ECO Animal Health Group plc (EAH) Earnings Call Transcript & Summary

My name is David Hallas, I am CEO and I'm just going to introduce you briefly to what we're going to do today. First of all, there will be no new financial information disclosed today. We're going to focus entirely on our R&D, on our portfolio and on the future. However, we will be providing next month in April, a brief trading update as we close our financial year at the end of this month. I would take adage that no news is no news or in fact that no news is good news, but there will be no financial disclosure today. Our agenda is this. I will provide an introduction. Look, what I'm doing now, a bit of feedback from last time, which last time we had a Capital Markets Day was November 2023. And one of the feedbacks was from certain investors were, it will be really helpful to get an outside view of this market, of this area. Not all investors are specialists in Animal Health. So to that end, we've invited Dr. Simon Middleton from L.E.K., a boutique life science consultancy with a particular knowledge of Animal Health. So Simon will talk after me. Then we have Dr. Hafid Benchaoui, who is our Head of Global R&D. He'll give an overview of our R&D pipeline. And then, we will have a double-click on our late-stage assets in the Mycoplasma segment for Poultry provided by Natalie. Our CCO, Chief Commercial Officer, Andrew Buglass, will provide an insight on how we might commercialize and how we're thinking about commercializing our vaccines. And this is an addition to what we did previously. And this is because we are now maturing the pipeline to such a stage that we are very proximate to commercialization. So partly from feedback and partly from our own view that we thought it would be interesting for you to see how the commercialization looks, how we're thinking about that. Then we'll look -- then Hafid will come back and look at some of our more disruptive innovative technologies that are in the next wave in our mid-stage pipeline. Chris will then bring this all together in evaluation, looking at peak sales, EBITDA of our pipeline, NPV and IRR, so that you can get a good insight into the value that we bring in this pipeline. And then we'll bring that all together with a summary and Q&A at the end. We'll start with questions probably from the online audience and then from the room. [Presentation]

So to grow our business behind the innovations, we'll talk about those innovations now for our R&D. And for those that perhaps don't know ECO Animal Health or to remind those that do, our strategy is quite straightforward, threefold. Primarily, what we're talking about today is invest in R&D to develop new products, to develop innovative solutions to economically damaging diseases in the marketplace, focusing on swine and poultry. Second leg of our strategy is to create partnerships to allow us to go to the market, to allow us to reach customers but also to create partnerships that might help us develop our R&D portfolio so we can think about strategic alliances, partnerships that will help us develop our R&D pipeline as well as develop commercially. And we are also open to mergers and acquisitions. We continue to look at opportunities, we're looking at a number right now that are in our new wheelhouse of preventative segment of animal health. And the third leg of our strategy is to continue to develop our blockbuster asset Aivlosin, which is a leading anti-infective in the [indiscernible] Poultry and in the Swine segments that is growing, continuing to grow globally. We still have opportunities to elaborate that out via additional claims and some additional geographies as well. So that's our threefold strategy: invest in R&D, create partnerships, M&A and continue to develop our organic business. Double-clicking on R&D, why are we doing our R&D? Why do we think we'll be successful? And what is the valuation of that? Well, I'm going to answer. In this afternoon, we'll answer all of those questions. But just on the, why are we doing it? Well, one reason is that there will be 2 billion more people on this planet by 2050. And whilst fish and alternative proteins and vegetable-based proteins are helpful to provide the nutrition that those people and those additional people will need, it's primarily going to be satisfied by poultry and swine protein. And in order to produce that swine and poultry protein, you need innovative animal health, veterinary medicines so that we don't suffer that loss through productivity that disease can cause. And one of the most innovative ways that has driven the market is to move from anti-infectives and therapeutics, which is where ECO is currently and historically sectored itself into vaccines, and so to move into the preventive segment. And you can see that the preventative segment over the last 10 years has been one of the most robustly growing parts of the animal health market, and is forecast to grow again being one of the most robust growth drivers of this animal health sector. So vaccines is really where you want to be, and vaccines can help to provide the additional productivity and the additional protein that the human population is going to need. So that's one of the reasons we're doing it. Now Animal Health in and of itself is an attractive industry. The graph on the right-hand side shows the top 10 animal health companies over the last decade, they have grown substantially. In comparison, ECO has grown less fast. Now arguably part of that, certainly, a least part of that is because we have not been in companion animals and more particularly, we haven't been in preventative medicine and that is -- those two factors as what have largely grown the top 10 animal health companies. Well, what would you know? We are getting into those segments. We're getting into those robustly growing segments. And if you look in our home turf, of the Farm Animal segment, that has grown over the last decade by about 4% on a compound annual growth rate. ECO on the other hand, in its home turf and historical place of anti-infectives, we've grown at 11%. So we've been able to show that ECO can outgrow the market. And as we enter these new segments of preventatives, we wish to do the same again to outgrow the market. And one of the things that drives the animal health market like other markets, but particularly true in Animal Health is that innovation and new products drive market growth. So as we come with our innovative new products that we're going to talk about, that is what's going to help grow us and help -- and we will grow on the back of a growing market. So if we can provide that innovation so much better that the market will grow, and we will grow with the dividends that, that will provide us. And just to compare us with the amount of R&D that larger peers do. Generally, animal health companies that are robustly investing in R&D are putting about 8% to 12% of revenue into R&D. And you can see some major players, the BI, the Zoetis, Virbac, Elanco on this chart and Dechra formally listed here in London also on this chart. Now ECO we're exactly in this sweet spot of investing. We're investing around about 9%, 10% of our revenue into R&D. And why do this? Because by doing this, by investing successfully in R&D, you really begin to drive your revenue. And by that way, ECO can narrow the gap between where we are now and the top 10 peers in Animal Health that would have grown faster than us, because they've been in the vaccine segment. And as we enter that vaccine segment, we can tap into this growth with our innovative portfolio. So these are six assets that we are going to talk about now. On the left-hand side, we've got two poultry assets, ECOVAXXIN MS that we are most advanced on and very pleasing to say only 10 days ago, we submitted ECOVAXXIN MS to the regulatory authorities in the European Union for approval. And all being well, that approval will happen in due course, not too, too far away. And we will show you all of the time lines of all of these projects as we go through. ECOVAXXIN MS will also be submitted -- it's being segmentally submitted to the U.S. authorities and final submission in the U.S. is not too far away. And MS will come on to the market in the EU first, but very, very shortly thereafter on the U.S. market as well. MG follows behind that. And those two vaccines are there to solve problems in the Mycoplasma segment of poultry medicine. Third asset, long-acting Florfenicol is an anti-infective that we have rights for in Europe and China. It's a little bit smaller, because we don't have global rights, but we do have rights in those geographies. And then, we have some major -- the last three on this chart on the right-hand side are some very major heavy hitters in our portfolio with substantive innovation, particularly around the two on the right-hand side, the PRRS, a monoclonal antibody and the necrotic enteritis biological, also a monoclonal entity that are there to solve really substantial diseases and have got high levels of innovation and great opportunity to really add value to producers and really transform the ECO Animal Health business. The ones on the left hand, three are all in the very late stage, where we've submitted MS, the probability of success there is well in the high 90s, the next two, it's very high, 80% probability success and the ones that are further away, a slightly lower probability success at this stage. But we'll also show you all of our portfolio and how we've migrated that since the last and matured that and migrated it towards a higher level of probability of success of all our assets as we've gathered more information and increase the scientific knowledge around these assets. So with that, that's my brief introduction. I'd like to introduce Dr. Simon Middleton from the L.E.K. Consultancy who will give us an outside view on the investment case for preventative medicines in Animal Health. Simon?

Great. Thank you, David, and thank you for inviting me to talk today. It's good to see everyone. As David said, I'm going to sort of talk a little bit around innovation of the sort of portfolio and the impact that could potentially have on the unmet need within the disease areas that the company is addressing. So I'm Simon Middleton, I'm a partner in L.E.K Life Sciences Consulting. I'm a scientist by training, but I've been consulting to Life Sciences about 18 years now. A lot of that work is in the broad Life Science ecosystem, but a lot of it has been also in the animal health and animal pharma sector. And that's why I have the pleasure of meeting David and the team at ECO and very happy to talk to you today. Now as David sort of highlighted, clearly, sort of over the next few years, ECO has a pipeline of products, which is expected to kind of reach market. And I think the team will clearly talk about that in more detail over the remaining slides. But all I wanted to kind of do is provide a little bit of context around the nature of the diseases that those will be addressing, the unmet needs that kind of really remain and why innovation and development here is important in order to address those unmet needs. So if we look at some of the diseases in detail. So there are a number of swine diseases, a number of poultry diseases that the products will be addressing. So if you look at the swine diseases, so we have mycoplasma, so MHP here. And that is a bacterial pathogen that causes chronic pneumonia and leads to reduced growth and increased susceptibility to secondary infections. There are kind of a couple of viral diseases; so Porcine Circovirus type 2, so PCV2, that is a viral infection linked to systemic disease, which leads to respiratory issues and immune suppression; and PRRS, which is a highly contagious viral disease causing severe reproductive failure in cells and respiratory distress in piglets. And on the poultry side, we have a couple of mycoplasma infections, so MG and MS. So MG is a bacterial infection, which leads to chronic respiratory disease and reduced egg production; and MS, which is a bacterial disease affecting joints, and respiratory infection leading to lameness. And finally, we've got Necrotic enteritis, which is a bacterial disease leading in severe intestinal damage, poor feed conversion and high mortality. So you can kind of clearly see here that, there are some significant sort of physiological kind of symptoms for these diseases. But in the sort of context of sort of animal health in terms of the economics around this is actually quite important impacts and quite significant impact in the livestock farming. So if we take a look at this in a little bit more kind of detail in terms of that impact. So if we take the sort of mycoplasmas to start with. If you think about the number of swine that can be affected by mycoplasmas, so MHP, it can be up to 80% of the swine population globally. Now that has clearly an impact physiologically, but also sort of economically. So in swine, mycoplasma can result in reduced weight gain and poor feed conversion efficiency and the economic impact of that in the U.S. alone is estimated in somewhere in the region of sort of GBP 400 million. So again, sort of physiological symptoms relating quite directly to economics of impact here. If you look at kind of some of the poultry mycoplasma diseases, somewhere between 30% and 40% of poultry can be affected with these infections. And that leads to reduced fertility and hatchability. So again, another significant disease burden which, again, can globally lead to around about sort of GBP 700 million to GBP 800 million in economic impact per year. For PCV2, around sort of 60% to 80% of swine in Europe and the U.S. can be infected. The infection leads to poor growth, reduced feed conversion, increased susceptibility to secondary infections. And again, those physiological symptoms can result in quite a significant economic impact estimated here between GBP 5 billion to GBP 6 billion globally. So clearly, extremely large. For Necrotic enteritis, again, relatively a small number of sort of poultry can be impacted by the infection. But because it needs to increase mortality and reduce feed conversion, again, it has a very sort of high economic impact around about GBP 6 billion sort of globally. And for PRRS, around sort of 40% to 50% of swine can be infected with the disease. It's very significant in terms of impact leading to reduced birth rates, increasing the abortion of still births, stunted growth and increased susceptibility to secondary infections and has an estimated impact of around about GBP 660 million in the U.S. alone. So as you can kind of clearly see these diseases have a particularly kind of high economic impact. And therefore, the idea of finding sort of treatment solutions for these diseases is clearly of high importance within the farming industry. So how do we sort of think about the context of innovation in this kind of setting? So clearly, there is a standard of care for these diseases. But the standard of care still has a residual unmet need and in many cases, a quite significant unmet need that need -- that can be addressed and address the additional economic impact that's remaining there. So in terms of standard of care within swine, so antibiotics are used to control the mycoplasma infection. We know there are no specific antiviral treatments directed towards PCV2 and PRRSV. And vaccines, although they're kind of widely used in MHP and the viral diseases, again, there's still sort of residual unmet need there. So we see that the kind of lack of specific antiviral treatments, current vaccines within the mycoplasma are not fully protective. And so they only reduce severity, but not actually preventing sort of transmission disease. And in sort of PRRS, the vaccines that are there and used actually have limited cross protection and therefore, not effective against new strains, which, as we know, through vaccines, emerging strains and new strains is a particular problem. In poultry, quite commonly is, the poultry are kind of treated with antibiotics for the mycoplasma infections and when they're diagnosed with Necrotic enteritis and vaccines are kind of using these conditions but are less widely used for necrotic enteritis as well. Now one of the kind of main concerns that are unmet need around the use of antibiotics within, I mean, poultry, but more broadly is obviously the growing concern around antibiotic resistance used to its kind of widespread and extensive use. And indeed, although the kind of vaccines exist, and kind of counteract some of that, they don't offer full protection, and therefore, they're not preventing transmission as well. So despite the fact there is a standard of care in these animals, the unmet need still remains and can be addressed through innovation. What are the kind of key reasons that we see that drive towards sort of innovation more broadly in the industry? So well, first of all, you have improved disease control. So as we've seen, current methods often fail to completely eliminate the pathogens. They lead to persistent infections and ongoing economic losses as a result. Innovative solutions, therefore, can provide more effective control, reducing the prevalence of diseases and improving overall herd and flock health. Now we've talked a little bit about the economic impact, and that's quite significant by any measure. Clearly, diseases in both swine and poultry caused by these pathogens have significant economic losses due to lost productivity, increased mortality, and the higher treatment costs that are required to achieve that. I've mentioned before, the elements around sort of antibiotic resistance. So again, innovation that can reduce the use of antibiotics that has led to the development of antibody resistance, is clearly top of mind in a number of areas. And there are many sort of antibiotic resistant, sort of, strains of bacteria, which kind of need to be addressed. So clearly, innovation can meet that unmet need. And sustainability. There's been a sort of ongoing drive towards sustainability in the industry. Again, these innovative solutions that we're kind of talking about here and that the ones that ECO are developing contribute to more sustainable farming practices, improving animal health and productivity and in reducing the environmental impact of farming. And that sustainability element also links to consumer demand. So consumers are looking for and I want to understand the products that they're kind of eating are from sustainable and human practices. And so innovation that addresses the sustainability is also addressing and it's been sort of the consumer demand that we kind of see. So innovation not only has a direct impact on these particular diseases, but it's more broadly aligned with the drivers of the market and improving animal, sort of, farming practices in general. So if you look at how that sort of relates to ECO's Animal Health, sort of, pipeline, I think clearly, you can see a number of areas here. So if you look at in swine, both the, sort of, vaccine and the monoclonal antibody there have significant benefits over the standard of care. So the ECOVAXXIN MHP vaccine has combined long-lasting protection. It has the opportunity to prevent secondary infections and increase productivity. Monoclonal antibody is expected to have an immediate response quicker than vaccine. So again, you're getting the impact more quickly. But also, and I think importantly, is expected to have a broad efficacy against a spectrum of emerging strains. So again, addressing the unmet need that exists in the current sort of vaccine market. In terms of the sort of poultry, across those kind of diesases, again, you'll sort of notice that typically standard of care involves antibiotics. Clearly, these products don't have -- vaccines, a biologic can reduce the antibiotic reliance and therefore, reduce the emergence of antibiotic resistance as and when it emerges. But also in the sort of any kind of biologic also has the ability to reduce information, increasing sort of feed efficiency and again, productivity within the animals. And then, the sort of, MS and MG sort of vaccines, they have and expected to have improved vaccine efficacy compared to existing kind of products in the market and sort of longer lasting immunity, which can also, kind of, also help the sort of antibiotic reliance. So again, I think the view is that the pipeline that ECO has is clearly looking to address the unmet needs in the market and clearly has significant commercial opportunity given the economic kind of impact that these diseases have. So thanks, so that was kind of just a sort of overview of those kind of diseases and the economic impact as well as the unmet need that remains there. As I said, I hope that's kind of helpful context as the company takes you through the rest of their sort of presentations, and I'll be available at the end of the Q&A. And happy to answer any questions that people have. Thank you.

Thank you, Simon. Good afternoon to you all. Thank you for coming in. We're grateful for your time today. Our goal this afternoon is really to share with you a progress update and give you a flavor of how our R&D pipeline is progressing and advancing and specifically, focus on the considerable value that is captured across our clinical stage and late-stage R&D assets, which will drive growth over the next 5 years and beyond. You've seen this slide already to put this message of building value from within -- through R&D innovation in the wider context of our direction of travel as a company. It is a key component of ECO's three-pronged strategy, the two others being to continue to grow Aivlosin through claim extensions and geographic expansion and to create external partnerships with the possibility of financially and strategically sound acquisitions. Before we delve into the details of how R&D is driving the growth of ECO, let's take a step back and very briefly reflect on a key ingredient to any creative process. Let's have a look. [Presentation]

So curiosity is indeed one of our core values at ECO and one that is geared to us in R&D in particular. This slide really captures the why we're doing, what we're doing. It summarizes at a glance the productivity costs on a global scale of the diseases that are, that we are focusing on and developing solutions for. And the range goes from GBP 300 million per year for mycoplasma in pigs in the U.S. to the global scourge of necrotic enteritis in poultry, which amounts to GBP 4.9 billion per year. And because today, we're principally focusing on the mid late-stage R&D assets. This slide only highlights the diseases that we are addressing with our clinical stage and late-stage vaccines and biologics. It excludes other infectious diseases that are equally important that we are addressing with our early-stage research pipeline. So when we presented to you this funnel depiction of our pipeline back in November '23, it looked like this. Since then, we have had a couple of attritions. One is PPE vaccine, a vaccine against porcine proliferative enteropathy, also known as ileitis caused by Lawsonia. This termination didn't cost us anything. It was mostly a paper exercise that led us to terminate the project at a very early stage of the project on the basis of an unconvincing antigenic target. The second termination was a PRRVS virus vaccine. We did take this one into proof-of-concept and we did conduct a couple of studies. And we just didn't see sufficient protection from the virus. However, we haven't lost the target PRRVS, which is still covered in our pipeline with a much more exciting technology, and that's the monoclonal antibody that is #6 on this graph, which I will cover later on. So these are the two terminations we have had to instigate since our last update to you. Our attrition rate remains very acceptable and we make no apology about killing projects provided we do it very early on in the R&D cycle. It's an undesired, but essential exercise for good stewardship of our resources, our time and our money. The animation you're about to see is what happened with the different projects in terms of progress and phase transitions since November '23. In a nutshell, ECOVAXXIN PCV2/MHP #7 has progressed from proof-of-concept to development. The long-acting Florfenicol injectable for swine respiratory disease, #9 has progressed to full development ECOVAXXIN MS, #10, you've heard from David has now entered the regulatory filing with our submission two weeks ago to the European Medicines Agency for product approval. And you must have seen the RNS that we released in relation to that. These are the three phase transitions that we've delivered. There has also been considerable progress within the proof-of-concept stage, most notably of the PRRVS monoclonal antibody #6 as well as the poultry necrotic enteritis biologic, #5. These two projects together with projects in development and regulatory filing, constitute our highest priority in terms of resource allocation. And we will now zoom to those six projects. So those six projects form what we have termed here as a current wave of innovation and next wave of innovation. This slide outlines the value of each asset expressed in peak sales, the development costs and the time to first approval. We have had some headwinds in the U.S. registration of ECOVAXXIN MS and Natalie will give you more detail on that. In essence, it's a combination of delayed reviews at the USDA as well as additional requirements from the agency that were unexpected and atypical for this type of vaccine. These headwinds are not specific to ECO, they are felt across the Animal Health industry. And we know that because the consultants who help us also help other companies and we hear from them that they are facing similar issues of backlogs as well as unexpected additional requirements from the USDA. This predates the new administration, so it's not related to the new U.S. government, although that could well be an added variable going forward. The contingencies that we have put in place in the wake of the U.S. delay are to decouple the rest of the world registrations from the U.S. approval. Our original strategy was to first secure the U.S. approval and then request approvals in rest of the world geographies. Our strategy now is to submit in those countries before U.S. approval using the EU dossier and supplementing it with some additional data depending on the needs and requirements of the local authorities in those countries. And this is what we are doing for Brazil, for example, and you'll hear more detail about that shortly. The other setback to mention here, and this one was technical, it was with ECOVAXXIN PCV2/MHP. The challenge we had to overcome was related to the manufacturing yield of PCV2, that was too low, and it did cost us 9 months to optimize the yield. And the good news is that we have identified the cell line that massively surpassed our expectations in that, it increased our yield 10-fold, which will significantly boost our profitability for this product. I'll take more time to explain more about this project later on. So on aggregate, the total value across the six assets is GBP 171 million, and Chris will talk more about the financials later. We are now going to focus on the current wave of future products and in the later session, I will cover the next wave of innovation in more detail. So the current wave is the two poultry mycoplasma vaccines, ECOVAXXIN MS and ECOVAXXIN MG, plus the long-acting Florfenicol single shot for swine respiratory disease, either these products will generate peak revenues of GBP 38 million. All three projects were taken from early-stage research all the way to where they are today by ECO against the backdrop of a lean R&D operational model with a total cost of GBP 18 million. I think, most people in this room will know and it's fair to say that it would be extremely hard, may impossible to find an acquisition opportunity of three late-stage assets that have entered or are about to enter regulatory filing with projected peak revenues of GBP 38 million at the price tag of GBP 18 million. So in terms of R&D productivity, based on these facts and numbers, we are definitely extracting great value. And to continue on that train of thought, we have just entered what promises to be a dynamic period of 24 months of regulatory filings and approvals for these three products. I've already mentioned MS with the EU submission. This will be followed by a submission to the VMD in the U.K. in September. Our filings in the U.S. actually started 2 years ago, because of the phased submission process at the USDA, and we will file the last technical section in May next year. To limit the impact of the U.S. delay, as I mentioned earlier, we have decoupled the submission in Brazil from the U.S. approval. So we will submit in Brazil also in May next year. For ECOVAXXIN MG coming up, we will submit in Europe in February next year, followed by both the last technical section in the U.S. and submission in Brazil in May '26 and the U.K. in September 2026. Natalie will elaborate on the rollout of the two vaccines for other geographies. I just wanted to focus on what's happening over the next couple of years. For the long-acting Florfenicol for swine respiratory disease, regulatory filing for both EU and Brazil will happen by January '26. And the U.K. filing will go in 6 months later in June 2026. There is no plan to register this product in the U.S. because the FDA wanted us to reestablish the acceptable daily intake, the ADI for human food safety, which would require a whole host of toxicological studies. This is the requirement when you try to develop an old molecule into a novel formulation that is not bioequivalent to the Pioneer product. And we just didn't want to go through the prohibitive cost of doing that for a molecule that has been out there for almost 30 years. So in summary, we have a total of 11 regulatory filings and 5 approvals that are anticipated over the next two years. So now we're going to give you a little bit more detail on how we are progressing with those three products. I'll talk about the long-acting Florfenicol and then I'll hand over to Natalie, who will cover the technical aspects of ECOVAXXIN MS and MG. And then Andrew, who will cover the planning of the commercial rollout of those two vaccines. Florfenicol is an Animal Health only antibiotic, meaning its use is derisked in relation to the One Health issue of antimicrobial resistance. And what we have here is a novel long-acting formula that we licensed in from a start-up company, and we made some improvements to it. We have repeatedly demonstrated its superior efficacy in treating pneumonia caused by APP, Actinobacillus Pleuropneumoniae, when compared to the market leader, Draxxin. And this greater efficacy was confirmed again recently using the final formulation that we have now taken into full development. As you can see from the bottom graph in the middle, which depicts the long consolidation resulting from the APP infection, whilst our product at the recommended dose of 30 milligrams per kilo on the right-hand side of the graph, the bottom graph, completely cleared the lung or the lungs of the treated pigs, those that received Draxxin, the teal box had a median of 20% of the lungs still damaged, really an outcome that was not dissimilar from placebo pigs in the red box. So really nice differentiation from the market leader. The upper graph shows the Florfenicol concentrations in the pig after treatment with the pilot formulation and the final formulation to which we have added excipients to improve stability. And as you can see, the two graphs are nicely superimposable, meaning that the added excipients didn't have an effect on the kinetics of the formulation that we have taken into development. On the manufacturing side, we have scaled up under GMP to 500 liters, and we have selected the primary packaging, and we are gearing up to start the field efficacy program in April. So the coming months are going to be critical for this project. We will complete the field efficacy program. We will complete the target animal safety and residue studies. And our CMO, our contract manufacturing organization will complete the process validation for manufacturing with a view of filing with the EMA and with MAPA in Brazil by the first quarter of next year. So with that, I'll turn it over to Natalie.

Thank you, Hafid. So my name is Natalie Desloges, and I'm one of the global project leader at ECO. So let's start to talk about mycoplasma and this economic impact. So here, as you can see on the graph, mycoplasmosis, which is affecting chicken, and it's mainly used by two bacteria, Mycoplasma synoviae and Mycoplasma gallisepticum, is ranking #6 in terms of disease causing economic impact in the poultry industry. If we focus on Mycoplasma synoviae, it is well known that MS and layers is causing a delay in the onset of the egg production, as you can see here on the graph in yellow, with an MS positive flock. And this has a direct impact on the economic return for the producer. If we have a look at the table, so MS positive flock produced less eggs per hen and more B-grade eggs as compared to MS negative flock. The feed conversion ratio and the mortality rates are also higher in MS positive flock as compared to MS negative. So the direct impact of the presence of MS is about 21 eggs per hen but if you take all the parameter together, the economic losses to MS, it can reach more than USD 3,000 per thousand birds. So now let's talk about ECOVAXXIN MS, which is our mycoplasma synoviae vaccine. So ECOVAXXIN MS, it's a live vaccine, and it contained the strain Q5 885A, which is a naturally attenuated U.S. isolate. This vaccine strain was proven to be safe at high dose in young chicken. And it is also free of antimicrobial-resistant genes. We have performed many study, efficacy study, and we have shown that the vaccine is able to reduce air sac lesion and colonization as well as footpad lesion caused by MS. We have also shown that the vaccine prevents ovarian regression and egg production losses caused by MS. We are very happy to announce that ECO has entered also an agreement with Calier for the manufacturer of ECOVAXXIN MS and the ECOVAXXIN MG. Calier is a Spanish company founded in 1968 and is part of the Indukern Group. Calier's main activity is the development, production and promotion of veterinary specialty and the GMP certified plant is located in León, in Spain. At the last R&D Day, we were presenting this slide to show you the press that we have done with the tech transfer to Calier. So in the last year, since the last meeting, we have completed the qualification of all the equipment as well as the cleaning validation of the facility and the storage of the material and product on site. We have continued with the process knowledge and the training of the ECO personnel. But most importantly, we have completed the analytical transfer of all the assay we will need for the release of this product. We have produced a working seed. We have scaled up the manufacturing process, and we have produced a couple of batches, which is now in our stability program. With one of the batches that we have produced at Calier, we took then ECOVAXXIN MS to the real world. So we have collected a field efficacy study in Europe, where we had two group, one group vaccinated with ECOVAXXIN MS at 4 weeks of age and one with the market leader at 5 weeks of age. And we have observed the birds for 90 days. We have observed them for mortality, body-wide development and zero conversion. So as you can see here on the table, the mortality rate was extremely low for both group during the 90 days observation period. So we were at less than 1% in both group. The body wide development were very similar in both groups. And we have also taken some blood sample from the chicken to see if they were expressing MS antibodies and both groups were reacting the same way. So taken together, these results show that Ecovaxxin MS perform as well as the market leader in the field. So now that we had all the data package, we prepare a dossier. And as Hafid was saying it in his presentation, we have submitted the dossier at the beginning of the month and this was a really great achievement for the team. So now I think these dossiers in hand, we will plan the submission in Mexico, in U.K. and in India. And the team currently is preparing a gap analysis to see if the data package is complying with all the requirements we need for Brazil. Once we will have the EU approval, we will also supply the dossier in other LATAM country as well as in Asia. So now let's talk about our U.S. approval and the delay we are facing. So in fact, the main reason why we are facing delay with the USDA is that they have a lot of additional requests. And we are currently mitigating this setback. And as Hafid was explaining, this setback is not specific to our product. We are hearing from other veterinary vaccine company that they are facing the same situation with the USDA. So to give you a little bit background. So each time that we do submission, we are often getting requests back from the USDA. For example, we were providing publication showing how long the MS vaccine is surviving in the environment, but then USDA wanted really specific data with our vaccine strain. So we needed to do the study. They asked us safety study in mice knowing that MS is not affecting mice. They ask us the sequencing of the complete genome and not only of the few important genes for variants as we had initially submitted. They ask us also to compile a very extensive risk assessment on the vaccine strain. Moreover, we have submitted an efficacy study where we were showing that the vaccine works perfectly fine, but the USDA decided not to accept this study, because they were of the opinion that our control bird didn't show enough disease, and therefore, that the validity criteria was not met. So we are currently redoing that study. But the biggest challenge we are facing here is that only a small proportion of our submission were reviewed within the official 90-day review time frame. And since the review process is sequential, we need to have the approval of one piece of information that we have submitted before we can go to the next activity, and this is even aggravating the impact of the delays. Nevertheless, we are doing all we can to answer very fast the USDA request, and we are planning to receive the approval in 2026. So now let's talk about ECOVAXXIN MG, which is our Mycoplasma gallisepticum vaccine. So Mycoplasma gallisepticum, as it was already explained by Simon. It's a chronic respiratory disease in chicken, and it's especially a problem when the flocks are stressed or when they are in the presence of other respiratory pathogen. So it's ranking #9 in terms of top 10 disease in cage ballot in the U.S. Worldwide, the loss is estimated at $780 million and only in the U.S. at more than $140 million annually due to mortality and production losses. Our solution to this situation is ECOVAXXIN MG, which is a live vaccine containing the strain 6067, which was isolated from a turkey in the United States in 2007. It is a naturally attenuated isolate. And we have proven that this vaccine strain is safe for chicken and turkeys. This vaccine strain is also free of antimicrobial resistant gene. We have produced now a master seed. It is tested and approved by the USDA, and now we are currently running the clinical program that I will explain in the next slide. So the first thing we have done is really to test the safety characteristics of the vaccine strain. So first, we have given the vaccine strain to young birds, at 4 weeks old, and we have shown that this is very safe for the birds. We did the same with very young turkeys, 4 weeks old all as well and it's also safe for the turkey, and we also have done the safety in quails. We know with the requirement of the USDA that we need to have a safety in mice, so we have done it and it's also safe for mice. We also run a reversion to virulence study, meaning that we have given the vaccine strain to a group of birds and then let this propagated to another group of birds at several in vivo passage. And we have shown that the vaccine strain is not reverting or including in virulence. And we have also run the complete genome sequencing and have also shown that it's genitally stable. So taking all this together, we have shown that this vaccine strain is very safe. We have also run an efficacy study for Europe, what we call an onset of immunity, where we have two group of birds, one group which was not vaccinated and one group vaccinated with ECOVAXXIN MG at 4 weeks of age, and we have challenged both group at 8 weeks old. Two weeks later, when they were 10 weeks old, we have done the necropsy, and what you can see here is that the vaccinated bird have really less egg sac lesion as compared to the non-vaccinated birds. We have also checked tracheal thickness, which is a good measure to know if there is tracheitis depending on the thickness of the trachea. And we have shown that the birds vaccinated with ECOVAXXIN MG has less thick in trachea as compared to the control. So taking all this together, ECOVAXXIN MG is efficacious against ulcerative colitis and tracheitis when administered at 4 weeks old. I already said that ECOVAXXIN MG will be produced at Calier so the assay are now all validated, and we are in the process of transferring them to Calier. The product will be a lyophilized product, as you can see here, and the stabilizer and the lyophilization process is also well defined. And with some of the batches we have run the stability study, we are reaching 9 months now. And we have a very strong stability of this vaccine. The stability program is still continuing to achieve the shelf life we want. So there's still a lot of work to do on ECOVAXXIN MG, so the year will be busy. So at the beginning of the year, we will complete the tech transfer to Calier with all the assay, we will produce the working seed, and we will scale up. And in the same time, then since the efficacy study, I have shown you, it's specific for Europe, we are currently starting a study for the USD who prefer to have a pen design with more birds. So our efficacy study specific for the U.S. is coming. We will also complete the duration of immunity study by the end of the year. We will produce the batches at Calier, and we will enter the field in Europe in the second part of the year, and we will do the same in the U.S. at the beginning of next year. So we are planning the EO at EMA submission in Q1 next year and our last USDA submission should happen by May 2026 next year. So that's all what I have to do for today. So now I will let Andrew explain you the commercialization pathway.

Thank you, Natalie. Good afternoon, everyone. I'm going to take the next 10 minutes to give you a relatively brief overview of how we intend to bring the ECOVAXXIN -- poultry vaccines to market. So, first of all, starting with what is the market. Essentially, it is commercial layers all around the world. These are long-lived birds. They take perhaps 18 weeks to reach the start of lay and then they may be laying eggs for 70 weeks thereafter. So that means there is a bigger window of opportunity for mycoplasma to infect those birds. You can see roughly there's 8 billion commercial layers globally. Roughly 1/3 of those are in China. So China is an important market. What you will also see there is the yellow or gold segments on the pie charts, and that shows birds that are reared -- not in cages. So they may be barn-reared laying birds or indeed free range laying birds and that's important to bear in mind. Typically, in developed countries, we expect bio security levels to be better than they are in other markets. But as we've seen this trend to free range in the developed markets for very good reasons, welfare, being one of them. What we see is that those birds have a potential for greater exposure to mycoplasma. So worth bearing in mind. So both Hafid and Natalie have talked about submission dates for EU, U.S. and then onwards. So how do we decide where we go after those to big ones. Of course, we look at populations of birds by country and also market potential. What do I mean by that? China has huge number of laying birds, but not all of them are in a commercial farm situation, backyard birds as well, which are more difficult to access. We looked at disease prevalence, is there currently an MS live vaccine in a market or not and then built our sales estimates from there and as Natalie hinted that with Brazil. In some markets, we have to understand, do we need to do additional local studies, is the vaccine efficacious against local strains in Brazil or Indonesia, for example. So from that, we developed our priority markets in the second wave, if you like. And of course, China, a very big market, but a different approach is required for many reasons. In terms of registration, we've decided that the domestic national registration gives us certainly a likelihood of faster to market and a higher degree of success compared to an import registration. In China, currently, you're not allowed to use contract manufacturing organizations for animal health products. So that is another conundrum. What do you do there? Do you build your own significant expense? Or do you find a local partner to work with together? And I'll talk a bit more about that. So thinking about route to market. Natalie mentioned, we are working with Calier in Spain as a CMO, a bit further north than the dot on the map of Spain there, but apologies for that. And essentially, we have three different distribution routes, if you like. Some markets, we will go direct ECO to the poultry company or the vet that supports them. For example, in the U.K., other examples might be Mexico or Brazil. In Europe, we have a long-established relationship with local distributors in the various markets in Europe who currently distribute, Aivlosin. It's pleasing to know that having done an audit of those distributors by and large, we can say, yes, they have a presence in the poultry market. They have experience of working with vaccines. Cold chain is an important part of that. And by and large, have a complementary product portfolio. And then as I already mentioned in the last slide, China is different. The domestic registration, as I discussed. That also requires domestic manufacturer. And China is a big country. So you need a partner with an established distribution network, which I believe we'll have. So our ECOVAXXIN launch team have spreadsheets we look at from quite often, actually, with more than 50 different prelaunch activities identified. So I picked seven, just to give you a flavor of the sort of things we're doing and need to do. So supply chain logistics, we're dealing with vaccines, the integrity of the cold chain is important to ensure that the vaccine does what it says on the packet and delivers the customer, the results they expect. Packaging is part of that and not just packaging, but the applicator, how you physically apply the vaccine to the bird through an eye drop. Pricing policy, particularly for MG, we're not first to market, so we need to take into account our competitors and also the different distribution models in different countries so that we have some sort of alignment. It's really pleasing to be at the point where we are now supplying forecasts to Calier, our CMO, so that we can plan our manufacturing for when we launch MS. So things are -- it's really happening now, which is exciting. And I can't overstress this part here. Customer segmentation and prioritization. If you are a very large laying company in any part of the world, my marketing colleagues will tell you, yes, we've got fantastic data, this vaccine is going to provide you a x return on investment. Typically, what do they do? They want to try it themselves. We've seen that with Aivlosin over the last two decades, I would say. They want to try it -- they want to try it on their own birds in their own situation. So knowing who we need to speak to as soon as we can, post registration having those conversations, agreeing trials with those customers ensures that we can ramp up towards peak sales quicker than we would otherwise. So that's an important thing. And of course, training, both technical training and selling skills. We have made Aivlosin a $100 million product basically in the mycoplasma field. So we know mycoplasma. Many of our staff have worked with vaccines in their careers, but we need to sharpen this all. Selling vaccine is a little bit different from selling pharmaceuticals. It's a bit more like -- I've never sold insurance, but that's an analogy I would use. So in terms of go-to-market strategy, it depends for Europe and much of Asia, this is about market penetration when I'm thinking about MS vaccine. There is one live MS vaccine in the marketplace already. So most of our customers are very aware of the economic impact of mycoplasma, they understand how to use a live vaccine. They probably have very good awareness of ECO and our expertise in poultry, because Aivlosin is licensed in poultry in those markets. So it's about how do we gain market share and I've already mentioned the need to demonstrate superior return on investment and also to provide technical support to these people. For U.S.A., it's slightly different. There is no live MS vaccine registered in U.S.A. today. So we have the opportunity to be first to market, which is great, but we also need to develop the market. So a slightly different approach to rest of world. Today, Aivlosin is not registered in poultry in U.S.A. So we don't have the fantastic relationships we do with key opinion leaders and customers that we have elsewhere in the world, so we need to work with a partner who does have those relationships. As far as the marketing side of things, as you may be aware, with anti-infectives in many markets around the world, you're not allowed to advertise these products for good reasons. The political and regulatory weather in terms of vaccines and biologicals is entirely the other way around. We want to encourage, not just we, but the regulators want to encourage the use of preventative vaccines. So that is -- it's a big tick to help us market these products successfully. So it'll be bored of me talking about economic benefits and ROIs by the end of this. But this is absolutely vital. Layer egg production, it's a penny business, very small margins. So demonstrating return on investment when they are spending money on a new medication is absolutely vital. So how we set up trials? And there's probably two main types of studies you could do. You could look at the growing period. So the birds growing up to 18 weeks before they lay. Are they hitting their target weight at that time? Are they uniform weight? Because these are factors which will affect the egg production and the quality once they move into the laying period. So that's a relatively short-term study. And then, of course, you get into the laying period and looking at egg production, how many eggs, egg size and quality, all of these sort of factors as well as mortality, which takes a bit longer, which is why it's important we start early. So field trials, demonstrating performance all good stuff. Diagnostics are very important as well. Do the birds -- are they infected? And also, once you vaccinated the birds have the birds had an immune response to the vaccine? Have I done it properly? Has it worked? And it's probably a question that might come up later, so I'll jump into it now. Andrew, are these vaccines going to cannibalize our Aivlosin business? And the short answer is no. Why is that? First of all, most of our sales of Aivlosin today are in pigs. But secondly, we can create strategic control programs, including both Aivlosin and the vaccines to give our end user customers and even better solution. As an example, if you think about a young chick, how does it get infected? Often, it's from its parent via the egg. So you have a young chick that already has MS in it. So if you then try and vaccinate that chick at maybe 6 or 8 weeks of age, and it's already infected. Typically, you won't get as good a vaccine take. However, if you were to treat that young chick and remove the wild infection, that enables the live vaccine to colonize the bird and provide a much more robust protection through that bird's life. So having both Aivlosin and our MS and MG vaccines in a portfolio together is a good thing. So how do we -- what are our commercial and business advantages? We are experts in Mycoplasma control already. We've been doing that for a long time. So really, we want to go from experts in mycoplasma control to experts in mycoplasma prevention and control. I've mentioned that we can provide bespoke treatment programs, including both of these solutions. And we already have an existing relationship with our distribution network, but also the decision makers in these key accounts around the world. So in summary, what would I say, well, can we achieve our financial objectives, I think GBP 32 million for MS and MG peak sales combined? Short answer, absolutely. We've got best-in-class solutions coming here. We have great relationships within the market. We have potentially superior efficacy, particularly with MS. We have the support in terms of our technical people in the field. We understand the need to use diagnostics in a smart way. And ultimately, I believe we can provide our end user customers with a superior return on investment compared to what they're doing today, and it's coming soon. Thank you.

Right. This was the current wave of innovation. We're now going to focus on the next wave with the three projects, the very exciting projects that we've got lined up in this pipeline. Just to recap, the value of these projects on aggregate, these projects capture about GBP 133 million. So a substantial portion of the value of the pipeline is actually in these projects, which are either in clinical stage or late stage of development. I'll start with our bivalent vaccine for PCV2 and Mycoplasma hyopneumoniae. Although this is a relatively crowded market, I think -- and there are a number of competitors. We believe we, as a swine company, we believe we have to have a presence in this segment. And we also believe we have some key differentiation that we can leverage to compete on the marketplace. You have seen the productivity losses caused by these two diseases. Both diseases have significant detrimental effect on the pig's ability to grow to its optimal potential with considerable financial losses to the producers if they don't vaccinate. Our PCV2 antigen is unique in that it is the capsid protein of the PCV2 subtype C, which is in no other companies' vaccine. So it's unique to ECO Animal Health, and I'm able to say this today, because we've recently filed a patent. The beauty of this subtype is that although it is non-pathogenic and therefore, non-obvious as a vaccine antigen it provides excellent cross protection, I should say, across all 3 pathogenic forms of the virus, PCV2 A, B and D. The project transitioned from proof-of-concept to development over a year ago, and we have been busy most of that time optimizing the PCV2 antigen yield, and we were thrilled to have been able to identify a high-yielding cell line that literally 10x our productivity for the antigen. At the same time, we have continued to optimize our other valency in this vaccine which is a recent immunogenic strain of mycoplasma, that most commercial vaccines contain much older strains that are arguably becoming less relevant. Another favorable and very exciting progress we have made with this vaccine relates to its clinical potency and performance. The efficacy study you see summarized on this slide is a dose titration with it in the U.S. head-to-head with the market leader, which was MSD's circumvent PCV2/MHG2. And what you see here is that even with the lowest dose of our vaccine, which was 12.5 micrograms, we remained clinically and significantly equivalent or statistically equivalent to the market leader. And you can argue that we haven't bottomed out the minimum effective dose, and we could go even lower if we wanted to. The other positive finding in this study was that we didn't have to purify the antigen to elicit the efficacy that we've demonstrated here and this finding together with the low effective dose and the 10x yield are excellent news in terms of significantly reducing the cost of goods and enhancing the profitability of this product. So although we have had to incur a 9-month delay, 3 quarters to optimize our antigenic yield for PCV2, we believe that the product is on a much better path to compete on the marketplace than it would have otherwise been. The upcoming milestones for the project are to select a CMO, a contract manufacturing organization that can produce the vaccine for us, transition the project to full development and embark on the pivotal field safety and efficacy program. PRRVS is a key area of interest for us because of the massive unmet need, it represents across the swine industry globally, and the huge opportunity therefore, presents us with to innovate. This is how we saw it back when we started this project as a discovery program to come up with a first-in-class monoclonal antibody that would effectively tackle this devastating and economically important disease. The picture you see is of a PRRS infected pig from one of our studies, and you can see why PRRS is also called the Blue ear disease. And the Y-shape structure is, of course, a depiction of an antibody. The figure we used to quote to illustrate the significant losses due to PRRS in the U.S. was around USD 600 million. That figure has nearly doubled in the last decade or so to reach USD 1 billion. The thing to note here is that, that increase would never ever have happened if the vaccines were truly effective. It's a highly mutable virus and unless the vaccine matches exactly the strain causing the outbreak, it is very difficult to control it. And this is why we wanted to design a solution that is agnostic to the strain or variant causing the PRRS outbreak. And I believe we are well on our path to success with that pursuit as you will see shortly. When we shared with you an update on this project back in November '23, we shared data on a successful proof-of-concept study that we conducted in France in pigs infected with PRRS virus subtype 1. And at that time, we said that the next step was to improve the half-life, either the durability of effect of the antibody and to test it against the more virulent North American PRRS virus subtype 2, to really establish the evidence that the antibody construct we have is truly cross-protective. And that's what we did and the data from that U.S. study is depicted on this slide. It is strikingly similar to the outcome of the French study with statistically significant and clinically meaningful reduction in viremia and increase in body weight. This slide puts side-by-side, the French study and the U.S. study. What is similar between the two studies is the outcome in terms of significant improvement in average daily weight gain. What is different is the subtype, PRRS 1 in the French study, PRRS 2 in the U.S. The other difference is the number of treatments that given, as you can see from the study calendar at the top of each graph indicating that in the French study where we had a non-optimized antibody, we had to increase the number of treatment given to achieve sustained levels of the antibody, because it had a very short half-life, about 3 hours. And this is also reflected in the high dose administered in total in that study, as you can see from the bottom right-hand side of each graph whilst in the U.S. study, we achieved a better outcome with a single shot of a lower dose of the antibody with the improved half-life and this against a much more virulent virus. So we have gained considerable traction here by demonstrating we can cross protect with the antibody. We can reduce the frequency of treatment to a single shot. And we've also demonstrated that the antibody is safe in the pig. But we're not yet satisfied and we're not yet there. We need to further improve the potency, and we need to further improve the half-life. But we needed the data from these two studies really to gain confidence in our product concept and in order to be able to double down and invest on further optimization. What you see on this slide is that optimization at play. This is work that we do in collaboration with the Roslin Institute up in Edinburgh, where we have developed an in vitro model to screen our antibody candidates for their potency. On the left-hand side, you have two graphs, one before optimization on the far left and one after optimization, where the curve shifts to the left, which is indicative of a lower inhibitory concentration, which is what we want. The lower the inhibitory concentration, the IC50 and IC90, the better the potency. When we talk about inhibition here, of course, we're talking about inhibition of viral replication. We like that shift of the curve to the left. In this case, the potency was improved eightfold, which will ultimately allow us to reduce the dose. We also wanted to test our antibody candidate against a highly virulent strain of PRRS that recently emerged in Spain called Rosalia, which wrecked havoc across the swine industry in Spain. So we got the strain isolated and shipped to the Roslin Institute, and our antibody was shown to be high potent in stopping the replication of that strain. And this speaks to the point I made earlier about our antibody concept being cross-protective and being agnostic to the strain causing the outbreak. Besides the Roslin Institute, another partnership that is key to this project is one we have with a mostly human antibody discovery CRO, contract research organization based in Portugal, called FairJourney Biologics. And this picture here on the right-hand side is of the headquarters in Porto. What you see in the middle are different antibody structures and formats that fair journey are helping us produce and characterize. And these next-generation constructs and formats will significantly extend the half-life from few hours to several days and possibly weeks. Ultimately, we want to end up with a long-acting monoclonal antibody similar to the simulation we have depicted here on the right-hand side, which provides protection for at least one month with a single injection. The idea here is to protect the pregnant cell, particularly in the last trimester of her pregnancy, when she is most susceptible to PRRS infection and thus preventing the abortion storms that are typical of the PRRS outbreaks. So the three key milestones for the year ahead are to identify a lead candidate with the best pharmacokinetic profile, the best long-acting profile and transition it to development. Start the tech transfer from FairJourney Biologics to a selected contract manufacturing organization and start finalizing the dose and the formulation in readiness for full development. The last novel technology I want to talk about is the vectored antibody concept. We have developed to control necrotic enteritis in poultry as an effective alternative to antibiotics. The animated schematic you're about to see captures two discovery work streams that we have undertaken for this target. The first one was to discover the antidote, the single-domain antibodies that potently inhibit the two main toxins that cause necrotic enteritis. And those are what we call here, ECO antibody-1 and ECO antibody-2. And we shared with you the efficacy of these antibodies when given in drinking water back in November '23. Because giving conventionally manufactured antibodies to chickens is not economical. Our second discovery work stream was to design an alternative and cost-effective delivery modality for these antibodies. So we entered into a partnership with a university in Boston in the U.S., Northeastern University, the researchers there managed to engineer a probiotic bacteria called bacillus subtilis to express and secrete antibodies. And they did that by asserting the genes that encode those antibodies into the genome of the probiotic. These probiotics are cheap to grow and formulate. So we asked our research partners at the University of Northeastern University to do the same for our two antibodies, which they did, i.e., they inserted the gene codes that you see here represented by the Yellow and Orange DNA pieces of ECO antibody-1 and ECO antibody-2 into two separate strains of B.subtilis. The idea is to then simply administer the engineered B.subtilis in feed or in water. The B.subtilis colonizes the gut of the treated birds. It starts multiplying and expressing and releasing the antibodies and those antibodies will go on then to neutralize the toxins and prevent the damage that they caused to the gut. The concept is established, we scaled up to 300 liters of the engineered B.subtilis, and we tested it in a CHALLENGE model of necrotic enteritis. We then use the efficacy metrics derived from the CHALLENGE study data in terms of reduction of mortality and improved body weight gain. We assumed a treatment cost of EUR 0.03 per bird to forecast the net benefit to the producer in the scenario of 40,000 broiler production cycle, and we came to a range of net return between just under EUR 2,000 and EUR 5,000, which would compound to a net return of EUR 1 million for every 8 million broilers treated, which we believe is a profitable proposition to the producers looking to effectively control necrotic enteritis without resorting to antibiotic use, which is currently a significant unmet need. The next milestone for the upcoming year are to scale up to 1,000 liters, conduct field efficacy study to confirm the value of the product under real-world conditions. And as this is an novel concept, we will engage with the regulatory authorities, both in Europe and in the U.S. to really understand their expectations and pave the way to registration. That's all I have for today, and I'll hand over to Chris to talk about the financial outlook. Thank you very much.

Thank you very much, Hafid. Well, good afternoon all, good afternoon colleagues. I feel like I've got the easy job. We've heard that there's a market. We've heard that there's considerable innovation, we've also heard that we've done it from Natalie. The first product has come out the end and has now been submitted. No more work to do there. We've also heard that we can commercialize it and how we're going to commercialize it. Therefore, my slide seem like the easy job and really they are confirmatory in nature. So let's get into it. I think, the first slide is all about what have we been doing to support the activities, the modeling. I think, we can all observe from the statements today how well the portfolio has progressed since we last spoke with you. It does incorporate a mix of risk and return. As it did last time, it continues to. Some of the earlier stage programs are risky, but they're full of innovation and of course, they're hitting the very big targets. Ten days ago, when we submitted for MS, it was a milestone in my mind. We moved from our lead project being all hope or promise are less proof of new product to it being a new product, which is there in a mere 18 months' time. We have modeled these all the way through the stages of development from Discovery. We never start anything unless we actually model the outcome, and we identify a ready market for the product. And we start with population numbers. We move through treatment rates. We move through sort of disease rates, vaccination rates. And we model a phased market entry. We'll talk about that in just a second. We look at competitors, where their USPs are, where the pricing is. And through all that modeling, we identify where our niche is going to be and what our market share is likely to be. Of course, we keep a tight handle on costs, and Hafid has to work pretty efficiently with his team to ensure that he works within an envelope of cost control. And so what we end up with is a model which predicts outcome. And we have flexed that model. We end up with a base case. We have an optimistic case and a pessimistic case. The base case, which we'll show you in a second, is really the best -- the most likely outcome. There is an optimistic case, which depending on where the particular product profile comes out and what happens to the competition in the market, we could easily get to. So we've seen this over and over throughout the presentation, but this really just to reinforce the fact that 10 days ago, we had the first submission, and that really is the start point for multiple submissions. These are the first submissions for the whole portfolio. This is a -- these are nine programs and we've got annual first submissions. And the first submission in the market is then followed up by submissions in subsequent markets. This very busy slide shows the rollout of each product into each market. And you can see that we're going to be very busy with RNSs. We're going to be announcing these as they come out each time I apologize for the RNS noise that will result in that. But really, the message I'm telling you here is that this is the regulatory support for the revenue and profitability that follows. So what does that look like? So in peak year sales, we've got the products set out here. Have we talked about waves. The first wave are those first three to the left-hand side. Second wave to the middle three. And the final three are the third wave, earlier stage programs. You can see the considerable contribution to revenue that comes from that middle three. But that said, we've clearly got GBP 22 million of peak revenue coming through just from ECOVAXXIN MS. And that is the one that we submitted and that translates into peak profit contribution of GBP 16 million in time. So one way of looking at this is, okay, we've still got some risk in the pipeline. But if we take that one product where there is very little risk in there, that GBP 16 million of profit right there, and that is in the context of ECO today, which has got consensus EBITDA for the year, which is about to finish of GBP 7.2 million. So how does that build up over time? These are all the new products and the revenue contribution and the profit contribution that comes in over the next 10 years. Clearly transformative. I don't think you could describe it in any other way. And the -- if you look at how that comes in across the three waves that Hafid was describing, this first wave of the first three products, MG, MS and the Florfenicol long-acting. Clearly, it's significant, and we've got 18% of that total EBITDA contribution coming through in just this first wave. If we then layer on the next wave when the slide responds, you can see over half of that contribution is in that second wave. These are all clinical stage assets, assets which are way beyond proof-of-concept. These are assets where we our conference level from a technical point of view is increasing. And then, of course, the earlier-stage programs filling the rest of the pie chart. Expressed in a different way, what are the relative values today of these programs? So net present value is the discounted value of each of the products. And they are discounted by a discount rate of 10%, which is what we've used as cost of capital. There's a good demonstration here of progress, because if you look at that first wave of products, the difference between the life cycle net present value and the probablized net present value is very small, meaning the chance of success is extremely high. There is very little gap between the two. In the mid-stage, there is a gap, but that is a narrower gap than it was when we spoke to you in November 2023. And in fact, when you look at the little table to the right-hand side, you can see that very clearly where the total portfolio net present value has increased from GBP 330 million to GBP 481 million and risks has increased from GBP 86 million to GBP 180 million, which is a more significant increase. In just a moment to talk about risk. This is more a measure of degree of completion. So it's derived from the work that is set out in the program to start with and applying a factor to that. The risk in our way of thinking about it is if we haven't done the work, then that must remain a risk rather than a true probability of success. So moving on to valuation, which is which is a slightly frustrating element of what I'm going to say. We have here on the graph, a depiction of ECO as it currently is. The revenue rise from Aivlosin being in dark green, this is still very much a core part of the group, and it is what ECO is today. Then layering on the new revenue from the new products and showing in gold, what percentage of that total revenue comes from the new products over the 10-year horizon. And it shows that the new products will be 70% of the group revenue in 10 years' time. How affordable is this program? Well, you've all noted that the last time ECO raised any money in the market was nearly 20 years ago. We have self-funded this program right from discovery right through to the first submission of the first product, and we will continue to self-fund this. You can see the cash generation moving along here. And very importantly, you see the closing cash. Now this is ex-China cash. This is cash not including that held in China. And you can easily see that by 2029, starting in 2028, we are starting to generate significant balances. What does that mean? Well, at that point, we will start to think about how we reward shareholders for their support, and we'll start to enter into dividend programs and/or share buybacks, whatever the right approach is at that time. So that's the kind of horizon we're looking at for rewarding shareholders and really embracing and supporting shareholder value. Now I mentioned frustration earlier on, and that's where this last table comes in, forgive me. CFOs shouldn't complain about share price. But in this case, I'm going to bend your ear for a moment. When I prepared this two days ago, it showed a market capitalization of GBP 40 million. Since then, share price has gone south again. So we're standing here today with GBP 36 million. And this is for a business which has net cash of GBP 14 million in it. These are all consensus numbers. These aren't -- I'm not giving any new information. This is all in the public domain, and this is what our analysts are currently reporting. And I have no reason to contradict them at this time. So that tells you that the enterprise value is GBP 16 million, GBP 21 million when I prepared this, GBP 16 million. And this is for a business which has got consensus EBITDA for the year, we're just about to close of GBP 7.2 million. I've shown you what the net present value of the new product pipeline is even on a risk basis of GBP 180 million. Something doesn't seem quite right in here. And the point of today is to try and demonstrate this to perhaps reinforce some belief from our shareholders and to try and act as some sort of catalyst for evaluation reassessment. That's probably all I've got to say before I get really angry. And we'll move on to some concluding remarks.

Thank you very much, Chris. We are coming towards the Summit push. I'd just like to summarize a couple of key points. What we were trying to do today was to give an idea of what [Technical Difficulty] using PRRS as an example. PRRS, we've heard is cost in the swine industry, USD 1 billion a year, GBP 700 million. Our peak revenue that we are forecasting with our uniquely innovative monoclonal antibody is GBP 60 million. You can see that we're not being hugely ambitious. We are being conservative with what we think we can bring. There is huge upside there. Why are we doing it? There is unmet need there. The vaccines can't hold this virus. There's substantial economic loss. We can bring innovation with monoclonals. And I remind you that monoclonals are completely reinvented and revolutionized human medicine and companion animal medicine. And what we're going to do here is do the same for livestock medicine. And PRRS is just one example. We also heard from Hafid that we also have the monoclonal in necrotic enteritis. And just to look at the valuation corner here, just to underline this, GBP 60 million peak sales is what we estimate for is monoclonal. In a huge unmet need market, I don't think it's possible to say that we're being overly aggressive or overly ambitious on this. This is a base case number. There is significant upside beyond the base case of GBP 60 million peak revenue. And I'm just picking out one of our assets. And as Chris picked out, if you just look at MS, ECOVAXXIN MS that we submitted to the EMA regulatory authorities a couple of weeks ago. We expect that to -- it's an unmet need or a very underserved market anyway. There's no vaccine in the U.S. market. There's only one in the rest of the world. We will come with a better offering to that market we estimate that we can get GBP 22 million of peak sales, around GBP 15 million, GBP 16 million of EBITDA. That will double where we are right now. So as a valuation corner, why are we doing it? There's a lot of upside here. And we're a long way along this path. And it's great to have this event so soon after we submit it to the regulatory authorities in Europe for MS. So this is where we are. We have a diverse and maturing portfolio. In baseball parlance, we've got a number of singles, MS might be considered single. We've got a number of doubles, and we've got a few home runs in our monoclonal pipeline, truly innovative products that we can bring to the market. We have a number of ways that we can monetize this. Andrew took us through how we can monetize these assets by taking these assets ourselves to the market. We also have other ways. There's multiple opportunities to deliver value here and a number of the global animal health players have already beaten a path to our door to ask us how they could be involved either in commercializing some of these assets or in helping us deliver them to the market further and faster. So a number of different opportunities for us to commercialize these assets that we've talked about. So I will leave it there. I hope we've done what we set out to do, which should give you an insight to open the kimono a little bit on our R&D pipeline, to show you the value that we think is inherent there. And I will now entertain questions. I will take the easy ones, difficult ones, I'll pass to my colleagues. And I think we will start perhaps if any online questions, and, I think, Hannah if you are master of ceremonies, with this, there you are, Hannah?

I am. But I'm going to do questions in the room first.

You're going to do questions in the room first, okay. So we have a roving microphone. And Jens, on the front row, has a question. Hannah?

Yes, two for me. First of all, on the [Technical Difficulty]

I can repeat the question, if you want, Jens, as well.

Right. Yes. So two questions from me then. First of all, on the necrotic enteritis product, just to clarify, if I understand it correctly, these bacteria, they actually colonized the gut, they integrated in the microbiome and provide a bit more than just a transitory antibody production and productive effect. Is there a concern at all that this strain might enter the human food chain as a result. >And is that a regulatory problem at all? My second question on the PRRS biologic. Given its high sort of projected potential contribution, I think you pointed to EUR 39 million of EBITDA potential by 2035. To what extent does that factor in the potential approval of all the gene-edited PRRS-resistant pig in the U.S. later this year.

So first question was around necrotic enteritis. And the question was the B.subtilis, which is the bacteria that enters the chicken's gut and cleverly becomes the factory to produce the monoclonal. The question is, is there a concern that enters the food chain and what's the regulatory approach? So just quickly, and then I'll ask Hafid to add in the blanks. Bacillus subtilis is a commensal organism. It's everywhere in the environment. So you've got it right now, I've got it right now, it's everywhere. So that's not a problem. The regulatory approach I'll ask Hafid to mention on that, but we do need to explore that. We do actually have to explore that, so Hafid.

It is a very good question. So B.subtilis is commercialized as a probiotic across species, including humans, as well as poultry. But the one that we're developing, of course, is engineered and it has those antibodies. That's why we want to engage with the authorities to understand what sort of safety package they would like to see. But we don't have any concern with those two antibodies, because they're specific to the bird to those toxins. We don't expect that to be a huge issue in terms of demonstrating to the authorities that they're not a danger to the environment or for human food safety.

And the second part of the question was the figures that we estimated for PRRS monoclonal, do they account for a potential gene-edited pig entered into the market that would be PRRS-resistant coming from gene edit or indeed others. So the short answer is, with the enormous impact of PRRS in the industry and across the world and at $1 billion impact and vaccines at a very large number of million dollars as well, estimating GBP 60 million, we think there's plenty enough space for a monoclonal even with a gene edit pig, not least that there will be penetration ramp-up for that gene-edited pig in certain parts of the world that might be harder than others. Short answer yes, I think there's plenty of -- it is factored they're factored against all competition, both non-use vaccines and potentially gene-edited pigs. Andrew, do you want to add to that?

Other than to say completely on scientifically that to me, parisvimab, particularly when I look at the market in China, where I've been operating for 6 or 7 years up until now. We're being extremely conservative in those numbers. But I'll try and keep my enthusiasm under control for now.

The question of obtaining and keeping talent. And I got the information that some of the research you want done, you select a university to do it. So how are the universities selected? And the other interesting thing is that companies are identifying this company as a place to come to? So some very interesting sort of developments that seem to be sort of coming out for the longer term.

So, I think, we've been able to attract talent as is evident by the progress that we've made. How have we done that? Well, we try and be flexible. We try and be small. We try and allow people that join us to have a significant impact to have agency in autonomy and to be part of a really interesting, exciting journey. So we've been able to recruit and attract on that basis. Second part of the question was around the universities. And I'll make one comment and I'll ask Hafid to add on. How do we select the universities? In a simple word or sentence, we go to the globally best universities. So we've partnered for MS and MG with the University of Georgia, that's the preeminent academic institution in the world for poultry diseases and mycoplasma. So that's simply put. Hafid do you want to add?

Yes. Well, David, that's a great example, the University of Georgia, a partnership where we got those two vaccines, MS and MG. We recently talked to a big pharma company, which will remain unnamed and they said to us, we have a relationship with the University of Georgia, but we never got the chance to work with them on those. So clearly, people like to work with us, whether it's the University of Georgia or Northeastern University in Boston. We have a good relationship with the partners. We give them interesting things to do and we let them get on with it. But we are -- we supervise them on a regular basis, but they seem to enjoy working with us rather than the big companies that are slow in terms of their bureaucracy, making decisions. I think we're a lot faster, a lot more nimble than those big pharma.

I'm Sean Conroy, Shore Capital. Just on the MS and MG vaccines. You've talked about you're aiming for these to be best-in-class and you mentioned today potentially superior efficacy. Could you just remind us how important the safety element is to these from a commercial perspective and your confidence in driving uptake of these vaccines when they eventually reach the market?

So I'll start, and then I'll ask Natalie to elaborate. How important is safety? That's kind of table stakes for all vaccines. And where in the poultry house you are doing thousands of birds, maybe even tens of thousands of birds. It's absolutely critical to -- you're putting your significant amount of capital at risk. It's a significant part of the regulatory process, the safety component, which we have completed very largely, and we're very, very confident. Some of the competitors on the MG side, this has nothing to do with their safety, but it is to say that they're pretty old. So our ability to innovate against some pretty old vaccines, it gives us some opportunity. We're bringing newer technology and much newer isolates. Some of the market-leading products were isolated back in the mid-80s. So they are growing whiskers a little bit here. But Natalie, maybe a bit more detail on the safety program.

So for MS, we bring it in the field, we saw it was very safe. We saw that we didn't have any adverse event. Everything was really great. For MG, you're right. So the products that are currently in the market are pretty old. And it's why when we started this collaboration with the University of Georgia. We selected a strain that is safe. So we have -- the first thing we have done is, okay, is it safe for the chicken, but is it safe also for the turkeys, because turkey is farmed always around the farm of the chicken. So if that is spreading, what will happen to the turkeys, because turkey's industry will not be happy with the vaccination. And we have shown it with many studies now, that it's safe for both species.

Chris Glasper from Singer Capital Markets. Can we just dive in a bit more to the underlying assumptions around peak sales for the portfolio? It looks like there's been a few moving parts since November 2023. It looks like the main change was a doubling in the estimate of peak sales for MS. MG has come down a bit, PCV2 has come down a little bit, but that's obviously had a knock-on impact on the NPV of the portfolio as well, which has increased materially despite some delays that we've talked about. Can you just run through a few of those moving parts for us, please?

Yes, I'll give some headlines, and then Chris can certainly elaborate on that. MS, we saw that the uniqueness of the products and the unmet market need was driving our peak sales above what we reported in November '23, but also not just us. We actually went out to one of the industry-leading consultancies which double underlined that we were previously in November '23, a little shy for our MS valuations. So it -- ours, yes, but also third-party consolidation around that as well. And an overall comment would be where we've seen increases, it's really based on innovation, really based on innovation and discrimination of our products against competition in the marketplace.

Yes. Thank you, David. I think, that's exactly right. The way we've modeled it for all of our projects is to start from a point of view of total animal populations. Then you break that down into those populations, which are actually treated, the disease incidents. And you finally get down to an addressable market. And then, you look at the people who serve that market, who the competitors are. And with the knowledge of our target product profile, what we're actually going to be bringing to the market compared with the USPs and certain points of the competition there, you can work out to derive an expected market share. That then gives you a peak revenue, and you work back from that as to how it builds up. That's how we do the modeling. Now of course, it's natural that as you get closer to market that you reassess that and you go about it in a slightly different way. You start looking at it through the other end of the telescope, which is a real forecast and a real budget, if you like. And the reason why you do that is because, of course, you're then putting production numbers and volumes into your CMO, in this case, Calier. So doing that exercise has made a significant difference to the expectation of volumes. And I think that, of course, is helpful and entirely natural. On the MG side, we do recognize that there are already pre-existing players in the market. And we are relatively new entrants to it. So we've been very cautious in terms of what our overall market share can be or will be. That said, the Whisker's comment, which I quite like. These are the established players out there are really quite old now. And we saw this evolution when Aivlosin was first introduced. The pre-existing antibiotics in the space were quite old. And gradually, over time, the latest entrant has displaced the older players. And so we would expect the same sort of evolution in the MG space. That's not baked into the numbers. PCV2 [indiscernible], you pointed out quite rightly, that also has changed. I think we're not fully capturing the opportunity in here. We saw the numbers earlier on from L.E.K. reiterated by Hafid, huge market potential. That sort of 10x effect yield improvement that we've seen, we probably need to go back to the models and just reassess what that improvement in COGS can do to our market share statistics. But this is relatively new, and we're probably still reflecting the older COGS position.

Michael, I think?

And obviously, a very exciting presentation if we look out, obviously, over the next few years. In that context and with the amount of cash even ex-China on the balance sheet, why would we be looking to do any acquisitions given how cheap our own portfolio of assets are? And secondly, in that context and the fact that obviously, slightly putting you on the spot, but the company issued 2% of its stock in options last year. Why wouldn't buybacks be incredibly high up the agenda and ahead of M&A?

Good question. And I think M&A is only there, because it's opportunistic. But it's also there because if you look at ECO today, we have a structure, which is designed to bring regulated products to the market. And that structure has a certain cost to it, whether you produce and bring one product to the market or 10. And so clearly, there's a very valuable or effective gearing effect if you bring more products through that structure. And M&A in that context has to make sense if you can acquire it at the right price. And that's really the envelope, which covers that approach. It's not that it's higher up the agenda than share buybacks. When you saw an RNS probably a few weeks ago when we sold some old licenses to South Africa. We mentioned in there that we would be engaging in another share buyback program subject to shareholder consent. And the only reason it's subject to shareholder consent is, because the shareholder authorization at the last AGM has now expired, so we need to get that reauthorization to do that. But we absolutely will. I think, if I speculate for a moment in terms of the share price movements we've seen over the last few weeks, it's very low volumes and where we to buy those shares, those lose shares in the market, then perhaps that would have provided support.

I've got a few questions online. So a few here focusing from China. How much of the peak sales number across the ECOVAXXIN assets come from China?

It varies a little bit. It varies from project-to-project from a maximum of half to maybe 20%, so 20% to 50%. And remember that 50% of the accessible market for sows and pigs is in China. So it's kind of proportionate to the size.

Would a Chinese partner want to see real-world efficacy in market sales before taking the product on?

No, I think, is the short answer. Because we've engaged in some conversations, what potential partners want to see is they do want to see a body of evidence. So they want to see scientific proof that does not necessarily have to mean that it needs to be launched in the U.K., the U.S. or Europe before there would be engagement in China.

You say you're looking at a number of M&A opportunities. Would this be asset acquisitions or full company's development stage or revenue stage.

It could be either. The two that are currently on the table are individual product assets, not companies that we're looking at. But to Michael's earlier comment, why would we do that only if it's financially and strategically sensible? And we look at that against the assets that we have in our portfolio. So how much is it costing us to develop such an asset and what it will return and then how much it might cost for an acquisition. And you can actually see from our history that we've looked at a lot, but we haven't actually paid for anything yet because we haven't found the right asset that's been, A, what we want, B, fits strategically and, C, most importantly, is financially sensible. But if there's A, B & C work, we do it.

Last one for now. What is the epitope of the PRRS monoclonal, something that is highly conserved and how has it been able to work so well across strains?

Hafid, would you like to?

Excellent question. We refrained from disclosing the target in the past. We filed the patent. So I'm going to tell you. It's the receptor. The specific the subsection of the receptor with which the virus engages on the macrophages to enter the cell. So it's not the virus we are targeting. We're targeting a specific receptor on the host cells. Does that answer the question?

Let's hope so. As a follow-up, is this an asset you would seek to partner?

Is it an asset we would seek to partner? Potentially, the answer would be yes. However, we're quite guarded with that particular one, because we see the value. And it's not one that we would want to give the value away either cheaply, easily or without due consideration.

And another one, would any of these new products have helped with Avian flu in the U.S.?

None of these products -- projects that we've talked about today would have helped. We do have a platform technology that theoretically might in the future. But what we talked about today, no, not specifically.

That's it for now, thanks.

Excellent. I think there's some more questions from the room. So behind you, Hannah.

Andy [ Bamford ]. Certainly, over the last couple of years, you've dangled the carat of partnerships. Can you be specific in the sense of, are you looking to partner individual assets in individual territories or is your mindset more in an overarching sense of partnership? And the second question related to that, when these pharma companies that have been passed through your door, as you describe it, how big a gap is there between your risk NAV and their appetite?

So first answer or first question, do we have a preference for what an arrangement of strategic partnership might be? Probably, we would have a preference for regional and by asset, because that is most likely, we believe, to be the most rewarding, the most financially best for us. The second part of the question, how big is the difference between valuations is essentially the question. Not all of these approaches have got to that level of detail, Andy, I'd have to say. But one of them, which was to reference my first answer was a particular geography and was a commercial distribution potential arrangement. The numbers that were coming to us were fractionally higher than we had, fractionally higher than what we have displayed today.

So what prevents these from getting over the line?

Assessment, making sure that we've worked up all our different avenues of opportunity. And we haven't -- we've only taken -- we've not overly gone out to the market to seek approaches. We're organizing our activity on a one-by-one basis. And I think actually, we need to -- what's stopping us getting over the line is making sure that we are assessing all approaches and all of our assets in the right way. To, simply put, Andy, another way to say that is we're not just going to say yes to the first person that asks.

No. I mean, it's been a great presentation and in stock markets of yesteryear. You might get some credit for it. But there is a show-me mentality today and partnerships might show you before sales.

Yes. And we see that, and that's one of the reasons that we are trying to entertain it as much as possible. But we do really want to do it in a considered way. We have other opportunities that we're considering in China as well, which are separate and different. But we have -- again, we are not happy with one of the approaches that we've got in China over a couple of our assets because currently, at this stage, it's too low. So where we've got that too low approach, we will go and find some other approaches. Anything you want to add, Chris?

No.

One here.

Edward Sherman from Singer Capital Markets. Just one on the delays to the MS vaccine approval. You've obviously had some pushback in terms of what you need to do and it seems to be -- there needs to be extensive work done in terms of you've demonstrated efficacy, but it wasn't accepted. So I just want to understand, do you guys know what you need to do now in terms of demonstrating efficacy to the U.S.? And how long will that take?

Yes, we do know what we need to do. So the delays have been several component parts. One, lack of response, as Natalie and Hafid mentioned. One was please do more studies and some surprising ones like find out what's happening in turkeys and mice and quail, by the way, do a full genome assessment. That was a bit surprising. And then one study that where they believed that the placebo group didn't quite get sick enough. And we know where those levels lie. And do we know how long that's going to take? Yes. The timelines that we show here factor our assessments of the length of time it's now going to take us for approval in the U.S. Does that -- did I cover it?

Have you factored in the costs as well?

The cost is factored, yes, the short answer. The cost is factored in the to-go cost on a couple of slides that we've shown in the blue chevron or figure. And that's the R&D that's still required to go to get to approval in the U.S. and Europe. [ Melvin? ]

Just one quick one, really don't want to stop everyone from drinks here. Would the management, CEO, CFO here consider selling off one of the molecules basically and unlock value or very kind of keen to keep it in-house and take it the finishing line?

Flippantly, I'm tempted, [ Melvin ], to say have you got an offer for us? More seriously, yes, we would consider that. But again, on the parameters of -- is it really going to be what is in the value for the company? What is worth it for the shareholders, time value of money now and later. So yes, theoretically, we would. But show me the color of your money or somebody else's money before I could sign.

Have you got kind of interest from commercial bigger players is my question, which the management has rejected in the past and which is currently are not a live deal?

We haven't rejected any in the past, and there are several approaches right now. They're not necessarily at the stage of x million sterling or what have you. Some are -- will develop to that point, I'm sure. Well, thank you very much to everybody online. Thank you to everyone who attended in person. And thank you, particular thanks to the speakers, and we will draw the afternoon's proceedings to a close. Thank you very much.