Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to today's half year report 2019 conference call. [Operator Instructions]. I must advise you that this conference is being recorded today, Thursday, the 15th of August 2019. And I would now like to hand the conference over to one of your speakers today, Rolf Sørensen. Please go ahead. Rolf Sørensen: Thank you, and welcome to this Q2 call. My name is Rolf Sørensen. And with me today, I have Chief Financial Officer, Henrik Juuel; as well as President and CEO, Paul Chaplin. And before we start the presentation, I need 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 could cause actual results to differ materially from the 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 concerning our plans, objectives, goals, future events, performance that is not historical information. 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 with this, I will hand the line back to Paul Chaplin.

Thank you, Rolf, and welcome, everyone, to our Q2 report. The first six months of 2019 have been very eventful for the company. We have had strong performance in our pipeline, and we remain on track for all our key milestones in the second half of this year. The BLA for -- or the approval process for our MVA smallpox vaccine is going according to plan, and we still expect an FDA decision in September. Our fill/finish facility, which is in the construction phase, is also progressing according to plan and budget, and this key activity upon its completion should return the company to profitability under our existing order with the U.S. government. As I said, we've seen key progress in our pipeline. We've initiated our Phase III freeze-dried MVA trial, which was initiated earlier this year. It's a $30 million Phase III study, which is fully funded by the U.S. government under our existing order. Our discussions with the FDA on the Phase III design for our RSV prophylactic vaccine are still ongoing, but I'll touch on that in the coming slides. Our partner programs are progressing. Our Ebola vaccine, in combination with Janssen, has entered a new large Phase III study in Uganda. And our HPV vaccine, again together with Janssen, has entered the clinic and is undergoing enrollment as we speak. In terms of our immuno-oncology, we've seen progression earlier than anticipated for our BN-Brachyury study. So we've seen a partial response with one of the first patients that we enrolled. That triggered moving into the second stage of that clinical study, and we're currently enrolling another 19 patients. And we anticipate more data in the next 6 to 12 months. In addition, we should be seeing some of our new concepts in immuno-oncology entering the clinic later this year, so strong pipeline performance. And as you'll hear from Henrik later, our financials are fully in line with our own internal expectations, and of course, we maintain our guidance for 2019. So turning to Slide 4. Our vision at Bavarian Nordic is to become a leading and profitable biotech company through harnessing the power of the immune system. We'll develop, manufacture but also commercialize products for infectious diseases and cancer within the next five years. To achieve this aspiration, we have four main goals. One is to maintain our global leadership in our smallpox vaccine business. To do this, we need to finalize the development, not only the approval of the liquid-frozen in the coming weeks but also the freeze-dried, and to secure broader sales. We also want to expand and rapidly advance our pipeline for infectious disease programs. We need to move forward and launch our RSV vaccine in the next five years, advance our partner programs with Janssen and bring more programs through into the clinical pipeline in the years ahead. Thirdly, we want to establish a broad and deep cancer immunotherapy portfolio. We want to continue our current strategy of combining our various vaccines with the standard of care, including checkpoint inhibition. But we want to explore more advanced combinations and treatments, which will be initiated later this year. And lastly, we want to expand the commercial footprints and our capabilities. One of our key strengths is our ability to manufacture, and we want to build upon that, look to expand our capacity and to potentially manufacture for others. And we want to build a commercial infrastructure to drive profitable growth, potentially accelerating our ambition by looking for M&A opportunities that may be out there. On Slide 5, I talked a little bit about our ambition to maintain our global leadership role in smallpox. Essentially, we are the only company providing a safer alternative vaccine -- smallpox vaccine that's safe for the entire population. We've had a very strong relationship with the U.S. government and have received funding to the tune of almost $1.8 billion. That has allowed us to complete 22 clinical studies, deliver 28 million doses through the Strategic National Stockpile, and we have now submitted the BLA -- our first BLA for the initial liquid-frozen formulation. Currently, by year-end, we'll have bulk valued at $33 million in our facility. We expect the approval of liquid-frozen in September this year. It should also come with a priority review voucher, which we intend to sell, and we've initiated, as I already said, our freeze-dried Phase III study. What the future brings is that on completion of our fill/finish facility, we will convert all this bulk that we're storing into freeze-dried doses, and that will trigger the $300 million -- or the $299 million option that's existing in the current order. However, this order that's awarded in '17 is a 10-year contract. We have already negotiated additional pricing for liquid-frozen, freeze-dried and bulk, and we fully anticipate new orders. Upon approval of the liquid-frozen, we believe it will open up new opportunities beyond the stockpiling, which many of you come to recognize us for. And for example, 50,000 soldiers are currently vaccinated against smallpox each and every year. That's one opportunity. If more soldiers were to be vaccinated, such as all recruits, that would be 400,000 personnel vaccinated each and every year. And there is currently a policy from CDC stating that up to 5 million people should actually be vaccinated against smallpox before an outbreak, which becomes possible when you have an approved safer alternative. So we truly believe there's been great historical business in our smallpox franchise. There is great current business. And we will be returning to profitability with the current order, and there are many new opportunities ahead of us. Slide 6, a little update on Ebola. Obviously, the Ebola current outbreak is continuing in the Congo. Unfortunately, just under 3,000 cases have been reported, and this comes with a 60% -- or greater than 60% fatality rate. This has led the WHO in July to declare this as a public health emergency of international concern. The WHO earlier this year also recommended the use of Janssen's BN vaccine, and that's the led to an initiation by Janssen of a clinical study in Uganda in 800 health care workers, which, obviously, neighbors the ongoing outbreak in the Congo. Slide 7 talks about our RSV ambitions. We are still in dialogue with the FDA. However, we've had very fruitful discussions at our end of Phase II meeting, and there are 1 or 2 aspects that still remain outstanding, particularly the rules about stopping after season one. But it's essentially a two season design that we're in discussions with the FDA. It's between 12,000 and 14,000 subjects split as a set over two seasons. The first season, we will enroll 6,000, and then there will be a futility analysis, which will determine whether we continue into season two, with potentially an adaptive design if we're underpowered based on the incident rate of RSV. So we do anticipate that this will be finalized in the coming weeks, of which we will then obviously inform the market of the final design and the statistical plan. The budget for this study is well within our reach. It's in the region of $80 million to $120 million, obviously split over 2 years. So it's well within our reach and something that we can fund, and as I said, we have probably the best RSV candidate vaccine in the pipeline and one that we're eager to get into Phase III. Slide 8, we talk about our fill/finish facility. This is the single largest CapEx investment Bavarian Nordic has entered in our history. However, it's one that will return the company to profitability. It will allow us not only to manufacture the bulk vaccine, which we've been doing for more than a decade, but it will now allow us to both freeze-dry and fill liquid-frozen products. This will be important for our current order, unlocking that option of $299 million. It will also allow us to launch our RSV vaccine upon completion of Phase III. It also allows us to potentially look at bringing in other products that fits our profile and our key set of skills that allow us to expand that commercial activity. So it's really an investment for the future that will allow Bavarian Nordic to return to profitability. Slide 9. Our immunotherapy strategy is basically on three legs. We currently are looking at the combination of our vaccines with standard of care, and the best example there is our BN-Brachyury in chordoma. We're also looking at vaccine combination with checkpoint inhibition as we believe cancer vaccines will stimulate T cells, and also checkpoint inhibition allows those T cells to become more powerful to eliminate tumors. I'll come back to the BN-Brachyury study in a minute, but we have three ongoing studies of CV301 in combination with different checkpoint inhibitors in different indications. The ongoing bladder study together with Roche's anticancer treatment will actually be reporting data in the second half of this year. We, however, are not resting on our laurels on this strategy even though we believe there's great merit in evaluating these in the clinic. We have, for more than a decade, been looking at ways of making our platform even more immunogenic, allowing us to hit the tumors with many more arms of the immunoresponse, and these concepts will be initiating Phase I studies later this year. So on Slide 10, our chordoma study. We completed enrollment in the stage 1, which was to enroll 10 patients. We were looking for an objective response in at least one patient to trigger moving into stage 2, which is to enroll another 19 patients. These are cancer patients which are treated with radiation, which is the standard of care, together with our experimental vaccine, BN-Brachyury. We had very positive and encouraging data earlier than anticipated as one of the first patients enrolled actually had a partial response, meeting the threshold of greater than 30% shrinkage of their tumor, which had been irradiated. That allowed us to initiate earlier this year enrollment in stage 2. The stage 2 enrollment is going extremely well. We're about halfway through that enrollment, and we anticipate finalizing enrollment later this year, meaning that as these patients are evaluated at their 3-, 6- and 12-month periods, we will have the opportunity to, obviously, hopefully see more data. And we're looking for a total of four objective responses to have a meaningful result from this study, which will allow us to open dialogue with the FDA on the next steps. So with that quick tour of what we've done in the pipeline, I will hand over to Henrik who will give you an update on the financials.

Thank you very much, Paul. First of all, I'm very pleased to report financial results that are fully in line with our expectations and our guidance. I would like to start taking you through the lower-right corner table number, which shows that for the first six months of this year, we delivered revenue of DKK228 million. The donut chart to the right showed that, that is composed of DKK49 million from our smallpox bulk manufactured under the contract with BARDA. These are three batches that were revenue recognized already in the first quarter of this year. We have previously guided that we will revenue-recognize 20 batches, and we are fully in line with our manufacturing plans to deliver on that promise, which, of course, means, again, that our revenue will be skewed towards the second half of the year for the smallpox business. But I'm very pleased to report that when you look at the breakdown of the revenue, we have for six months, DKK179 million is coming from contract R&D work. And as we have said previously this year, we are blessed with the fact that we are actually playing on more different horses. So this DKK179 million actually comes from our contract with BARDA on the CMC. It comes from our contract with the sponsored Phase III trial that we have initiated this year. There is income from our agreement with the Department of Defense on the equine encephalitis, and there is still income from our Janssen agreement included there as well. So all of our revenue in the second quarter, which was DKK101 million, actually comes from R&D contract work under these four contracts. This revenue line and our progress on projects and our general spend, et cetera, translated into an EBIT loss of DKK201 million, so fully in with our guidance again. And with the investments that we are this year doing primarily within our establishment of the fill/finish facility, we are ending first six months with a cash preparedness of nearly DKK1.9 billion, so again, in line with our expectations, which enabled us to confirm and maintain our guidance for the full year. And I will just here remind you of our guidance. We are guiding a revenue level of DKK600 million for the full year and an EBIT loss of DKK360 million and a cash preparedness of DKK1.6 billion by the end of the year. So let's turn to the next page where we will see a breakdown of our financial position. You will recognize the nearly DKK1.9 billion in current cash preparedness. That consists, first of all, of our cash and investments we have done in low-risk securities, and then it also includes a loan from the European Investment Bank of EUR 30 million, which we have not drawn down yet. Below that table, you will see the breakdown of our current debt that we are carrying. There's a small mortgage loan of DKK26 million and then an older European Investment Bank loan of DKK372 million. So again, all in all, we have a very strong financial position that enables us to continue the execution of the current strategy. As said, we are guiding a cash preparedness of DKK1.6 billion by the end of this year, and by the end of this year, we will also have finalized the biggest part of the investment in the fill/finish facility, so giving us a very strong position. Let's turn to the next slide. Given our progress that we have seen during the first half year, we are able to confirm the exciting news that we have ahead of us for the second half of this year. And if we look at those, I think within our smallpox vaccine business, that is, of course, the expected approval of the liquid-frozen smallpox product by the U.S. FDA, with triggers the award of a priority review voucher, which we intend to sell. On the other infectious disease programs, here, the big thing, of course, will be to finalize the RSV development plan. And as Paul said, we are in the final discussions with the FDA, and we'll be able to share relatively soon an update in that program. We are also working already on the study of equine encephalitis virus program, sponsored by the Department of Defense. And later this year, we are going to initiated a Phase I study here. Amongst the Janssen programs, we are expecting Janssen to initiate a Phase I/IIa study of the HIV vaccine later this year as well. Within our cancer immunotherapy business, we have already this year, as Paul said, reported initial objective response rate from our BN-Brachyury study and have started the recruitment of stage 2. We are also, later this year, expecting to report on the CV301 bladder study. And also this year, expecting to initiate studies to test new routes of administration. More specifically, there will be a Phase I study testing BN-Brachyury intravenously and CV301 intra-tumor. So again, exciting news to happen also within the cancer immunotherapy portfolio. Finally, within the fourth strategic objective, the plan this year is to finalize the full construction of the fill/finish facility that will really enable us to return to a more stable revenue level in the future and return to profitability as well. So an exciting news flow ahead of us, which we are very pleased that we can confirm again given the progress we have seen both financially but also on all our projects during the first six months of this year. And with that, I will ask the operator, please, to open up for question and answers.

[Operator Instructions]. Your first question comes from the line of Chad Messer.

Great. And congrats on all the progress. As usual, a lot going on. Just for the chordoma study, I'm wondering what we should expect in terms of reporting on that. Are you going to just sort of report responders as they occur? Or will you let us know when you hit four? Or are you just going to wrap the whole study up before we'll get a report?

Yes. Thanks, Chad. Yes. So obviously, just to explain how the study goes. Obviously, we've enrolled 10. We completed enrollment in February. Their first scans are three months post the initiation of radiation and then six months and 12 months, which is the period that we evaluate. So obviously, early next year, those first 10 will be fully evaluated. And then, obviously, we started enrolling the next 19 in June. As I said, we're about halfway there approximately. So depending on when we complete enrollment -- let's say we complete enrollment in October, for the sake of timing, that means we would complete the whole study by next October. So that's the sort of time frame we're looking at. Obviously, your question relates to if we see more objective responses, will we report them. I think we'll probably report them in the quarterly announcements, but obviously, if and when we hit four, which, of course, could happen between now and the last patient, we would obviously report that.

All right. Great. Yes. No, very exciting. We'll stay tuned for that. And then on MVA-BN or PROSPECT, I don't know when we started -- stopped calling it that. I must have been asleep; how long do you think it will take to run the freeze-dried study? And if that's not something you can provide, maybe just remind us how long the liquid-frozen study took.

Yes. So the freeze-dried Phase III, which has been over -- about 1,000 subjects with three arms, we expect recruitment to be finalized towards the end of this year, kind of on track for that. But the study itself won't be completed until early '21.

Your next question comes from the line of Thomas Bowers.

Yes. Great. Just on -- first of all, on the RSV, you -- it seems like you narrowed the number of patients from 12,000 to 18,000 to -- down to 12,000 to 14,000. So I'm just wondering what these adjustments are for. Is it just to continue dialogue with FDA? Or is there anything else that you are considering here? And then on the Ebola vaccine, just remind me, do you have any regulatory milestones with Janssen? I'm just thinking that you should be quite close with a filing to the European authorities. Or is there anything we could expect here in -- before the year ends? And also on the Ebola, anything pending, any additional WHO meetings that need to be completed before you think that Janssen is given the greenlight to potentially deliver vaccines to DR Congo? And then just on the chordoma, so I guess, given that you state that you will probably report any partial responders in the quarterly updates, I guess you still have one PR. And is it fair to assume that you'll have 6 or 7 patients through the -- at least the first and maybe even a few patients on the second analysis?

Thanks, Thomas. I'll try to remember all those questions. It has been a barrage. But your first question related to the RSV. And you're correct, you're very quick in saying that we narrowed the total number of subjects, 12,000 to 14,000. It's just a reflection of the status of where we are with the FDA. So it's -- as I said, I think the trial design -- there should be no surprise when we come out and announce it. The trial design, as it's depicted on that slide, is basically what we're in discussion with the FDA. So it's 12,000 to 14,000 subjects. It will be 6,000 subjects in the first season. The things that are outstanding with the FDA are some of the definitions of the endpoints. So how do you measure lower respiratory tract infections and acute respiratory disease, some of those discussions are still ongoing. But primarily, the big discussion is really on the stopping rules after season one, which has to do with, obviously, the stats plan, which is outstanding. So the trial itself is pretty much -- design is shown in that slide, but there's a couple of outstanding points that still needs to be put a home -- put to bed with the FDA. Your second question related to Ebola and other regulatory milestones. There are regulatory milestones, but I don't believe we've actually disclosed what they are, but there are regulatory milestones. Regarding that whole process, Janssen, our partner, is in discussions both with the FDA and the European authorities on filing and what will it take. So I can't really comment on the timing of when that will be. But we have a lot of clinical data as we've shown in the slide. We're currently validating the process. So we are moving towards filing, but as I said, that's in the hands of Janssen. Again, I think one other question you have related to potentially supply with the WHO of the vaccine to the Congo. Those, again, are lengthy ongoing discussions between our partner Janssen, the WHO and various other bodies and authorities, and they've been going on for some time. But let's see what comes out of that. As I said, I can't really comment on that either. The last question related to chordoma. You're correct, a lot of the patients have gone through screening. Obviously, if we'd see more partial responses, it would be in the quarterly. I would say that there are some encouraging signs in what we see in that we have actually, out of the first 10 patients, quite a number of patients with stable disease. Now that's also kind of expected with a slow-growing tumor, but it's encouraging that there are still patients to evaluate in that first 10 that were enrolled.

So when you say stable patients, so do you see any tumor reduction? Or...

Well, the definition of stable is either that there is a tumor reduction that is less than 30% because, obviously, if you hit 30%, you'd be a partial response; or there's no growth of the tumor. And I'm not really going to say what it is, but we are encouraged by what we're seeing. But again, our feet are on the ground here because it's a slow-growing tumor. We've seen one partial response, which is highly encouraging. And we are seeing some encouraging results, but we haven't met the threshold of a reduction of 30% in another patient.

Okay. Got it. And then just quickly on the one patient that had a partial response or the first patient. So what's your consideration here given that, that partial response came very fast? It was the first analysis after three months of treatment. So what do regulators say on how to interpret that response? Is it likely to be related to the radiotherapy? Or give us -- I guess given that vaccines are well known to have a delayed effect, so what's your consideration here?

You know what, it's a very small dataset of one, right? So I think it's dangerous to speculate too much. As I said, I think we're encouraged that we've seen a response, but clearly, we can't start attributing that response totally to the vaccine. It could be radiation. It could be the vaccine. We could just be lucky. It could be random. I mean we have to keep our feet on the ground, and that's why the trial was designed the way it was. One response was statistically been worth expanding the number of patients, and that's what we've done. And we need to see four responses to be convinced that we're seeing a signal from the vaccine in combination with radiation.

Your next question comes from the line of Peter Welford.

Yes. Just coming back to RSV. Just curious to understand -- is the debate here around the allocation of output for the interim analysis? Or is this a case -- a debate of whether there should be an interim analysis? Or is it rather based on the hierarchy of the endpoints and which endpoints are considered at the interim? And I guess just curious what -- is it essential that the interim analysis triggers filing of the RSV? Or is it that actually the interim analysis -- you would still continue with the second season irrespective of what happens at the interim, i.e. this being a 12,000-patient study irrespective, but the question is whether or not that first stage could potentially hit the primary endpoint? And then just turning back to Brachyury. I'm just curious. Are you able to disclose how many patients of the original 10 have had an evaluation? So then presumably now all 10 have had the first evaluation. Or are some of those 10 still awaiting even their first evaluation after receiving the vaccine?

Thanks, Peter. As usual, quite good questions there. On RSV, it's kind of all of the above of what you said, to be honest. It's the definitions of some of the endpoints and the hierarchy of those endpoints. It is around the interim analysis. It's not really on the power because we won't be utilizing any power on that analysis. However, it is really about the stopping rules on that analysis, what would trigger a stop and what would trigger a continuation. I would say none of this is alarming or shouldn't be. It's pretty standard. And we're very happy with the dialogue we're having with the FDA, and I really think we're just waiting for some feedback on our last proposal that we've submitted. Your other question related to how many patients. Now I don't -- I think I'm right in saying that of the first 10, all have gone through their first evaluation. As I said, we do have quite a few patients that have stable disease. So they're still being evaluated in -- or will obviously be evaluated in their follow-up visits, but they have not progressed. So we're encouraged by that.

[Operator Instructions]. Your next question comes from the line of Boris Peaker.

This is John Scott on for Boris. First was PDUFA date coming up for IMVAMUNE. Do you anticipate having a black box warning on the label based on the safety profile you've seen on your trials? And then on the cancer immunotherapy program, you mentioned some additional combinations are being considered. Would that continue to be combinations of your virus with a drug that already has an approved indication? Or are you looking potentially at combinations of multiple null agents?

Thanks. No, we certainly don't anticipate a black box warning. The safety profile that we've seen with our smallpox vaccine is one that you typically see with live virus-based vaccines, so some local swelling and redness but nothing -- at the injection site, but nothing alarming. We have obviously also given the vaccine to people with HIV who are actually considered severely immunocompromised but haven't seen any safety issues. So we don't anticipate a black box warning. I think your other question was relating to some of the new studies that we're planning on with our new approaches. Those approaches are administering the vaccine by different routes, either directly into the tumor or intravenously. We're excited by those concepts because they're stimulating different arms of the immune system that potentially down the road would allow us to look at other combinations other than just checkpoint inhibition, such as antibodies targeting the tumors such as an anti-herceptin -- or herceptin targeting HER2. However, the initial studies we'll be doing will be initially safety studies with the current vaccines we have before we move forward next year, hopefully, with some of the more optimal constructs, which we'll be announcing hopefully later this year.

Your next question comes from the line of Jacob Lademann.

Yes. So a clarifying question here just for the next-generation BN vaccines. So just wanted to make sure that I'm understanding correctly that these are actually new constructs and not just different routes of administration or different sites of administration. And maybe if you could also explain a little bit about the overall strategy of the cancer immunotherapy portfolio. So you have currently ongoing Phase II trials, and I guess I'm sort of trying to gauge here how many are -- how many of these, you could say, strategies are you actively interested in moving forward, maybe all of them. Or if you could sort of narrow the scope a little bit for me here.

Yes. Thanks. So just to clarify. The -- well, let me talk about the overall strategy, and then I can clarify your first question about the constructs. So basically, you're correct, we have multiple strategies in immuno-oncology, which is in line with our overarching strategy to build the portfolio. Cancer vaccines and curing cancer is going to be a tough nut to crack. We currently have a number of concepts which are combinations with radiation or combinations with checkpoint inhibition, which isn't anything really novel. Many other people have tried it. It is supported by strong preclinical evidence that those combinations may be synergistic and merits being evaluated. How we're evaluating them is in a careful fashion in that we're doing smaller studies, looking for signals and then expanding those studies as we've done with chordoma and with the bladder study -- or potentially could with the bladder study if we see the signals. So we're looking for signals, expanding those cohorts to generate proof of concept that these strategies bear fruit. They will lead, if they're positive, most likely to more confirmatory clinical studies, which, of course, we will follow because, obviously, that will be because we have clinical -- strong clinical data and a headwind -- tailwind, I should say, behind us. Now the other new strategies that we're evaluating are because -- it doesn't mean that we don't believe in the current strategies. It means that the new strategies in terms of going intravenously and directly into the tumor offer new paths to stimulate the immune system, which we're not currently evaluating in a current strategy and as I tried to indicate in the last question, could open up new combinations which currently don't match when you go subcu, as we currently are, with CV301 and Brachyury. And again, what we're doing initially is looking for -- initially, for the studies we're starting this year, they're the current constructs of BN-Brachyury and CV301. So we're trying to generate safety with those constructs, allowing us to come with optimal new constructs later, for one definitely next year, where we will be doing follow-on studies. And again, we're looking for signals, proof of concept of efficacy where we can expand the cohorts and then follow the signals wherever we see them.

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

Okay. Well, thank you, everyone, for your time and joining the call. Have a great day. Bye.

This does conclude our conference for today. Thank you for participating. You may all disconnect.