James Hayward
Analyst · Morgan Stanley
Okay, thank you, Beth, and good afternoon, everyone. Thank you for joining us today. Although it was not represented in our quarterly results, this is a very exciting and a pivotal time for Applied DNA and the adoption of our DNA technology platform. Today, I will give you updates on our activities in key verticals, as well as describe a new approach to sales management that we have implemented in textiles, before we open the call to your questions. I'm going to start today's call with a review of our opportunities in cannabis; more specifically, our exclusive licensing and collaboration agreement with TheraCann International that positions fiscal 2019 to be a transitional revenue year for us -- TheraCann and cannabis industry's uptake of our DNA technology platform with the potential for additional revenue this year as well. The establishment of our cotton practice in 2014 provided our first experience in tagging and authenticating agricultural product flows, with much of the experience proving beneficial in learning about the rapidly emerging businesses that represent legal cannabis. Unlike cotton, cannabis gets to the market after a variety of physical and chemical transformations. We've already demonstrated that despite these transformations, our molecular tags are the perfect means to track the complex cannabis supply chains, excluding the entry of sometimes dangerous black-market product and ensuring traceability to origin and improving safety. As Beth has already described in detail, our agreement with TheraCann calls for $5 million in fees payable to us through the end of August, which will benefit our balance sheet and our revenue. Additionally, there are significant annual minima that begin with $7 million in Year 3, scaling to $20 million by Year 15. We have already established an aggressive sales and deployment strategy with TheraCann. Our pipeline ETCH cannabis opportunities with TheraCann continue to grow across the globe. Our demand funnel has a mix of opportunities at various maturity levels, with short-, medium- and long-term horizons. The potential opportunities in front of us are significant in size and scope with large global entities. The interest level is coming from cultivators, processors, government entities and label and packaging companies. Potential customers are seeing the benefits from multiple angles -- to protect their brand and IP, to verify the origin of source biomass for purified cannabinoids such as cannabidiol isolate. The absence of this capability is now becoming a barrier to CBD commerce, and so it needs our technology. Counterfeit packaging is a big concern within the industry. Applying a molecular tag to labels and packaging will help to combat this issue and can also help with potential product diversion. The addition of cannabis tagging to our portfolio adds to the critical mass we already have of molecular tagging around the highly related markets of cannabis, pharma, dietary supplements and food. They all leverage the same product development in packaging, must fit similar manufacturing processes and environmental constraints at our customers', and must comply with a range of related regulatory rulings, which tend to gate market adoption. All of these industries are regulated by FDA, and our team has a history of solid FDA interactions. And cannabis, specifically, finds its way into all of those categories -- drugs, dietary supplements, food and cosmetics. An update on this category beyond cannabis begins with our work with Colorcon, who is planning a market launch this year following last year's operational focus. With regulatory approval remaining a gating factor for accelerated market adoption, we are now working with a well-regarded regulatory consulting agency to sharpen our execution with FDA. In parallel, we are working closely with Colorcon to formulate tags for a broader product line in anticipation of the interests they maintain from large pharma companies. In other business in this industry, we have completed a feasibility study with an ingredient supplier for dietary supplements and nutritionals. Their intent is to protect their patented product against adulteration or copying in the supply chain as it moves onto retail shelves. The next step is a pilot test at their contract manufacturer this month. More broadly, towards the end of the last fiscal year and into the beginning of this fiscal year, we took a step back and restructured our approach to sales. Now, this was a difficult decision. We knew what had gotten us here would not continue to serve our future needs. Walking the fine balance to avoid disrupting sales already in place, but at the same time, setting ourselves up to grab more of what we can see is a large untapped potential for our future. Now, that transformation, now nearly complete in textiles, is dramatic. We brought on stellar talent with firsthand experience in the industries we identified for growth and who could help us transform and accelerate our go-to-market approach. In textiles, teaming with MeiLin Wan in the U.S. and Tony Benson in the U.K., we have hired Wayne Buchen, who led supply-chain operations at Lacoste, Nautica, VF Corp and Under Armor, and we have retained Steve Birkhold as the newest member of our strategic advisory board and a close working consultant in our transformation. Steve has been the CEO of Lacoste, Bebe and VF Corporate brands, and he's worked closely with Wayne. They share tenures and a passion for improving supply chains to improve product quality and integrity. Collectively, our redefined sales team has taken steps to accelerate our product readiness for market and to scale more quickly after the required precommercial pilots. In fact, Dr. Mike Hogan, who leads our technical team, is now just completing a 3-week tour, essentially completing pilots daily in Taiwan, India and China with some of the world's largest manufacturers, who are implementing our CertainT platform. Most importantly, these developments are moving us from working one supply chain at a time in a silo, a kind of point-to-point model, to working a hub-and-spoke model, where we certify upstream suppliers on our CertainT platform who, in turn, can service downstream manufacturers more efficiently. The hub-and-spoke model allows us to both use the multiplexing our partners' sales and distribution channels and to maximize a one-to-many molecular tagging network. Let's look back at our recent accomplishments and then forward to describing the benefits we expect. The partners we've announced in recycled polyester -- Loftex, GHCL, Reliance, Techmer, Tex-Ray and the Sun Chemical group -- have together taken our CertainT product from raw materials onto shelves over the last 2 years. Together, we sold CertainT to the brands and retailers; with their help, recruited and trained their supply chains to become certified on handling CertainT tagging, testing and tracking, but the result, we taught one factory at a time, realizing the revenue from each manufacturer's supply chain one after the other. We learned to do business in one country at a time. While these experiences have provided us access to large retailers, the ramp-up to the revenue levels we would have liked is too slow and far too labor-intensive. The good news here is that over 2 years, our customers have tagged over 20 million pounds of a variety of synthetic fibers. These CertainT branded products have just started to appear now at Amazon and 3 big-box and online retailers, with 2 more on the way this fiscal year. In fact, over the last 2 years, the retail channels into which our product is now flowing have grown from 1,800 U.S. doors to nearly 4,500 doors doing business globally. But we can do much more, much faster and at less cost. We're now working to implement the integrated supply chain, acting in a hub-and-spoke model, recruiting and training raw material providers to feed many manufacturers. Since Wayne Buchen joined in October, he and Meilin have been relentlessly knitting together the best supply chain we can do for customers with a go-big mentality. This is empowered by the enormous DNA manufacturing capacity in systems we have carefully established under the guidance of Judy Murrah, our intrepid CIO. Sun Chemical group, announced in January, is our logistics and implementation partner providing infrastructure in Taiwan, China and Vietnam to enhance our integrated supply chain model. In addition to being trained in our portable SigNify onsite authentication system, they are currently holding inventory as SigNature T coded pellets and are holding commercial DNA locally in countries to help expedite speed to market needs. They have already participated in 4 tagging sessions at major recycled PET suppliers in both China and Taiwan. They offer us a local presence with established lines of communication and formidable strength in field operations, with expertise in manufacturing, import/export, and have close-knit connections to the largest companies in the region. And while I am not yet able to mention the names of the other companies with whom we are working, but who are depicted in this slide, I would like to share how the picture is already unfolding in the Asia hub-and-spoke model. A large strategic partner located in Haiyan [ph], China, on a supply of recycled PET, begins with collecting post-consumer bottles in 20 locations throughout China, where they crush bottles and then carry the recycled material all the way through to filament yarn in a 3-million-square-foot facility with the capacity for 300 metric tons per day, running nonstop. A pilot in this facility is under way as we speak. They are investing in kind by having built new processing lines specifically for our CertainT pilot. This hub shows commitment to becoming a CertainT verified recycled PET manufacturing hub. They and we are already recruiting brands and manufacturers to this source that include one of the largest global retailers of home textiles; and Tex-Ray, a high-tech fabrics house with whom we've signed a strategic alliance agreement; and the largest spinners in Vietnam, China and Taiwan. Now here's a brief update on our textile programs we've reported previously. As we announced yesterday, A&E thread products have reached manufacturing lines in the U.S., Europe and Canada. Producers of apparel, automotive components, home furnishings, medical supplies, footwear and a diverse range of industrial products rely on A&E's industrial sewing thread. In the viscose hub, three of the world's largest viscose suppliers, together providing over half the world's viscose, are actively engaged in our sales pipeline from precommercial production runs to negotiations of statement of work. In our leather hub, work continues with a sponsor the pilot completed in 2018. A second tannery will be producing SigNature-tagged product to be used for demonstrations to brands who are already expressing interest. In our down-feather hub, an integrated supply chain will begin with a pilot in down feather next month. Brands have already expressed interest in protecting and tracing this high-value material. Egyptian cotton, announced last week. The DNA Transfer System is being installed at the gin as we speak, with tagging projected to begin within the next 2 weeks. This paid commercial run will offer samples for sale and marketing to brands and retailers. In wool, two initiatives are just beginning with signed, funded projects in traceability and in brand protection. One theme that I would like to call out underlying our textiles business is the movement of authentication testing closer to our customers, and in most cases, right onsite. We have now proven the use of our portable SigNify onsite authentication systems as a critical piece of manufacturing quality control procedures at the factory and are beginning customer training and adoption as we speak. With a dozen readers shipped or forecasted for shipment to customers, the last couple of weeks speaks volumes of that trajectory. Sun Chemical group, the certified testing partner, performed authentication onsite at two of the large installations mentioned previously. At a pilot in India last week, our R&D and India lab teams were onsite testing for the customer who will adopt the system in the future after training. Four other customers in other industries are also using the system for manufacturing quality control. Now, the benefits of this model are significant -- reducing turnaround times from days to minutes and offering quality intelligence prior to goods leaving the factory. With these early innovative customers, we will continue to simplify the protocols and the recurring shipments of authentication systems as their volumes ramp up. As our textiles grow in the realization of our current opportunities, we will share the benefits of our integrated supply chains across all our verticals to ensure maximal growth in revenue. Now, with regard to LineaRx, we acquired the assets of Vandalia in 2015 at a superb price and then integrating their customer base into Applied DNA, and now are migrating them into our wholly owned subsidiary, LineaRx, that we created just 8 months ago. The creation of LineaRx made great sense, since we had innovated and tamed large-scale PCR, and then began applying our technology to assemble gene-sized fragments that could be manufactured in larger scale than anyone appears to have contemplated. The production of genes at large scale in linear format opens a wide array of new opportunities, some of them just being discovered by our customers, some of whom have come to us in an epiphany triggered by the notion that linear DNA even exists at large scale. Large-scale PCR allows for new approaches to therapeutics and diagnostics that were once only the province of expensive chemistries or complex bacterial- or viral-based methodologies. The dawn of synthetic genomics enabled gene editing, immuno-oncology, redirected cell therapies, RNA therapies and gene therapies. But we believe that large-scale linear DNAs will let discoveries be utilized in more patients more safely, and with the ability to customize personalized therapies for patients that are refractory to some of the most ground-breaking new therapies. As we look forward, by combining large-scale PCR manufacturing with robotics, we believe that personalized genetic therapies can one day soon be generated at the point of care, in close proximity to the patient's bedside, in record time and at record costs. Now, we have already shared our vision with a number of the best known hospital networks in the U.S., and we hope to develop a sponsor for this strategy at some time in the future. These high-minded goals will be costly to achieve and will only be accomplished with customers and partners. We believe that by providing services as a contract research organization, or a CRO, and eventually a contract manufacturing organization, or CMO, which, by the way, operates at a much higher margin, we can recruit the income necessary to completely cover the costs of operating LineaRx. To that end, we have already recruited multiple CRO and CMO customers in both diagnostics and therapeutics. These activities have now attracted the attention of large pharmaceutical and biotech companies who see the utility of our linear DNA platform in the production of their next-generation therapeutics. We believe that in time, we can attract the sponsorship of big pharma in the development of our own therapeutics, 2 of which are currently evolving as preclinical packages. In this context, we believe that LineaRx can attract significant revenues and create value for our shareholders. Currently, LineaRx has no dedicated employees, and its project load is serviced by the employees of Applied DNA. So in conclusion, cannabis, textiles and our wholly owned subsidiary LineaRx are expected to drive our top line performance for the balance of fiscal 2019, while we also progress nascent opportunities in other industries, including pharmaceuticals. We believe that market trends are becoming tailwinds for us. Sustainability in manufacturing is becoming increasingly relevant to today's consumers, and manufacturers are seeking to elevate brands and projects by establishing the transparency and truth that consumers desire. Our DNA technology platform is becoming the basis for the trust that both sides seek. Well, this concludes my prepared remarks, and operator, can you now open the line to questions, please?