Andrew Last
Analyst · Stifel
Thank you Chris and good afternoon everyone. Thank you for joining our third quarter 2017 earnings call. Your support and interest in Intrexon is appreciated. Earlier today we issued our earnings press release and filed our Form 10-Q which we hope you had a chance to review. Since our last quarterly call, they have been a number of significant events and advancements in the industries Intrexon serves and within our portfolio as the engineering of biology continues to expand the reach of biotechnology within human health, agriculture and into new sectors such as energy and environment. First and foremost, in the world of gene and cell therapy, the FDA has recently granted the first two approvals in an emerging class of CD19 CAR-T therapies for select cancer indications. We congratulate the thought leaders involved. These approvals of viral-based CAR-T set the stage for our next generation approach to design in T cells as they near the clinical stage. Our non-viral manufacturing builds upon the success of viral CAR-T therapy with two meaningful differentiators; reduced cost and time. The team has been steadfastly improving upon the foundational Sleeping Beauty platform acquired in early 2015. The result is the first CAR-T therapy that can be generated and administered in less than two days or as we and our collaborators ZIOPHARM, call it, point-of-care CAR-T therapy. Our first engineered point-of-care motif is a CD19 CAR-T that co-expresses the powerful cytokine IL-15 and a switch for its control that we intend to move into the clinic in 2018. In addition to the manufacturing benefits, this combination of T cell persistence via our membrane bound IL-15 and it's control viral gene switch will provide expanded access to these therapies for patients in need and the evolution of CAR-T therapy into an affordable care setting. In addition, CAR-T therapies for the two unnamed targets in our collaboration with Merck Serono also utilize our non-viral platform and capitalize on the benefits of IL-15 and our switches. We continue to advance these important programs towards the clinic in 2018, which is promising to be a pivotal year for our CAR-T platform. Non-viral Sleeping Beauty is also the basis for the crater that Intrexon and ZIOPHARM have with the NCI and Dr. Steve Rosenberg. As disclosed earlier this week by ZIOPHARM, IND application is expected in the first quarter of 2018. We’ve made considerable progress on our goal of establishing precedents at dedicated gene and cell therapy, company by year's end to capitalize on our leading DNA engineering capabilities and advance a broad pipeline of internal and partnered therapeutic programs. Under the guidance of Dr. Helen Sabzevari, the Head of Precigen R&D, our portfolio of internal, unpartnered targets has expanded to include water immunity and infectious disease. Additionally, our partnered immuno-oncology portfolio is expanding with new targets in both hematological and solid tumor indications. The team is focused on innovative combinatorial approaches using multiple technologies including the recently acquired GenVec platform. We believe Precigen will be well positioned to attract strategic and financial partners in the future and drive shareholder value. The Precigen team has worked hard on our innovative cardiac disease gene therapy and we are pleased to announce that an IND has been filed for Xogenex' leading clinical candidate INXN-4001. An industry first, this multi-gene therapy expresses proteins to target three components of cardiac disease and is exemplary of what is possible with our platform. Cardiac disease represents a significant unmet need that places a massive burden on the US healthcare system. More than five million people are afflicted and over 600,000 people die in the US each year. The substantial potential of gene therapy and heart disease has been limited today by approaches that focus on only one cause of heart disease. By targeting three at the same time, we believe this pioneering multi-genic approach has the potential to live a meaningful benefit to patients in need. Our promising pre-clinical data in rat models showed the reversal of established disease after single treatment of our multi-gene therapy. Furthermore, in large animal models, GOP toxicology study demonstrated our approach is safe, with no adverse effects and efficacious. We will provide further updates on this important program when appropriate. With respect to our joint venture with T1D Partners, we anticipate filing an IND for of Type 1 diabetes therapy in early 2018. T1D is a significant and growing health problem affecting over 1 million children and adults in the US. And the treatment market is expected to expand to $14 billion by 2023. This chronic condition is characterized by autoimmune destruction of the insulin producing beta cells in the pancreas. Currently, there is no therapy approved to address the underlying cause of disease. Therefore lifelong injection of insulin is the first line treatment. Our antigen specific immunotherapy represents a unique therapeutic approach for T1D to prevent retard or reverse the destruction of the beta cells. This therapy is intended for early phase T1D patients before they become insulin dependent, yet see applicability also in late stage patients. In the early stage diabetes setting, our approach in animal models has shown very high remission rights of 80% to 90% in new onset diabetic mice. Separately, we have decided not to move forward on the wet AMD program with our JV partner Sun Pharma given the results from additional pre-clinical work undertaken this year. We continue to be encouraged with the expansion of our partner gene and cell therapy programs into the clinical stage. And we expect to see further collaborative progress on this front in the months ahead. In particular, we are very encouraged to see ZIOPHARM moving their controlled IL-12 gene therapy for recurrent brain cancer into a pivotal trial as well as initiating a phase 1 trial in combination with a checkpoint inhibitor by year end. In food, we've had some exciting developments as we top the potential of engine biology in high valued fruits and vegetables as well as an eco-friendly crop protection. Both had meaningful drivers underpinning potential commercial success. With respect to fruits and vegetables, browning plays a key role in the troubling FAO statistic that 45% are wasted each year. Our Arctic non-browning solution is unique and helping to reduce this significant ways by driving value across the entire supply chain from producers to shippers to stores and most importantly to consumers. Our first commercial launch in the fruit category utilizing our non-branded platform is underway with Arctic Golden slices hitting the market in roughly 400 stores across the Midwest and other regions. By eliminating the need for chemicals that ought to taste and texture, we are providing a superior product that we will anticipate will not only grab significant share in the $500 million US sliced apple category, but also expand the market overall. Consumer feedback has been encouraging. In consumer research, over 90% of those who tried Arctic apples said they would buy them when available. We have undertaken one of the most ambitious apple growing campaigns to position the company with available supply to become the leading player in this market. By 2020, we expect to have 4 million Arctic trees in the ground. The return on our upfront investment to plant trees increases they mature and yield increasingly more fruits over time. As previously detailed, we expect our sales from just apple slices alone to reach 20 million in 2020, 100 million in 2022 and $500 hundred million in 2026 representing a CAGR of 70% during that time frame. Much of this rapid growth comes from the increase in fruit yield I just referred to and we expect to reach greater than 50% gross margin by 2022. We continue with the development of additional fruits and vegetables, and today our non-browning pipeline includes avocados, cherries, pears and lettuce. Each of these faces the same challenge of high-waste and represents significant addressable markets that can be expanded with our non-browning solution. Shifting in food from its production to protection increasing resistance to chemical insecticides and GM crops in agricultured pests is driving a need for new solutions. Intrexon crop protection delivers just that and has had some meaningful developments over the past few months. Most recently, ICP achieved a key milestone in our collaboration with a leading agricultural company on our fall armyworm solution, along with the receipt of a milestone payment and the continued advancement of this important program. Native to the Americas, the fall armyworm invited Africa in early 2016 and has now spread to 28 countries with another nine currently awaiting confirmation. During the short timeframe, this pest has caused roughly $14 billion in estimated losses to several important crops including corn. Our pioneering solution prevents fall armyworm from reaching adulthood and can help counter the increasing resistance of this devastating pest to chemical insecticides and transgenic crops. We look forward to providing further updates as we make additional scientific advancements and progress towards commercialization. Additionally, during Q3, we announced our innovative SLI or self-limiting insect solution to suppress the diamondback moth began field trials in New York following the finding of no significant impact issued by the USDA. The diamondback moth caused farmers over $4 billion annually and it's considered one of the most difficult ag pest to control due to its resistance to dozens of insecticides as well as its resistance to BT proteins in the field. This groundbreaking trial concluded in October and we expect to provide preliminary reports on field data during the first quarter of 2018. The issue of rising pet resistance to chemical insecticides and GM crops is a serious one. Today, worldwide spending annually on pesticides is up for $30 billion and yet we still lose roughly 30% of crops to ag pests and fungi. The enormous challenge facing us is not only the significant loss of crops today, but the increasing ineffectiveness of conventional methods. In numerous trials, our solution has shown elimination of a variety of damaging pests and we believe our pipeline of SLI products will play a major role in insect pest management practices without damaging the environment or ecosystem in which they are deployed. Validation for Intrexon crop protection SLI approach from a large agricultural company bodes well as we stride to penetrate this large market opportunity. Shifting to environment, we announced regulatory jurisdiction for our friendly Aedes mosquito has been transferred to the EPA as a pesticide product based on new FDA guidance. Simply put having the product viewed as a pesticide is a welcome situation and we are making the final preparations to submit an application to the EPA Outside the US, we announced our second multi-year revenue contract in the state of Minas Gerais, Brazil. In India, we expect results from our regulatory case studies in the fourth quarter. And pending positive effect look, forward to taking next steps to make our solution available in this country, battling multiple virus outbreaks including dengue and chikungunya. In Energy, our methanotroph bioconversion platform is a powerful example of the engineering of biology to expand biotechnology’s reach into new sectors. Our proprietary tool box has allowed us to successfully unlock this biofactories potential to produce high-value products through cost effective fermentation. So far we have produced six fuels and chemicals and we believe MBP has a potential to change the gas to liquids landscape. During the quarter, we continued to make solid progress in our lead candidate 2,3- butenadiol, 2,3- BDO yield increased by 15% reaching over 60% of our targeted yield. The commercial robustness of this strain was also demonstrated with continuous production runs exceeding 400 hours. Additionally, the 2, 3-BDO produced and the 500 liter pilot plant had a purity exceeding 99%. We also increased our yield in our isobutanol strain by 78%. While encouraging to see this level of improvement, we continue to work on correcting the specific pathway bottleneck on isobutanol production previously highlighted. Once that is resolved, we expect even more substantial improvements in yield. With our bankers, our engagement with energy and chemical companies continues and we will announce further developments as appropriate. Now, I will turn the call over to Joe.