for several years, actually, on the therapeutic indication for NR as a treatment of a rare pediatric orphan disease called Cockayne Syndrome. We expect to file for orphan designation, as well as an IND, with the FDA in 2016. Collaborators such as NIH are currently performing preclinical studies on the use of NR to treat several other orphan indications as well. In November, the company announced an extension of our MCRADA, or collaborative research agreement, with National Institute of Aging at NIH, which will expand the scope of the original agreement to perform additional preclinical studies for Cockayne Syndrome, as well as several other new orphan diseases, such as ataxia or xeroderma. So if we move now to science and a clinical update, in August of 2015 the company announced the results from our first human clinical trial of NIAGEN, which demonstrated that nicotinamide riboside effectively and safely increases co-enzyme NAD+. The results of the study constitutes a significant milestone, as it was the first time an increase of NAD in humans have been demonstrated through NR supplementation. A week ago, the company announced the initiation of a second human trial for NIAGEN. This study will have a larger population and duration as compared to our first study and will study a number of therapeutic endpoints, in addition to continuing to study the success for the effect of NR as an NAD precursor. In February 2016, the company announced an obesity-related clinical study of NIAGEN in collaboration with the University of Copenhagen and Aarhus University. That started in January and we expect that to probably finish up by sometime the end of the year. In June of 2015, ChromaDex announced a human clinical study on NIAGEN with the University of Colorado at Boulder. The Integrative Physiology and Aging Laboratory, headed by Dr. Douglas Seals, will investigate the effects of NIAGEN on physical function and metabolism in healthy adults age 45 to 79. It’s also important to note that where these studies came from. Since 2013, we have signed over 50 collaborative agreements with universities and research institutes. Several of these have led to peer review published research, and I think it's also important for me to comment that if we only had four or five such collaborative studies, that would have been considered to be a good result. Having over 50 studies is well beyond anything that I have ever seen before. I have just never seen anything like 50 studies over a matter of just three years. It just goes to show you how important this is not just to us, but it is also very important to the research community out there, to see that much interest in it. Several of these collaborative studies have now transitioned from preclinical studies to human studies. I highlighted a couple examples with the Copenhagen and the Colorado study. Several more of these collaborative studies are also in the process of moving towards human studies. Some of those should start in 2016 and we have other ones that are slated for 2017 as well. Peer-review published data and clinical data is what drives media attention and media attention is what we need to build consumer awareness. And it is key to note here that science is always the best, especially independent peer-reviewed published science from independent researchers is what you need to really drive that media attention, and again, that media attention is critical because media attention is what we need to drive consumer awareness towards the value of an ingredient like we have created with nicotinamide riboside. Switching to our pipeline, we do have other things other than nicotinamide riboside and we are currently working on developing several other new ingredients following our model. In May of 2015, we announced an exclusive worldwide license and supply agreement for anothcyanin enriched Suntava Purple Corn. ChromaDex will use Suntava to produce highly concentrated anothcyanin ingredient at a price point that should appeal to mass markets, meaning we really firmly believe that we have a cost-effective solution for being able to produce a highly concentrated anothcyanin extract and that just doesn't exist in the market today. We're also working on several other new NAD precursors. Some of these are moving towards commercialization. We’re not exactly sure on the timeline for commercialization, but they're moving fairly quickly through that process right now. So, our plan as a Company is not just to be the NIAGEN nicotinamide riboside company. We plan on being the NAD precursor company, and we plan on bringing several of these NAD precursors to market and really be the controlling force behind the NAD precursor market as it really starts to gain traction not just within the research community, but in the commercial markets as an ingredient technology as that really starts to get traction. We're also working on several other new licensing deals regarding new technologies that we are putting into the pipeline as well. And again, the business model that we have right now of accumulating or licensing intellectual property that we then bring forward as novel ingredient technologies, that model is working fairly well and should continue to work as well. In conclusion, I’m convinced more than ever that we have an extraordinary opportunity to create substantial shareholder value with our patented NIAGEN nicotinamide riboside. A new vitamin this magnitude is the type of opportunity that comes along once every 25 years and all the important pieces of the puzzle, peer-reviewed science, media attention to the NAD story, and the rise of treatment of aging as a disease create an exceptional combination for NIAGEN to become the next billion-dollar ingredient. With that, I will open the floor for questions.