Bavarian Nordic A/S
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Good day, and welcome to the third quarterly report Q3 for the 9-month period ended 30th of September 2018 conference call. Today's conference is being recorded. At this time, I would like to turn the conference over to Rolf Sorensen. Please go ahead, sir.
Yes, good afternoon. My name is Rolf Sorensen, Investor Relations. With me, I have President and CEO, Paul Chaplin; and I have, for the first time, Executive Vice President and CFO, Henrik Juuel.But before we start the conference, I would like to read the following. This presentation includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside our control that may cause actual results to differ materially from the results discussed. Forward-looking statements include short-term objectives and opportunities, financial expectations, financial preparedness as well as statements concerning our plans, objectives, goals, future events, performance, et cetera. All forward-looking statements are expressly qualified by these cautionary statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. And after this introduction, I will hand it over to Paul Chaplin.
Thanks, Rolf, and welcome, everyone, to our Q3 announcement. I'm going to walk through a couple of slides, highlighting the events of the last quarter, but we had a very exciting quarter with a lot of key achievements. The first and probably one of the biggest milestone achievements for the company is that we filed the BLA for our smallpox vaccine. It's undergoing the standard review right now for acceptance, and we anticipate the approval of our smallpox vaccine next year, which as I'm sure you all know, would also then trigger the award of a Priority Review Voucher. This quarter, we've also supplied some IMVANEX smallpox vaccine to the U.K. as part of their response to the first-ever recorded cases of monkeypox. And what this has really highlighted is a need for preparedness, and it has stimulated a lot of discussions, not only in the U.K. and in Europe, but also in the U.S. in terms of how governments and agencies can be better prepared to outbreaks such as monkeypox, but obviously, which is also related to smallpox. On RSV, we've initiated the discussions with the FDA on the path forward, and I'll get to that a little bit later, but we've had some very positive discussions, which will continue into 2019. On our immunotherapy, cancer immunotherapy, we've actually now initiated 4 Phase II studies, 3 are with CV301 in combination with checkpoint inhibitors in 3 different indications in collaboration with the 3 major players in this space, Roche, AstraZeneca and BMS. And we've initiated a pivotal Phase II study with our Brachyury vaccine in chordoma. And on the financials, as you'll hear more about from Henrik, we remain completely on track to meet our full year guidance. So a very successful first 9 months. If we go to Slide 4, as I said, we've filed the BLA. It's undergoing its 60-day review, which we still expect to hear later this year that it's accepted, the submission is accepted. The approval is anticipated to be in 2019, and that will lead to a Priority Review Voucher, which as I said, is our intent to sell. However, although I'm not guiding for 2019, I just need to say that we will never guide with the inclusion of any revenue of a Priority Review Voucher, as we obviously currently now do not know when we will be awarded. Secondly, we don't know what the final value of that will be. And thirdly, we don't know exactly when we will be selling. We have a strong cash position, we will wait for the opportunistic moment to get the most benefit from such a voucher. So while the BLA -- most people believe this is all about Priority Review Voucher, it could actually, once IMVAMUNE, or I should say, our MVA smallpox vaccine is approved in the U.S., could open up other commercial opportunities beyond the stockpiling contract that we have with BARDA. So if you go to Slide 5, I think this is highlighted by the recent cases of monkeypox in the U.K., but there's also been a recent case in Israel. Now monkeypox is related to smallpox. It's within the same poxvirus family. It's normally spread from animals to humans. There's been an outbreak in Nigeria since 2017. And obviously, once it's infected a human, can be transmitted from human to human. It's nowhere near as infectious or fatal as smallpox, with only a fatality of 1% to 10%. However, it's not a good infection to have, and although there's no current approved vaccine, it's known that smallpox vaccines generally protect against all members of the poxvirus family, including monkeypox. So when the first 2 cases were diagnosed in the U.K. earlier this year, despite the fact that U.K. have a stockpile of replicating smallpox vaccines for the entire population, they reached out and asked for the supply of IMVANEX, as obviously, this has a much more favorable safety profile. So while we were very happy to be able to respond and supply the vaccine, what this has really done is highlighted the need for preparedness. Because by the time we supply the vaccine and by the time the U.K. realized they had 2 cases of monkeypox, unfortunately, a nurse had been infected. And what that demonstrates, not only to us, but many governments and agencies around the world, is that rather than buy vaccines and stick them in the freezer and hopefully never use them, if there is a safer alternative that's approved, it's much more prudent to start vaccinating first-line responders, military and healthcare workers. And those are some of the discussions that have already started to be initiated also in the U.S., which opens up other opportunities, if and when a smallpox vaccine is approved in the U.S. Slide 6, I give an overview of the current contracts with the U.S. government for freeze-dried, which was awarded last year. So this contract, which is more than $0.5 billion, includes $100 million for additional bulk, which we're manufacturing and revenue recognizing, evenly split between 2018 this year and 2019 next year. There's $140 million, some of which has already been awarded to support Phase III. Others, we anticipate awards coming to support C&C. While we're manufacturing and doing the Phase III, we're building a new plant, and this plant will come online in '21, which will allow us then to convert all of bulk under these existing contracts and previous contracts into approximately 13 million freeze-dried doses. And that option, which will be triggered in '21, is valued at $299 million, and the manufacturing of those doses will occur in '21, '22, and be finalized in '23. Now it's important to stress that this contract, which was awarded last year, which is the single largest award that we've ever received for a smallpox vaccine, is actually a 10-year contract and includes pricing for additional doses of the liquid frozen formulation, freeze-dried doses and also vaccine bulk. And we fully anticipate that more orders will come through as they continue to build the stockpile that has depleted. On Slide 7, our collaboration with Janssen goes from strength to strength. We have 4 license agreements with Janssen and a very fruitful relationship. It all began with Ebola, a license that's now in Phase III and is pushing towards approval. We also have 3 other license agreements for therapeutic approaches for HPV, HIV and HBV. And the HPV vaccine Phase I, we believe, will be initiated in the coming weeks and HIV soon thereafter. It's important to note that while this has been a very strong and lucrative collaboration, there is still potentially $1 billion of future milestones and royalties on top as these programs move towards approval. Slide 8 talks about our RSV vaccine. RSV is a virus that causes flu-like symptoms. We've all been exposed to this virus by the age of 2, but there are frequent reinfections during our life. And as you get older, unfortunately, these infections can become more severe, and RSV kills as many elderly people as influenza, and yet, there is no prophylactic vaccine or treatments currently approved. What we know with RSV is that while there are frequent reinfections, we know that if you're infected in one year with RSV, you're generally then protected for at least one year. And that's the concept of how we've designed our vaccine in that our vaccine is trying to mimic an RSV infection in stimulating a broad antibody T cell response. So for that, we have a unique vaccine design where we're targeting 5 separate proteins expressed by RSV to stimulate these broad immune responses, which we previously reported in our Phase I and Phase II clinical studies. On Slide 9, earlier this year, we reported the booster results. So we enrolled subjects from our successful Phase II study one year after they had received an initial booster vaccination, and we gave them another booster mimicking the regime, we believe, we will need, which is an annual booster, such as flu. And what we found here is that the responses that were stimulated were actually fairly durable in the majority of the people that we reenrolled, but these responses could be further boosted, just as we'd seen in the initial Phase II, generating these broad antibody responses, both in blood, mucosa and also broad T cell responses. And these data clearly support a seasonal vaccination with our MVA-based RSV vaccine. On Slide 10, there were 2 other things that we had planned to do this year. One, we wanted to look at whether we could develop a more virulent human challenge model. So currently, the human challenge model for RSV, which we and others don't believe is very suitable for looking at vaccine efficacy as not many of the subjects for the challenge actually developed symptoms. We believe that based on the literature, there was an approach that we could potentially grow a more virulent form of the RSV, and in such -- and in that case, generate more symptoms in the people that we would challenge. However, that feasibility or that approach has failed in that it -- we cannot grow a more virulent form, and therefore, the model that we would have would be no better than the existing model. And for that reason, we have discontinued that path. The other approach that was in parallel was to start discussing with the FDA on a clinical Phase III design to demonstrate efficacy, which would always be needed, regardless of a human challenge. And the first meeting was very successful. We got great insights into what the agency is currently thinking, and we plan to have follow-up meetings in the first half of next year, with a view that we would finalize the next steps in designs to demonstrate efficacy by mid of next year, with a view that we will be initiating Phase III in 2020. On Slide 11, we talk a little bit about our strategy for immuno-oncology. So we currently have 2 vaccine candidates, CV301 and Brachyury, which I'll talk more about in the coming slides, which are targeting solid tumors. We've enhanced the dosing regimes so that we give much higher doses of vaccine, which we believe is driving much more powerful priming and activation of the T cells. The booster vaccinations have been extended to cover the entire course of standard of care, whether through a checkpoint inhibition or chemotherapy. We have improved antigen selection in terms of we're targeting now CEA, MUC-1 and Brachyury. And in most cases, we're combining this with checkpoint inhibition, as we believe, despite the fact that you can stimulate T cells, if you don't block the inhibitory signals with checkpoint inhibition, you won't be able to get those T cells to infiltrate the tumor and actually kill tumor cells. And we're doing all this with adapted trial designs to seek rapid signals of efficacy in numerous different clinical settings. And in addition to that, we are also developing the next-generation approaches, which is via the intra-tumoral or intravenous administrations, which as I'll explain in the coming slides, we believe have added advantages to the approach that we're currently testing in the clinic. So on Slide 12, we're talking a little bit about our Brachyury vaccine. Brachyury is a tumor-associated antigen that is expressed in the majority of solid tumors. It's a transcription factor that is involved in how tumors metastasize or spread, so it's often expressed in late-stage tumors that are often difficult to treat. We've already performed a Phase I study and -- which has already been published, and demonstrated that we could vaccinate with a Brachyury-based vaccine and stimulate T cells, broad T cell responses in cancer patients. There's an ongoing Phase I, looking at the safety immunogenicity of the booster vaccinations using the fowlpox in coding Brachyury, which we still plan to report later this year. But we've already initiated the pivotal phase II study in chordoma, which received orphan drug status earlier this year. And this trial is discussed on Slide 13. So chordoma is a rare cancer of the base of the skull and spine. There are only 1,000 new cases in the U.S. and the EU annually, and in the late stage of the disease. So those patients who aren't cured by surgery, there really is no real treatment and radiation has responses in less than 5% of the patients that are treated. So the trial design is in 2 stages. The first stage will enroll 10 patients, and we'll vaccinate in a prime boost approach with our Brachyury vaccine in combination with radiation, which is the standard of care. Radiation itself, we've already shown, is synergistic because it inflames the tumor and is synergistic with the stimulation of T cells. And if we see one objective response in the first 10 patients, we will then go to the second stage and enroll an additional 19 patients. And we believe, if we were to see a minimum of 4 objective responses, that would be sufficient and compelling data that could lead to accelerated approval. The CV301 on Slide 14, this is a vaccine that's targeting both CEA and MUC-1. These are 2 tumor-associated antigens that are overexpressed in the majority of solid tumors, meaning that we can target multiple tumor indications. The approach here is to look at the combination with checkpoint inhibition because we believe, if we could improve the efficacy of checkpoint inhibitors, we would benefit the 70% to 75% of the patients that currently do not benefit from that treatment alone, and that's primarily because those patients haven't generated T cells against their tumor. So that's where we come in with CV301 that we believe we can generate strong T cell responses against CEA and MUC-1, and in combination with checkpoint inhibitors, would therefore improve the efficacy of that treatment to -- for those patients. On Slide 15, just highlights the 3 studies that have now been initiated. We have a study in bladder cancer, looking at CV301 with -- together with TECENTRIQ, which is an anti-PD-L1 from Roche. 2 study -- another study in colorectal cancer in collaboration with BMS, using nivo. And the third study, looking at colorectal and pancreatic cancer, looking at CV301 with durva in collaboration with AstraZeneca. All these studies have been initiated and we should start seeing some exciting data in the next 12 to 18 months from these approaches. Slide 16 talks about the new -- the addition to the strategy is looking at different approaches. So in our research labs in Munich, we've been looking in a number of years of how to make our vaccine platform even more immunogenic and how we can overcome many of the other inhibitory mechanisms that tumors employ to evade the immune response. And what we found is that if you vaccinate directly into the tumor or you apply the vaccine intravenously, it's a much more powerful way of stimulating T cells. It also activates another arm of immune response called natural killer cells, which also can kill the tumor, which we currently don't stimulate. And thirdly, we can change the suppressive tumor microenvironments, which is key to allowing the T cells that are activated to infiltrate and actually kill the tumor. And just to show you some of the animal data that we've generated on Slide 17. If you look at the 2 graphs at the bottom of that slide, you can see that if we apply the vaccine intravenously, we get much stronger stimulation of CD8 T cells and these natural killer cells, or NK cells, compared to the subcutaneous administration we're currently testing in the clinic. And these T cell responses have shown to have much greater killing ability of tumors and controlling tumor growth in animal models. And we're now at the stage where we want to evaluate this in the clinic. And to evaluate this initially, we're looking at Brachyury vaccine, which will be applied intravenously in the first half of next year, while we continue to work on more optimal constructs, which encode another co-stimulating model for a [indiscernible] body ligand. And as we get -- as we generate initial safety and proof of concept with Brachyury, we plan to bring in more optimal constructs, targeting other tumor indications. On Slide 18, we talk about the intra-tumoral approach. Again, the graph at the bottom is showing a mouse model where we've allowed tumors to grow and then we've applied the vaccine directly into the tumor. And you can see that on the red line, you get a reduction in tumor growth just by applying the vaccine directly into the tumor, as this inflames or heats up the tumor, so to speak, allowing the T cell responses that are induced to actually get in, infiltrate the tumor and kill the tumor, or control tumor growth. Again, we're at the stage where we want to evaluate this in the clinic, and we'll be entering a Phase I study with CV301 in the first half of next year. So with that, I will hand over -- happily hand over to Henrik to give you the financial overview.
Thank you very much, Paul, and it's a pleasure and an honor to be here today at my very first investor call representing Bavarian Nordic. So let's start with Slide 19, providing you with an update on the financial highlights for the 9 months completed. If we start with the revenue for the 9 months ended, totaled DKK 319 million, driven by strong IMVAMUNE revenue in the third quarter of DKK 194 million. And that was exactly as expected, as we communicated earlier that the IMVAMUNE batches would be revenue recognized in the third and fourth quarter of this year. The DKK 319 million, obviously, included more than the IMVAMUNE revenue, it included the DKK 88 million of R&D contract work revenue associated with our collaboration with the U.S. government and our Janssen agreements. If we take the revenue for the 9 months and look at the full year expectations of DKK 500 million, here, we remain with the same guidance for the full year. And I can actually say here that all the IMVAMUNE batches needed to deliver that revenue, they have been manufactured and are just awaiting release and invoicing during the fourth quarter. So therefore, we can very safely reiterate the revenue guidance for the full year of DKK 500 million. And taking that revenue guidance for the full year, combining it with our current R&D pipeline and expected investments during the fourth quarter, we also reiterate our EBIT guidance for the full year of DKK 385 million. Looking at the cash preparedness, we ended end of September with a cash preparedness of DKK 2.4 billion. And as we have had questions to how to measure this cash preparedness, we have on the next slide, this time, provided a simple breakdown of the cash preparedness. And if we start with the other part of the table, you will recognize the DKK 2.401 billion in total cash preparedness, and that consists of the securities, cash and equivalents from our balance sheet, DKK 2.4 billion, and then our unutilized credit lines, which corresponds to the EUR 30 million loan we announced in August from the European Investment Bank. These have not been drawn down yet. And then, we have entered into April transactions with our bank, meaning that we are actually selling securities with predefined repurchase terms. And from an accounting perspective, that means they still stay in our balance sheet, so they are included in the underlying assets, in the securities, cash and equivalents on the balance sheet. And in order not to double count the money, we have to deduct those assets when we talk about our real and meaningful cash preparedness. So when you add those 3 lines together, that gives us the total cash preparedness of DKK 2.4 billion. On the debt side, we have a small mortgage loan in the facilities here in Kvistgaard, and then we have an older loan from the European Investment Bank of EUR 50 million, adding up to a total debt of DKK 400 million. So again, here, the key message is that we are in a very strong position, really enabling us to continue the execution of our strategy, which, among other things, entails investment in our R&D pipeline and the establishment of the fill/finish plant. So let's turn to the next page, which is kind of a repetition of some of the material that Paul took you through, and it provides an overview of the anticipated news in the near term ahead of us. And to the left, we start with our infectious disease part of the business. And just on the smallpox vaccine side of the business, after having submitted the BLA, next step would, of course, be to get the acceptance, which we expect to happen this year. And thereafter, we anticipate an approval during 2019, which would trigger eligibility of the Priority Review Voucher in 2019 as well. Beside this, we have also -- we anticipate to initiate a Phase III freeze-dried lot consistency study for the freeze-dried version, and that is already fully funded by the U.S. government. On RSV, we will continue our ongoing discussions with the FDA on the regulatory pathway for approval, and we are anticipating some clarity during first half of 2019, which would enable us to initiate a Phase III study in 2020. In our broad collaboration with Janssen, we are expecting initiation of 2 studies later this year. First one is the Phase I/2A HPV study, and the other one is Phase I study on HIV. On the left side, we're looking at our immunotherapy business. And there, we have our 2 programs. First one is the CV301 where we are, later this year, expecting results from the Phase I/1B lung cancer study, and we are expecting first half of next year, initiation of a Phase I intra-tumoral administration study in patients with solid tumors. And on the second program, the Brachyury, we are, later this year, expecting results from the Phase I study, and first half of next year, initiation of a Phase I intravenous administration study. And in the second half, results from the recently started Phase II study in patients with chordoma. So quite an anticipated eventful near-term period ahead of us. And with that, I will turn the word back to the operator and ask for you, please, to open the line for questions.
[Operator Instructions] We will now take our first question from Chad Messer of Needham & Company.
The first one on RSV. Can you maybe give a little bit more detail on what issues you're working through with the FDA on the Phase III design?
Yes, so I think we've talked, or I talked a little bit about it before in the sense -- learning the lessons from past failures in the sense of maybe, conducting a study over 2 seasons, having an adapted design, potentially an adapted design, allowing you to modify after season 1, both for futility or whether you're -- some of your assumptions on the infection rate are off. Basically, also talking about what the assumptions are for efficacy, of what was accepted as the lower level of efficacy. So they -- those are the standard discussions that you always have on efficacies, and none of that is a surprise. As I said, it was a very positive meeting. I think we came away with most of the things we wanted. What I can give you a little bit more clarity on is where the agency is thinking, which is actually in line with the European Medicines Agency's guidance where they brought up that if you actually want to have a seasonal vaccine, you're probably going to have to demonstrate that in your Phase III, meaning that they're looking at a potential crossover study design. So placebo one season, and that will crossover to begin vaccine in season 2. That, I must admit, was not something that we had initially thought was on the table, but that's one of the things that we need to follow up on. And clearly, could add a couple of complications to the study design. But as I said, the meeting was positive. You never get everything you want in one meeting, so that's why there have to be follow-up meetings. But as I said, I think we will get a lot more clarity in the next meeting, and certainly, the goal is to have a finalized study design by the latest, mid of next year.
Great. Appreciate those added details. Maybe one on CV301 in your checkpoint combination study. So across the 3 different studies, you're using, respectively, ORR, overall survival and PFS as different endpoints. Classically or historically, when you think of immuno-oncology drugs, PFS for example, isn't thought to be a great endpoint. Just wondering, what your rationale for using PFS in the colorectal, pancreatic and objective response in bladder cancer is?
Yes, good question. So I mean, what we're really trying to do with these 3 studies is look for early signals of efficacy. And I think what you're alluding to is that objective responses in PFS often aren't approvable endpoints. But I think they're certainly endpoints that give you an indication that your approach is doing something. Of course, overall survival will still be measured. But rather than do a lengthy long study with that as a primary endpoint, we're actually looking for faster readout of efficacy, tumor shrinkage, or obviously, benefit in terms of the progression-free survival.
We will now take our next question from Thomas Bowers of Danske Bank.
First of all, could you give us any -- if there is any new color on the, let's say, pending decision on whether IMVAMUNE orders, once approved, will remain under BARDA? Or it will be moved to CDC? That's the first question. Then secondly, just on, again, IMVAMUNE, how should we think of the production capacity for 2019? I believe you will, of course, continue producing the current third bulk order in the first half of '19. And then, of course, revenue [recognize] to the remaining $50 million of debt as a bulk order. But I mean, if you were to get another bulk order in the next, let's say, 6 months’ timeframe, for example, would that potentially have impact for -- any P&L impact for 2019? Or are you already quite busy with other projects in vaccine production? And then, maybe just a final, just to sort of follow up on RSV. Just to get an idea on when you concluded on the feasibility assessment for the human challenge study. I'm just figuring what this actually means for the phase III design? And has this been actually also discussed with the FDA in the meetings you have held with them? And so that's -- I think I'll leave it at that.
Okay. So the first question related to is there any more clarity on new purchases once it's approved, is it with SNS or is it with BARDA. So there is new legislation going through the U.S. government where the SNS or the responsibility for the SNS will move from CDC to BARDA. The language in all that is clear, but the bill is still passing. I think it's the Senate. So it hasn't been put into law yet, but it looks like very much so that the SNS responsibility will move to BARDA. So once IMVAMUNE is approved, the responsibility will remain with BARDA. The other question was, if we were to get a new bulk order, would that have an impact potentially on your models for next year? The answer to that is, it wouldn't, because yes, you're right, we're manufacturing the half of the original bulk order next year, but our manufacturing is already filled up 12 months in advance. So the raw materials and everything have to be ordered 12 months in advance. So our books are basically fill -- full for next year, so if we were to receive a new order, it will be going into 2020. Or of course, again, it depends on the urgency of that supply, we would have to move other things out and bring that in. So I think, basically, the answer is, we're full with what we have. And any new order, unless it's an urgent request, would be going into 2020. The third question was on the human challenge and what impact does that have on the Phase III design. Thomas, one of the reasons we wanted to do the human challenge was to get an indication of what level of efficacy we're looking at, because clearly, that has a massive impact on the number of subjects that you need, depending on what you -- how you believe your -- how efficacious you believe the vaccine is. Having said all of that, a human challenge way, it may have given us some really useful information and more confidence. It probably wasn't going to help in the Phase III design that much because of the number of subjects that we could actually do in the human challenge. So all in all, it's a disappointment that we don't -- we won't be able to do a human challenge and really look and raise the confidence that the great immune responses that we've been stimulating is leading to a reduction in viral load. But nonetheless, a Phase III efficacy study was always going to be needed. And in that sense, it hasn't really derailed any of the discussions with the FDA.
We will now take our next question from Michael Novod of Nordea.
Yes, it's Michael from Nordea. Just a follow-on to the RSV question. So now, you're saying that you would likely see that it's going to be more complex or add some complication to -- or complexity to the study design, has that changed your view whether or not this is something that you need to, say, move forward with on your own? Or whether you would actually need someone with a larger development capability than the new guys and regulatory capability in order to efficiently move on this project because it seems to be dragging out and dragging out. And then, secondly, on the Brachyury Phase II data in chordoma, do you still expect that -- or do you still have the same anticipation with the results that you've previously been saying could potentially lead to this being a pivotal trial? Is this still the anticipation going into the data in the second half of next year?
Thanks, Michael. So you asked 3 questions. I think it's clear that if -- and I think we've been clear in the past that if a Phase III design is a very large or complicated study, that would obviously fall out of our ability to fund. Then obviously, we wouldn't be doing it without a partner. None of that is necessarily clear still today. There are many ways of skinning a cat, as I say. Even if there is a firm requirement for seasonality in the Phase III, that doesn't mean that you couldn't do an initial efficacy study to prove efficacy before you move on to the seasonality. So there are many ways of looking at it. And as I said, until those discussions are finalized, we don't know what the design looks like. So the position hasn't really changed. I don't agree with your comment that things are dragging out, because, I mean, we've said all along that our plan was 2020. That's still the case. So I would say that things are moving at the pace that we anticipated and we're on track. Regarding chordoma, it's a 2-stage design. I think what we're alluding to when we're saying the data will be coming in the second half of next year, we anticipate, with the recruitment -- the planned recruitment, that the first stage should be finalized. And obviously, there, we will know already we're moving into the second stage. That in itself, with the move to the second stage, is implying that there's -- we're seeing some sort of effect. And yes, we believe, if the outcome is as we've indicated, what we're looking for, we still believe that could lead to accelerated approval.
[Operator Instructions] We will now take our next question from Peter Welford of Jefferies.
Just 2 quick ones please. Firstly, just with regards to RSV again. When you talk about the FDA discussions then, they were implying they'd finalize a plan by mid '19 and then start Phase III. And is the plan to get those started though for 2020 northern hemisphere season, if you like? So essentially, end of '19, going into the 2020 season? Or would it start like, therefore, in the southern hemisphere, I guess, in the -- our summer, if you like, of 2020? I'm just thinking from the point of view, this isn't a Phase III that can be just rolled out anytime is my understanding. So how do you sort of think about assessing that? And then when we talk about seasonality of the vaccine, would that require, I guess, a crossover that you sign on in each hemisphere? Would it require -- could it potentially be done, if you like, one hemisphere and then the other? Or how would you go about doing that from the point of view of getting the data necessary to meet the needs of, what are 2 northern hemisphere regulatory authorities?
Thanks, Peter. And so our view for the 2020 is to actually start Phase III at the beginning of the 2020 season, going into '21. So we would start vaccinating in Q3 in 2020. And then, we will go into '21. And then, on the seasonality thing, you asked me a lot of questions that, there are good discussions that we're still having. But I mean, basically, we're looking at doing the Phase III only in the northern hemisphere. If, indeed, we have to demonstrate seasonality, those thoughts we're still thinking about. But yes, I think the best way of doing that is a crossover design from the placebo and the vaccine group after season one and you go into the second season.
It appears there are no further questions at this time. I'd now like to turn the conference back over for any additional or closing remarks.
Thank you, everyone, for your time and the questions. Thank you very much.
This concludes today's conference call. You may now disconnect.