Andrew Last
Analyst · Bank of America Merrill Lynch. Please go ahead
Thank you, Chris, and good afternoon everybody and thank you for joining our first quarter 2017 earnings call. We appreciate your support and interest in Intrexon. Earlier today, we issued our earnings press release and filed our Form 10-Q with the SEC. And we hope you’ve had the chance to review the reported financial results. During the first quarter, our dedicated team continued to make solid advancements across our 30 plus collaborations and achieved significant progress with several of Intrexon’s platform technologies and programs, which we’ll discuss in more detail today. Our business focus remains steadfast on engineering biology to bring superior and environmentally responsible solutions to the commercial marketplace across five verticals; health, energy, food, consumer and the environment. The construction of biofactories genetically designed by Intrexon to achieve this continues to increase. One such biofactory that has the potential to drive meaningful change in the energy landscape is taking plentiful inexpensive natural gas feedstock and creating valuable chemicals and fuels in a more sustainable and efficient manner. You will hear more about that shortly from Bob Walsh who leads both our energy sector and our industrial products division where this exciting work is being done. He will provide an important update on our methanotroph bioconversion platform that represents a new paradigm in gas to liquids technology. However, before that, I will provide some highlights on our marketable product portfolio and the health sector. On Slide 5, you see several of our biologically engineered products that have received various regulatory clearances, including the Arctic apple, the Friendly Aedes mosquito and the AquAdvantage Salmon. We believe that each of these individual products represents substantial revenue opportunities for the company. And as individual technology platforms, they represent the beginning of what is possible through engineering biology in the much larger commercial markets of agriculture, insect control and aquaculture. So starting with our non-browning fruit platform currently centered on apples. Okanagan Specialty Fruits are approaching the commercial launch of non-browning fresh sliced apples later this year. In the world of healthy and convenient snacks, we see Arctic apples attaining a leading market position. Convenience for the consumer is a major driver of value in the growing healthy snack market. There are many examples of convenience driving consumer demand including the baby fresh-cut carrot which not only reduced wasted carrots but also substantially increased total carrot consumption. With the Arctic apple, we have a non-browning product and brings benefits to consumers, retailers and producers alike. In our view, the multiple benefits of this unique product will accelerate adoption of fresh-cut sliced apples, increase apple consumption, make a substantial difference in the roughly 40% of apples wasted each year and enable entirely new apple-based products to come to market. In the U.S., sales of sliced apples are estimated near $500 million annually even though they are treated with chemical preservatives that inhibit browning, but they also change the texture and taste which we believe has constrained category growth. The Arctic solution resolves these issues and does not change the apple’s texture or taste. And importantly, from a business perspective, we expect the Arctic apple will have a meaningful margin advantage because it eliminates the cost for chemical preservatives. Having completed the planting of 70,000 trees in 2016, we expect to plant over 250,000 trees this year and over 0.5 million in 2018. By the end of year 2020, we are planning to have planted close to 4 million Arctic apple trees. We are looking forward to the initial product launch later this year. Packages will hit the shelves in a limited number of retailers and we expect to see strong consumer interest. We believe the Arctic apple business can eventually reach $1 billion per year with attractive margins and return on investment. For our non-browning platform, apples are just the beginning. We are actively working on additional fruits, including cherries, pears and avocados. Intrexon has also begun development on its first vegetable, lettuce. Our Oxitec subsidiary continues to gain momentum in 2017. The significantly superior control of the dangerous Aedes aegypti mosquito has attracted the attention of new countries and geographies. Since the start of the year, we have commenced a regulatory trial in India and announced a MOU to bring our solution to Colombia. Additionally, we announced suppression results from CECAP, Piracicaba as shown on Slide 9 that illustrates the strength of Oxitec’s solutions. For the second consecutive year, we maintained the excellent level of over 80% suppression of Aedes aegypti in the treated areas versus standard approaches including pesticides in the control area. We achieved this sustained control in the second year with 60% less mosquitoes, thus demonstrating durability and a cost benefit. Moreover in this area where Oxitec solution is being deployed the longest, public support for our genetically engineered solutions is exceptionally favorable. The CW7 Market Research Institute survey shows 93% of citizens in Piracicaba support its use. We expect to add additional geographies and countries in 2017, including a regulatory trial in the U.S. upon receipt of final clearance from the FDA. Oxitec is investing in personnel as well as additional production capacity in order to meet anticipated demand in both existing and new geographic regions. Finally, under our marketable products is the AquAdvantage Salmon. We believe that sustainably farmed fish that can be produced in half the time from one quarter less feed and do not require vaccines or antibiotics, like other farm fish, are positioned well for success. AquAdvantage Salmon is the only approved fish that delivers these advantages. During the first quarter, AquaBounty listed on the NASDAQ stock exchange broadening exposure to the U.S. markets. In the 150 billion aquaculture industry, this faster, better land-based farming solution is initially targeting the $2 billion Atlantic salmon product category in the U.S. We are also working on other high-value targets with AquaBounty, including tilapia, in which we have achieved a 50% increase in fillet yield. We look forward to seeing continued progress at AquaBounty through the remainder of 2017, including movement on their plans to increase production capacity. Moving onto our development portfolio launches, we will focus the remainder of our update today on our health and energy sectors before turning the call over to Joe for financial comments. With respect to our health sector, during the first quarter we announced the formation of Precigen, a wholly owned subsidiary to consolidate all of our health-related assets. The formation of a dedicated health company focused on gene and cell therapy is a significant step to increase the focus and inherent value in our platform technologies and programs, which are advancing in clinical development. We are actively evaluating a number of strategic and structural alternatives to maximize shareholder value. Additionally, we’ve been fortunate to attract several highly qualified candidates to lead Precigen and expect to provide an update in the near future. The clinical development outlook for 2017 is detailed on Slide 14. We continue to believe this will be a breakout year for our health sector given the number of programs entering the clinic in 2017 with additional programs from our broad pipeline following the same path in 2018 and beyond. As shown in these tables, we have four active clinical trials utilizing our gene and cell therapy platforms today and expect that number could increase to as many as 14 by year end. In the oncology space, we recently provided an update on the development of the next-generation CAR-T therapy in our strategic collaboration with the biopharmaceutical division of Merck KGaA and ZIOPHARM Oncology. As detailed, the therapeutic candidates for the two CAR-T targets selected by Merck in mid-2015 will utilize the non-viral Sleeping Beauty system to generate CARs the co-express membrane-bound IL-15 under the control of our RheoSwitch platform to regulate in vivo expression. Additionally, it was disclosed the two CAR targets are expressed on a wide range of tumor types, which has collative implications for potential commercial milestones and royalties. We anticipate entering the clinic in 2018 with this controlled CAT-T approach. During the first quarter, Intrexon and ZIOPHARM also announced a CRADA with the NCI and Dr. Steven Rosenberg, a pioneer in immunotherapy. The CRADA is for the use of Sleeping Beauty to genetically modify autologous PBLs to express TCRs targeting new antigens for patients with advanced cancers. This taps into Sleeping Beauty’s potential to target unique new antigens found in solid tumors, thereby enabling personalized immunotherapy for cancer patients. Additionally, ZIOPHARM has been working to reduce the time and high cost associated with manufacturing and delivery of CAR-T cells with the goal of making them a bedside or point of care option for cancer patients. ZIOPHARM’s Q1 conference call last week covered this potentially game-changing approach. We are enthusiastic about their plans to bring this platform to the clinic and expect to hear more as the year progresses. Slide 19 provides a brief overview of the four active clinical trials utilizing our technologies. During the first quarter, ZIOPHARM reported a successful end of Phase 2 meeting with the FDA for the IL-12 RheoSwitch program for recurrent glioblastoma. They will be progressing to a Phase 3 trial this year and there will be an update on this program at ASCO next month. ZIOPHARM also improved production times in its ongoing Phase 1 trial of second-generation Sleeping Beauty CD19 CAR-T cells lymphoid malignancies with T-cells manufactured in as little as two weeks. Subsequent to the quarter, ZIOPHARM announced FDA acceptance of the IND application for a Phase 1 trial for CD33 CAR-T therapy that incorporates the kill switch for relapsed or refractory AML. These unmet needs are amongst the most challenging scenarios in the management of AML. The first patient is expected to begin treatment in the third quarter. In rare diseases, Collaborator Fibrocell Science received fast track designation for its orphan drug FCX-007 to treat a devastating skin blistering disorder known as RDEB. The first patient in the trial was dosed in February and earlier this week Fibrocell reported the Data Safety Monitoring Board has recommended the continuation of the trial. Data from multiple patients are expected in the third quarter. In cardiac disease, our majority owned subsidiary Xogenex is developing a groundbreaking three-gene therapy approach to heat failure. We also believe cardiac disease is caused by multiple genes that we are targeting simultaneously with this pioneering approach. Echocardiographic measurements in preclinical animal studies have demonstrated reversal of established ADM cardiomyopathy or congestive heart failure after a single treatment. Nuclear localization of the PHH3 mitotic marker has also confirmed cardiomyocyte regeneration. We intend to file an IND on this groundbreaking program by year end. In addition to maintaining forward progress in all our health programs, we are also continuously strengthening our technology capabilities for our current and prospective partners. To that end, in the first quarter, Intrexon entered into an agreement to acquire GenVec to develop a viral platform with significantly higher payload capacity of over 30 kilobytes or 3x greater than current viral delivery systems. We expect to close on this transaction following approval by GenVec’s stockholders. At this point, I’d like to turn the call over to Bob Walsh, Senior Vice President and Head of Intrexon’s Energy Sector.