James Hayward
Analyst · Maxim Group. Please go ahead
Well, thank you, Beth and thank you, Clay and good afternoon, everyone. Thank you for attending on our fiscal 2018 second quarter earnings conference call. Applied DNA made significant progress in the quarter in executing on our strategy to expand awareness of our molecular tagging platform and to develop new revenue opportunities based on strong foundations in multiple business verticals. Having built a base of recurring annual revenue during the prior year and in the first half of fiscal 2018, our goal for the remainder of this fiscal year is to further expand the applicability of our technology platform to drive revenue in the near-term and add to our base of recurring revenue for the long-term, while we approach sustained profitability. Now, as indicated previously by Beth, this fiscal quarter saw the largest non-textile, non-government-related initial deal flow in the company’s history, with the signing of multiple commercial feasibility contracts worth approximately $2.5 million in their aggregate over their terms. This is clear evidence of the broader adoption of our disruptive technology and supports our current go-to-market strategy. Our more mature verticals provide the foundation to fuel expansion. Building on those prior successes, companies, market leaders have come to acknowledge and adopt our technology and its value proposition, namely, that our platform enables them to increase the value of their goods throughout their supply chains by ensuring security, certainty and trust and to grow their market share by giving them a unique competitive advantage in the marketplace. Let me briefly review our activities during our fiscal second quarter that reflect the progress we are making in building our base for future revenue and revenue diversity. Now, the looping video that played before we began, portrayed the signature DNA-branded Videojet 1860 continuous inkjet printer and the technology we provide for both their visible and invisible inks. We are moving to broaden the exposure of our security print platform solution within Videojet itself and within their customer base and our combined efforts have generated for us a pipeline of prospects. One area of particular focus with Videojet is in regard to its fit within track-and-trade serialization solutions for the pharmaceutical industry. Bar codes and other form of serializations are copyable and our value to Videojet’s customers is that our DNA ink will allow them to tell the difference between real and fake drug packaging. This is the perfect complement to our work with Colorcon and ACG in tagging the doses themselves that combined will offer the pharmaceutic industry what we believe to be the first multilayered supply chain traceability and security solution. Our partnership with Videojet is on track and each party is highly motivated and we will bring our unique and disruptive solution together to the market. In our pharmaceutical vertical, the signing of definitive agreements with Colorcon creates a clear path for long-term revenue for Applied DNA with approximately a 60% share of the global market for film coatings used on solid oral dose tablets. Colorcon gives us unprecedented access to pharmaceutical and nutraceutical manufacturers worldwide. Under the terms of the agreements, we will supply tagging and authentication materials to Colorcon in exchange for long-term royalties on the sale of Colorcon products incorporating our molecular tags and on the sale of related authentication services. Now as Beth noted in her remarks, first of two milestone payments became due with the signing of the agreements and was paid in early April. The second milestone payment of an equal amount will be triggered upon regulatory approval of a solid oral dose pharmaceutical incorporating our taggings. We are working very closely with Colorcon’s substantial regulatory and sales teams to position ourselves for regulatory approval and to engage customers and our early customer meetings have been very promising. Last quarter, we also entered into a Memorandum of Understanding with the Associated Capsule Group, or ACG, for the marking of solid oral dose capsule shells. ACG, the world’s second largest manufacturer of capsules, together with Colorcon, gives us visibility into a very significant share of solid oral dose drugs and nutraceuticals being manufactured today. Now with the announcement of our results today, we are also announcing the filing of our drug master file just last Friday. It will be reviewed by FDA for administrative conformance to their filing requirements at this time. It will be accessed by FDA for technical review upon a customer’s request to use the Applied DNA product within the customer’s pharmaceutic product. Pharmaceutical industry interest in our platform is helped by the FDA’s November 2018 deadline to manufacturers and other supply chain stakeholders to comply with its Drug Supply Chain Security Act and the associated serialization enforcement requirements. Our platform of multilayered tagging, testing and tracking offers the platform of data to the world of pharma, one that’s proactive, not reactive, one that offers insights and intelligence, not just transactions. Now, we leveraged our cotton textile expertise in an agricultural supply chain to enter the burgeoning legal cannabis market. Following the completion of the successful pilot project, we announced an initial 2-year $1 million contract with TheraCann to integrate our molecular tagging and testing technology into TheraCann’s blockchain-based seed-to-sale legal cannabis ERP platform. With nearly 3.5 million square feet of cannabis operations under management, TheraCann is a recognized technology solutions and services leader to the international cannabis market. Ours is a commercial feasibility contract under which we are working with TheraCann to develop molecular tracking systems for legal cannabis worldwide. Given TheraCann’s global footprint, our collective solution is relevant to all countries around the globe in which cannabis is either being grown or distributed. Here in the U.S., with growing momentum in Congress to decriminalize marijuana and with approximately 20 states moving to legalize it by 2020, our supply chain solution is timely and supports proactive testing by growers and processors as well as by the regulators. Other near-term North American opportunities are also in due, with Canada said to have a final vote on nationwide legalization by June 7, 2018. Countrywide recreational sales of cannabis in Canada are expected to begin by September of this year. Our partnership with TheraCann is progressing nicely, with meetings underway with state legislators and administrators in parallel with our platform development. We have already seen early success in the tagging, testing and tracking of legal cannabis and its derivatives in the laboratory pilot. The ability of our molecular taggings to be detected throughout key points in the legal cannabis supply chain and for the tagged products to be forensically analyzed is an important strategic advantage for our platform. We will soon test the first prototype of our unique cannabis tagging system that will deliver a safe and automated way to consistently tag cannabis at large scale. This system, which leverages our know-how derived from the design of our cotton DNA Transfer System, will be anchored by TheraCann’s seed-to-sale software solution and will offer a first-mover advantage to early adopters across the legal cannabis supply chain. Performance under this 2-year contract, we believe will put us in a position to secure commercial cannabis tagging opportunities. Now, textiles are our most advanced business vertical. The synthetic textiles market is many times larger than the global cotton market. Building on our successes with synthetics customers like Techmer PM, Reliance Industries, GHCL and Loftex, we have just added a new CertainT customer to our list in the form of WestPoint Home, who service the hospitality industry. At the New York Home Fashions Week in March, we launched a line of CertainT verified recycled PET products together with GHCL and Reliance, the latter being the largest integrated producer of polyester fiber and yarn in the world. In just the 3 last years, our marketing and sales programs in this industry have truly paid off as we now continuously are invited as speakers at key industry events and we feel frequent inquiries from manufacturers, brands and retailers, which have converted to pilot projects that are not – that we are not able to announce at the current time. And the proof of CertainT value is in the pudding as they say. Our latest three contracts in synthetics include royalties on finished good sales, revenue that goes to our bottom line. Leather is another segment of our textile opportunity and we were very pleased to announce just a few days ago that we had successfully completed our sponsored pilot project with British Leather Technology Centre based in the United Kingdom on schedule at the end of March. This funded pilot proved that our technology can be used in the harsh leather production environment to provide forensic traceability for leather from farm to shop. In the week since the pilot project’s conclusion, we have begun working with pilot sponsors on detailed plans for funded commercial pilots to prove the technology at a commercial scale over the next several quarters. Therefore, we seek to convert these commercial pilots into commercial scale revenue opportunities. The applicability of our platform to leather has captured the attention of the National Wildlife Federation, Puma, the Scottish Leather Group and Tong Hong Tanneries, among others whom we are not able to announce. The latter are comprised of a range of businesses from major suppliers of leather to global footwear brands. Turning to our fertilizer tagging business, we received our first commercial scale order for tagged fertilizer from Rosier in the second quarter. Now, this order has already been delivered and it is our understanding that the DNA-tagged fertilizer is destined for use in Africa and in Turkey. And with regard to Turkey and its mandate to DNA-tagged fertilizer, following our recent visit there, we believe that Turkey continues to be a potential source of sales for us. In recent weeks, we have filed additional U.S. and international patent applications addressing our proprietary methods to tag, test and track fertilizer of products to prevent fertilizer diversion, to quantify fertilizer dilution and even to recover fertilized DNA tags from the environment after fertilizer application whether that tagged fertilizer was applied to enhance crop yields or to disrupt society. We have additional meetings planned in the coming weeks in Turkey to further refine our go-to-market strategy. Now with all of the technology we have just described, there is one more that is seemingly invisible, but very powerful. It is what gives CertainT its value both to us and to our customers. It is what extracts value from DNA and that is data, information, insight, intelligence. Our IT platform now has close to 300,000 records related to electronics marking and collects over 650,000 data points per day, when all 9 gins are operating. By the way, we had the first international DNA system up and running, including integration with the gin systems, within 3 months from the time that they said go. This is a performance of which we can all be proud. The last two quarters have been particularly insightful for us as the data from our cotton tagging, testing and tracking systems have brought new insights to our merchant and manufacturer, allowing them to better manage their business. We reconciled marked balance against contracts, we have provided source traceability, we acted as third-party arbiter in contract fulfillment, we monitored gin operations with key alerts to personnel from our remote access industrial Internet of Things design. We are now sharing data with a customer’s ERP system. We are applying our know-how from cotton to cannabis as the first models of tagging systems and testing designs are emerging. We continue our prototyping with blockchain designs and are exploring new data visualization platforms for customer use, particularly in pharma. So, our IT roadmap continues to build a platform that brings proof positive to our customers in security claims and traceability. And I am very pleased to say that the person leading these valuable initiatives, our Chief Information Officer, Judith Murrah, will be available for your questions at the end of our prepared remarks. As those of you who have followed Applied DNA for sometime are aware, our ability to produce ultra-pure linear DNA at scale via the PCR method forms the value of our biopharmaceutical business. Much like in pharmaceuticals, once a supplier is baked into a diagnostic or therapeutic, these suppliers are often engaged for the lifetime of that product. Now, we have received many inquiries from companies in the biopharma market. A good example is Evivax, an Italian biotech company focused on healthcare for companion animals. Late last year, we entered into a research and development project with Evivax to quantify the advantages of PCR product over alternatives for use in DNA-based pet vaccines and eventually in human vaccines. The project is on schedule with results of this study expected over the next several quarters. We have also provided feasibility scale product to well-known European Life Sciences institutes to American Cancer Therapeutics companies and to others with whom we continue through the steps of paid feasibility work that we are not able to announce at this time. But to quantify the market opportunity, the global DNA vaccines market is predicted to grow at a compounded annual growth rate of 45%, generating $22 billion in sales between 2017 and 2025. We believe that our ability to create DNA at scale can be a game changer for the biotherapeutics market. The forefront of medical science research today is immunotherapy, therapies that enlist and strengthen the power of a patient’s immune system to treat cancers and other diseases such as sepsis. These therapies have captured the attention and imagination of researchers and the public alike because of the remarkable responses they have produced in some patients, both children and adults, for whom other treatments had stopped working. All CAR therapies, however, use plasmid DNA as their basis. Plasmid DNA production is slow and contains toxic byproducts that require it to be extensively cleaned. So in 2018, we are building on the success we have had in the diagnostics market to-date to establish PCR-produced DNA as a viable and in many cases better alternative to plasmid DNA for use in the biotherapeutics market. Now, we have recently demonstrated the ability to use our linear DNA in transfection models, resolving one of the most significant hurdles, slowing the implementation of DNA vaccines, gene therapy and personalized medicine. And that is the availability of large-scale linear DNA as an alternative to less desirable plasmid DNA. Moreover, we have developed and filed patents on new methods to ensure PCR-produced DNA used in therapy is absolutely error-free. We currently have multiple projects underway with commercial allies to validate PCR-produced product as a better alternative to plasmid DNA. And as this slide shows the market available to our technology is very large and extremely relevant to current personalized medicine therapies. We see this market as synergistic with that of our generalized pharmaceutical base from marketing and sales resource utilization points of view. Our go-to-market approach is cautiously measured at the current time to work in concert with regulatory and other data that will accrue from our proof-of-concept initiatives. Now, I hope that the prepared remarks we have given you provide a sense of the growing applicability of our technology platform across multiple verticals and how our penetration of each vertical is beginning to generate revenue today and laying the foundation for greater and recurring revenue tomorrow. We are seeing growing acceptance of our disruptive platform’s value proposition and are converting that interest into commercial opportunities. We remain committed to leveraging our technology platform to meet the needs of the markets we serve and others that have the potential to generate significant value for Applied DNA and our shareholders. With our platform, together with the business development foundation and the base of business we have built to-date we are on the path to ensuring our long-term success. Now, this concludes our prepared remarks. Operator, please open the call for questions.