Full Year 2022 Allergy Therapeutics PLC Earnings Call Worthington, West Sussex Sep 29, 2022 (Thomson StreetEvents) -- Edited Transcript of Allergy Therapeutics PLC earnings conference call or presentation Thursday, September 29, 2022 at 11:00:00am GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Alan Bullimore Allergy Therapeutics plc - Head of Communication & Market Development * Manuel Llobet Allergy Therapeutics plc - CEO & Executive Director * Nicolas Alexander Ulrich Wykeman Allergy Therapeutics plc - CFO & Executive Director ================================================================================ Conference Call Participants ================================================================================ * Lala Victoria Gregorek Trinity Delta Research Limited - Research Analyst * Patrick Ralph Trucchio H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst * Paul Cuddon Numis Securities Limited, Research Division - Director for Healthcare Equity Research ================================================================================ Presentation -------------------------------------------------------------------------------- Manuel Llobet, Allergy Therapeutics plc - CEO & Executive Director [1] -------------------------------------------------------------------------------- Good afternoon from London and many thanks for joining us today for Allergy Therapeutics' preliminary results for the year ended 30th of June 2022. It is lovely to be joined by those in the room after past year of virtual meetings and a warm welcome also to those joining us online. With me here today, we have Nick Wykeman, Allergy Therapeutics' Chief Financial Officer and our Head of Business Innovation, Alan Bullimore. And before we begin proceedings, I will quickly bring your attention to the standard disclaimer slide, which is included in this presentation for completeness. So let's go through the disclaimer. And let us start the presentation on Slide number 4, we are seeing here the main highlights -- financial highlights reported sales of GBP 72.8 million, reflecting planned streamlining and operating profit pre R&D of GBP 3.4 million and a net loss of GBP 13.8 million, ending the year with a cash balance of GBP 20.5 million. On the operational side, we are mainly focused on the clinical developments. We have got a highly successful exploratory field trial, G309. FDA gave us green light to start PROTECT the study, which is the Phase I trial for our Peanut vaccine and everything is ready for the pivotal Phase III trial, which is about to start. So if we take a quick look at the business and strategy. I can say that this has been a year where we have made material progress on the key pillars of our strategy. If we look at the pipeline, the most important project, as you know, is the Peanut development. We completed all the preclinical work and all the package for the submission to FDA that was granted. Also worth to mention the study that we conducted with Imperial College London that was a study to test safety in human blood sample. We got results much better than expected, where we saw a reduction of 24-folds in basophil and histamine release. And that gives us confidence to go ahead with the Phase I with PROTECT study. Then in Europe, the most important factor has been the focus on highly differentiated products. We'll talk later about it. And the U.S. preparations have been focused on the G306 preparations and post analysis of the G309 trial. So I'll hand over to Alan now to give us a little bit more flavor on the clinical progress. -------------------------------------------------------------------------------- Alan Bullimore, Allergy Therapeutics plc - Head of Communication & Market Development [2] -------------------------------------------------------------------------------- Thanks, Manuel. So the pipeline won't have changed over the last year from those of you who can remember. And as Manuel said, the key -- the key projects moving forward are the Grass Phase III, moving into the pivotal Phase III trial due to start this year. And then also looking forward to the start of the Peanut trial. We then would look to move into the Birch/Ragweed products thereafter. So as Manuel mentioned, we've had a great year in terms of Grass. The exploratory Phase III field study delivered a 40% improvement compared to placebo, which is as far as we're were one of the highest efficacy rates that we've seen in a field trial. We are due to start the Phase III -- the pivotal Phase III, the G306 very shortly. It's a fully funded study. It's around 1,200 patients looking at a 6 injected course over a period of about the 13, 14 weeks duration. In Europe, should the G306 be successful, we then just need to commence the pediatric trial, and then we will begin the registration process in Europe. And then for the U.S., we will need to complete a small safety database that we've spoken about previously that the FDA requires. And then we would be in a position to file the BLA in the U.S. Key products moving forward other than Grass would be the Ragweed and Birch and they would follow after the completion of the Grass pivotal Phase III. For the Peanut program, again, as Manuel mentioned, excellent results from the 001 trial that we did in collaboration with Imperial College London. Large reductions in basophil activation and subsequent histamine release. This gives us the confidence to move forward with the first in human study, which is due to start very shortly. The study is split into 2 parts, Part A and Part B. Part A is open label, is going to be looking at injecting healthy subjects subcutaneously and then doing skin prick testing in peanut-allergic patients. Before we then move on to Part B, which is a -- the close part of the study it will take slightly longer before we can read out the results because it's blinded, where we start to do up-dosing in peanut allergic patients. And we start to do subcutaneous up-dosing. Top line is expected around summer '23 in terms of that first part. As we've already announced, all of the materials, obviously completely manufactured, Scale-ups come up to measured in the hundreds of little sizes, and we're ready to go. Obviously, a very large market, around $8 billion food allergy market, current treatment therapies have to be taken daily, they can be quite cumbersome. So this really could -- if this shows the results that we hope it will, really could be transformative to patients with peanut allergy. So at that, I'll hand back to Manuel for covering Europe. -------------------------------------------------------------------------------- Manuel Llobet, Allergy Therapeutics plc - CEO & Executive Director [3] -------------------------------------------------------------------------------- In Europe, where we are running the trading business, it was affected by the streamline of 2 non-differentiated products. That was a strategic decision we made to focus on highly differentiated, value-added products. And therefore, we were focused on that, and that had this impact on the sales, which is the main factor that explains the sales results of this year. We are convinced that the way forward in this market are short-course vaccines as opposed to very long course treatment, like the ones that we have in U.S. or in Europe with oral treatments. And therefore, this ultra short course concept, which is the base of the MATA MPL platform or Pollinex Quattro platform as well, it will be the base for the peanut vaccine, which we expect to design an ultra short course vaccine too. These are the kind of value-added products that we want to bring to the market, and it's going to be our strategic focus for the years to come. The revenues were also affected by some other factors like COVID in Germany during the last quarter. Last year, many allergists were injecting COVID vaccines that had an impact on the fourth quarter of our German sales. Some other factors like works in the factory that affect the supply chain, some delays at the year-end. We had some delays also distributing the products. So all these factors, including exchange rate that was quite adverse made the sales to decline in the last fiscal year. Though as you can -- as you see, we've been growing double digits for almost 2 decades on a row, and that should be an exception. The good news is that the core business, the key products that we want to preserve in the portfolio and to keep developing are in good shape. We had a robust performance, as you can see here in this bar chart, and we had outside Germany, good performance in markets like Spain, the Netherlands, U.K. and rest of the world where we had double-digit growth. Also good performance on products like Pollinex, which, as you know, is the previous version of Pollinex Quattro. This product is registered in many European countries, the Netherlands, the U.K., Switzerland, Czechoslovakia, Poland, and that this product is growing double digit very nicely. Venomil also is an important product that is emerging one -- as one of the best products in our portfolio and Acarovac which is the House Dust Mite vaccine that we commercialize in Spain, also with very good performance. If we take a look at the U.S. in Slide number 14. I think here, this slide we have shown sometimes and the only message here is that we are probably closer than ever. That's the pivotal trial that will read out in October, November next year. If positive, that will open the door for the U.S. market, as Alan said, we'll need to complete the safety database. And after that, we'll be ready to submit the biological license application in a market that is yet an untapped opportunity. So there are not pharma grade products in the SCIT segment. As you know, that tablets have not got any commercial traction in this market. And if Pollinex Quattro Grass gets registered can capture an important part of the share of this relevant market that it is estimated to be worth $2 billion to $3 billion. In next Slide 15, to remind you that our ambition in the U.S. is not to be a one product company. We are also -- we have also INDs opened for products like MATA MPL Ragweed, where we did Phase I trials, Phase II and Phase III trial. And also, we have an IND open for MATA MPL Trees where we reach Phase II. These products, once we complete the Grass development, we want to incorporate in the U.S. portfolio, along with the VLP Peanut or Polyvac Peanut but we'll confirm the portfolio that we intend to commercialize in the U.S. market. And now I'll hand over to Nick, that will talk about our sustainability strategy. -------------------------------------------------------------------------------- Nicolas Alexander Ulrich Wykeman, Allergy Therapeutics plc - CFO & Executive Director [4] -------------------------------------------------------------------------------- Thank you, Manuel. Moving to the next slide, that's Slide 17. Last year, we talked and gave an outline of ESG strategy. This time, we've actually gone into some more detail and put some skin on the bones. So here, as you can see, we split it into 4 pillars. The first pillar is to do with the Planet. So what we've set ourselves are some targets for emission reductions and I have to say our progress over the last year has not been great. We've actually increased the amount of emissions, and that's really a reflection of -- as the end of COVID has occurred, there's been more activity, more travel and things of that sort. We have set the targets which we show in the bottom line, so to that to reduce the Scope 1 and 2 emissions by 45% and Scope 3 emissions by 20% by 2030. The actions which are currently undertaking, as many of you will have heard, we're actually building an energy center of our own. So that will remove the necessity to use the GSK facility, and that should lead to lower energy use. And also, we've been looking at various other changes we can potentially make in the factory to reduce the energy level there. If you look at the second column, which is about People. I think the progress that we've made, I think the Board diversity, we've reached that -- we reached that target in 2021. And also, we've reduced the gender pay gap in the U.K. We obviously continue to work on various things to do with people, whether it's internal or external. And also, one of our key markets, which is around a target, which is around employee engagement and our ability to achieve those goals. Moving on to the third pillar, that's the -- all about the Patients. Naturally, obviously, as a pharma company, our absolute key thing is looking after the patient. We've been very active in involvement with patients. As you may well know, we already are quite active in bringing education to patients about what potential treatments are out there in the market in a general sense, what type of allergy treatments are out there. We've become involved in some of the patients, groups around peanut and also on -- obviously focusing on our quality culture and as well as that, looking in our trials to try and make them as patient-focused as possible in other words, improving the education that patients have before they join the trials and so on and looking to how they will be treated in those trials. And then if we look on to the fourth area, which is Responsible Operating, and we obviously have a Global Code of contact -- Conduct and Ethics, a Speak Up Facility and a very close safety culture. We've been working very hard in our factory and also in the whole environment of our work in relation to safety and accidents and so on. Okay. Moving on to the financial results, and that's Slide 19. As Manuel has talked about, the revenue for the year is GBP 72.8 million was down 14% on the prior year. That's 9% in constant currency terms, and that was obviously affected by the streamlining of the business plus a variety of other factors that Manuel's talked about. On the gross profit level, we have gross profit margin of about 68%. That really reflects the fact that we did -- the revenues on the top line did reduce. And like any other pharma business, we have a lot of fixed cost in our manufacturing. The cost of running the facility is quite high. As well as that, we have been investing further in the facility, as Manuel talked about for various upgrades and so on. So that obviously has been a bit of a drag. In terms of overheads, obviously, coming to this year, we were already planning for this reduction in the revenue. So we've held the costs very tight. So we only got a 2% increase in overheads across the year, which is pretty good as we came out -- started to come out of COVID. So that gave us an operating profit pre R&D of GBP 3.4 million, which I think is quite a robust performance given all the challenges we saw in the market. We have R&D spend of GBP 15.7 million. As you would expect, we're starting to increase our spend through the successful 309 Grass trial and all the work preparing for the Grass Phase III trial, which is about to start and the preparation for the Peanut trial as well. We have also been investing further in our own infrastructure in R&D, and that is a reflection of taking control because our feeling is that, that one of the reasons we were successful in the 309 trial is we brought various of the functions in-house rather than depending on third parties, and that has further strengthened our position. So overall, we made an operating loss of GBP 12.2 million and then obviously, financial costs and tax, tax which is always affected by IFRIC 23, one of my favorite standards left us with a loss after tax of GBP 13.8 million for the year. Moving on to the next slide, which gives us a view of the balance sheet. So I think really the critical items here to point out is inventories are still up a bit like a lot of other businesses, we've been buying in a lot of raw materials to give us some protection. The global supply chain still hasn't been really sorted out. And with the problems in Ukraine, it seems to have got worse. So therefore, our inventories are quite high. The trade and other receivables are up. We've made some prepayments in relation to our trials. At the end of the year, we were left with cash of GBP 20.5 million. That's still a strong figure considering what we've invested in the research and development and once I'll come on to talk about the fundraising a bit later in the presentation. And at the end of June, we had debt of GBP 2.4 million. I'd like to point out that we have a revolving credit facility of GBP 10 million, which is completely undrawn at the end of that period. Moving on to the next slide, which is Slide 21, which is the cash flow. I think there's not much really to say here. Obviously, the lower performance in the business has affected the overall cash flow if we compare with the prior year, but the main driver, obviously, of the reduction in cash over the period has been that investment in research and development over the period. There has been a certain amount of extra expenditure on CapEx. That relates to the energy center. I think that's probably all to say on that. So moving on to the fundraising. We're now on Slide 23. So we just completed yesterday a successful fundraising of GBP 17 million. That was an equity raise of GBP 7 million, which is at a price of 20p, which is actually above the market price. I'd like to point out that and the loan notes, we had GBP 10 million of loan notes we also raised. That's subject to a general meeting vote. However, we do have irrevocables for about 82% of the shares. Just talking about the loan notes to give you some idea about what that will involve. So it's GBP 10 million worth of loan notes. There are warrants attached to that to the same value with an exercise price of 30p. Those loan notes will be issued in February '23. The interest rate is 8.25% above the Bank of England Rate. That obviously is quite a high interest rate, but that obviously reflects the fact that this loan is unsecured. There is a negative pledge but it's an unsecured loan. And finally, moving in relation to the fundraising. Slide 24, and we've given here some detail of what we're actually spending the money on. So first and foremost, obviously, critical is the balance of the Grass Phase III trial, which Alan has talked about. We did highlight earlier that we were increasing the number of patients from 940 to 1,200 in order to increase the confidence level, which is absolutely critical. And as well as that, it includes some initial funding for the G306 b. That is when we finish the G306 trial, what we want to do is to take the placebo arm of that trial and for those placebo patients to be treated with the active product that has a benefit in the longer term. So it starts to build up our safety database, but at the lower cost than if we were to do an independent trial. Thirdly, it was to complete the funding for the Phase I Peanut trial, which Alan has obviously talked about. But also importantly, this was to pay for the IMP batches for the Phase II Peanut trial. And the reason that we brought this funding through at this moment is, as you can imagine, we have a third party who produces these batches for us. And there's quite a long time line in order to get these manufactured for them to sit on stability and those -- and that product to be available for a Phase II trial. So we want to minimize the length of that we have to wait before we start the Phase II trial. As well as that, we -- it is also to fund part of the fixed cost of R&D. As I mentioned earlier, we're investing more in our fixed area of R&D, the staff we've got in-house in order to take control of the trials, and that means it does need some support by equity or debt funding. And some preparation for the U.S. market as well as we move forward with 306. And moving on to the summary and looking at the key milestones, which is on Slide 26. As Alan has already talked about, we'll be starting the Phase I Peanut trial shortly. That's a trial that's taking place in the U.S. And then a bit later in the autumn, we'll be starting the Grass Phase III pivotal trial, which is our key trial for Pollinex Quattro Grass. As to the results, the Phase I Peanut trial, the readout will be in the summer of next year as it notes in the box below, we'll be going through a series of cohorts, so we will be able to report to the market as we move forward across those cohorts. We won't be able to give details of -- of results of the trial, but we will be able to indicate we've moved to the next cohort. And then the results from that Grass Phase III pivotal trial will come in the autumn of next year. And with that, I'll hand over to Manuel Llobet to talk about the summary and outlook. -------------------------------------------------------------------------------- Manuel Llobet, Allergy Therapeutics plc - CEO & Executive Director [5] -------------------------------------------------------------------------------- Thank you, Nick. Yes. So next year will be dominated by clinical news flow. We have 2 important milestones, as we have been mentioning, the completion and readout of the pivotal Phase III Grass trial and the completion of Phase I trial and as soon as possible, start with the Phase II trial for the peanut vaccine. This will be 2 really important results for the company, 2 key inflection points that will be game changers in their respective fields. So the outlook, we are very excited, looking forward to report to you on these results. And the trading side of the business will be driving growth across the streamlined portfolio that, as I said at the beginning, are made of highly differentiated value-added products with focus on innovative approaches to allergy treatments. So that brings me to the end of our presentation today. So we'll now take any questions. Firstly, in the room and then on the phone lines. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Manuel Llobet, Allergy Therapeutics plc - CEO & Executive Director [1] -------------------------------------------------------------------------------- Lala? -------------------------------------------------------------------------------- Lala Victoria Gregorek, Trinity Delta Research Limited - Research Analyst [2] -------------------------------------------------------------------------------- So I have a question about your commercial business. You've indicated that you're expecting a return to growth on the revenue side for next year. Can you talk a little bit about how you're expecting your major market, Germany specifically, the headwinds that unwind for next year? And also, if you've got any insights that you can share for financial year '24? -------------------------------------------------------------------------------- Manuel Llobet, Allergy Therapeutics plc - CEO & Executive Director [3] -------------------------------------------------------------------------------- Right. Yes. So I think in Germany, we've always got a good position. We have a really good team. Some of the headlines, clearly, the headwinds clearly are not going to be there. For example, the one that I mentioned, when in October, November, December, many allergists were vaccinating COVID. It seems that COVID is now totally under control. The exchange also shaved 5 or 6 points to our growth provided the parity that we are seeing this year, we don't expect that to inflict additional damage next year in Germany. And the portfolio that we have in the market once we have removed these 2 me-too products, it's best-in-class. So I believe that the performance, if nothing extraordinary happens or something, anything unpredicted should be good. We have talked also that there are some pressures and discussions on reimbursement on certain products. But we believe that, that will not affect materially the development of our commercial performance in that market. The other markets, we see a good outlook. As I said, almost all the other markets were growing double digit last year. And we would expect this to keep happening. In terms of the macro figures for next year, I'll hand over to Nick. -------------------------------------------------------------------------------- Nicolas Alexander Ulrich Wykeman, Allergy Therapeutics plc - CFO & Executive Director [4] -------------------------------------------------------------------------------- Thank you, Manuel. Yes. Yes, as Manuel said for next year, I think '23 we're probably looking almost double-digit growth. I think we'll probably expect '24, and that's obviously subject, as Manuel said, to unknown [forces] but we would generally expect to continue that. We -- that's something we've seen over quite a long period is the fact that we have grown our sales on the back of the high-quality products that we have. They really are leaders in class. And I think also, as we've noted in the press release, we are in the middle of the TAV process. It is a challenging process. However, that also has another side, which is also challenging for our competitors. And we're starting to see that in the German market as some of the competitors, their products start to drop away in various areas, and that should open up opportunities for us as well. So we would expect assemble type of growth for 2024. -------------------------------------------------------------------------------- Paul Cuddon, Numis Securities Limited, Research Division - Director for Healthcare Equity Research [5] -------------------------------------------------------------------------------- I've got 2 questions, please. Firstly, on the kind of outlook for the consumer being a bit challenging in kind of Europe, cost of living, lockdowns, energy or that sort of stuff coming through now. Could you remind us how much sort of out-of-pocket expense kind of goes into these kind of treatments within Europe? Is it all government reimbursed? Do you expect more pricing pressure to come? And then secondly, just on the kind of inventories of the raw material that go into the products, any kind of disruption there through kind of various macro kind of issues that are going on globally? -------------------------------------------------------------------------------- Manuel Llobet, Allergy Therapeutics plc - CEO & Executive Director [6] -------------------------------------------------------------------------------- Yes. We -- so far, we have not seen any change on the reimbursement policy. So normally, in Northern Europe, it's fully reimbursed. Southern Europe, it's partially reimbursed. In Spain, for example, is 50% in Italy, depending on the region. In Portugal, for example, is 0. But our -- the bulk of our sales that are coming from Northern Europe, it's fully reimbursed. In Germany, there is, from time to time, the rebate changes. So sometimes the government asked the companies to increase the rebates that has not been confirmed during the last year, not this year, but it's something that eventually could happen. But in terms of reimbursement, we do expect to keep, to keep our products with the same reimbursement policies. Your second question, sorry, it was... -------------------------------------------------------------------------------- Paul Cuddon, Numis Securities Limited, Research Division - Director for Healthcare Equity Research [7] -------------------------------------------------------------------------------- Raw materials that go into the vaccine, the [pollins]... -------------------------------------------------------------------------------- Manuel Llobet, Allergy Therapeutics plc - CEO & Executive Director [8] -------------------------------------------------------------------------------- Yes, there's been inflation. Of course, maybe you want to add something, Nick? In some specific supplies. There's been a big impact, though, fortunately, it's not been that material for the cost of goods as a whole. And the biggest problem has been the supply chain itself. We've got some parts, kind of things like filters, very specialized filters and some other things that where we have got a struggle to get supply. In the end, we've been able to keep with our supply chain with big -- without big disruptions. But the global supply chain is in bad shape, and I think it's not only in our sector. We -- our sector was affected especially by COVID because most of these very specialized parts were kept for COVID vaccines and all the vaccines that were not COVID have not the same access to these things. But in general, I think we -- our team has done a very good job. And in terms of inflation, maybe you want to add something else? -------------------------------------------------------------------------------- Nicolas Alexander Ulrich Wykeman, Allergy Therapeutics plc - CFO & Executive Director [9] -------------------------------------------------------------------------------- I think we are seeing inflationary pressures. I mean, for us, actually, the largest cost is the employees. But if we look at the other areas, the raw materials, we're certainly seeing quite a lot of pressures coming through. We're obviously negotiating hard, but I think inevitably. But it is a small -- relatively small percentage of the overall costs. And obviously, we'll do whatever we can to try and control that. -------------------------------------------------------------------------------- Operator [10] -------------------------------------------------------------------------------- (Operator Instructions) We will take the first question from Patrick Trucchio from H.C. Wainwright. -------------------------------------------------------------------------------- Patrick Ralph Trucchio, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [11] -------------------------------------------------------------------------------- All right. Just a follow-up on Peanut (technical difficulty) or about expected to be generated (inaudible) looking for group (technical difficulty). -------------------------------------------------------------------------------- Unidentified Company Representative, [12] -------------------------------------------------------------------------------- And we'll give (inaudible) but you could see (inaudible) so I think we someone (inaudible) need to know we need to finish the line (inaudible) Sorry about that. -------------------------------------------------------------------------------- Manuel Llobet, Allergy Therapeutics plc - CEO & Executive Director [13] -------------------------------------------------------------------------------- Sorry, yes, we couldn't hear very well. I think the team is trying to solve the issue to understand exactly what was the question. But in the meantime, we have another question in the room. So please go ahead. -------------------------------------------------------------------------------- Unidentified Analyst, [14] -------------------------------------------------------------------------------- Yes. On the gross margin -- the gross margin impact (inaudible) Yes, sorry. The gross margin impact was quite substantial. So obviously, top line, we see there's headwinds in Germany that I understand. But it's the product portfolio streaming, does that translate into an improved margin on the products you've selected? So you're going to return to double-digit growth. That's fine. Reduction in sales because of headwinds. But the streaming, shouldn't that improve the margin? so you're selecting high-value products, right? -------------------------------------------------------------------------------- Nicolas Alexander Ulrich Wykeman, Allergy Therapeutics plc - CFO & Executive Director [15] -------------------------------------------------------------------------------- Yes, that's correct. The products that we removed from the portfolio are well -- are lower margin, although I have to say all our products are have good margins, but certainly -- it's certainly lower margins than some of the other products. However, we've also -- that margin also reflects the fact that we've increased the manufacturing costs as well which I mentioned, we've done investment in the manufacturing, which part of it is capital items, but also is expenditure items is actually investing in extra employees in the factory, and it's a variety of other things. It's also increases other costs. So therefore, that also affects the overall margin. But... -------------------------------------------------------------------------------- Manuel Llobet, Allergy Therapeutics plc - CEO & Executive Director [16] -------------------------------------------------------------------------------- Also, we had a natural price reduction of 5% due to exchange because our products in pounds were 5% lower due to the exchange rate that affected the gross margin too. -------------------------------------------------------------------------------- Unidentified Analyst, [17] -------------------------------------------------------------------------------- We see it -- we expect to swing the other way in terms of historic margin, right? So you've made changes, you picked higher-margin products, exchange rate will stop. Can we expect a reverse of that? -------------------------------------------------------------------------------- Manuel Llobet, Allergy Therapeutics plc - CEO & Executive Director [18] -------------------------------------------------------------------------------- Yes. Not immediately, but clearly, these products and especially once we get them registered, and we start commercializing in the U.S. market, we should see a material change on the gross margin, but it's not going to happen next year. Do we have the question from the [row] Okay. -------------------------------------------------------------------------------- Unidentified Company Representative, [19] -------------------------------------------------------------------------------- This one is actually coming through from Mike who's on the phone. You would like to know how the regulatory engagement is going on peanut in light of the DBV withdrawal. Is that the reason that Peanut starting later than expected? Or is it more to do with what you're doing on your clinical program? -------------------------------------------------------------------------------- Manuel Llobet, Allergy Therapeutics plc - CEO & Executive Director [20] -------------------------------------------------------------------------------- Do you want to handle that? -------------------------------------------------------------------------------- Alan Bullimore, Allergy Therapeutics plc - Head of Communication & Market Development [21] -------------------------------------------------------------------------------- Yes. So the interactions that we've got with the FDA are going fine. We're not -- I'm not aware that we've had any conversations with FDA about anything that's happened with DBV. It's not impacted our program. The program is still on track. We are -- IMPs at sites. We are beginning recruiting, so we should be in a position to start the trial on time. -------------------------------------------------------------------------------- Unidentified Company Representative, [22] -------------------------------------------------------------------------------- Well, the question for Wainwright is going to come through. So just going to try to do (inaudible) it doesn't work (inaudible). There no other questions from the webcast. (inaudible) you got -- might mentioned in the room. -------------------------------------------------------------------------------- Manuel Llobet, Allergy Therapeutics plc - CEO & Executive Director [23] -------------------------------------------------------------------------------- Good. So are we going to have it? Yes? No? -------------------------------------------------------------------------------- Operator [24] -------------------------------------------------------------------------------- The next question coming from Michael Mitchell. -------------------------------------------------------------------------------- Manuel Llobet, Allergy Therapeutics plc - CEO & Executive Director [25] -------------------------------------------------------------------------------- Thank you very much to everyone for coming along today. And thank you, Nick and Alan for joining me. And if you have further questions, including this from H.C., then please do get in touch with us directly. And I hope you all stay safe and well, and we look forward to update you on the progress of these trials as soon as possible. Thank you very much, and have a nice day. Thank you.