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Edited Transcript of BAVA.CO earnings conference call or presentation 22-May-19 12:00pm GMT

Q1 2019 Bavarian Nordic A/S Earnings Call

Kvistgaard Jun 12, 2019 (Thomson StreetEvents) -- Edited Transcript of Bavarian Nordic A/S earnings conference call or presentation Wednesday, May 22, 2019 at 12:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Henrik Juuel

Bavarian Nordic A/S - CFO & Executive VP

* Paul Chaplin

Bavarian Nordic A/S - CEO & President

* Rolf Sass Sørensen

Bavarian Nordic A/S - VP of IR & Communications

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Conference Call Participants

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* Chad Jason Messer

Needham & Company, LLC, Research Division - Senior Analyst

* Jacob Lademann

Carnegie Investment Bank AB, Research Division - Research Analyst

* John Thomas Scott

Cowen and Company, LLC, Research Division - Associate

* Michael Novod

Nordea Markets, Research Division - Director of Healthcare, Healthcare Analyst & Sector Coordinator

* Nick Peter Russell Nieland

Citigroup Inc, Research Division - VP and Analyst

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Presentation

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Operator [1]

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Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to today's 2019 Q1 interim report. (Operator Instructions) I must advise you this conference is being recorded today, Wednesday, the 22nd of May 2019. I would now like to hand the conference over to your first speaker today, Rolf Sørensen. Thank you, and please go ahead, sir.

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Rolf Sass Sørensen, Bavarian Nordic A/S - VP of IR & Communications [2]

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Yes. Thank you, operator. My name is Rolf Sørensen, VP, Investor Relations. And with me here in the room, I have Paul Chaplin, President and CEO; and Henrik Juuel, Executive Vice President, CFO.

Before we begin the presentation, I would like to read the following statements. This presentation includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside our control, that would cause actual results to differ materially from results discussed. Forward-looking statements include statements regarding our short-term objectives and opportunities, financial expectations for the full year and financial preparedness as of year-end as well as statements which are -- concerning our plans, objectives, goals, future events, performance that is not historical information. 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 with this, I will hand the line over to Paul.

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Paul Chaplin, Bavarian Nordic A/S - CEO & President [3]

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Thanks, Rolf, and welcome, everyone, to our Q1 report. If you go to Slide 3, we've had an extremely productive first 3 months of 2019, really setting up an exciting year ahead.

Our BLA for our MVA smallpox vaccine is on track, and we still anticipate our first U.S. approval later this year. And as I'm sure many of you know, that will also come with a Priority Review Voucher with our intention to sell.

We continue to invest for the future and are expanding our manufacturing footprint. And earlier this year, the U.S. government is chipping in with that with $44 million option to support the tech transfer of the manufacturing process to a new facility. And everything is going according to plan, nudging us ever nearer to return to profitability in the near term.

In terms of RSV, we're extremely excited about the opportunities that we have ahead of us, and we're finalizing our discussions on the Phase III design, and we will be coming back to the markets later this year.

With our partnership with Janssen, we've seen 2 significant events. We've entered Phase I/IIa for our HPV vaccine, treating chronically infected women to prevent cervical cancer. And we've seen development in Ebola in -- with the WHO Advisory Group recommending a combination vaccine to be used in the current outbreak.

In cancer immunotherapy, we've completed enrollment in our pivotal chordoma study, and that will have an exciting readout later this year. And in terms of financials, we remain on track, but I'll leave that for Henrik to discuss later in the presentation.

Going to Slide 4. We aspire to be a leading and profitable biotechnology company that through harnessing the power of the immune system will develop, manufacture but also commercialize products for both infectious diseases and cancer.

This vision is underpinned by 4 strategic objectives: One is to maintain our global leadership of our smallpox vaccine business. And to do this, we want to finalize the development not only of the liquid frozen but also the freeze-dried and secure broader sales, which I'll come to in the coming slides. We want to expand and rapidly advance our infectious disease programs. By that, we want to launch our RSV program, advance our partner programs with Janssen but also bring some exciting new opportunities from preclinical into the clinical pipeline in the months, years ahead.

We also want to establish a broad and deep cancer immunotherapy portfolio. We want to explore the current strategy of combining our vaccines with checkpoint inhibitors and other standard of care. But later this year, we're also bringing some new, exciting opportunities and different therapies that will hopefully help patients in the near term.

Finally, we want to expand our commercial footprint and capabilities, and what do I mean by that is that we want to harness one of our key strengths, which is our manufacturing capability. If you look at most manufacturers of live virus vaccines, they have difficulty in providing the market. There are stock-outs. We've had a continuity of supply for the last 10 years, and we believe that's a true asset for us. And we want to harness that both through the expansion of our facility but also in our current capability, and we also want to build a commercial infrastructure in the years ahead that will help us commercialize the business.

On Slide 5, I want to talk a little bit about our global leadership in smallpox vaccines. Honestly, we've had a very strong presence in this arena for the last 10 years. The reason we believe we're a global leader is we're the only company that is currently providing a safer alternative smallpox vaccine that's suitable for the general population. And we've been extremely successful over the last 10 years, securing nearly USD 1.8 billion in both investment in R&D but also in acquisition of the product.

In the past, we've completed 22 clinical studies, and that's one of the reasons that the approval date of our product was extended. It's a vast amount of data that we've generated.

Currently, we'll have bulk vaccine by the end of this year of $333 million. We expect our first U.S. approval later this year, which will be coming with a Priority Review Voucher. And we'll also be initiating our Phase III freeze-dried trial, fully funded by the U.S. government, later this year.

The future, of course, we see huge potential. There is currently, in the current order, $299 million to convert all this bulk that we've manufactured over the last 3 years into approximately 13 million doses. That will return the company to profitability once the facility is up and running. But with a safer alternative vaccine that is likely to be approved later this year, there are new opportunities to start vaccinating first-line responders, military and the like. That will expand the opportunity well beyond the current stockpile that you've seen over the last few years.

And talk to that point on Slide 6. Monkeypox has been -- is a growing threat. There's been a number of cases. There's a current serious outbreak of monkeypox in Nigeria. And there's been recent cases in the U.K., Israel, all from people returning from those areas. And what this highlights is that there's a true need for better preparedness by governments around the world because what's happened here is health care workers have also been infected, who've had to deal with these infected patients, and we see a huge opportunity in the better preparedness against monkeypox but also smallpox in the years to come.

On Slide 7, we have a very exciting asset in that we have a completely differentiated RSV vaccine targeting the elderly. We have a very exciting Phase II data where we've shown that our vaccine concept induces broad antibody T-cell responses against RSV, which, as I said, is completely differentiated approach to anyone else. And we're currently in the process of finalizing the discussions with the authorities on a Phase III design, which we plan to initiate next year.

And currently, our concepts that we're trying to push through is a 2-season design with a futility analysis after season 1. So that would be in 2021, if we start the study in 2020 as planned. And if it's obviously positive, we'll continue to go into season 2 with a very high degree of certainty if we pass that futility analysis. But as I said, we need to finalize our discussions on the exact size and the exact strategy moving forward, which we'll come back to the markets sometime in the summer.

On Slide 8, as you all know, we're investing $75 million in a state-of-the-art fill/finish facility, which will allow us for the first time to really take full control of our manufacturing, not just manufacturing the bulk vaccine but be able to fill either liquid or freeze-dried versions. And this is really a game changer for us. The investments in this facility are going to peak this year, meaning that everything all being equal, meaning that the cash burn should reduce next year. But this is a state-of-the-art facility. It will allow us to return to profitability with the current order we have, but obviously, we've been encouraged by the U.S. government to make this investment, which is not about the existing order, but it's about future orders and future supply.

On Slide 9, to just give you an update of our pivotal trial in chordoma. Our Brachyury vaccine is being evaluated in an ultra-rare indication. Chordoma is unique in that it expresses Brachyury throughout the tumor and makes it an ideal indication to test the Brachyury-based vaccine.

We enrolled 10 patients ahead of schedule, which, I guess, highlights the interest that there is by chordoma patients in this study. And this is in combination with radiation, and we should start to see the first results later this year, which will be, hopefully, the first indication that our strategy in oncology is along the right lines in that, in combination with standard of care, vaccines can actually improve the efficacy and prolong survival.

Likewise, on Slide 10, we have 3 ongoing Phase II studies looking at CV301, which is targeting MUC-1 and CEA, which are 2 tumor-associated antigens in 3 different indications, all with different checkpoint inhibitors. The concept here is that checkpoint inhibitors obviously work in about 20% of the patients who have an existing immunity against the tumor, but the majority of patients don't respond because they haven't -- their immune system has not recognized the tumor. We believe that with CV301 we can stimulate an immune response and make that immune response a lot more effective with a standard of care in many of these indications.

And in terms of bladder, we're well on road -- we're well on track to complete enrollment in the first stage, and we would expect data from this pivotal -- from this interesting and important study later this year.

So we have an exciting year ahead based on a solid foundation of the first 3 months. We're looking to have our first approval of our smallpox vaccine but also some pivotal data from our oncology programs as well.

And with that, I'll hand over to Henrik to walk you through the financials.

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Henrik Juuel, Bavarian Nordic A/S - CFO & Executive VP [4]

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Thank you very much, Paul. And welcome to all the listeners for this conference call.

On Slide #11, I just want to reiterate our message that we are right now in a phase where we are investing for the future. And I believe this is best illustrated by the graph below here, showing how much we are currently investing in our pipeline or our R&D assets. In 2019, we expect DKK 570 million invested in R&D, with the majority of that going towards our infectious disease programs and a smaller part to our oncology business, where we are very cautious on our spending using adaptive trial designs, et cetera.

But besides the R&D investments, we also, as Paul alluded to, we are investing significantly in expanding our manufacturing capabilities, which again will be one of the means to -- for us to return back to profitability in the near term. 2019 will be the peak year in terms of investing in our fill/finish plant as we are planning to actually to finalize the construction of the plant this year and ready for the qualifications -- to start the qualifications of the plant next year.

So let's turn to Slide #12. Looking at the results for the first 3 months of 2019. If you look at the lower left table, you will see that we reached a total revenue level of DKK 127 million, comprised of DKK 49 million from revenue recognition of 3 IMVAMUNE batches. Remember, we have previously guided that we -- this is the second tranche of the contract we have USD 50 million or 20 batches of IMVAMUNE should be recognized this year. Then we also have, as part of the revenue, we reached DKK 78 million of revenue from our R&D contracts. And during the first 3 months, we saw contributions from our agreement with the Department of Defense on the equine encephalitis vaccine development. We saw contributions from our BARDA agreement on the tech transfer that Paul alluded to previously, and we also had some contribution from our agreements with our partner, Janssen.

Looking at the EBIT for first 3 months. We saw a loss of DKK 104 million. And finally, after the investments that we conducted during the first 3 months as well, we ended up with a cash preparedness of nearly DKK 2.2 billion cash preparedness (inaudible) plus some unused credit facilities.

So all in all, I think we have delivered on our own expectations and our guidance, and we are maintaining the guidance for the full year. And again, I just have to state here, for the sake of clarity, that any potential income from our Priority Review Voucher, which we expect to be awarded after approval of our IMVAMUNE products in September, is not included in any of these guided numbers.

Turning to Slide #13. I think this slide we have included again just to help provide a little more clarity on the what we call the cash preparedness. Here you will see the approximately DKK 2.2 billion in cash preparedness broken down by the amount you will find in the balance sheet, the DKK 1.9 billion of securities, cash and equivalents. And then we have DKK 244 million in unutilized credit lines, primarily the EUR 30 million loan we have from the European Investment Bank.

In the table below, you will see an overview of our current and total debt. That is primarily the European Investment Bank loan that we have utilized. That's the first one we got, DKK 372 million, and then we have a smaller mortgage in our facilities here in Kvistgaard, Denmark.

So that was the breakdown of the financial position. And I think, again, the conclusion is here, yes, we are investing in the future, but we are making very deliberate investments both in our R&D and in our fill/finish plant, and we are very well prepared to continue executing on the strategy.

We are -- as you will remember, we have guided that we expect to end 2019 even despite these significant investments with a cash preparedness of DKK 1.6 billion.

Let's turn to the next slide, which is basically a summary of some of Paul's presentations focusing on our priorities and goals and the expected news flow for 2019 and here again grouped by our key strategic objectives.

So within our smallpox business, very obviously, I think the big thing to happen this year will be the approval of the first product in the U.S., which we anticipate in September with the following award of a Priority Review Voucher, which we're intending to sell. But secondly, we are also planning to start initiation of Phase III study of our freeze-dried version later during this quarter.

Within the other infectious disease programs, big thing here naturally will be to go out into the market and announce our development plans for RSV, which we expect to be able to do around mid this year. We are also anticipating to start Phase I dose-finding study of equine encephalitis. This is our agreement with the Department of Defense, and we expect actually to initiate that study during the second half of this year. And then finally, within this strategic objective, we also expect Janssen to start their Phase I/IIa study of HIV later this year.

Within our cancer/immunotherapy portfolio, I think we have an exciting time ahead of us as 2 of our currently running studies will have their first readouts. And as Paul mentioned previously, this is in the chordoma study where we could expect first results in the fourth quarter of this year. And secondly, it's also in our CV301 project in combination with checkpoint inhibitors in bladder cancer where we also expect to have the first readouts later this year.

But then besides the running trials, we are also, this year, going to test new groups of administration, planning to initiate a Phase I intravenous administration study of BN-Brachyury and a Phase I intratumoral administration using CV301 in solid tumors. So also an exciting time ahead of us within the cancer immunotherapy area.

And finally, within our ambition to expand the commercial footprint and capabilities, we are still on track to finalize the construction of fill/finish facility by the end of this year.

So with that, I will hand the word back to Paul.

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Paul Chaplin, Bavarian Nordic A/S - CEO & President [5]

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Thanks. So I think we'll open up the call for Q&A.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Your first question comes from the line of Chad Messer of Needham & Company.

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Chad Jason Messer, Needham & Company, LLC, Research Division - Senior Analyst [2]

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Great. First, just on the equine encephalitis program. Just wondering if you could give us an idea what the ultimate opportunity here might be. I guess the U.S. government would be your major customer here. Any idea how big of an opportunity to sell this to them? I mean what revenues potential might be outside of obviously them funding the program to begin with.

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Paul Chaplin, Bavarian Nordic A/S - CEO & President [3]

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Yes. Thanks, Chad. So the opportunity right now is, obviously, DoD is very interested in developing a vaccine primarily to vaccinate military personnel because it's a potential biological threat. They've actually evaluated a number of different vaccine platforms in preclinical studies. And in fact, our platform came out on top, and that led to the initial award to evaluate the safety, immunogenicity of our current construct. That's basically the concept of the contract we have to date. However, obviously, if we show that it's immunogenic, as we believe it will be in the clinical studies, there's potential that this is going to lead to a much larger contract to develop this all the way through to licensure. So that in itself could be a substantial contract award. And then, of course, post successful licensure of the product, we're really looking at a DoD supply. And again, the opportunity there is potentially quite substantial if you look at other vaccines that have been sold to DoD for new recruits. So it is potentially quite a big opportunity both in the near term in terms of new contracts but also in the longer term in adding to the top line in sales to the U.S. military.

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Chad Jason Messer, Needham & Company, LLC, Research Division - Senior Analyst [4]

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No. Great. Great to see you guys leveraging the platform and some of your relationships to expand business. And then another one on the Brachyury readout. I know what you're looking for is at least 1 objective response out of the 10. Just wondering how the sort of conclusion of the data set or what triggers the readout. When you get a response, is that -- does that trigger it? Or is there some kind of amount of follow-up on the last patient that we're waiting for?

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Paul Chaplin, Bavarian Nordic A/S - CEO & President [5]

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So actual fact, if you look at what -- if you go back to Slide 9, we actually show the course of events in terms of the trial. So we start vaccinating prior to the standard of care, which is radiation. And then the first MRIs in terms of -- or CT scans in terms of having a look at the tumor lesions is actually sometime later in the normal course of events. So of course, as you mentioned, we're looking for 1 objective response. We've enrolled 10 patients ahead of schedule. However, I believe we only have 1 or 2 patients that are currently being evaluated at their first CT scan. If one of those scans shows a potential positive response in terms of objective response, it would go to the independent DSMB Charter who would look at the data independently, and they would actually request a confirmatory CT scan 4 weeks later. And once that's been confirmed, then obviously we would have our first objective response, which would trigger going into stage 2. We're anticipating the data readout will be in the second half of this year simply because of the time course of the treatment and the standard of care.

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Chad Jason Messer, Needham & Company, LLC, Research Division - Senior Analyst [6]

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All right. Very exciting. And then, Paul, I just got to ask you. I was a little surprised to learn about the departure of Dr. Heery, especially ahead of all the exciting cancer immunotherapy readouts that we're expecting. You just got to ask, does this affect you guys at all? And are there plans to get another Chief Medical Officer? And if so, what would the profile of that person ideally be?

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Paul Chaplin, Bavarian Nordic A/S - CEO & President [7]

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Yes. So -- yes, you're right. Chris has left us, which is obviously a shame because Chris is a great guy, has really contributed a lot in the short term that he was here. But as I'm sure you're very aware, it's a very highly competitive market to retain attractive talent like Chris in terms of oncologists. So he's gone with our best wishes, and I'm sure he'll do great where he's gone. Of course, we're going to replace him, even though that's a difficult task, but we will. And again, we're looking for someone who has got industry experience in clinical development both in oncology but also in infectious diseases.

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Operator [8]

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Your next question comes from the line of Michael Novod of Nordea.

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Michael Novod, Nordea Markets, Research Division - Director of Healthcare, Healthcare Analyst & Sector Coordinator [9]

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Yes. Just a question to the RSV program and in terms of the Phase III trials. I know you're still, I can say, working with the FDA to determine the final design. But can we conclude that if the full trial cost is DKK 820 million, it's going to cost you DKK 40 million, DKK 50 million to take in the data for the futility analysis? Just to get a feeling for, say, the cost to go there because DKK 40 million, DKK 50 million would be quite easy, I guess, for you guys also with the PRV in mind that you can sell.

And then secondly, on chordoma. Maybe I missed it. But just try to describe a scenario for us. Now you need 4 responses or 1 response out of the first 10 patients, 1 OR, and then you need 4 out of the total 29 if you can progress it into the stage 2. What happens -- I know it might be an unrealistic scenario, but what happens if you get 4 responses out of the first 10 patients? Maybe you can just elaborate a bit on that for us.

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Paul Chaplin, Bavarian Nordic A/S - CEO & President [10]

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Sure. So thanks for the questions. So yes, I think your assumption on what the season 1 would cost is in the ballpark. The reason again we're not giving clarity right now is we really don't know the total number of subjects that we're looking at, which is all to do with the statistical plan. But yes, I would say, to help you guide, a figure of DKK 40 million to DKK 50 million for season 1 is in the right ballpark.

In terms of chordoma, yes, you've got an -- yes, so it's an interesting question. What happens if we see 4 already in the first 10? Well, that would be unprecedented, unheard of in this situation, and that would certainly accelerate our discussions with the authorities on how to proceed. However, typically, when the FDA already knows you, 10 would be a very small number. And when they already know you're enrolling more, they would probably want to see what the outcome is. But if we got 4 out of 10, it would be unprecedented in this indication and would really stimulate a lot of discussions with the authorities on how to move forward.

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Michael Novod, Nordea Markets, Research Division - Director of Healthcare, Healthcare Analyst & Sector Coordinator [11]

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What about if you get -- after you get 2, would that qualify also for this to potentially get a breakthrough designation? Or what should be, say, required for this to be qualifying for a breakthrough designation with the FDA?

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Paul Chaplin, Bavarian Nordic A/S - CEO & President [12]

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Well, we believe the 4 out of the total number of patients, it would also be an outstanding result. Again, if we got something in the first 10, it would be a strong indication, but it's only 10 patients, right? And although I know we're only enrolling 29 in total, which is still very small, 10 is a relatively small sample size to draw strong conclusions on a breakthrough. However, as I said, let's see what the data reads out and what the discussions with the authorities entail.

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Michael Novod, Nordea Markets, Research Division - Director of Healthcare, Healthcare Analyst & Sector Coordinator [13]

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Okay. And just one more follow-up, if I may. So I just came back from seeing J&J at CMD in the U.S., and they clearly have revisited their RSV strategy to do a major write-down on one of their assets they bought in. And now they're running a new phase or a Phase II or Phase IIb with the one they call RSV senior vaccines, so for the elderly. They are in Phase II, Phase IIb. Maybe you can just, say, elaborate a bit on the competitive environment. Because it seems like, also with the recent failures, that you're actually ahead of, say, ahead of the pack now. Or do you see someone, say, moving in, say, in front of you on the vaccine side? I know there are other approaches, antibodies, et cetera, but on the vaccines side, maybe you can just give us a bit of your thoughts on the competitive environment.

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Paul Chaplin, Bavarian Nordic A/S - CEO & President [14]

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Sure. So who's in the lead is always subjective of where you're sitting, but I would say that we're definitely in the lead. When I look at the competition, including Janssen or J&J, their concept is to use the fusion F protein within their vaccine platform, which is adenovirus, as you know. They have a slightly different concept in that they're using one form of the F fusion protein, which is believed to give you stronger neutralizing antibodies, but it is basically based on initiating neutralizing antibodies. This concept of using F, whether it's the pre or the post, has failed for numerous companies. In our hands, when we use F alone in our platform, we can't protect animals in the relevant animal models, which is why we have developed our concept to have 5 encoded antigens. One of the reasons that a lot of the competition don't go for the same strategy is their vaccine platforms don't allow them to encode 5 antigens, which is the advantage we have.

Who is right at the end of the day? We're going to find out pretty soon because we plan to start Phase III next year, and we'll have a readout in '21. So I'm confident in our approach. It's rare, I would say, in vaccine development that you design a vaccine to do something that actually does exactly what you designed it to do in the clinic. You often design a vaccine, and it does some of the things you want it to do, and you convince yourself that that's good enough. This is doing exactly what we wanted it to do, and I believe it's worth evaluating in the clinic.

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Operator [15]

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Your next question comes from the line of Nick Nieland of Citi.

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Nick Peter Russell Nieland, Citigroup Inc, Research Division - VP and Analyst [16]

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So firstly, with the news flow regarding the outbreaks of monkeypox infection in various countries, has that directly led to any orders of IMVAMUNE from governments outside the U.S.?

Secondly, you mentioned in your release that HIV vaccine is expected to initiate later this year. Is there a milestone associated with that initiation similar to the HPV? And then do you see any of the health care reform in the U.S. as a -- and potential budget cuts as a threat to your long-term IMVAMUNE revenue?

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Paul Chaplin, Bavarian Nordic A/S - CEO & President [17]

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Thanks, Nick. So your first question is related to if the outbreaks in monkeypox that you've seen has led to any orders outside the U.S.? Well, yes. Small orders in the U.K., where we supplied our IMVANEX, as it's licensed in the EU, to vaccinate those who were already exposed and others dealing with the infected patients. Interestingly, in the U.K., they actually have a license replicating smallpox vaccine which is stockpiled, but they actually requested the safe alternative from us. We do anticipate that the monkeypox indication -- or the monkeypox situation is actually generating a lot more discussion in various governments, but we'll have to see how that market develops.

Your other question related to the initiation of HIV, would it stimulate a milestone payment? Again, we haven't revealed any milestone payments on that program, but we'll probably make that clearer when that study gets initiated.

And your other question related to budget cuts and the like in the U.S. and how could that affect us. Well, of course, it could affect us. I can't deny it that there are cuts. However, having said all of that, over the last 2 administrations or, in fact, I should say 3 or 4 administrations where there have been budget cuts and constraints and even shutdown of the government, the one thing that remains funded at the levels that's requested or even above is biodefense. So independent of which party is sitting in the White House, it seems to be universally well funded. That's certainly been our experience over the last decade.

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Operator [18]

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(Operator Instructions) Your next question comes from the line of Boris Peaker of Cowen.

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John Thomas Scott, Cowen and Company, LLC, Research Division - Associate [19]

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This is John Scott on for Boris. I have a question on RSV. Would that interim analysis be powered for efficacy for potential early stop in filing after 1 season of data? Or they're strictly to stop the trial only if there's unlikely to be a benefit?

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Paul Chaplin, Bavarian Nordic A/S - CEO & President [20]

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Thanks for the question. How do I answer that? I think most likely it is futility, but again, it just depends on just how efficacious the vaccine is. As you know, when you do an efficacy study, you make certain assumptions and you power it for those assumptions. If the vaccine is a hell of a lot more efficacious than your assumptions, it could. But most likely, I wouldn't be promoting that as a likelihood. However, the way we're trying to power the study, if we pass the futility analysis, at least the way we're discussing it with the FDA, it would really increase the chances of success in the second season. But again, these details I would rather leave until they are really confirmed in the protocol design that we're discussing with the FDA.

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John Thomas Scott, Cowen and Company, LLC, Research Division - Associate [21]

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Okay. And then on smallpox, you've discussed some additional settings for health care and military personnel. Would the first step in that process be responding to a request for proposal from the U.S. government? Or can you approach health care providers directly for their workers once there's an FDA approval?

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Paul Chaplin, Bavarian Nordic A/S - CEO & President [22]

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Let's see after the FDA approval, but it's our working hypothesis that we will be able to directly approach health care workers once we have an approved product. Of course, one of the customers outside of BARDA who are stockpiling it is DoD. And of course, there are ongoing discussions already with DoD as obviously changing their policies or ordering vaccines is a relatively slow process. But yes, we see really good opportunities once we have a safer alternative that's suitable for the general population.

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Operator [23]

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And your next question comes from the line of Jacob Lademann of Carnegie.

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Jacob Lademann, Carnegie Investment Bank AB, Research Division - Research Analyst [24]

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My question is around CV301 and your new administration methodology. Could you update us if you have any further preclinical result? And what is the current plan to take it into the clinic, also in relation to ongoing CV301 Phase II studies?

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Paul Chaplin, Bavarian Nordic A/S - CEO & President [25]

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Yes. So we've reengineered CV301. So we start with a priming dose of MVA, encoding the relative antigens in TRICOM. And we do it in a slightly different way than we've done in the past in that we give the highest dose possible. And to achieve that, we vaccinate high doses in each limb, so both legs, both arms. And we repeat that vaccination 4 weeks later. So we're giving a lot more vaccine than we've previously done in terms of priming. And the reason we go in each limb is that we have some evidence that that's a great spot in terms of the draining lymph nodes, which is where all the immune activation occurs. And then we follow up with our pox boosters at relative different intervals but throughout the entire length of the standard of care, whether that's with a checkpoint inhibitor or with radiation.

There is some data that NCI have already generated indicating that this approach, both Brachyury and also CV301, is a lot more immunogenic than the previous approach with PROSTVAC, which are great. It's really encouraging, but we'll have to wait and see whether those greater immune responses bear out in a larger number of patients in the ongoing study because we're [studying] of course whether those immune responses can lead to clinical responses in combination with standard of care. We have 3 ongoing studies, as I indicated in the presentation. And importantly, we will have data readout from one of those in terms of the first data readout in bladder later this year, which will hopefully confirm that our strategy is going in the right direction. Similarly, with chordoma, as I've said, with the similar vaccination regimen, we should have data readout later this year, which will again hopefully confirm that the new approach is working.

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Jacob Lademann, Carnegie Investment Bank AB, Research Division - Research Analyst [26]

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I was actually thinking about the intrasurgical and intratumoral injections. So I guess you're discussing what you're currently doing in the current clinical trials, right?

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Paul Chaplin, Bavarian Nordic A/S - CEO & President [27]

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Yes, yes. And we do have a couple of studies planned where we want to vaccinate both directly into the tumor. Again, the preclinical evidence there is that we can really change the tumor microenvironment, where we'll make it much more inflammatory, which is great for the T-cell response to be effective. We have some really exciting preclinical data that is not only changing the tumor microenvironment, but it's also stimulating great T-cell responses that are attacking and killing the tumor. While CV301 and Brachyury may not be the optimal constructs both for intravenous or intratumoral, which we'll be testing, these are going to be important studies for safety and also for some initial indications of efficacy while we come, hopefully, next year with more optimal constructs once we've already established the safety with Brachyury and CV301.

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Jacob Lademann, Carnegie Investment Bank AB, Research Division - Research Analyst [28]

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So -- and just a final follow-up here. Would that mean that if you -- for instance, if you observe 1 objective response in Brachyury here in the first stage of the trial, would you then consider switching to a new construct? Or is this too long into the future that you'd rather prioritize moving forward what you currently have in the clinic?

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Paul Chaplin, Bavarian Nordic A/S - CEO & President [29]

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Yes. Once a study is ongoing, it's difficult to swap and change about what you're doing. We have -- I know it's -- a number of people have criticized it, but we actually have multiple studies moving in parallel. It's a difficult nut to crack, as you all know, in oncology. It doesn't mean that we don't believe in CV301 or Brachyury with checkpoint inhibitors or radiation. We still believe in those concepts. We have a lot of solid data suggesting that, that is a good strategy. However, we have other strategies as well which indicate that they may work in different indications with other products that we're also pursuing. So we're pursuing multiple strategies in parallel. And again, we're doing it in a very cost-effective way that hopefully will bear fruit in the months and years ahead.

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Operator [30]

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We have a follow-up question from Michael Novod of Nordea.

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Michael Novod, Nordea Markets, Research Division - Director of Healthcare, Healthcare Analyst & Sector Coordinator [31]

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Just a question to your comments on the Investing for the Future slide regarding manufacturing for partners and/or collaborators. I was just thinking how much can you actually do in terms of contract manufacturing when everything is up and running and ready in 2021. Because we have seen other companies even also here in Denmark, Lundbeck generating a lot of income from contract manufacturing. So is there going to be a specific strategy that you're going to allocate some of your capacity for contract manufacturing? And how much can you actually do in terms of capacity for this?

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Paul Chaplin, Bavarian Nordic A/S - CEO & President [32]

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Yes. Thanks. Having manufacturing capabilities is both a blessing and a noose around your neck in some ways in that it's a blessing that we have the capabilities. However, of course, the infrastructure for manufacturing live vaccines is very costly. Nonetheless, the best way of utilizing that expertise is to utilize the capacity as best you can. So we are looking at opportunities both to do contract manufacturing, I would say, more strategically for certain partners both on the bulk potentially but also on the fill/finish. Again, the mix of how much contract manufacturing do we do versus how much of our own filling depends really on what's on the order books, but we're looking to optimize the facility costs by filling the facility both with our own products and with strategic partners.

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Michael Novod, Nordea Markets, Research Division - Director of Healthcare, Healthcare Analyst & Sector Coordinator [33]

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And if you have the capacity...

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Paul Chaplin, Bavarian Nordic A/S - CEO & President [34]

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(inaudible)

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Michael Novod, Nordea Markets, Research Division - Director of Healthcare, Healthcare Analyst & Sector Coordinator [35]

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No, no -- maybe also asking it also in a different way, if you had the capacity today, would you be able to have contracts already? I mean, is the interest there?

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Paul Chaplin, Bavarian Nordic A/S - CEO & President [36]

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There's a lot of interest. I can tell you already, we haven't even finished building the building, there's already a lot of interest. There is a shortage of filling capability both for liquid and freeze-dried for live viruses for starters and/or specialty filling. And this is a state-of-the-art facility for live viruses, but of course, we can fill other things. So there is a lot of interest, yes.

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Operator [37]

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There are no further questions at this time, sir. Please continue.

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Paul Chaplin, Bavarian Nordic A/S - CEO & President [38]

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Thank you. Thank you, everyone, for your time today and for your questions. So thank you very much, and goodbye.

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Operator [39]

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Thank you, ladies and gentlemen. That does conclude our conference for today. Thank you all for participating. You may now disconnect.