James Hayward
Analyst · Alliance Global Partners. Please go ahead with your question
Well, thank you, Beth, and good afternoon, everyone and thank you for joining us for our third quarter results call. For a biotech company, the Opportunity Trifecta is the combination that literally describes Applied DNA and is the reason told to me by many investors for their interest. It is the combination of great science, huge markets, and strong IP. These three qualifiers describe Applied DNA at its core and provide our team with the vision that drives this. Our strategy is a protector of large commercial ecosystems, a phrase that I’ve used in talking with you before is steadily coming together. Booked revenue is a truer indicator of our progress as it combines recognized revenue with deferred revenue. Our orders booked were the strongest for this quarter in the last two years at approximately $2.1 million even though, most of that revenue must be recognized in future quarters. This follows our strong booked revenue from Q2 of 2018, which was approximately $1.9 million. Our strong back-to-back quarterly performance powered by sales and desperate markets is evidence of our platform’s growing adoption. Now it’s not easy being disruptive. But our uptake is steadily improving and we strongly believe that trend will continue. Now, our platform is centered about our unique ability to produce DNA in very large-scale using the biochemistry behind Polymerase Chain Reaction or PCR. PCR assays are the most ubiquitous assays in the clinic, but they performed in just microliters of liquid, sometimes barely voluminous enough to see. The ability to scale this reaction which reproduces the same reaction done naturally in the nucleus of the cell arose from the advancements made in the chemistry of DNA precursors, their increasing scale and decreasing price and steady improvements in the design of instrumentation, excuse me. Applied DNA develops the fluidics, the mechanics and the software to bring this to liter scale or even to continuous flow more than a million-fold increase in volume and we protected our inventions with a strong portfolio of patents. Just as important, we established the knowhow to control this reaction and its products to mitigate the impurities that accompany the traditional ways of making large-scale DNA, which use bacterial fermentation. In our Biopharma business where we are producing DNA to be used in therapeutics like vaccines and cancer therapies, we have highly beneficial methods of production in contrast to the use of plasmid or viral vectors, which are the traditional tools of the industry. That is PCR is a purely biochemical reaction and it’s well suited for the introduction of chemical modification into the gene sized, linear amplicon of these therapies, especially at one or both of withins by a addition of peptide or other ligands which be used to enhance cellular uptick and transfer the gene sized amplicons from the cytoplasm into the nucleus. As in our taggant business, chemical modifications can be used with PCR to ensure our tags remain bound to the material they are meant to protect and while we have done a superb job at PCR scale-ups, we have equaled that performance in the chemistries of our DNA formulations - excuse me - to really fit every industrial vertical and in the detection modalities that are so essential to authentication. We have another new stepping on our approach to field authentication that makes us smaller, more portable, internet-accessible and quicker. We recently introduced at the Cannabis Industry Association Conference a new PCR platform that literally sits in the palm of your hand powered by an iPhone. We will have more to tell you about this in future calls. Over the next few years, we have steadily advanced – sorry, over the past few years, we have steadily advanced the development and commercial rollout of our DNA taggant platform. In that time, we worked diligently to capture the opportunities afforded us by this disruptive technology and we have executed on a strategy we believe that puts us on a path to higher revenue growth and sustained profitability and as we’ll discuss today, our value proposition has never been stronger. In our supply chain business, you will hear today how new partners are in place to deepen our value proposition breaking some of the challenges we’ve had in expansion to global customers. In our Diagnostics and Therapeutics business, I will give a brief insight into the growing demand for our PCR products. Now, textiles represent our most established business vertical. The story for this quarter is in our growing footprint in the synthetics addressable market, as we continue to support our cotton business and position it for growth. The third quarter historically signals the start of the demand cycle for our SigNature T DNA taggant for cotton ahead of the coming ginning season. So, our cotton order announced on July 17 followed this historical trends and signals that demand is present and growing. Our Pimacott brand remains a gold standard for traceability. Our HomeGrown upland brands supported by the politics of the day with American made is growing in footprint at Bed Bath & Beyond stores. Walk into America’s number one home and home accessories store today, and you will see high-end Pimacott on the sheeting wall, but also in non-sheeting home goods, Acala and Delta, DNA tagged and marketed as HomeGrown are also enjoying expansion in these stores. In May, our ninth SigNature T Tagging system was installed at an Australian cotton gin based in Moree in New South Wales, Australia. This is the first international gin to tag pure HomeGrown Australian cotton and we are looking to our partners Himatsingka and Louis Dreyfus to be ready to match increasing consumer and retailer sentiment for sustainable cotton by demonstrating traceability along the value chain with our taggant technology. Our CertainT platform has gained traction across several business verticals that offer the opportunity for near-term revenue and several adjacent markets to which our platform is directly applicable. During the quarter, we began commercial cotton testing in our laboratory in India replicating our Stony Brook operation to provide full forensic authentication services to support customers in the Asia-Pacific region. The facility offers greater utility to our India-based exclusive cotton partner, The Himatsingka Group and to their many supply chain partners, but with the majority of global cotton supply chains traversing this region, it also puts us right in front of prospective customers. Our CertainT IT platform is now exchanging data with Himatsingka’s ERP system for more efficiency. The ability to test cotton samples in India also supports Himatsingka’s commercial cotton traceability initiatives. In April this year, we visited Himatsingka’s India-based spinning facility, which is now the world’s largest cotton spinning plant under one roof. A major manufacturer of sheeting, Himatsingka has also begun construction of a terry towel plant that will be one of the largest in the world when it’s completed. Last year, the company completed the expansion of its sheeting facility more than doubling its annual capacity. From Himatsingka’s expansion plans, we can derive only one conclusion. Their increased production capacity signals a growing market share and we know that authenticity and traceability is central to its goal. Their success will be our success. The market is responding well with trade associations inviting our team to conferences to tell our story. In June of this year, our textile team presented at the Better Cotton Initiative’s Annual Conference in Brussels, Belgium to over 300 brands manufacturers and cotton leaders on how to track and trace their cotton goods with SigNature T. The presentation was very well received and exiting the conference we saw interest from supply chain stakeholders from throughout the world. Now synthetic textiles are where the bulk of our textile resources will be focused for the near future. The incredible attention being paid to problems with plastics in the oceans with carbon footprints, and with a need for differentiation by suppliers has increased our paid pilot work this year. Our partners GHCL Loftex, Palmetto and others established the value propositions and are having discussions with high profile retailers about the CertainT platform. As the central hub among them, we see the synergy of marketing the platform from all directions but to the same retail targets. In fact, we have introduced and created working collaborations among some of our customers to do just that. To assist us in this complex global market, we are pleased to announce that we have hired a well-respected industry insider as a consultant for our synthetic textiles business who we believe will assist us with additional market penetration and he is the former head of global operations and supply chain for apparel brands known the world over. The net impact of our business development and other initiatives across our textile practice has been very positive. We’ve positioned our taggant platform in front of a growing number of opportunities that relate to the tagging, testing and tracking of more cotton, recycled PET fibers, to finished goods, as well as other renewable and recyclable materials that can be used in home, apparel and in footwear. Over the next several quarters, we will look to convert these opportunities into commercial scale opportunities and orders. Moving on to our leather practice, as you know, we successfully completed a feasibility project in conjunction with the BLC Leather Technology Centre Limited and sponsored by five global brands, one NGO and two large tanneries in March of this year. Our technology is ready to go in this harsh environment to provide forensic traceability for leather from farm to shop. In the third quarter, we started industrial scale commercial trials with some clients that are all tracking nicely and we are negotiating additional commercial trials with others. With this consortium model in place, we are on the path to commercial scale tagging in leather with expected revenue material to our quarterly performance perhaps as early as the second half of fiscal 2019. Our cannabis business continues to be a key focus of our efforts. Within – with a recent market projection that the cannabis industry could reach $50 billion by 2025, it remains a very worthwhile market for us to focus on. It’s moving along well. As we have shown, the industry’s first Cannabis Tagging System at the NCIA Show in San Jose at the end of July. The interest at the show relative to the physical tagging of cannabis for real track and trace goods was conceptually well received by cultivators, processors and dispensary owners. The business prospects in both the U.S. as well as international markets are strong for in-country as well as export opportunities. We will collectively continue to refine our potential timing and next steps with these and other opportunities. Our partners, TheraCann International recently launched its modular Seed to Sale offering, which is branded, ETCH Biotrace integrated with our cannabis tagging system and CertainT platform. This combined offering will be aimed at new international or state-wide programs that had not yet selected as Seed to Sale Systems. In addition, our CertainT solutions also be a fit for opportunities where programs are already established with existing Seed to Sale systems and are looking for a mechanism to add a physical tag to prove prominence within their existing track and trace system. Now, a second component of our basic growth strategy is to leverage commercial agreements through which to enter new markets for additional growth opportunities. And our momentum in pharma continues along three pathways, product qualification, sales and marketing and regulatory approvals, very important. We establish access to this market last year via a partnership with Colorcon, the industry’s leading coatings, colorants and ink manufacturer. Following the administrative acceptance of Type 4 Drug Master File by the FDA in May, Colorcon’s management and its development, regulatory and sales teams have been highly engaged in commercialization activities. To remind you, with the administrative acceptance, IDMS is ready for technical review when a Colorcon customer for our SigNature DNA product reaches that stage in their product development. Colorcon continues to drive product readiness for that eventuality and we have several candidates already in the pipeline. We’ve also initiated steps in conjunction with partners to seek regulatory approval in Europe to open its markets to us. With regard to ACG, the second largest capsule manufacturer globally, we are on target with the milestones set out in the MOU signed last year after the Colorcon MOU. Technical feasibility of capsule tagging is proven in pilot with continuing work in the required stability testing global regulatory compliance and marketing and sales on the way. Discussions toward a definitive agreement are underway and aligned to the work in each of those tracks I mentioned. Subsequent to the close of the quarter, we announced a strategic partnership with UL that established a new standard for product authentication and supply chain traceability based on science. It’s called the UL Verification Program and extends their testing, inspection and compliance business to new products and commodities UL has a global footprint, a large sales team and aggressive marketing. We are in dialogue with several UL customers under our partnership with Videojet, we are continuing to implement marketing initiatives which as a result are cultivating evangelists within Videojet’s industry silos that are championing our technology and platform. Now, we continue to build the IT side of our platform supporting the CertainT pillars of tag, test, and track. Our recently announced partnership with Everledger teams us up with a leader in blockchain-enabled technology. They have demonstrated capacity for both technical and business execution with a large-scale implementation managing over two million diamonds. We both see partnerships as the vital link between physical goods and digital transactions. As Leanne Kemp, Everledger Founder and CEO states, if an asset does not have an identity, it does not have ownership value or existence. In the high-end products market, authenticity, prominence, as well as value can’t be separated. By incorporating a forensic layer to uniquely identifying an asset, we can provide the added confidence in the data captured and track on our blockchain-enabled platform. Our teams are currently in development of a combined platform to both tagging and authentication events to a blockchain with an initial focus on the leather industry. Other supply chain networks from both companies can be considered for implementation of our joint platforms driving revenues for both companies. Now, in each of the last three quarters, I have updated you on our progress with customers coming to us for therapeutic and diagnostic applications of the linear DNA we manufacture by PCR. In each of the last three quarters, we’ve attracted new collaborators and customers for contract research and contract manufacture of the DNA that they were previously sourcing for therapeutics via a bacterial fermentation and production of plasmids. However, plasmid-based gene therapies and adaptive cell therapies do pose a number of well-defined risks for patients. Number one, the risk of bacterial toxin contamination and the potential for a generalized inflammatory response in patients, number two; the risk of contamination of the target DNA by sequences of plasmid non-target DNA including the gene for antibiotic resistance; and three, the risk of contamination of the target plasma DNA sequences by DNA from the bacterial host genome. We are also negotiating cooperative development agreements in which we share in the intellectual property and the subsequent revenue for any FDA approved or European Medicines Agency approved products. We’ve already begun collaboration with well-known groups developing cancer vaccines, adoptive T-cell therapies known as CAR T and more recently using similar PCR produced amplicons as the template for in vitro production of RNA vaccines. We will be presenting our linear DNA capabilities at the Immuno Oncology Conference in Cambridge Massachusetts at the end of this month. So in summary, we are encouraged by the all of these signs of growth and we hope that you will hear the same. Our value proposition has never been stronger. And this concludes our prepared remarks. Operator, please open the call for questions. Thank you.