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spk06: Good day, everyone. Welcome to our report on H121 financials and general business updates. Well, the first half of 2021 has been marked by tremendous success on our R&D side of the business. We have nicely delivered against our key major R&D objectives. And of course, the most recent new slow probably at this moment in time, the most important one is related to our chikungunya vaccine. We are very proud to be the first company in the world that has successfully delivered a phase three for a chikungunya vaccine, which continues to be a significant unmet medical need. We made excellent progress on our other clinical assets on Lyme. We successfully recruited the the additional phase two study called VLA15221, which includes also now the full pediatric target group, which is a key prerequisite for having the entire target population taking part of the future field efficacy study. And for our COVID-19 vaccine, VLA2001, we have successfully completed the enrollment and are now proceeding with the serology testing. Despite of our commercial travel vaccine still being heavily adversely affected by the ongoing pandemic, we have a strong financial position and platform. We successfully conducted our US IPO according to plan with net proceeds of more than $100 million. And we have cash and cash equivalents today of more than 300 million euros. And this is something that will be further detailed as part of the financial report. Let me first talk about chikungunya. The primary endpoint of our study, VLA 1553301, was to measure seroprotection. Seroprotection is the amount of study participants that showed protective neutralizing antibody titers. We have agreed on a surrogate of protection. This surrogate of protection was developed together with the agencies and based on a passive transfer study in non-human primates and a few other supporting non-clinical experiments. We have shown 98.5% of subjects reaching those protective levels after a single shot, and this has been even better than one could have hoped in this regard, and it's really remarkable for such a type of vaccine. It is also important to note that we have seen a similar level of seroprotection in the elderly, not only in the younger adults, which, again, is a great result. It is also important to note on this slide, which is slide number six, that with 98.5%, we are well, well above the FDA non-acceptance margin, which was set at 70%. When you look at slide seven of the presentation, you see that our vaccine induces very high neutralizing antibody titers. We see a fantastic immunological profile across all age groups, including the elderly. Safety. With regards to safety, our vaccine shows a safety profile that is absolutely in line with what one would expect for such a type of vaccine. We evaluated safety in more than 3,000 participants who received the vaccine. We had an independent data safety monitoring board continuously monitoring the study, and they identified no safety concerns. The safety profile that we have seen in the phase three is consistent with what we have seen in the phase one. The majority of solicited adverse events were mild or moderate and resolved within three days. Around 1.6% reported severe solicitive adverse events, mostly commonly fever. Approximately 50% of the study participants experienced solicited systemic adverse events, most commonly headache, fatigue, and myalgia. Approximately 15% of the participants experienced solicited local adverse events, so overall, a good safety profile and also a very good safety profile in elderly. And, of course, we need to follow the study subject now for a further six months. And that's why the final analysis of the study will only be ready once this follow-up period has been completed. With regard to next steps, of course, we are working now towards the final analysis, which is expected within the next six months, as I just mentioned. You also know that we have in parallel a lot-to-lot consistency study running. This study is fully recruited, and the data is expected later in the year. The antibody persistence follow-up trial, VLA-1553 is ongoing, and they will be followed up annually for five years after single immunization because our hope is that with a single shot, this vaccine may protect for a long time, even up to five years, which of course would be tremendous. And we are now in active discussions with the agencies, primarily the FDA, to bring BLA-1553 to a potential licensure as soon as possible. So overall, very, very pleased with this outstanding result in an area not only of high unmet medical needs, but also by way of reminder, a disease area that allows the first one to achieve BLA approval to access a priority review voucher, which is probably the single largest short-term commercial return for this product candidate. Talking about Lyme, we are Still the only company that has an active Lyme disease vaccine program in advanced clinical development worldwide. The program got FDA fast-track designation granted. We reported good results from the Phase II trials to determine dose and schedule. As I mentioned earlier, we completed recruitment for the Phase II study VLA15221, including the PITS-5 and above. And this marks then the total target population that we're going to include in the pivotal field efficacy trial, which is about to commence next year. The vaccine contains six serotypes to protect against the most common serotypes of Lyme borreliosis in the Northern Hemisphere and follows a proven mode of action for Lyme disease vaccines. And as you know, we have an excellent partnership with Pfizer, with whom we are progressing this development forward. The details around the current state of play, the recruitment for the study VLA15221, which was recently completed, included 625 participants, 5 to 65 years of age. The trial triggered a milestone payment from Pfizer of about $10 million. The top-line results are expected in the first half of 2022, and we will also investigate a booster dose administered one year following the six-month dose. We expect the phase three pivotal efficacy trial to commence, of course, pending positive readout from the phase two study in 2022, and the clinical readout based on one tick season is projected by the end of 2023. And this will then allow for an initial submission for regulatory approval anticipated in H2 2024, assuming, of course, positive data. Let's move on to our COVID vaccine, VLA201, which is the only inactivated vaccine in clinical development in Europe today. You know that we have a partnership with the UK government. The UK government has ordered approximately 100 million of the vaccine doses, and the government is supporting us with development and manufacturing funding, and we continue to have an ongoing dialogue with the European Commission for European Supplies. The program acceleration enabled us basically to go based on our platform that we have established in Scotland with our iXiaro vaccine, and the commercial manufacturing commenced in January 2021. Our vaccine differentiates from other inactivated COVID vaccines in development, for example, those in China or India. because we combined our vaccine with a modern adjuvant, Dynavax's CPG1018, which is a toy-like agonist, supposed to increase T-cell immunity by shifting the immune response towards Th1. We have reported good Phase I, II clinical results and are now in the middle of our Phase III. As I mentioned, recruitment completed. of our study COV-Compare and now in clinical serology testing. The regulatory submission to MHRA is still planned in the autumn, so in the last quarter of this year, and then subject to data approvals and so on, we will be able to commence deliveries thereafter. The current study called COV-Compare VLA20301 is a randomized observed applied controlled comparative emergency trial in over 4,000 adults. We are the only company that targets to show effectiveness of the vaccine by immunological comparison against a licensed vaccine. And this approach is expected to reasonably predict the vaccine efficacy. We do this. by way of testing superiority of VLA201 in a two-dose immunization schedule, the 028. And we measure the GMT ratios in between the active comparator and our vaccine at two weeks after the second vaccination. The study is conducted in the UK, supported by DHSC and NIHR, with testing being conducted at PHE The protocol has been agreed with MHRA, and we have advanced discussions with other regulatory bodies on a similar approach. Top line data, I expect it early in the fourth quarter, and we expect to commence rolling submission with the MHRA in the coming weeks. And subject to the phase three data, we believe that the initial approval may be granted by the end of the year. We are also participating in the World's First COVID-19 vaccine booster trial in the UK where our vaccine is being used to booster people with a third dose who have been primed with other vaccines. And this could become a very interesting target product profile for our vaccine going forward. And additional studies are also planned including reduced booster dose, but also studies, for example, in elderly. And we are also studying other variants in order to be in a position to manufacture variant-based vaccines, because you may know that especially for whole virus inactivated platforms, there are a lot of examples how strain or variant shifts can be addressed, e.g. in the world of influenza. And with this update on our R&D activities, I would like to hand over to David.
spk04: Thank you, Thomas. So just to move on to slide 15 for those of you who are searching. And good morning to those of you in the US and good afternoon to those of you in Europe. Just before I hand over to Manfred to go through the financial results, as is usual this year, I'd like to say a few words regarding the broader business dynamics and indeed future guidance. Firstly, though, I'm at our Livingston site today. And many of you will know that the team here is working hard to produce our inactivated COVID vaccine and working around the clock to complete the new plant, which is just across the road from where I'm sitting right now. We've strengthened our teams globally. And in the context of today's call, I'd also like to mention that Josh Drum recently joined us as VP of Investor Relations. And Thomas and I will introduce Josh to many of you in the coming weeks and months, including hopefully some of those meetings in person. So, while today is very much about our chikungunya data, we have several strings to our bow, as you all know. We're reconfirming our core guidance, which is testament to the ongoing excellent execution and control of our R&D programs, combined with mitigating the effects of COVID on our travel vaccine business. And we've always been clear that we plan to invest fully in our unique and valuable R&D assets. So the level of R&D investment is consistent with that aim. So we would have been pleased to provide guidance on our COVID program, but that's still difficult for a couple of reasons that I'll just explain just now. Firstly, and as Thomas has alluded to, our Phase 3 trial recruited on time And the execution of that trial itself has been managed extremely well. So we're just waiting for the output of the serological testing and the subsequent data analysis. And clearly that data forms part of the rolling submission to the MDA and HRA that Thomas also mentioned. We've said before that phasing of the 60 million dose order to the UK government will move across also into 2022. And what we want to be able to do is to give meaningful guidance. We've also got ongoing discussions with EEC as most of you will know, and therefore for now we're not giving guidance that includes COVID. Rest assured we'll do that as soon as we have sufficiently robust information, and we hope that's not too far away. I think what's most important regarding COVID and indeed the other programs that we're executing very well is the fantastic work that many people are still doing to provide solutions to the ongoing challenges that COVID-19 presents us with, and that includes the execution of non-COVID R&D programs. Our neighbor will contribute to the COVID challenge and we'll give you more economic insight into that as soon as we can. And with that, I'd like to hand back to Manfred. Thank you.
spk07: Yeah, thanks a lot, David. I want to continue the finance section with providing more details on the product sales generated during the first six months of 2021. which in total amounted to 31.8 million euros. Sales of third-party products further gained momentum and, driven by both Ansipur and Radipur, contributed a total of 5.9 million euros to our H1 product sales. Xero sales to US Military were still related to the base year of the contract signed back in September 2020 and delivered about 22.3 million euros of sales during the first half of 2021. As you continue seeing the travel industry being impacted by COVID-19 related restrictions, sales of Tukulawa and Mixiara were during the first six months still quite compressed and in combination added about 3.5 million euros to our H1 top line. As you can see on the right slide, slide number 16, the overall product sales were quarter over quarter down by about 19% at constant exchange rates and almost all of our sales were delivered through our own commercial infrastructure. Gross margins on product sales ended up at 39.2%, impacted by compressed product sales, some idle capacity costs, and also continued need for write-offs of aging inventories. Next slide, please. On the next slide, I want to walk you through the H1 profit and loss statement. Here, I would first want to draw your attention to the total revenues, which remained only 1% below the first six months of 2020, with the reduction in product sales almost completely offset by our other revenues, which more than doubled from about 7 million in H1 2020 to about 15.7 million in the first six months of 2021, which is mainly a consequence of revenues added from the Pfizer collaboration for Lyme, higher revenues in the CTM unit in Sweden, and some incremental revenues related to the Chikungunya program for LMRC countries together with Instituto Butantan. Overall COGS increased from previous year as a result of idle capacity costs as well as inventory write-offs, while cost of services increased in line with the increase in our other revenues. R&D investments continued growing significantly and again more than doubled during the first six months of 2021 in line with our R&D portfolio progressing into later stage clinical development, but primarily impacted by incremental COVID-19 related R&D spend amounting to 46 million euros during the first six months of 2021. Marketing and distribution expenses declined moderately compared to the first six months of 2020. However, investment into launch, preparation, and market access related to our nicely progressing Chicken Gunja program have added 2 million euros of incremental sales and marketing spend in 2021. So excluding these additional expenses for Chicken Gunja, our marketing and distribution spend reduced by about 25%. G&A spend continued increasing materially, mainly driven by non-operational costs, mostly related to corporate projects, such as the US IPO preparation, combined with investments in support of our COVID program, as well as included some non-cash effects related to the company's stock option program. Finally, a few more words around the finance results, including taxes. This continued being positively impacted by foreign currency valuation gains, primarily related to the British Pounds denominated cash and balance sheet positions, which almost offset the increased interest charges related to our debt financing agreement with OrbiMet and Deerfield, as well as other interest charges related to our refund liabilities. And finally, EBITDA shows a total loss of 80.1 million euros, mostly driven by strongly increased R&D investments in the first half. Next slide. So this additional slide shows the impact of the COVID activities on the company's income statement, also showing that a considerable part of the EBITDA of the first six months is attributable to the COVID-19 related investment in R&D. From the total EBITDA of 80.1 million euros, about 53 million related to the COVID business. leaving about 27 million euros attributable to Vanita's core business, excluding COVID. And also the core business shows significant R&D spend of around 32.6 million euros, mainly driven by investment into the phase three of our Chikungunya program. Also important to note that still no COVID revenue has been recognized for the period ending June 30th. And then finally on the next slide, at last quarter we thought it would also be helpful to again give a few comments on the balance sheet statement per June 30, given some material movements continue impacting our balance sheet. So firstly we see our fixed assets taking a step up and meanwhile amounts to almost 75 million euros, which you can see on the property plant and equipment line. Inventories keep on increasing and meanwhile we hold about 125 million euro of inventories. which largely are COVID-specific. As expected, we saw our cash position further increase, driven by both the proceeds generated through the global offering of new shares, as well as further prepayments received from the UK government. Our cash position further increased and amounted to almost €330 million by the end of June 30, 2021. And on the liability side, I again want to highlight the continued increase in the contract liabilities which related to further cash considerations received from the UK government during the second quarter related to the COVID supply agreement. If you start supplying COVID vaccines to the UK government, we will gradually see the contract liabilities moving into the P&L. And with this, I want to conclude the finance section and hand back to Thomas to give us an update on the expected news flow. Thank you very much.
spk06: Thank you, David. Thank you, Manfred, for the comprehensive financial report. Page 21 of the presentation summarizes the key upcoming catalysts and potential value inflection points that we see ahead of us. So for Chikungunya, the final phase three trial results, which includes the six-month follow-up period, including the Lot-to-Lot Consistency Phase 3 study that we expect later this year. Those two studies form the basis for licensure, so these are the pivotal studies and are part of the submission that we expect to do with the agencies. Then, of course, for the Lyme disease vaccine candidate VLA15, We continue, of course, execution on the study VLA15-221, and we expect some minor follow-up readouts of the Phase II studies, which are primarily follow-up time points that will come over the course of the next month. And on COVID, of course, this is the next very important readout that we are expecting. And here, the clinical results on our study 301, the COVE Compare study, but also the study that is being conducted in Southampton where we are part of the different booster strategies called COVE Boost. And then, of course, later in the year, the first initial potential licensure. We expect to initiate and execute additional clinical activities on COVID, as mentioned earlier, to complement the UK trials, primarily to increase label over time, not necessarily for initial licensure. These are the key points, and I think with that, I would like to hand back to the operator to take your questions.
spk00: Thank you. So as a reminder, if you would like to ask a question, please press star and one on your telephone keypad and wait for your name to be announced. And if you wish to cancel that request, please press the hash key. Once again, to ask a question, please press star and one on your telephone keypad. And the first question comes from the line of Murray Raycroft at Jefferies. Please go ahead. Your line is now open.
spk03: Hi, good afternoon and good morning, everyone. Thanks for taking my questions, and congrats on the Chikungunya, based on your results. First question on Chikungunya, just wondering if you can provide any more specifics on what the regulatory timeline could look like, and is there anything you're going to be looking for in the longer-term safety follow-up?
spk06: So, Maury, hi. So, first of all, the six-month safety follow-up is a prerequisite for licensure, I mean, in the non-COVID vaccine world, I would say. And we are basically reviewing the same that we have been reviewing already during the ongoing Phase 3 study, and there will be no additional readouts, so we will measure the same parameters and continue to watch the same parameters as we did for the ongoing study and the top-down results. We do not expect any changes to this profile overall. With regards to the submission, of course, we are preparing our different pieces here according to the regulatory dossier, different modules, CMC, clinical, non-clinical. And as soon as we have our clinical lot-to-lot consistency data and the six-month follow-up data, we will start the submission process. You know, right now, I would say to predict timelines with regards to submission to approval for non-COVID-related vaccine development activities is difficult. You know, authorities are allowed and give priority to COVID-related vaccine developments. And hence, we are careful in providing any further detailed guidance on potential approval at this point in time.
spk03: Okay. That made sense and is helpful. And then for the second. COVID phase three, looking at 2101 in variants. What could timelines look like for that one? Is there anything else you can say on how 2101 will fit into your strategy?
spk06: You are referring to which study, Murray?
spk03: This is the study in COVID variants.
spk06: You talk about the study that is on trials.gov, 304?
spk03: That sounds right. I think it's the 304. So we can follow up offline.
spk06: Yeah, no, no, no. I can answer the question. It's not a problem at all. I just want to make sure that we have a lot of COVID studies ongoing or in the plan. I thought it's important that we align. So we are planning a further study called VLA2001-304. And this study will include elderly. And it's a study that is designed to allow for a potential variant bridge. And the study is about to commence. This is also why you find already the study description on twice.gov.
spk03: Got it. Okay. And for that one, is there any more specifics on how that could fit into a launch strategy for COVID?
spk06: We do not expect that this study will be needed for initial licensure, but it is a study that is expected to support broader age range claims. And of course, as I mentioned, it's also expected to provide a platform that we can use for a potential clinical bridge into new variants. And I think you will see a respective announcement upon initiation of the study, and it's fair to say that this is imminent.
spk03: Got it. Okay. That's helpful. is if you think the COVID discussion with the EC will materialize or get finalized after the phase three COVID results are disclosed, or how should we think about timing for an EC decision?
spk06: Well, I would say we hope to be earlier, but we are in active discussions with the EC for a long time. And so this is all we can say at this point in time.
spk03: Understood. Okay. Thank you for taking my question.
spk06: You're more than welcome, Maurice.
spk00: Thank you. And your next question comes from the line of Seamus Fernandez at Guggenheim. Please go ahead. Your line is now open.
spk01: Oh, great. Thanks for the question. So just a couple of quick ones. I just wanted to get a sense of the timing of the initial sort of COVID trial data set. I believe that you had announced that patient enrollment had completed towards the beginning of 2021. And, you know, I guess the structural sort of timeline would be six weeks plus from the timing. So could you just give us a sense of the timing updates? if additional data points are actually required to measure the sustainability of the antibody boost benefit. So is it requiring kind of evaluation of multiple time points just to see the durability of effect? Or is it just structural to the trial from a timeline perspective? And then in terms of the evolution from a manufacturing perspective, towards the variant capabilities, what would it take to kind of move towards an inactivated variant vaccine that's, let's say, oriented either towards Delta or Beta, you know, and how quickly can that be incorporated into your existing process should the initial ancestral effort be successful? Thanks.
spk06: Good question. So let me start with the timeline to repeat the timeline on our current study 301, right? So we have the 301 study is the COV-Compare study. This study compares our vaccine head-to-head against the AstraZeneca vaccine. So AstraZeneca is an active arm in this. So AstraZeneca vaccinated people are presented an active arm in the study. We have completed the enrollment, so this means that people got the two shots, and thereafter, serological testing starts. And our primary endpoint is two weeks after completion of the primaries in immunization series. And as we announced, we expect that this top line data early fourth quarter and so we are not entirely in control of our own destiny here. We collaborate with the UK government and the serological testing is being done at Public Health England as we mentioned at one of our previous calls already and from there we expect that this primary endpoint data will form the basis for the initial licensure. We will in parallel continue follow-up time points to observe antibody persistence, but this is currently not expected to be the basis for the initial conditional licensure. That will be part of the I would say the ordinary, if I may say so, process later on. The same is true for the COVB study. Here, of course, it's also a primary endpoint that would be measured, and at a later point in time, there will be follow-up time points to observe antibody persistence. When it comes to the manufacturing part of your question, So whole viruses require, of course, that you isolate the virus and then you create a respective viral clone that you can use to generate a viral seed bank. And from the initial, we call it research viral seed bank, to the master viral seed bank that you can then plug into production, you need to assume roughly eight to 10 weeks. And this is something that is, this is a timeline that is well known from the world of influenza. And that will allow then to commence manufacturing and it is expected that the manufacturing process will be identical. So no change to manufacturing process overall. However, again, as per influenza, there are existing guidelines in the meanwhile also published that will apply for COVID variant vaccines or potential COVID variant vaccines, which are also based on an immunocompatibility These are not big studies, but a few hundreds of people where you need to show in a head-to-head comparison against a surrogate which will be neutralizing antibody titers. And this, coming back to Maury's question earlier, therefore, we have also created the platform around our study VLA201304, where we have designed the protocol in a way that we can add whenever we have a potential variant vaccine ready and add this comparability arm to an ongoing study. Thank you.
spk00: Thank you. And your next question comes from the line of Samir Devani at RX Securities. Please go ahead. Your line is open.
spk05: Hi, everyone. Thanks for taking my question. Just let me add my congrats on the chicken gunya data. Very pleasing to see that. Just on CovBoost, Thomas, I'm just wondering, is it your expectation that you need to do a company-sponsored study to get the booster label added, or do you think the data from that study will be sufficient?
spk06: Well, this is a good question, Samir. So basically, by the end of the day, the decision around boostering is a JCVI decision in the UK. And so whether the data that we generate there will be sufficient or not is a discussion that we got to have with the MHRA once we have the data at hand, right? There are certainly multiple possibilities including that we don't need an additional study. But nevertheless, we have, as you may recall, already announced during the last analyst call that we amended the current protocol for Phase 1.2 to add a booster arm just to also include company-sponsored booster data in case we're going to need it. And the same will be true, by the way, for study 301, where we'll also add on a booster arm.
spk05: That's great. And just can you remind me, I know the COB boost is looking at a full dose and a half dose to 001 boosting. In your additional arms in your studies, are you using the full dose or half dose?
spk06: Full dose.
spk05: Okay. That's great. Thanks very much.
spk00: Thank you. And your next question comes from the line of Jacob Michalak Kempen. Please go ahead. Your line is open.
spk08: Hi there, and thanks for taking my question. So my question is regarding the upcoming readout for the COVID-19 vaccine. I'm just curious if there are any factors that would give comfort for the expected readout.
spk06: Well, so basically, we are measuring GMT ratio neutralizing antibody titers against AZ. And the level of comfort that we do have, and this is the reason why we entered positively in this endeavor, is of course that there are reported neutralizing antibody titers from the AZ vaccine in the UK. from their phase 1-2 study and from our phase 1-2 study. And those neutralizing antibody titers were generated at the same labs with the same assays by the same people. And those numbers are published, both ours as well as theirs. And this ratio, if I may say so, or the order of magnitude of those neutralizing antibody titers give us the level of confidence that we have right now. Of course, we are in the world of vaccine development, and by the end of the day, we are in the world of biology, and only the study readout itself will tell.
spk08: Okay, thank you. Makes sense.
spk00: Thank you. There are currently no further questions. Apologies. But as a further reminder, if you would like to ask a question, please press star and one on your telephone keypad to ask a question. And you do have another question on the line. It comes from the line of Simon Shoals at First Berlin. Please go ahead. Your line is open.
spk02: Yes, good afternoon. I just have one question. I was just wondering if the slightly later timing of the expected release of the Phase 3 results is going to have any impact, or you expect it to have any impact on the availability of your results from CovBoost?
spk06: We are not the sponsor of CovBoost, so there are, from our perspective, no interlinks to that. that we are currently envisaging. We are indeed a few weeks, just a few weeks behind the original expectation, probably two to three. As I said earlier, we are not entirely mastering the process here within the partnership that we have with the UK government, but it is not expected to have a knock-on effect on CoveBoost, no.
spk02: Okay, thanks very much. That's very helpful. You're more than welcome.
spk00: We do have a follow-up question from the line of Samir Devani at RX Securities. Please go ahead. Your line is open.
spk05: Thanks for taking my follow-up. It's really just a question for David and Manfred. I appreciate you don't want to give too much COVID-related guidance, but I'm just wondering, in light of the R&D spending Q2, Is that a reasonable run rate to assume going into Q3 as well? Thanks.
spk07: Let me take the question. This is Manfred speaking. I think so where we are sitting today, I think this would be a reasonable assumption to assume continuation of the same level.
spk05: That's great. Thanks very much.
spk00: There are currently no further questions on this line. On the lines, please continue.
spk06: All right, so many thanks for your time today. Many thanks for your excellent questions. Many thanks also for sharing our level of excitement around Chikungunya and this really unprecedented achievement It was in the middle of a COVID pandemic, which is not to be underestimated. And, of course, we are looking forward to talking again once we hopefully are going to report good COVID data. Have a nice day. Bye-bye.
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