Precigen, Inc. (PGEN) Q2 2017 Earnings Report, Transcript and Summary

Good afternoon, and welcome to the Intrexon Second Quarter and First Half 2017 Financial Results Conference Call. [Operator Instructions] Please note that today's event is being recorded. I would now like to turn the conference over to Mr. Chris Basta, Vice President of Investor Relations. Please go ahead.

Thank you, Operator. Good afternoon. I am Chris Basta, Vice President of Investor Relations for Intrexon Corporation. Welcome to our second quarter and first half 2017 earnings conference call. Joining me on the call today are Mr. Randal Kirk, Chairman and Chief Executive Officer; Dr. Andrew Last, Chief Operating Officer; Dr. Helen Sabzevari, Senior Vice President, Human Therapeutics; and Mr. Joel Liffmann, Senior Vice President, Finance. Slides that will be presented on the call today can be viewed on the Investors section of our website, dna.com, by clicking on the link for Intrexon Corporation second quarter and first half 2017 financial results conference call. During this conference call, we’ll make various forward-looking statements within the meaning of the Safe Harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements, with respect to revenues, earnings, performance, strategies, prospects, and other aspects of Intrexon's business are based on current expectations and are subject to risks and uncertainties. A number of factors could cause actual results or outcomes to differ materially from those indicated by such forward-looking statements. Please read the Safe Harbor statement contained in the earnings press release, which was released earlier today and is also available on our website under the Investors link, as well as Intrexon’s most recent SEC filings for a more complete description. The press release references and our discussion this afternoon may reference certain non-GAAP financial measures, including adjusted EBITDA and adjusted EBITDA per share. Reconciliations to GAAP measures are contained in the earnings press release as well as on the Investors section on our website. Now, I would like to turn the call over to Andy Last, Intrexon's Chief Operating Officer. Andy, the floor is yours.

Thank you very much Chris, and good afternoon everybody and thank you for joining our second 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. We hope you’ve had the chance to review the reported financial results. Our business remains focused on the industrialization of engineered biofactories to bring superior and environmentally responsible solutions to the commercial marketplace across five verticals; health, energy, food, consumer and the environment. And during the second quarter we continued our momentum in this endeavor. The transition of Precigen into a fully integrated pharmaceutical development company and leading player in gene and cell therapy continues and we are targeting year-end for its completion. This will provide us with a number of options regarding strategic and structural alternatives to maximize shareholder value. The consolidation of health-related assets into Precigen is progressing and the company has accelerated recruiting key personnel and executives. On that note, I would like to welcome Dr. Helen Sabzevari to the call today as the new Senior Vice President of Intrexon Human Therapeutics Division and Head of Research and Development for Precigen. Dr. Sabzevari is internationally recognized for her work in the field of immuno-oncology and has an impressive track record in drug development. She has held senior leadership roles at EMD Serono, the biopharmaceutical business of Merck KGaA; the NCI, and most recently as Founder and CFO of Compass Therapeutics. During her tenure at the EMD Serono as Senior Vice President of immuno-oncology, Dr. Sabzevari brought forward numerous preclinical and clinical assets including what has become one of most promising molecules in immuno-oncology, the anti-PD-L1 antibody avelumab. Prior to EMD Serono, she led translational research programs to deliver novel vaccines and immunotherapy at the NCI. We are excited to have Dr. Sabzevari on the management team and look forward to her leadership in taking our innovative therapies from bench to bedside. Under Helen's guidance we are evaluating Intrexon's health programs, both partners and internal with the view to enabling what we believe will be an extensive internal and external pipeline of therapeutic candidates utilizing a broad set of tools and genetic engineering capabilities. Helen will provide some comments later on, after which Joel Liffmann will cover financials before we open the call for Q&A. During the second quarter, Intrexon added two collaborations that capitalized on our expertise and microbial expression platforms and fermentation processes. The first is with Johnson Matthey a leading provider of complex active pharmaceutical ingredients and an ideal partner to capitalize on efficient fermentation production of peptide-based APIs. Under the terms of this collaboration, Intrexon will receive reimbursement for R&D costs, as well as milestone payments and future royalties. We also entered into a research collaboration with Huvepharma. This is first to use on new proprietary fungal expression platform to produce a new animal feed enzyme that they have developed. This agreement expands Intrexon's reach into the large animal feed additives market where we see many opportunities to apply bio-based production methods. During the quarter we also announced EnviroFlight a joint venture with Darling Ingredients plans to construct the largest commercial scale Black Soldier Fly Larvae production facility in the United States. This plant will enable the expansion of high quality BSF ingredients for sustainable animal feed and nutrition. Initial BSF larvae production is expected in the first quarter of 2018 and the product will be sold in the livestock, agriculture and pet food markets. Also in the food sector, our majority-owned subsidiary AquaBounty announced the purchase of a land based agriculture facility in Indiana to produce AquAdvantage Salmon, This facility will have an annual capacity of 1200 metric tons with opportunity for expansion representing over $10 million gain in potential sales of locally grown antibiotic and vaccine free Atlantic Salmon. More recently the company achieved a major milestone with a very first sales of a eco-friendly AquAdvantage Salmon in Canada. AquaBounty is currently evaluating opportunities for larger facilities in the U.S. to increase their production for the $2 billion a year U.S. Atlantic Salmon market. The second quarter was also a busy one for wholly-owned subsidiary Okanagan Specialty Fruits. In preparation for the first commercial sales of Arctic apples this fall, the OSF team has laid the foundation for our entry into the $500 million a year U.S. like Apple market. Several retailers have made commitments to place Arctic Golden slices on store shelves beginning in October. Feedback from consumers also continues to be encouraging as our 2017 survey shows over 90% of consumers are either very satisfied or satisfied with Arctic Golden slices. Reinforcing our belief that our preservative-free, non-browning Arctic apples will be well received and generate substantial market expansion in the coming years. OSF has completed over 75% of this year's scheduled plantings with additional trees been planted this fall. As previously disclosed between 2017 and 2018 we expect to plant approximately 800,000 trees. And by year-end 2020, we plan to have a total 4 million Arctic trees in the ground. This initial phase of planting sets the stage for meaningful sales growth as these trees reach maturity. To put that in perspective, we expect Arctic sliced apple to eclipse $20 million in sales in three years time, $100 million in five years and to generate over $500 million in revenue for the gross margins about 50% and EBITDA of approximately $200 million in 2026. Our longer term model is $1 billion per year in sales with attractive margins and ROI. Additionally Intrexon continued its commitment to new product development and advancing its platform technology to enhanced variety tree foods including cherries, pears and apricots as well as valuable vegetables such as lettuce. Each of these affords Intrexon potential partnerships opportunities as we focus on the Apple business. Now shifting to the environment sector our wholly-owned subsidiary Oxitec continues to expand into new territories and regions with our friendly Aedes aegypti mosquito control solution. During the quarter we further advanced our regulatory case studies in India and are expecting results by year-end. We also announced and MOU to bring our solution to the city of Kali in Columbia. In July, we announced our second multiyear revenue-generating contracts in Brazil for the first time in the state of Minas Gerais. These recent developments confirm our superior control of the dangerous Aedes aegypti mosquito is increasingly becoming recognized and we are engaged in a number of contract discussions for further expansion. We intend to invest an additional production capacity in order to meet anticipated demand in both existing and new regions. From a regulatory perspective are non persisting friendly Aedes is the most stringently evaluated mosquito-based vector control solution and has excelled in these extensive evaluation. Most recently our friendly mosquito received a positive evaluation from the National Institutes of Public Health and the environment in the Netherlands with concluded negligible risks from our technology to human health in the environment. This 74 page report issued in July add to an extensive review from the FDA as team includes members of the CDC and the EPA the National Technical Commission Supply Security of Brazil as well as the WHO. Additionally in June Oxitec Solution received a supportive position from France's High Council for Biotechnology. In the energy sector our team continues to push the boundaries with our methanotroph bioconversion platform we have designed to enable a highly profitable use of low-cost natural gas to replace oil to manufacture industrial products. We have achieved six different high-value molecules to-date using single step fermentation with our platform and the full product actively underdevelopment 2,3 BDO and isobutanol 1,4 BDO and isobutyraldehyde have a total addressable market that exceeds $100 billion annually. With respect to our two partner molecules isobutanol and 1, 4 BDO we continue to make progress on a technical hurdle regarding the isobutanol program. We've made improvements and attain higher isobutanol yields but we still have work to do and expect to provide an update on our progress later this year. The 1,4 BDO program remains on schedule. As discussed on our last conference call high yields on 2,3 BDO and isobutyraldehyde placed these valuable unpartner chemicals in the money based on current natural gas prices. This achievement led Intrexon to retain Moelis and company during the second quarter to advise us on strategic and financial options with respect to our platform on the specific product being generated. And this engagement is proceeding. We are pleased to report that on top of the 30% increase in 2,3 BDO yields achieved during the first quarter we have maintained solid momentum and achieved an additional 30% improvement in 2, 3 BDO yields during the second quarter. Additionally our bioengineered micro designed to transform natural gas into 2,3 BDO were utilized in 500-liter fermentation pilot plant in south San Francisco. We successfully ran the plant continuously for over 100 hours with the microbes performing as expected and repeated this test with the same positive results. Running 2,3 BDO at pilot plant level with no contamination issues is important and indicative of the scaling potential of this micro. We are shipping the 2,3 BDO produced to multiple chemical catalyst companies for conversion to butadiene and quality testing. From a commercial perspective butadiene is an important chemical utilized in the synthetic rubber industry and other markets and its annual sales are estimated near $22 billion. Combining the cost of producing 2,3 BDO through our platform and converting it to butadiene our projected cost of south $1,000 per metric ton resulting in industry-leading markets in the sizable market opportunity. We anticipate selecting a site for its small-scale fact facility by year-end and subsequently taking off detailed design of a plant that could break ground in 2018. For this and the remaining unpartnered products we will announce further developments as appropriate. Now I'd like to discuss our collaboration with the Harvest Intrexon Fund managed by Harvest Capital Strategies. Thus far, the fund has established six startups in the health, consumer and food space and today would like to update to you on progress on Thrive ActoBiotics, a startup focused nutrition to piglets. Pork is the most widely eaten meat in the world accounting for 36% of global meat consumption. It is estimated that by 2050 global consumption and animal protein will be two-third higher than current levels and increasing production of healthy pigs will be vital to meet this growing demand in a sustainable manner. In the porcine industry, early weaning is a common practice that can result in healthy faster growing pigs and to help drive overall production higher. However, the transition of piglets at weaning from their mother's milk to solid feed is a significant change and can be challenging, piglets can experience health issues, love food intake, and poor growth post weaning due to an immature digestive tract. Therefore to be most effective early weaning required correct levels of nutrient and high-quality digestible ingredients. The product and development by Thrive ActoBiotics uses our ActoBiotics platform to express proteins that support enhanced growth nutrient update and gut maturation in order to improve early weaning outcomes in piglets. And efficacious cost-effective biologic that easily integrates into current commercial practice and increases healthy fast growing piglets is a high-value target that would help confront the aforementioned issues and help achieve a more sustainable food supply. We recently reached a milestone with positive data from an in vivo animal study resulting in roughly 10% to 12% more total weight gain over the three-week dosing period in pigs. Additionally, we have developed a new formulation with the favorable cost of goods that is commercially relevant. Thrive is now preparing for a large pig study using this feed additives. We are also making progress across a number of other harvest led startups and look forward to sharing more details on these in the future as we reach milestones and further advance these programs. The remainder of our operational update today will be centered on our health sector. As we have previously discussed 2017 is shaping up to be a breakthrough year for the company with respect to a number of programs moving into clinical setting. As detailed on the clinical development outlook slide our collaborations now six programs transitioning to clinical stage utilizing our gene and cell therapy platforms. This is significantly up from two years ago and by year’s end we anticipate a number of clinical trials maybe in the double-digits as we expect INDs to be filed for Xogenex cardiac program, rare disease program targeting linear scleroderma and additional oncology programs, amongst others. And nearly three-fourth of these program we bear no cost for the clinical trials and our positioned to receive potentially significant royalty streams upon commercial successes by our collaborators. Notably this is just the clinical outlook for 2017 we have broad pipeline of additional programs moving to a clinical stage in 2018 and beyond. One of these programs is a promising next-generation CAR-T therapy program with the biopharmaceutical division of Merck KGaA and ZIOPHAR. As disclosed during the second quarter this distinctive methodology centered on two technologies sleeping beauty, nonviral gene integration and our proprietary RheoSwitch platform to regulate expression of membrane-bound interleukin-15 co-expressed with costs that are expressed in a wide range of tumor types, including hematologic malignancies and solid tumors. Another program that we utilize Sleeping Beauty to treat cancer is the CRADA that Intrexon's ZIOPHARM have with the NCI. The research conducted on the CRADA will be carried out under the direction of Dr. Steven Rosenberg's, and as ZIOPHARM highlighted on their call last week, progress continue to watch clinical evaluation of Sleeping Beauty's ability to deliver personalized neoantigen T-cell therapy in solid tumors. We believe these upcoming Sleeping Beauty clinical studies will offer further insights in advances of non-viral approaches or rather viral med based methods for introducing genes encoding CARs and TCRs into T-cells. As the most clinically advanced non-viral gene transfer method, Sleeping Beauty is clearly leading the charge. Additionally, we continue to be excited by the point of care CAR-T program that ZIOPHARM is moving close to the clinic. This has the potential to revolutionize CAR-T manufacturing approaches by significantly reducing time and cost and thus enabling broader availability and adoption of these promising T-cell therapies. We also had a number of other important updates during the quarter in oncology including ZIOPHARM’s positive update ASCO on its recurrent GBM study. With this initiation of the stereotactic arm which enables pediatric studies and a planned anti-PD1 combination therapy of our controlled IL-12 gene therapy in brain cancers and FDA’s acceptance of IMD for the Phase 1 trial of CD33 CAR-T cells therapy targeting relapsed refractory AML. That is expected to treat the first patient in the third quarter. In rare diseases, our collaborator, Fibrocell Science, completed dosing the first cohort in the Phase1/2 trial of its leading gene therapy candidate, FCX-007 for the treatment of RDEB and initial date from the trial is expected in the third quarter. Additionally, Fibrocell was gone to a rare pediatric disease designation for FCX-013, it’s second gene therapy candidate developed in conjunction with Intrexon for the treatment of linear scleroderma and chronic autoimmune disease. As reflected in our release today, there are also several positive preclinical therapeutic updates during the quarter and quarter using Intrexon technology. In addition to maintaining forward progress in our health programs, we’re continuously strengthening our technology platform. So that ends Intrexon completed the GenVec acquisition. One of the key project getting on the way of the development of viral platform with a payload capacity that exceeds 30 KB, significantly above current viral delivery methods ranging from 4 to 9 KB. While this platform will have numerous applications in the ex-vivo cell-based therapies, its greatest potential lies in the advancement of groundbreaking in vivo therapeutics that complement Intrexon’s multigene programming and keen focus on safety with limited off-target effect. So with that, I would like to turn the call over now to Helen for some commentary.

Thank you very much, Andy. Good afternoon, ladies and gentlemen. It’s definitely a privilege to be here at Intrexon. And I just decided to actually share some of my view, and I hope that you don't mind very unscripted and uninhibited with you today, in regard to the vision that we have for Precigen and also the opportunities that exist at this point. As you’re aware, I joined Intrexon in close to a month ago, and obviously have been quite familiar with the platform over the years as I’ve kept my eyes under cutting edge technology. What is different, and for me what was exciting in order to join Intrexon Precigen is really the number of the platform that Intrexon has been able to either internally develop or acquire over the years, this is really unprecedented. I have worked both in big pharma and I have also co-founded Biotech. And I had never seen anything like this. As I came in and I took the deep dive in the number of the programs that Intrexon had started and pushing forward toward the clinic, it became very clear to me and as a result, I was really discussing this with the leadership of the Intrexon that what I was seeing was something that I had never seen previously, either in big pharma or in a Biotech. The reality of the situation was the breadth of the platform, and the evolution of these platforms was shocking to me at this point. The result that I saw and the possibilities to take them forward under the roof of Precigen it’s something unique that neither Biotech is capable of doing it or pharma because of variety of reason which we can go further in our questions and answers. However, one of the aspects that really excited me is not only the existence of the program that currently is there with the technologies, but the ability to combine these things. I come from a field of immuno-oncology which you’re all very well aware of. The biggest right now the trend immuno-oncology is combination, but unfortunately has been random combination which can lead to billions of dollars in clinical trial not necessarily adding that much to the survival of the patient. What I saw as a uniqueness of Intrexon and Precigen is having the platform that it can fit like a puzzle together very specifically to device a precision medicine for the patient. This is what it makes Intrexon a Precigen different. So we can actually come with combinatorial pathway as very specific for a specific indication. A good example of this is the RTS-IL-12 that Intrexon has forwarded and that now passed the Phase 1, successful Phase 1, and moving towards the Phase 3. IL-12 has been considered one of the miracle molecules actually in immunology. Unfortunately, many, many years ago as you’re all aware of, due to the toxicity that arose in the clinic, they had stopped. Intrexon has come up with a switch that can actually turn on and off the expression of this molecule. So in a way, finding a method to get across this toxicity, I have worked in my capacity with IL-12 over the years in many directions and the data that I saw here was quite compelling for me to see how we can control this molecule and use and harness the benefit of IL-12. In the setting of GBM, of course, our company is moving forward but more interestingly, we have identified new indication with a combinatorial pathway to checkpoint inhibitor and we’re moving this in 2018 into the clinic which will speak to the breadth of the technologies that we have. Further, also to give you another example of where our technology is, I have decided two areas that I’m going to speak to very shortly about. One is the CAR-T cell, and one is CAR Tregs. In the next slides, what you see is the challenge. I’m sure you have seen these slides many times. The biggest challenge of all the pharma's, biotech’s, anyone who plays in this arena is simply get away from the toxicity. If you have developed a army of T-cells that is so specialized and they have become such a killer, when you unleash it, you have to have a way of bringing them back. And up to this point, this has been the biggest task and challenge for the field. If you go to the next slide, what we’re seeing is actually Intrexon, through this platform and technology that they put forward many years ago and they evolve it, now it’s paying off, and they have been able to turn on and off the switches that can either activate or deactivate these T-cells by just simply taking a pill. And the moment that the patient takes the pill, the T-cells are activated. The moment you stop it, the T-cells will become deactivated. And in the next slide, I’m not going to bother with you too much scientific, and I’m sure in the future we will have more time to do this, but if you look at the right hand side of this diagram, it’s very simple. With the switches that genetically have been engineered in the T-cells, CAR-T cells, you can see the CAR expression. The green is when you are taking the pill, the veledimex is on, meaning your T-cells are quite active, they are the killer. The red is off. The moment you take away veledimex, the T-cells go back to the neutral zone and they stay quiet. Underneath we also have been able to develop another switch that and this is more of a safety a second safety if you may. And that is a chill switch in a case that everything else sells then we have a switch that can actually directly chill the freezer and this is the level of sophistication that to be very frank I have not seen before in any of the competitive arenas. And I have to say I am quite aware of our competition. So in the next slide what I like to address is the IL-15 why this switch and as allude to why is it important in the field, actually right now this is – Intrexon is front runner in this field for simple reason. Another issue is you have seen a lot of CAR-T in the hematological and probably the first approval this year would be in the hematological indication. Solid tumors have been lagging behind because number of things had to come together one advancement that it’s absolutely necessary of the survival of these T-cells and expansion of it. But more importantly going back to what Andy mentioned about the POC and the way that Intrexon is envisioning to provide these CAR-T without any extension outside and directly sending it to the patient. The IL-15 membrane-bound switch become extremely important because now instead of doing all this manufacturing outside you’re going to be doing it internally inside the patient lead the control switches so that anytime you can turn it on and off. This reduces the time going from manufacturing to the patient which unfortunately we lose a lot of patient life during that time but also it gives the control of toxicity. And this is the beauty of these systems that when I came in and I look at it and I very openly expressed that to our leadership that I’m and may at the amount of the knowledge data that exist and the program that we can make forward and move forward. In the next slide what we’re going to discuss is not only in the cancer and the field of the cancer immunology but another area that benefits tremendously from this technology platform is autoimmune diseases. I always say autoimmune disease is a flipside of the cancer. In cancer we are trying to activate the immune system in autoimmune disease we are trying to suppress the immune system. And one of the major player in the autoimmunity is what we refer to as T regulatory cells which are suppressive T-cells that they keep the immune system in check. In the disease allowed to immune disease many of the times you can see that the Treg suppressive activity is lost and that is one of the major cause of the autoimmune diseases. In that breadth what we have done and what Intrexon has established is CAR-Treg which is a very unique a frontrunner in the field. And in the next slide I'm just going to give you a caveat a show of a little bit a data in the future we will obviously address this much more but here after producing the CAR-Treg what we have done is we have tested this and what you see is the percentage of the inhibition of T-cell activity meaning suppressing immune system. The cell that we have generated when we put it with other activated T-cells now they suppress them and this is exactly what you need in the field of autoimmunity Lupus, Crohn’s disease, IBD. So what we have here is this is the two example but at the same token as we discussed antibiotics is the area that it’s a platform that we have internally which addresses not only the microbiotics of the area and using microbial as a producing different peptide but in combination with any of these either in the field of autoimmunity or cancer immunology can add advantage that its unprecedented and no other by the way – other companies have all of these platform under the same. And finally I just speak to Xogenex because we discussed the possibility of Xogenex but now we have the possibility of also developing cancer vaccine that can be combined or vaccine against infectious diseases that can be combined here. So that I hope in that few minutes I was able to give you a overview of what we think about Precigen. The capabilities that Intrexon has put in place and now under their umbrella of Precigen what we can harness and bring a new combinatorial pathway that it’s based on the indication has been precisely designed for the combination. And when I said that this is a change in the paradigm of the biotech and pharma that what I exactly meant, when you at the biotechs they are small units with a small portfolio. When you look at pharma they have portfolios and they have certain platform but currently they are randomly just combining with anything and everything in order and hope that something will come out of it. What we are going to do is develop a very unique portfolio continue with the portfolio that we have add in the different areas, combining and very – in a precision immunology and medicine and using the platform to advance the cutting edge technology and bringing new treatments for the patient. So with that I thank you for your attention and I will pass it to Joel.

Thank you, Helen. And I’ll move quickly on our financial comments today so we can get your questions. Today we reported second-quarter and six-month revenues of $54.4 million and $107.9 million respectively representing increases of 3.7% and 12.5% over the same period last year. Collaboration and licensing revenues were 52% of total second quarter revenue an increased by 2.5% year-over-year. Product and service revenues increased by 4% as our Trans Ova subsidiary saw an uptick in demand for certain bovine reproduction services. Second quarter SG&A expense was $38.5 million and increase of $8.2 million from a year ago. The increase primarily reflects growth in our employee headcount and legal and professional fees as we grow our company. R&D expense in the second quarter increased by 20% to $34 million as we are continuing to invest in our multiple platform technologies, and as Andy mentioned a number of our partner programs move into preclinical and clinical phases of development. Second quarter adjusted EBITDA was a loss of $1.6 million compared to the prior year loss of $5.4 million. Cash received for research and development services covered 46% and 50% of our cash operating costs excluding operating expenses of consolidated subsidiaries for the second quarter and first half respectively. Total consideration received from all operating sources were approximately 65% of consolidated cash operating expenses in both the second quarter and year-to-date. At the end of the second-quarter our deferred revenues were $285.3 million we had consolidated cash and liquid investment position of $157.2 million and we also held equity securities and preferred stock in our ECC partners valued at approximately $168 million. More detail regarding our results can be found in the 10-Q that we filed earlier today with the SEC. With that I am going to turn it back to the operator for opening up the Q&A line.

[Operator Instructions] Our first question comes from Jason Butler of JMP Securities. Please go ahead.

I have two questions on the healthcare sector. First, I guess a bigger picture question on Precigen. Can you talk a little bit about how you plan to prioritize programs and I guess the strategic options you have for this different programs versus the capital resources that are going to be required for broad pipeline and then I have a follow-up on the CAR-Treg program afterwards.

Hi Jason this is RJ, I am not sure I am following your question. You want to know how we're going to prioritize among our many programs in therapeutics?

Right, and how you're going to decide what strategies to apply to different programs or are you looking at different therapeutic areas, different technologies just broadly how do you determine capital allocation.

So as we have a pretty strict discipline at Intrexon. So as Joel just went over the numbers for you and these numbers are in line with our plan that we’ve had in place for several years. So today is - actually this week is our - celebrates our fourth anniversary as a public company and we always said we wanted to cover really all of our operating expenses with partners money. And that should be roughly allocated according to one half from cost recovery and one half from deal money. And we've been able to sustain that I think since the second quarter of 2014. And so far as we look into the future we think that can remain the case. So with regard to our partner programs, they have dedicated teams really all of our programs are pretty much have dedicated teams in therapeutics and certainly by program type. So it's not really that we have a lot of programs that compete for resources internally. And so long as we can adhere to a conservative financial model the one we have in place and the one we've been living by, we see virtually unlimited ability to expand. So I don't think choosing between them - maybe what you're really getting as which ones would we favor developing internally versus in partnership.

Right, I guess when we’re thinking about Precigen we’re envisaging a broader pipeline of internal programs versus partner programs is that the right way to think about it?

Yes, it is certainly in part, yes. So let me tell you what we're trying to do, we alluded to it in the press release but let me just be very clear about the four things that the team signed onto to complete in the remainder of this year. We don’t to get ahead of ourselves but these are all things that we think we can complete this year. The first thing is a lot of legal and accounting. So with legal to get the assets that are peculiarly healthcare assets into Precigen to get those assets that are actually shared among sectors other than health, to get those licensed over to Precigen with the service agreement in place, I think therefore it’s an ActoBiotics platform as an example of that one. And so that is well underway the financial accounting is looking really good. I was inspired when I thought so it’s an early cut so nothing to publish today, but anyway so all of that is well underway. The second thing is of course to recruit a first-rate enterprise management team is genuinely commensurate to the potential of the most significant gene and cell therapy company on the planet. So in my view when you consider our technologies both by breadth and depth just a number of them the number of platforms that we have right, whether it’s our GS or nonviral transduction the ActoBiotics platform et cetera, et cetera, et cetera. The lead platform going on we don't see anyone who comes anywhere close to Intrexon in terms of technology breadth and I was talking about depth right. We believe fundamentally I think this was covered in our S-1 four years ago fundamentally that the next generation of biotech relies principally on two motives. Number one, being able to control the gene program whatever their gene program is being able to control its activity in real time all right. The second thing is it clearly multigenic, the entire world of biotech - rely chiefly on single gene solutions. And we saw the need to move beyond that into multifactorial factors as Helen was just describing. We see this increasingly vindicated everywhere today I think the researchers at NCI published a paper in nature about 10 days ago that clearly show that being effective in cancer is going to be a multigenic exercise and just not going to do it with the map, you're not going to do it with a gene program with a single or frankly even a CAR-T that just has and the CAR. So we’re feeling pretty vindicated by everything we’re seeing around that. And so Helen is certainly a shining example of the kind of people we need in Precigen in order to succeed because obviously just having the technology is not enough it really requires a first-rate team. But the great thing about being able to recruit a team of the quality of say, Helen I don’t know whoever get anymore Helen’s, but anyway we have been recruiting some other drug developers, we’ve been successful, we've another developer who actually reports to Helen who is actually very good we’re very proud of him. And so we have a number of recruits we’ve made more ongoing we have some searches coming on right Andy, right now. And so the great thing of being able to recruit from the basis of having such a technology platform is it’s almost a self selecting universe. You should realize and I find this is true really in every industry to which I've ever had an exposure the top people they can go to work pretty much anywhere they want they are always going to do well financially and so forth. So they really have their options. Well we have to think about what kind of people they are and why they are in the fields they are - having the most interesting capability and being able to do the most interesting and impactful work is the winner that’s how you get the best people. And I think that’s what we got so that number two, number three frankly although we don't have anything that is under active consideration today since I am asked frequently by you and others Jason let me go ahead and acknowledge that at some point during the development of Precigen its going to - we should look at some of our smaller ECC partners to see if they would be a better fit inside of Precigen. But again let me point out that we have none of those under active consideration I'm really merely stating somewhat obvious proposition there. The fourth thing is look if we’re setting us as a separate company obviously what we’re thinking about is capital, how to capitalize that company so that it can in fact take down more and more of its own internally developed platform that’s going to require independent financing. So the really good news here is we have exposed this opportunity to a number of major investors around the world, stopping world funds and so forth. And we see very, very strong and clear interest from major investors who would like to own a piece of Precigen over the long-term. So those are our objectives to really complete by the end of this year. Obviously there are other opportunities that will come up in 2018 and subsequent years and we’ll be interested in examining those but first thing is first those are the four things we want to accomplish. Did that answer your question?

Yes, that's really helpful. And maybe if I could just quickly squeeze in Treg question just from a technological perspective are there any key difference between a Treg cell and a factor T-cells that makes it more or less challenging to direct it to a certain antigen?

Right, I think from a perspective of the function as you can imagine they’re quite different. So to identify and this is what I’m extremely proud of the Intrexon team that they have accomplished that. They had to identify a number of the pathways that they had to be either knocked in or knocked out in order to be able to establish a Treg outside of the body obviously. And to bring this now and expand and then we can return it to the patient, so yes there are differences and in their activities and also in their sort of the constructs that they need to be used which as you can imagine at this point we obviously cannot discuss publicly.

Our next question comes from Derik de Bruin of Bank of America. Please go ahead.

This is actually Mike Ryskin on for Derik, a couple quick questions for you one is on the sort of both on the EnviroFlight and the Thrive Agrobiotics. I appreciate the update you gave there. But I was curious if you can talk a little bit more about what the next steps would be beyond scaling up production. Is there something that has to be done in terms of getting approval from the USDA or the EPA potentially? Just wondering what are the barriers for adoption and getting these onto the market. And then second question was on the Oxitec platform. And one area that I noticed you didn’t update on the call was on the Florida Keys potential trials. So I was wondering if you had any news there? Thanks.

This is RJ so first with regard to I think both Thrive and the BSF from EnviroFlight they both do require USDA approvals. The USDA is I think among the science and technology agencies. Fortunately, over the last several years, what we’ve all seen, some reason for both Intrexon and others to, at sometimes be frustrated with some of these agencies. The USDA is actually not one of them. I think that they’re the shining star in terms of genuine science based regulation and consideration. So we're very optimistic. Frankly, if we can’t get USDA approval, we don’t want to market the product anyway. But we’re optimistic about what we're doing in both cases. Some of the regulation I think about for Black Soldier Fly larvae are actually vestigial of the fact that insects are regarded in food as a contaminant. Well, obviously, in this case, we're going to feed these two insectivores, and it's almost purely insects. But – there are regulations pertaining to that. I mean, they flow from the fact that insects originally in food are considered to be a contaminant. Anyway, so we're up for that, we’re very aware of that. Some regulatory filings are in already pertaining to the EnviroFlight product, and more are underway. Your second question related to field trials in the United States.

Yes just an update on the Florida Key trial?

Yes, so as you know, we received finding no significant impact and environmental assessment from the FDA some time ago. The Monroe County, Florida fathers held a referendum. The neighborhood in which the original site was designated voted against deployment of our mosquito, but the rest of the county voted for the deployment of our mosquito. So we're working with the Monroe County officials, the mosquito control district down there to designate another area for that field trial. And we’ll have more to say on this topic in the near future.

Our next question comes from Tom Shrader of Stifel. Please go ahead.

So the GenVec, the adenoviral program, is part of the game here to build in tissue tropisms? Or are you -- are they all going to go to the liver? Just as we try to guess about where you're going to go with this program, what can you tell us? So much of gene therapy is focused on the CNS. Is that a possibility for your approach? Or what can you tell us?

This is RJ, Tom. And then Helen will speak that because she knows more than I do. But in general, the first thing to note about this library of adenoviruses, of course, is that they’re gorilla adenoviruses. So that’s the first thing that really drew us to this. I mean, I think it’s no big secret that we've been trying to acquire GenVec for a few years. And I think it was our third attempt to do so. We've always been drawn to this library because the gorilla adenoviruses should have a considerably reduced, if any, immunogenicity in man. Whereas the other adenoviruses can be expected to encounter a much higher incidence of immunogenicity. Our first objective for a global vector, of course, is to render it gutless so that it should have no immunogenicity right. Now beyond that there many, many possibilities and tissue tropism is definitely something we’re focusing on. With that, I’ll turn it to Helen.

Yes absolutely I think as R.J. mentioned the possibilities with adenoviruses on many different directions brought. I think we alluded to some of the usage in infectious diseases that we would be able to clearly go after some of the chronic infections even, and it’s huge in the field of the cancer vaccine. The possibility of addition of number of gene, and that can expressed simultaneously in this vectors. And this would allow us to create a unique cancer vaccine that can be combined with our other platforms, and it can be either CAR-Ts or with our ActoBiotics as we’re using it in the near future, not only in the autoimmune setting, but also in the gastrointestinal indication. It will offer a huge advantage, actually something that no other companies will have access to at this point.

Consider Tom, just as an example I mean, we’re talking about prophylactic vaccine. The ability to have a gene program that expresses from the antigen that is regulated by the switch so that you can provide boosting, right through application for example of a topical cream or take an oral pill three times. I started out in the vaccine business, and I'll tell you, among vaccine that do reach approval, ultimate efficacy is driven by compliance. And the number one compliance issue is getting those boosters. So the ability – to hand the patient the cream and say, put this on once a week for three more weeks or whatever, is potentially huge in this thing. So we're really excited about the vaccine potential as well.

And quickly in the fish purchase, is this the tip of the iceberg for your manufacturing? Or just I think based on what you said, this would -- this plant could cover 0.5% of the market. Is this -- do you expect many more purchases like this? Or is this a CapEx-intensive business? Just what you can say about the build-out in fish.

So first of all bear in mind, this is a majority-owned subsidiary AquaBounty. They have their own financials they’ve their own shares that trade on NASDAQ and so forth. We do not expect them to have to pony up whatever they provided on this particular exercise at all times as they advanced their plans. I don't want to get out ahead of AquaBounty in terms of sort of setting the course, but of course, we’re very familiar with them. The necessity here, of course, Tom is to demonstrate that the scalable operation of an RAS system that is designed for these particular fish produces the sort of economics that we believe should be displayed. And those economics will drive I think a lot of opportunity for worldwide expansion of this opportunity, worldwide expansion of this fish which we believe is superior. But I have to confess to you, the main thing that really excites me, of course, getting this plant is extremely exciting, but I'm tremendously excited by the fact that today Canadian diners are actually enjoying this fish. Now, it's not in hugely financial significant, doesn’t have huge financial significance today. But Tom, you know how many people and for how many years told us this would never ever happen. And let me remind you and our other investors that we acquired our nearly half interest in, our initial ownership position in AquaBounty for $6 million and so we’re feeling pretty vindicated. We saw it, others didn't. We were told by many, many people that it would never ever happen, and it did happen. And so it’s making me feel, along with our energy programs and some other things, we are growing on in therapeutics and so we’re pretty vindicated that our view of the future and like I was talking a few moments ago, Biotech 2.0 I mean look almost every day we see increasing vindication of the view that was really set forth in our S-1 four years ago. It’s about multi-genetics, it’s about – ability to induce and regulate expression in real-time like we do with IL-12 today so we’re feeling pretty vindicated. And so we think it’s a hugely vindicating move. The press since Friday, I think AquaBounty released this news Friday that Canadian diners are now enjoying this fish, has been I would say 95% positive. A newspaper in Fairbanks, Alaska published today an extremely favorable article. And of course Alaska is the state of the senator that has been our most local opponent. So anyways, we’re just feeling really about this. Like I couldn’t resist the temptation to brag to you, Tom.

Our next question comes from Tycho Peterson of JPMorgan. Please go ahead.

RJ, question on energy maybe to kick it off. You called out last quarter, a technical hurdle. Has that been overcome? And if any commentary on timelines for the broader energy transaction, the hiring of Moelis just curious as to how that process is going?.

As Andy mentioned in his remarks, Tycho, we continue to work with what we believe to be the most significant remaining challenge on isobutanol, but let's put this in perspective. First of all, this was a program that was partnered. We sold a 50% interest in this program to cover everything we thought would be required to reach success. We’re not there yet, but we are still within budget too. So it's not like we're actually spending Intrexon shareholder capital toward this object. But now let’s really put it in perspective. Isobutanol is potentially a replacement for gasoline. We always talk about it as a fuel additive in the numbers we publish, we say oh, it could be $80 billion et cetera. That has a fuel additive, but if you really look at it look it’s 98% of energy density of gasoline. It is less caustic, it is cleaner. So it can move in the same transport system and if you handed it to a gas blender, now I’m talking about outside the United States now, so outside of the regulatory regime that we operate within in the United States. If you handed isobutanol to a gas blender at low price, moderately cost isobutanol to a gas blender, he would think that he has the best starting material that he’d ever received. In fact, he’d then be able to use his gunkiest, cheapest stock in order to formulate ASTM gasoline. So we think that the ultimate market for this particular molecule is in an astronomic range. And so well worth the effort so while it is true that we are not yet we’re not declaring that we have a victory in isobutanol. Our team believes that we’re very close and they continue to struggle with what they believe to be the last remaining hurdle. At the same time, to get the second part of your question, as we reported on our last call, we are very much in the money in commercial with commercially significant yields on two very significant multibillion-dollar molecules. And led us to hire -- we’ve named the banker I think publicly, right? Moelis and Company – to potentially partner the entire platform, that process is now underway with across the world. And like the British say, Andy, watch this space. We will have more on this later.

And then as we think about both AquaBounty and the Arctic Apple, I’m just curious on a couple of things here. Pipeline for follow-on manual products, you mentioned a few in the slide. When could we see developments there and then pricing, I guess the salmon's being priced at kind of market rate, is that right about 5.30 per pound and should we assume similar pricing on the Apple?

No, you should not. So it's always been our objective to see, and I believe that this is the stated by Dr. Stotish at AquaBounty to really see the AquaBounty salmon for what it is which is nutritionally identical to a wild type salmon. Noted with the chief differences being, it will be grown closer to market. So it will be fresher. It won’t have antibiotics and vaccines on it and it will be free of sea lice. So if you want both things, then you probably won't like this salmon. But really it should be, we've always imagined that the salmon should really be regarded, just as the FDA said in their ultimate report, it’s nutritionally without any noticeable difference. In the case of the Arctic Apple however, there’s one of the reasons we're really looking forward to this fall’s harvest because as Andy mentioned in his comments, we’ll be doing some very deep market research to test what kind of price premium this Apple should come in. So unlike the salmon we do believe that the pre-sliced Arctic Apple will deserve what the people in AgBio are called a trade premium. And we’ll be in a better position to model I can tell you that on the numbers that Andy provided during his comments these were based on the absolute minimal price premium that we're capable of imagining. I think the market research could turn out to support a larger price premium in which case our profitability will be higher than what we projected.

And then last one could you get EnviroFlight’s revenues next year I know you’re scaling up production I am just curious as to when think that started to impact the P&L?

We should start to see some small revenue building next year, but we’re not going to make any projections on those numbers quite yet analyst we want to get the plant up running secure the customer contracts and then have a good time reporting the results as we move forward.

Our next question comes from Robert Breza of Northland Capital Markets. Please go ahead.

Maybe just as a follow-up to the prior analyst RJ as you think about the energy platform longer-term do you think about anticipating spinning that out as a individual asset per se I mean how do you think about the energy platform longer term?

Yes, it’s a really good question and I could tell you when Bob Walsh and his team produced the data that showed us that we really have a technical success on two of these significant molecules. As I think I may have mentioned on the last call the first thing I told our Board I'm not smart enough to figure out the answer of the question you just asked. So we better get some people who are smarter than we are. So that's the reason initial reason we hired Melissa and company then we later worked out with them and talked to some people in the industry. We later transitioned to a transaction-based engagement for more or less because we clearly see both options on the table. So let me answer and thank you for the question because it's a really good one. So there is a potential we really have two markets we look at their two markets for partners one is major chemical companies we’re talking worldwide class chemical companies. And the other would be IOCs international oil companies who have access to a lot of gas. In the former class it stands to reason that some of them could be more interested in particular chemical than the other. So for example if they have some complementary assets and skills, that they have already a large market share. If you look at something like 1,4 BDO I think they're only for significant but there are only really four companies I think in the world that make that stuff four or five. So some of them are pretty rarefied already and so it’s unlike that somebody else could really look at 1,4 BDO and say I got to have that. So I think what we're likely to see in among the chemical companies is the possibility of doing more than one deal really a segregated a set of deals around the number of molecules with each company. We’ll see how that works out. On the other hand IOCs we view them as potentially really be more interested in the entire platform as they’re partnering with us on the entire platform because to an IOC what does this technology represent. In my view it represents the most compelling proposition ever to occur in history that rebalances oil versus gas. So if you look at, you consider the entire petrochemical complex the 15% of gross world product that is represented by these molecules right. All of it except for natural gas and the tiny sliver of what we call NGL natural gas liquids which are sort of accidentally made from natural gas for all intensive purposes occurs from the breakdown of oil. Now despite that, we know that the lowest cost source of industrial available carbon in the world today is natural gas. So and the only significant technology that’s ever been developed to upgrade natural gas into more complex hydrocarbons is Fischer-Tropsch. So that was developed I think in 1923, its massively it produces a fixed ratio of the complex hydrocarbons. So some of them are really good, some of them are not so good and some of them are actually frankly marketable. This is produced in a massively exothermic reaction, so it's either depending on how you build your plant its either incredibly inefficient right, or if you want to recapture that energy and put it back into the process then it’s incredibly, incredibly high in terms of CapEx. So our technology is a simple fermentation step. It’s very, very low in CapEx and it’s very low in OpEx. I should mention Fischer-Tropsch which is the only technology out there that really perform significant upgrading. I think there are - I can’t remember the number Andy but it’s like 10 or 12 Fischer-Tropsch plants in the entire world. This is a technology that if we’re able to get it to work on a large number of molecules that - well everybody is always saying game changing, I don’t know what to say if this is a game changing than everybody else is if this is merely game changing than everything else is an exaggeration, every other use of that term. Because this I think will be really the biggest thing that's ever happened in terms of natural gas upgrading potential and the ability to equivocate gas/oil. We think this will be very, very compelling to IOCs not only because A) they’ll want it but B) they’ll genuinely fear a world in which their competitor has this and they do not.

The next question comes from Keith Markey of Griffin Securities. Please go ahead.

I just had one question, I was wondering if you might be able to give us an update on through Type 1 diabetes program?

You know, thanks Keith for the question but because of some ongoing developments in this program, I'm going to have to pass. I will say this program is under very active discussion and we have some moving parts we can say, but because of the moving pieces I’d rather defer on this question for now.

You just stayed tuned you’ll get it.

And this concludes our question and answer session. I would like to turn the conference back over to Mr. RJ Kirk Chairman and CEO for any closing remarks.

Thank you. Well as I've observed this is our fourth anniversary as a public company. It hasn't always been fun, I know it has always been fun for our public shareholders who expected our stocks is going to go up every week. And that said, I have to tell you I think that are intrinsic value today is an all-time high. I’ve stated in full recognition of the fact that our market capital - our market - I think share price in the summer of 2015 was in the high 60s. But we as a management team and I know I'm speaking correctly on behalf of our Board, we focus on intrinsic value. And we do it knowing that look a company that is based on doing world first instance things can't expect in a world that that loves conventionality right. And only likes novelty if it's being done by someone who is 90% conventional. It's the new thing for them for General Motors and we made like a new cars better than the old car but it's a car still. So we understand the world in which we operate, we knew when we went public four years ago that it would likely be the case for many years that our market capitalization would be less than what we adjust to be are intrinsic value. But there were some benefits by being a public company that we have reaped, we still believe that those are valid. So we like being a public company, but I just want to acknowledge I know that it has at times been painful for some of our public shareholders. All that said, I'm very comforted when I look at companies like Amazon and Netscape. And I see that these companies their share prices really didn't do well for the first three or four years after their IPOs either. We built this company to be potentially one of the greatest companies in the world. And when I consider the potential for engineered biology today, I'm more than ever convinced that we chose the right field in which to lead. If you told me four years ago because you’re right I mean it’s certainly true I thought that this would evolve more quickly than it did, I mean the ecosystem not us I think we've done a great, but I thought the ecosystem would evolve more quickly than it did. And what I mean by that is, I thought that for example major - if big pharma would understand that they really need to be multigenic and they need to be able to induce and regulate gene programs, I thought that would occur to them before now. The truth is it’s occurring to them now and one of the reasons it’s occurring to them now is because they just realized over the last year that gosh some of this 1990s era gene therapy technology is really cool. And so they bought into some of that, but having bought into some of that is really open their eyes and we're having really good dialogues on that front. So I feel ecosystem improving now and my point is, it has not - it didn’t advance as quickly as we hoped it would. That said, we adapted and how we adapted was we found that in a world in which people are not yet getting the importance of engineered biology and the potential of what we refer to as biotech 2.0 that means that the assets are underpriced. And so for example in 2015 we acquired some great assets at some incredible valuations that I think are tiny, tiny fractions of what those platforms ought to have been valued. So, we saw the opportunity to acquire positions of genuine industrial leadership like with Oxitec like our acquisition of what is now our ActoBiotics division in Belgium and Okanagan Specialty Fruits. That was also in 2015. And so we took full advantage, so in a way it’s actually moved our developmental cycle forward more rapidly than we could have projected under our ECC model exclusively. And so now we're in amalgam of marketed products already across the board. We have approval of the world's first genetically modified weird animal, we have regulatory approvals on the world first genetically engineered mosquito, we have approval on the world's first genetically engineered fruit and we see market acceptance which is regulatory acceptance. We see market acceptance and we see as expanding. So we're mighty encouraged. I say all this just to say on the one hand I don't think we have any apology to make. I just want to know I’m sympathetic to our shareholders. On the other hand I think that our prospects are extremely good now, not only because of what this team has achieved, but also because of the evolving ecosystem. I would just observe - Helen and I were discussing before the call, count the number of big pharma companies that basically are completely retooling their entire R&D right – they have just declared this within the last two and half weeks. Lilly, AstraZeneca, Sanofi, GSK well how much money do you think that puts on the table for genuinely world changing R&D right. In other words, there is one thing for them to get it but it’s another thing for them to have the budget to do anything about it and what I'm pointing out is and we see this across the industries in which we're operating. These companies now not only get it but they have the budget to do something about it. So we're really encouraged. So again, thanks to all the shareholders, thanks to our team. And we look forward to speaking to you again soon.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.