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PGEN Q4 2017 Earnings Call Transcript

Operator: Good afternoon, and welcome to the Intrexon Fourth Quarter and Year End 2017 Investor Conference Call. All participants will be in listen-only mode. [Operator Instructions]. After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions]. Please note this event is being recorded. I would now like to turn the conference over to Tom Shrader, Vice President of Communications and Strategy. Please go ahead.

Tom Shrader: Okay. Good afternoon, everyone. Welcome to Intrexon's fourth quarter and year end 2017 investor conference call. I’m Tom Shrader, Vice President of Communications and Strategy at Intrexon and I’m joined by Joel Liffmann, Senior Vice President of Finance; and Thomas Bostick, Intrexon’s COO. R.J. Kirk, our CEO will join us for the Q&A session. During this conference call, we’ll make various forward-looking statements. Investors are cautioned that our forward-looking statements 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 our forward-looking statements. Please read our Safe Harbor statement contained in the earnings press release as well as Intrexon’s most recent SEC filings for a more complete description. This afternoon’s press release and our discussion this afternoon may reference certain non-GAAP financial measures, including adjusted EBITDA and adjusted EBITDA per share. We use these financial measures as a more accurate estimate of our ongoing financial position. Reconciliations to our GAAP measures are contained in the earnings press release as well as on the Investors section of our website at www.dna.com. The format of today’s call will include some background along with a review of Intrexon's progress in 2017 by myself and Tom Bostick. We will also recap some events from early 2018. This recap will be followed by a financial update from Joel Liffmann and the call will end with a Q&A session. Next slide. As an overview of two Intrexons here, I'd invite investors to think of Intrexon less in terms of its areas of business focus such as health, food and energy and more in terms of its core expertise, the precise and when necessary regulated expression of genes in a wide collection of host cells and organisms. As a further simplifying principle, I think it helps to think of our work as falling in four buckets: microbes, plants, non-human cells and human cells. Why are these buckets useful? Principally because they represent the areas within which Intrexon scientists enjoy significant technical synergy leading to experimental leverage. For example, the day-to-day work of an ActoBio scientist working to express IL-10 in L lactis to fight Type 1 diabetes. Isn't that different than the activities of a San Francisco scientist working to express the enzymes that convert methane to liquid fuel? As we recap our year, I think it's useful to think about our progress in terms of these buckets because of the synergies and this idea that advances within the bucket, are likely to be impactful throughout the bucket. Next slide please. So Intrexon in 2017. Within that framework, we view 2017 as a year of some of our most important achievements to-date, including reaching profitable yields for the conversion of natural gas to 2, 3 BDO as a precursor of rubber and also profitable yields of isobutyraldehyde. In addition, in 2017, we fine tuned the pieces of our point-of-care CAR-T approach with ZIOPHARM that allowed us to partner with a major US medical center in early 2018. However, in addition to these two important advances, we view 2017 as a year of steady build for many of our core areas. For example, beyond 2, 3 BDO, the yield all of our methane bioconversion products continued to increase, including the brand good to grant price isobutanol. In addition, our agricultural technologies progressed further that we are now in partnering discussions with many of the major players in the field. In healthcare, Precigen, ActoBio Therapeutics and our EC partners ZIOPHARM and Fibrocell, all started important new clinical trials. And finally, assets like apples, salmon and our friendly Aedes mosquito, all enjoyed either regulatory successes or at least greater clarity in their required pathway to regulatory successes. Intrexon cell and gene therapy is now Precigen. One of the key focuses for Intrexon in 2017 was building strong internal development capabilities in the healthcare space. Our healthcare assets within cell and gene therapy have now been organized as Precigen and Helen Sabzevari has been named Precigen's President. Helen is an experienced drug developer. Much of Precigen's pipeline is not yet public and we don't expect significant disclosure for programs prior to reaching the clinic. But we have disclosed that Precigen will focus on oncology, autoimmunity and specific infectious diseases. In addition, for many applications, we expect Precigen will leverage Intrexon's gene delivery tools to take multi-genic approaches, especially in situations where single gene approaches have shown signs of efficacy. Next slide, point-of-care CAR-T cells in the new oncology. One of the most important efforts at Intrexon in 2017 was getting ready for human clinical trials with a point-of-care CAR-T cell. This is a therapeutic immune so that can be re-delivered to patients within a couple of days of harvesting. Our point-of-care approach is designed to remove the need for lengthy and costly centralized cell manufacturing. Our approach that involves in-hospital manufacturing should reduce both the delay in treatment of very sick patients and the associated treatment costs of these therapies. Technically, our point-of-care manufacturing approach involves removal of virus-based engineering steps. These steps require high levels of containment and are not generally available in hospitals. This goal was achieved by our use of non-viral Sleeping Beauty technology. In addition, our approach required that engineered cells don't need to be amplified ex-vivo before delivery to the patient. We delivered this step by introducing a second gene beyond the tumor targeting receptors into our CAR-T cells, namely our proprietary membrane-bound IL-15. As we have previously reported, we’ve signed one major academic partner for this program and we now have term sheets out to additional hospitals very worse in conventional CAR-T therapy. The first IND should be filed soon. We believe we will dose the first patient in the second quarter of 2018. We are not providing details of the trial design but our slides have indicated that the target is CD19. A word on that, choice, we believe that membrane-bound IL-15 could be key to attacking solid tumors with immune cells. But to our first trial we’re choosing CD19 based on the consideration that the best way to test something novel is in an area where success is well-defined. The deal terms are confidential, but we have reported they involve yearly fees to Intrexon, a per patient fee to Intrexon, as well as double-digit royalties on the final realized reimbursement for the CAR-T therapeutic. So next slide. So overall, we believe Precigen's approach to combinational -- combination therapy fits modern oncology. You should expect more detail on Precigen’s pipeline later in the year. However, it’s already safe to say many of the approaches will be multi-genic combination therapies and keeping with the current focus of immune system mediated medicine. A clear example of that focus is the fact that there are now a 1,000 ongoing clinical trials with checkpoint inhibitors in combination with other therapies. So it's pretty clear that these molecules are seen as important backbones, but not the whole treatment solution. At Intrexon, we have long invested in delivery technologies required to make multi-genic approaches a reality. For example, in 2017, we acquired GenVec, a leader in adenovirus based gene delivery along with its portfolio of gorilla adenoviral vectors that are expected to have reduced immunogenicity. These approaches allow for payloads as large as 30 kilobases to be delivered to cells. Just to put that in perspective, these payloads are five to 10 times those possible with current approaches. In addition, Intrexon has a great deal of experience with AttSite based gene integration technologies that also allows large payloads to be specifically integrated into cells. So we have two independent technologies focused on the delivery of large gene segments and the potential utility of these payload applications is shown in the figure. The schematics on the slide indicate a CAR-T cell equipped to express two independent immunomodulators, a construction well within the reach of our delivery technologies. Also shown is the same treatment regimen delivered by conventionally with three separate therapeutics and the associated very high cost. So overall, we believe we’re on the cutting edge of the development of medicines involved in combination approaches and we are fully aligned with the sentiment that even the remarkable results seen to-date, costs will eventually need to stop escalating. Next slide. So moving away from oncology. Xogenex is multi-gene expression solutions for heart failure. Again, Precigen has what we consider to be a relatively de-risked effort in cardiac gene therapy, specifically in heart failure. In this program, Intrexon has engineered vectors to deliver genes from each of the major classes of proteins implicated in repair of cardiac tissue. So, each of these classes has shown some signs of efficacy in isolation. We think we can deliver all three. The data below shows -- cell data showing appropriate levels of expression followed by preclinical data in an animal showing significant cardiac benefit. This trial is IND -- the IND has been filed in November and is now considered accepted and we expect to dose the first patient in first half of ‘18. First half of ‘18 represents a modest delay from earlier expectations and is really the result of our PI increasing the number of hospitals involved in the trial. But we should still be in the clinic in the first half of ‘18. Next slide, fibroblast based therapies to Synthetic Biology Atop Harness Biology. These programs are in partnership with our longtime ECC partner, Fibrocell. And Fibrocell works to develop therapeutic proteins with human fibroblasts. They had a very solid year for their first therapeutic FCX-007, the company reported Phase 1 safety data and efficacy data in RDEB patients that resulted in the FDA greenlighting the Phase 2 portion of this trial, involving pediatric patients. So, based on this safety and efficacy data, the FDA okayed the treatment of young children. For their second therapeutic FCX-013, Fibrocell filed its initial IND for linear scleroderma and that trial has the potential to start in 2018. Both of these applications require complex protein replacement strategies and make use of our autologous fiberglass engineered to express correctly folded complex gene products. Okay, next slide. The next slide is a snapshot of Precigen’s clinical portfolio. Much of it is in collaboration with ZIOPHARM, and you know it well. So I will just make a few points on the programs indicated in red. The combination trial in glioblastoma, including both a PD-1 antibody and regulated IL-12 we view as very important because safely combining these two powerful immune modulators is an important step for many of our programs. In addition, the ongoing AML trial is a first attempt to treating this disease and use of conventional approaches. However, AML and its extremely sick patients represents an exciting place for our point-of-care technologies. So as a result, the AML trial, although it’s important in its own right to validate the target, also plays an important part of our learning curve. Okay, next slide. Moving away from Precigen to our second healthcare business unit, disease tissue-specific delivery, the L lactis is now ActoBio Therapeutics. Much of the remainder of Intrexon's human therapeutic activity is now organized as ActoBio Therapeutics. Pieter Rottiers has been named as ActoBio’s CEO has an extremely experienced management team. Some of the key people at ActoBio have worked on this platform for 25 years. The platform is based on disease site specific delivery of active therapeutic moieties. We believe ActoBio represents a novel delivery approach but a relatively de-risked overall approach because many of the active therapeutics they are delivering via L lactis are already known to be active as systemic therapeutics. Importantly, the ActoBiotics platform delivers these therapeutics directly to disease tissue and has the potential to be more efficacious and safer. In addition, the ActoBio approach opens the door to low cost of goods combination therapies. Again, a common thread to our approaches. The ActoBio -- on this slide is the ActoBio pipeline with two clinical trials expected to be ongoing throughout 2018 and the first important clinical data is expected in 2019. Next slide. This is important background data. ActoBiotics Therapeutics produced in mucosal surfaces are active. So, although certainly a novel approach, we believe our existing data from preclinical studies and clinical trials de-risk the ActoBio pipeline and support the overall mechanism. For example, therapeutics known to be active systemically ActoBiotic delivery has been shown to be active for one mucosal healing in the mouth and this is based on clinical data and Phase 1 data as shown at the top of the slide, and then pre-clinically for immunomodulators in the GI system. And this feature has been shown both for cytokine, the lower figure as well as an anti-TNF nanobody in studies that aren’t published yet. Next slide. Okay, our updated scorecard for healthcare. With that overview, I will restate what we believe are our most important healthcare accomplishments for 2017, and early 2018. First, Precigen and ActoBio Therapeutics were organized and staffed throughout the year. Second, a CRADA with the NCI was signed to exploit the use of Sleeping Beauty technology in order to target tumor neoantigens. More details on this program are likely to come from our partner ZIOPHARM. Third, our first hospital partnership deal was signed for point-of-care CD-19 CAR-T, again with ZIOPHARM more details are expected and more deals are expected throughout 2018. Four, the Xogenex heart failure IND was filed in November 2017, and the first patient is expected to be dosed in the first half of 2018. Fifth, ZIOPHARM initiated a CD-33 CAR-T trial in AML and a pediatric GBM trial delivering regulated IL-12. Sixth, Fibrocell initiated a Phase 2 pediatric trial in our RDEB and a Phase 1 trial in linear scleroderma. Seventh, ActoBiotics started the Phase 2 oral mucositis trial and filed the IND for its Type 1 diabetes trial. And finally, the GenVec acquisition was completed. This was an important step for all of our multi-genic approaches. I'll now turn to a brief overview of our methane bioconversion program. Our methane bioconversion program is our program to turn natural gas, the lowest-cost and most available source of carbon into more valuable and useful energy forms and chemical forms. Our approach was conceived internally and entirely developed by in-scientists at Intrexon. Next slide, large markets were relatively simple products. Here, I wanted to spend a minute reminding people that the conversion of methane to relatively simple four and five carbon products is very valuable. As you can see from the slide, even the smallest of our internal markets are worth more than $2 billion and most are many times that value. An additional point I would make here is that there are many slightly more complex specialty products we could focus on in the future. However, we have principally worked to-date on large market fuels and chemicals, partially because once we were able to send large amounts of carbon flux into our first products, these additional products are expected to be relatively straightforward. With that brief background, here are our more important recent accomplishments in the energy sector. An important update and an important thing to keep in mind in the energy sectors is we’re getting better at things. On the top of this slide are the yield curves for three different products isobutanol, 2, 3 BDO and isobutyraldehyde. And what's really clear is that the curves have gotten much steeper as Intrexon scientists have gotten more experienced, getting to useful yields has gotten very rapid. Additional recent accomplishments, including following -- the following: In the money yields will reach this year for 2, 3 BDO and isobutyraldehyde. Those are some of our most important milestones for the year. We've also developed an industrial process and what I mean by that is, we can now run these reactions for 1,200 hours, a requirement for any sort of industrial process. In addition our 500 leader pilot plant has been operational for 16-months and has completed multiple 100 hour runs at this large-scale. We make quality product. Intrexon recently produced 2, 3 BDO of 99% purity at the pilot scale and test conversion to 1, 3-butadiene is underway. Finally, the high quality -- this recent high quality product was extremely important as it allowed us to complete the engineering of a FEL-2 engineering package that detailed a 40,000 ton per year facility. This is still called a small scale plant in the industry but it's a commercially meaningful facility. And based on the runs to-date, we believe we know how to design it. And then the final point is that partnering discussions are ongoing. So with that overview of the healthcare and energy sectors, I'll turn it over to Tom Bostick to discuss our other businesses.

Thomas Bostick: Thank you, Tom. Healthcare and energy remained important areas for Intrexon but several other programs in the general area of engineered plant and animal cells are important and all advanced nicely in 2017. I’ll quickly review our three core programs in growing better plans. Then I will cover what we view as the natural partners of our programs in agriculture as well as our attempts to protect crops from pests that are increasingly resistant to conventional control mechanisms. Following that overview, I’ll give an update on these programs, including our efforts to protect humans from disease causing pests. Next slide. On the agriculture side of Intrexon, most people are aware of our work with apples, our subsidiary Okanagan Specialty Fruits, now has three approved varieties in non-browning apples and our version of golden delicious apples, Arctic Golden, we sold on a very limited basis in 2017. The differentiating feature in all of these apple varieties is that because they brown much more slowly, they can be sold pre-sliced without preservatives. Our apples are probably the only apples that can be sold this way because other apples turn brown extremely fast on the order of hours rather than weeks. Our 2017 crop was large enough to get controlled consumer feedback that was extremely positive and supports our program and progress to aggressively plant our apples. The second line on this slide is an indication of four other products that are advancing through the development phase. In each case, there is a strong rationale that slowing the browning cycle will lead to a better tasting and more natural alternative. The third line in this slide, shows some data from our second agricultural platform. This technology is an increasingly mature research that we acclaim Botticelli, as like the birth of Venus. No ganic stage is involved in the growing cycle. Despite the gild name, it’s a serious technology since the biggest period to rapidly improving plant genetics, is the time required for test plants to grow. Botticelli shortens that time considerably. In 2017, this platform moved from an internal research tool to a significant focus in partnering conversations. In more technical terms Botticelli is a proprietary method to elicit a genotype independent pluripotent response in plant cells or tissues that allows high throughput plant regeneration. The approach has two important applications. First the efficient prorogation propagation of plants that produce valuable ingredients. Second, significantly improved transformation and mass propagation in commercial crops. In this latter area we have generated proof-of-concept data in two important crops, lettuce and tomato. Again on the third row of this slide, the left [3p3] tissues show lettuce tissue growth. On the far left is an example of standard tissue growth protocol and next to it is lettuce using the Botticelli proprietary method during the same amount of time. Then the right [3p3] tissues show a similar example with tomato tissue growth. Next slide, the final platform we employ in the agricultural space is called Florian. Florian allows for the on demand expression of plant traits. As might be anticipated it’s an agricultural application of our switch technology that in principle can control a genetically defined trait, a particularly colorful example is shown on the slide with the Florian switch is controlling a color gene. When the Florian switch is off the flower color is purple and when the Florian switch is on the glower color is white. The commercial driver for our approach includes the general issue that advantageous traits in a plant, such as drought resistance are not always advantageous. For example, a plant expressing drought protection genes is very likely to grow poorly in normal conditions. On the next slide we show you more serious application that is currently in testing. Next slide. The control of traits in plants was shown on the last slide with a playful example involving flower color. There are much more commercially important examples that we have already demonstrated such as the control of flowering. In some forge crops flowering is not a positive outcome since it reduces the plant’s focus on creating biomass and requires the field to be cut that before significant flowering occurs in order to reinitiate the growing phase. And it’s also, a grower does not want the plant to flower because it decreases the yield and forge quality. However, flowering is still needed for seed production. Florian allows for the best of both worlds. Without Florian on the top half of the slide, the field grows without flowering and on the bottom half of this slide with Florian on flowering allowed the seed production for the seed companies. We are involved and partnering discussions with this technology. Next slide. The flip side of our attempts to improve food production via genetic control is our efforts to combat the pests that destroy crops. Our company called Intrexon Crop Protection is developing two key platforms to address crop pests, self-limiting insects using the technology very similar to our successful mosquito platform, and ActoBiotics which uses a food grade bacterium to deliver a suite of pest management actives. Again, we are involved in partnering discussions with both technologies. Next slide. I will now provide an updated scorecard in a few key areas. We have our third non-browning apple the Arctic Fuji apple approved in United States and Canada. Our apple tree program gained momentum as we planted 266,000 trees in 2017 and are on track to plant approximately 4 million trees by 2020. Florian and Botticelli, partnering talks are in progress with multiple partners. Four SLI derived insect technologies have the green light for field trials. We have achieved partner milestones for an SLI-based approach for controlling fall armyworm. And with friendly Aedes mosquito the regulatory process has moved to the EPA. On this last bullet I’d like to provide a little more detail. In early October following new guidance issued by the FDA Center for Veterinary Medicine, regulatory jurisdiction for Oxitec's friendly mosquito 0X5138 was moved under the jurisdiction of the Environmental Protection Agency as a biopesticide product. This move was seen as positive, since it is scientifically more appropriate to evaluate potential environmental health and safety aspects of our product as a biopesticide rather than an animal drug. Moreover, the EPA’s guidelines and requirements for the evaluation of these technologies are familiar, well-known and transparent and subject to well articulated timelines. However, this move to EPA also meant we were required to begin the regulatory process again with a new agency. We are currently proceeding down two parallel paths to release our product into the environment in the United States. Firstly, with have completed a Section 3 commercial approval filing based on field trials previously conducted outside of the United States. Based on the recent filing of our Section 3, we anticipate a regulatory decision on our commercial approval early in 2019 if not before. Secondly, in the event that we need to supplement our efficacy data with US data, we've also applied for an experimental use permit and EUP to begin a field trial in the Florida Keys. We are targeting an area of the keys were recent flooding suggest this next mosquito season maybe unusually severe. It’s worth noting that experimental trials conducted under an EUP are also taking place in Florida for an alternative form of self-limiting mosquito. However, we believe that we have a more effective and potentially less expensive solution and a local willingness to try self-limiting mosquitoes is a positive. Now, Joel Liffmann will provide a financial update.

Joel Liffmann : Thank you, Tom. The financial results that were reported today reflect a considerable scientific partnering and commercial progress, as Tom Shrader and Tom Bostick just described. I'd like to point out that as we closed out 2017 and implemented our plan to internally develop several of our most promising opportunities, we undertook an analysis of our entire portfolio of ECCs, technologies and other assets. As you'll see in our fourth quarter and year-end results, we terminated an ECC which produced an accelerated recognition of previously deferred revenues. And separately, we recorded an impairment charge against goodwill and intangibles. Each of these are non-recurring and non-cash items, but we may again have accelerated deferred revenue recognition in 2018, should we terminate additional ECCs as we focus our efforts on each of our maturing and our in-house early stage programs. Now, getting to the numbers. First quarter and full-year revenues were $77 million and $231 million respectively, increases of 67% and 21% over the prior year periods. These results include approximately $29 million of revenue recognition from the termination of one of our ECCs which we report as a component of collaboration and licensing revenues which grew by 32% over the prior year. Our Trans Ova business contributed substantially all of our product and service revenues in 2017. And combined, these grew by 14% and 5% in the fourth quarter and full year versus the prior year periods. Throughout 2017, we saw improvements in the Trans Ova business and we continue to have expectations for a high return on the investments we are making in transforming this business from the bovine reproductive service to proprietary product supplier to the dairy and beef cattle industry. Total reported operating expenses, including the impairment charge that I mentioned, for the fourth quarter and full year were $103.5 million and $368.9 million, increases of 32% and 70% over the prior year periods. Excluding the previously discussed impairment loss, adjusted EBITDA for the fourth quarter was a gain of $13.7 million versus the prior year loss of $5.8 million. For the full-year, adjusted EBITDA was a loss of $11.8 million and compared with a loss of $26.6 million in 2016. Our management team is executing against the broad set of opportunities at hand. We are focused and financially disciplined. We ended 2017 with consolidated cash position of approximately $75 million, and we have common and preferred equity securities in our ECC partners with a value of $176 million. In early January, we completed a second carry stock offering, which raised gross proceeds of $86 million. I refer you to the earnings release and 10-K for additional financial information. And we will now open the call up to questions.

Operator: We will now begin the question-and-answer session. [Operator Instructions]. And our first question comes from Jason Butler with JMP Securities. Please go ahead.

Jason Butler: So, first one -- first question on Xogenex, can you just talk about the goal of the Phase 1 trial in heart failure? For example are you including pharmacodynamic endpoints that could be predictive of clinical benefit?

Randal Kirk: Hi, Jason. R.J. here. As you can see from the slide that Tom showed you and of course that does come from animal models, but yes we are looking at ejection fraction for example.

Jason Butler: Okay, great. And then for…

Thomas Bostick: Nobody is going to do a study like this in healthy normals, right?

Jason Butler: Right.

Thomas Bostick: So we will be dealing with significantly impaired patients and of course we expect the Phase 1 to really let us know if it we’re improving our efficacy at least to our satisfaction at that point.

Jason Butler: And then the second question on the Botticelli platform. Can you give us any numbers around the improvements in speed of development or yield or essentially how can we quantify what the value add is here? And then can you just confirm is the partnering efforts here separate and distinct to the partnering efforts for Florian?

Randal Kirk: The answer to the second question is yes, it’s separate and distinct. And the answer to the first question is I can help a little, so from -- in other words, I can’t state what the total value is but I can tell you as a matter of just benchmarking against known methods of propagating plant list without going to seed, we believe we are currently at least in lettuce 150 times faster. Now what does this mean? As Tom mentioned in his comments, there’re really two -- we see two immediate applications to this technology. One is to accelerate for people in agbio, right, people who are developing plant traits, to get results much more quickly. And that’s why we have such broad interest in this technology. It was really what inspired us to create this technology. But once we had it and the results seemed so dramatic, we are still trying to wrap our heads around other ways we used this technology in specialty crops, in which if you think about, let’s use lettuce as an example, so if you are growing lettuce in let’s say hydroponic greenhouse or something like that, controlled environment they call it today, in a controlled environment maybe you get a crop per year, if you can get rid of the requirement to produce seeds and germinate seeds, then you could produce -- you can increase productivity by say 50% in that environment in that crop. And that’s the one, as Tom mentioned, that’s the one on which we have the greatest amount of data. I think we have done over a dozen different species of lettuce. And then we have less mature work in tomatoes. We don't know how many how many crops this technology will work in but we have ongoing programs too to find out.

Jason Butler: If I can just add one quick question there. Can you give us any sense of what the time or cost or development hurdles are to test in each one of these new projects as it were and essentially what is the limitation to asking questions for new species?

Randal Kirk: Afraid I can’t help you. I know that it varies. I know that it varies from species to species Jason. And for some of them, the application and significance is much more than would be the case for others. As I said, in a production platform, obviously this technology to produce corn is useless, right. But to achieve a stable corn trait for one of the companies that is active in that field, we think is highly useful.

Operator: Next question is from [Derek D. Bern] with Bank of America Merrill Lynch. Please go ahead.

Mike Ryskin: This is Mike Ryskin on for Derek actually. A couple of questions. First one on the energy platform. You mentioned some key highlights, cash positive yields, and a couple programs, 99% purity into 3 BDO. I was just wondering what the next steps were for these two leading platforms. You talked about partnership discussions ongoing but is there incremental benefit about -- around getting higher yield, is there incremental than incremental benefit around doing higher purity or what’s the focus for this year as you work it out internally to scale up production and higher power plant, bigger plants et cetera?

Randal Kirk: I’d say higher yield is the goal there. It’s pure enough or we are out for testing but…

Thomas Bostick: Especially once you are in profitability right, then any improvement in yield is pure profit.

Randal Kirk: Right and also -- and this is actually an important question because as the yields get better the details of the plant change. And so, you don't want to build a plant that’s designed for one yield only to avoid another. So I think there is a lot of information in the fact that we were able to complete the engineering package that tells you how far we are down the line. There is some information in that comment.

Mike Ryskin: So if I could ask a follow-up on that then. So even though you achieved cash positive yields, how long is the runway until you -- I don’t want to say max yield but I know what you are going to say okay this is good enough let’s scale up the plant at this point. Is this a multiyear runway just to achieve on the next several quarters? What’s the remaining upside?

Randal Kirk: I think we have said we will break ground on a plant this year. So we're not there yet, but we're confident enough that we will be there in 12 months, is I think the best answer I can give.

Mike Ryskin: And then really quickly on the Precigen platform if I could. Appreciate the heightened focus on the multi-genic approach, that’s very interesting. Could you talk about any -- I realized you may not want to disclose this but anything you can say about any multi-genic approaches you are looking at besides the Xogenex heart failure platform?

Randal Kirk: Yes, absolutely. So as you’ll recall, all of our work in CAR-T is directed toward a point-of-care CAR-T capability, and all of these constructs are multi-genic. Some of them are quite complex. You you'll see more details about these as our partners begin initiating their clinical trials and this is coming up in the very near future. But I can tell you just to give you some idea, each one of our gene programs that we are putting in the human primary T-cells is larger than that which our competitors could manage in an antivirus. So they are all large, they are all more complex. So in order to have -- some of them have multiple switches and multiple open reading frames and we -- it's consistent with what Intrexon always set out to do. We talked about our desire in CAR-T states in 2013. We talked public other than -- and we think we've achieved that. So we have clinical data upcoming and we are looking forward with great excitement to those data because we think that will bear out the predictions that we have and the work we've done over the last several years in the field. But yes, all of these are multi-genic constructs.

Mike Ryskin: And any color on why the graft-versus-host project was canceled?

Randal Kirk: Focus, it's about focus. I mean we and our partner ZIOPHARM believed that the point-of-care CAR-T is extremely compelling and both companies are very tightly focused within that partnership, very tightly focused on that objective.

Operator: [Operator Instructions]. Our next question is from Tycho Peterson with JP Morgan. Please go ahead.

Tycho Peterson: Maybe just following up on the CAR-T discussion. Can you maybe talk about the pipeline for additional similar hospitals deals to the ones you have -- the one you had and how many you think you could sign in the first half of this year for example?

Randal Kirk: Yes, I can't give an estimate on the second question Tycho. But on the first one, we have term sheets out to other parties right now where we are recording considerable interest. I don't think that people have really realized how significant what we've done here in terms of inverting the business model. So these are leading cancer research and treatment centers, which you can suppose are the ones that are most familiar with the competitors’ product. They are licensing this technology from us and going to bear the cost of these clinical trials. So we suggest that perhaps some of the finest cancer researchers and physicians who examined our data believed that this program is pretty compelling. But again, as I mentioned a couple of minutes ago, it's all about clinical data ultimately and the way we’re looking towards that which is not too far way now.

Tycho Peterson: And then can you talk about I guess the FEL-2 engineering package what that entailed, and you what that implies for the construction of the 40K ton production facility?

Randal Kirk: Let us get, yes, the phone with Bob Walsh. He will be much better at explaining the details. But he once told me I was the only person who always said no to FEL-2 engineering plan was but I'm not I'm sure that's correct. Let us keep offline. He will take you through the detail. But thanks for the question.

Tycho Peterson: And then last one on OpEx just kind of higher level question as you have moved away from ECC model. Can you talk a little bit about where you are making incremental investments and I guess when we should start to think about royalties in commercial sales starting to kick into the model?

Randal Kirk: Sure, yes. So, I think what you will see initially Tycho and what we think is really going to be the big driver we hope to be and expect to be the big driver for us financially in 2018 is transaction money. And what I mean by that is, look, we publicly announced we have four partnering programs on mature platforms underway at the current time. And so, I think the first thing we would expect because our target in each of these cases would be to achieve something like a joint venture, so I think the first thing you would see would be the transaction money from these. But some of them are actually commercializable now, and as they’re mature, and so stay tuned.

Operator: And our next question is from Alex Schwartz with Stifel. Please go ahead.

Alex Schwartz: My first question was with your point-of-care CAR-T trial. Approximately how many cells do you infused back into the patients so we have pretty good sense of how many cells your competitors are infusing into their patients? How many are you looking to infuse? And any sense of how long your membrane bound IL-15 cells are persistent in comparison to the competitor cells?

Randal Kirk: I don’t believe we disclose the data related to the second question. But I am sure you -- the fact that you posed a question at all means I think you rest one of the chief implications. And your first -- the first part of your question, improve that you do. Obviously we are not doing ex-vivo cell expansion. So the cell number is considerably smaller, and that’s because our membrane bound IL-15 we think will drive sufficient cell proliferation in-vivo to do the job. So, the dose is and we’ve -- I don’t think we have disclosed what it will be but it will be orders of magnitude less than that is used by the current players.

Alex Schwartz: And then just on your energy platform. So congrats on achieving cash positive yields of 2, 3 BDO and isobutyraldehyde. Maybe can I just pose a question a little bit differently, where are you in terms of yields achieved as a percentage of your targeted yields for these products? And then secondly, you previously talked about maybe some isobutanol technical hurdles. Looking at slide 17, the isobutanol trend continues to go up. Have you ever come out and maybe just an update there please?

Randal Kirk: Yes. So, first with regards with isobutanol, we are not where we want to be. We press the bulb all the time for -- to tell us that we are solidly in the money on isobutanol. And look we are very conservative and Bob is even more so. So, for example we calculate the constant natural gas in each of our financial calculations at the [HH] index price. Even though it’s quite obvious you can buy natural gas on a forward contract at considerably less than that. But -- so using $3 per million btu and as the cost of the input, we are not yet where we want to be on isobutanol. The team is showing I think very recently a very positive trend on the main technical hurdles that they have been working on. But we are not in a position today to provide numbers on that. I forgot the first part of your question. Oh yes, in relation is theoretical, yes. So we're close enough that we think that we're going to actually get very, very close to see, which is very exciting. Please bear in mind that the total -- the overall objects of the methane bioconversion platform is to turn these large commodities into genuine biotech products with genuine biotech gross margins. And that’s our objective. And so, when we say that we're in the money on something, we don't mean you know by a trivial amount. It’s highly significant. It’s extremely, extremely compelling, in my view. And that’s the reason we think we're right for partnering.

Operator: This concludes our question-and-answer session. I would like to turn the conference back over to management for any closing remarks.

Randal Kirk: Okay. Well, first let me say that as usual I have to comment on the team. I mean we have a phrase about tap dancing, tap dancing all the way to the office and so the first thing I’d like to do is just express my gratitude for place we occupied today, the place interest on occupied. The team that we have on our board today which is by far the best team I've ever worked with. Our Board which I would contend is potentially, well, I just -- I can’t imagine how they could be better as they are highly supportive and extremely accomplished and very, very helpful to all of us, our scientists. Some of the work that you saw in the presentation today and bear in mind we are not showing everything we are doing as I mentioned in my little attribution in the press release. We really like the fact that we've achieved this inflection in our evolution so that we don't have to partner in a very public way early stage programs and then talk about those. So we're doing a lot of early stage work now. And some of this I think is extremely compelling and some of it will simply have to await data. At Precigen, for example, we show a pipeline slide and I think the title is disclosed targets. Well, that’s done with our knowledge that we have candidates that are in development now that were only initiated a couple of months ago that we expect to see in the clinic if everything continues to go the way it’s going. So we expect to see in the clinic this year. So all of these achievements are telling me that our scientific team of nearly 700 people working in our labs is just doing phenomenal work and I tell them and I remind the guys at the table here with me and at our board as far as I am concerned, our number one job is to enable their work to really make a tangible difference in the world. And so, I want to thank them. A word to our investors. I too am an investor, in fact I think I’m largest investor in Intrexon. And I can observe both in the case of Intrexon and in some prior experiences I have had and some of you on this call were shareholders in clinical data when we were -- we thought the time was here for pharmacogenomics and that was 2004, and clearly the time was not there for pharmacogenomics 2004. But -- and the reason I mentioned that is because sometimes it can be painful to be early. And I think that Intrexon from a pure -- from a shareholder perspective it's certainly fair to say that we've exhibited that. But the most important thing is whether or not you are going to win. And I hope that what you've seen today and what you heard today and certainly this is our view. We think that we are going to win. And we think that 2018 is going to be a indicating year. I would just want the other investors and shareholders in Intrexon to remember what I remember every day, which is the reason that we became investors in Intrexon. And when you examine that proposition in that way, you realize that Intrexon has actually executed. I mean go back and look through our entire nearly five year history as a public company now, we've actually executed what we hoped to do and the large things have actually cut our way and they've not only cut our way internally yes regarding in the money on methane conversion. There were times during prior to that time when we could seriously wonder if that was ever going to be achieved. It was by far as the most audacious ambitious biotech endeavor that I'd ever seen, and yet we think we are there. But what's happened in macro is that meanwhile thanks to fracking, that natural gas, the delta between the cost of carbon items on natural gas versus oil is such that you can think of natural gas as something like $14 or $15 a barrel, in comparable used to put in oil terms. So the macro events have cut our way and the internal development has cut our ways. Similarly in cancer therapy this point-of-care CAR-T, we had a name for it that was even broader than point-of-care CAR-T. We had a name four years ago we called that Modular Inducible Cancer Immunotherapy MICI for short M-I-C-I. And when we look at this today we see that we are actually attaining the realization of our desires of even five years ago to create that kind of platform, which we think is going to be hugely beneficial to cancer patients, and also patients of autoimmune disorders and also infectious disease. So that's what happened internally and again clinical data subject to clinical data we're going to look in the near future to see if we have really achieved what we believe that we have. Externally, however, with the amount of blood in the water transactionally on what we believe to be inferior technologies, it ought to give us some idea of how powerful this originally deal was. Listen, we -- when we began in this area, it was -- we though of it as a category, but practically no one else did. And we were certainly aware of the work of Dr. Rosenberg and -- in June. We talked about this on our IPO road show. But we didn't believe that those platforms were ever going to be truly industrializeable. And frankly that is still our view despite the transactional values they have obtained. Now I'm not saying that to criticize anybody else’s product or transactions. I'm saying it just to illustrate the fact that the macro environment is informing that the path that we have set ourselves on was a good one and the valuable one. Now obviously, we have to succeed and that's really my point. As investors, fundamentally, it's about are we going to succeed. Intrexon was intended and always has been intended and is intended today to be one of the leading companies, if not the leading company in the field of engineered biology. And the way this team is executing today, I am more than ever confident that that is so. So, thank you very much.

Operator: The conference is now concluded. Thank you for attending today’s presentation. You may now disconnect.