Bavarian Nordic A/S

Bavarian Nordic A/S

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Bavarian Nordic A/S (BVNKF) Q3 2017 Earnings Call Transcript

Published at 2017-11-09 00:20:05
Executives
Seth Lewis – Vice President-Investor Relations Paul Chaplin – President and Chief Executive Officer Ole Larsen – Executive Vice President and Chief Financial Officer
Analysts
Chad Messer – Needham Peter Welford – Jefferies
Operator
Good day and welcome to the Third Quarterly Report for the Nine-Month Period Ended September 30, 2017 Conference Call. Today’s conference is being recorded. At this time, I would like to turn the conference over to Seth Lewis. Please go ahead, sir.
Seth Lewis
Thank you, operator, and thank you for joining us today. My name is Seth Lewis, Vice President of Investor Relations, and I’m joined today by Paul Chaplin, President and CEO; and Ole Larsen, Executive Vice President and Chief Financial Officer. Before we begin, I’d like to remind everyone listening to today’s call that this presentation includes forward-looking statements that involve risks and uncertainties and other factors, many of which are outside of our control and that could cause actual results to differ materially for the results discussed in the forward-looking statements. We undertake no obligation to publicly update or revise our forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. With that, I will turn the call over to Ole Larsen, CFO.
Ole Larsen
Thank you, Seth, and thank you everyone for joining this Q3 call. If you go to Slide 3, you will find the key news in Q3. In July, Bavarian Nordic entered into its third and fourth license agreement with Johnson, this time on HIV and HPV. The total deal value is US$879 million of which US$10 million was an upfront payment and US$33 million was in new equity. That brings J&J’s ownership in Bavarian Nordic to just shy of 6%. On September 14, we stopped the PROSPECT Phase 3 monotherapy study for futility after recommendation from the Data Monitoring Committee. And as you will see in the next slide, it had an impact on our Q3 financials. Later in September, we updated our clinical plan for RSV. We announced initial Phase II data showing durable immune response to six months after vaccination and at the same time also informing about the Booster study and the human challenge trial that Paul would take you through later in this presentation. At the end of September, we were happy to announce a new contract with BARDA for IMVAMUNE freeze-dried. Initial value of the contract is US$539 million, which consists of a base contract of US$100 million and optional part of US$439 million for filling the bulk we have produced as well as clinical development, regulatory work and validation work for the fill/finish facility. As a result of the new commitment from the U.S. government, Bavarian Nordic will invest in a fill/finish facility with a cost of US$75 million spread over three years. Moving to Slide 4. When we made our revenue guidance for 2017, it contained three items: DKK800 million of IMVAMUNE, the revenue recognition of the PROSPECT upfront of DKK399 million and contract income of DKK100 million, totaling DKK1.3 billion. By the end of Q3, we have met that target. As you can see on the right hand side, the pie or the donut shows that we have had IMVAMUNE revenues of DKK854 million. This is higher than guided and partly due to better exchange rates and partly due to new sales that we didn’t know of when we guided. With the discontinuation of the PROSPECT study, we have revenue recognized in upfront from BMS on PROSTVAC one quarter earlier than expected. The contract income is currently DKK77 million, and we expect that to reach DKK100 million guidance in Q4. We maintain our guidance for 2017 with revenues of approximately DKK1.3 billion and EBIT of DKK350 million and cash preparedness of DKK2.6 billion. On Slide 5, you will see the profit and loss account for the nine-months. As shown a gross profit of more than DKK1 billion. That equals a gross margin of 79%. The gross profit or the gross margin of IMVAMUNE deliveries just shy of 75%. The R&D cost of DKK373 million, and in these costs are included the write-down of the PROSPECT assets we had in the balance sheet. With distribution and admin cost a little lower compared to 16, we have an over rating result of our EBIT of DKK531 million for the first nine months of 2017. And as you can see on the very low or last line on the financial statements the cash position is strong and amounts to more than DKK2.8 billion. With that I will hand over the presentation to our President and CEO, Paul Chaplin.
Paul Chaplin
Thank you, Ole. And welcome everyone to Q3. So if you go to Slide 6, just to give you an overview or to confirm this strategy that we have [indiscernible]. We primarily want to maintain a global leadership in our smallpox vaccine franchise and as always mentioned that goes from strength-to-strength with an award of very attractive contracts to re-supply the U.S. government with freeze-dried version of IMVAMUNE. And I will come more to that in the coming slides. We are advancing our efficiencies programs, we are the world leader in the prophylactic vaccines RSV and we’ve expanded collaboration with Janssen’s now include also HIV and HBV. And that collaboration just goes from strength to strength and is going to be a long-term value drive for the Company. In addition to infectious diseases, we want to have a balanced pipeline by establishing a broad and deep cancer immunotherapy franchise. We are moving ahead with CV301 in combinations through collaborations with industry partners. The same is true also for Brachyury in the months ahead. What prospect is the monotherapy discontinued we are still eagerly awaiting the readout of the combination studies that are ongoing with BMS’ checkpoint inhibitors. And of course underline the strategy, that strong cash position driven by revenues of our IMVAMUNE and our license agreements which will allow us to execute the strategy and demonstrate proof-of-concept to multiple indications. Go Slide 7. I'll just try and walk through the whole IMVAMUNE franchise and I'll actually start to the bottom of the slide. We have a Phase 3 ongoing. Which is the last piece of the efficacy data that we've agreed with the FDA, that we’ll read out now early next year. As we anticipate that will be successful that will lead to following a BLA in 2018, with the approval in 2019. And as we've discussed before, smallpox indication now has the right for priority review voucher, which we anticipate will be awarded or provided to be in 2019. If we look at the future of IMVAMUNE in terms of the freeze-dried contract, we, as you heard from Ole, have received a new contract for USD 539 million. That includes USD 100 million from our bulk, bringing the total bulk value to USD 333 million. That USD 100 million award this year will be manufactured over 2018 and 2019. And then there's USD 439 million, which Ole has already highlighted, includes various aspects for filling the bulk, converting that bulk into final drug product for conducting Phase 3, for supporting manufacturing activities and the like which we anticipate will be awarded in the coming years ahead. Once we have generated all the data necessary, we will extend the BLA approval for liquid to include freeze-dried. And that will allow us to move into potentially CDC procurement, where we believe government will start building up a much larger stockpile to meet the stated requirement to protect 66 million Americans. So the IMVAMUNE franchise has gone from strength to strength. It's already received contracts in the order of USD 1.8 billion. We see now with a new contract that we will be securing our revenues and margins for the years ahead. If we go to Slide 8, so given the strong support that we see from the U.S. Government and also in part prepare ourselves for the commercialization of some of our other pipeline assets, we have made the decision to increase the manufacturing footprint in Denmark and invest USD 75 million in the state-of-the-art fill/finish facility, this will allow us to obviously manufacture all the IMVAMUNE products ourselves of retaining the full manufacturing from beginning to end. And obviously making the immune franchise even more profitable than what we've seen in the past. If investments will take three years so the facility will be up and running in 2021, where we will start manufacturing the freeze-dried IMVAMUNE and as I said in part it also is helping us prepare for the launch of the commercialization of our other pipeline assets. Slide 9 gives you a snapshot of what is becoming a very, very successful collaboration with Janssen. It all began back in 2014 with the license agreement for Ebola, which is really rapidly gone from strength to strength in generating very solid clinical data supporting the combination of our two platforms generating strong durable immune responses. And that clearly has led to the excitement in both companies to expand the relationship to include HPV, HIV and HBV. We've received more than $200 million in upfront equity and deliverable such as the Ebola doses and there’s more than $1 billion in additional milestones – future milestones and royalties. As I said, its going to be a future long-term, value driver for the company and it’s a strong endorsement of vaccine platform that we utilizing in our pipeline. Slide 10 gives you a snapshot of our RSV program, we are differentiated from the competition and the previous failed attempts to develop a prophylactic vaccine in that we're targeting five proteins of RSV, which you can see in the top right hand corner. We're doing less because in preclinical or animal models, we've demonstrated that the more antigens, we include the broader the T cell antibody response that we can generate. And in fact, we can mimic the sort of responses that we see compared to a natural RSV infection. So compared to the competition, we're targeting both T cells and antibodies, we are inducing a mucosal immunity, which we believe is important as this is a site of infection and we are seeing durable long-lasting immune responses lasting for an RSV season. If you look at the bottom left, there's a T cell responses, which is almost identical from both the Phase 1 and 2 where we get broad T cell response is not only to the whole RSV virus but all of the five encoded antigens. And on the bottom right hand side is the latest six months follow-up data from the Phase 2 showing that a single vaccination with our vaccine induces a strong booster, which is also durable for six months, which is actually longer than the whole RSV season. Later this year we will be enrolling some of the volunteers from that Phase 2 study so that we will get 12-month follow-up data, and then we’ll be providing another booster prior to this year's RSV season such that we will get the data next year, whether an additional booster is required or whether we're looking at an annual booster regime with our RSV vaccine. On Slide 11, a couple of weeks ago now we have a little bit more detail of our feature RSV strategy, in that we actually want to develop and then generate efficacy data in a human challenge – in a human RSV challenge model. There is actually an existing RSV challenge model, but it has a limitation in that the virus that is used for the challenge is highly attenuated. And in our opinion, gives clinical symptoms that aren't necessarily meaningful that you’ve seen in field. So that’ll go into too many details where we have partnered up with SGS who have successfully developed a very robust flu challenge model. And we believe we will be able to develop a more virulence or non-attenuated RSV challenge that will be able to generate some meaningful efficacy data next year. Obviously in human challenge models you can control the challenge, you can look at the onsets and the severity of the disease, while at the same time mapping very closely the immune responses that have been induced both by the vaccine and pre and post challenge which provide invaluable data in helping us design the Phase 3, and indicating how efficacious our vaccine approach is. As I’ve said, the work on this has already begun. We expect to initiate human challenge that in next year and have the top line results by year-end. If you go to Slide 12, shows the next steps in the RSV program. As I’ve said, we will be in the coming weeks re-enrolling some of the volunteers from the Phase 2 and doing this booster study to see the longevity of the response and whether a booster is required annually. We will be conducting and developing the human challenge trial I’ve just discussed while in parallel opening up the discussions with the FDA in other authorities on the design of the Phase 3. And obviously by year-end as I said 2018 year-end we will have that human efficacy data. In 2019 we plan to – begin to enroll in the Phase 3. The Phase 3 concept that we have right now which has not been agreed with the FDA is a utility component after the first season, which will be 1920. And then based on, the positive utility and our first enrolled in the remainder of the subjects in the 2021 RSV season. Slide 13 changes gears and talks a little bit about CV301, CV301 is a very promising cancer vaccine candidate, which encode CA in MacEwan. We're positioning CV301 in the – hopefully it will be the prefer treatment in combination with other treatments such as checkpoint inhibitors. We have and I'll come to that in the next few slides strong preclinical evidence that a vaccine, our vaccine platform can stimulate T-cell responses against tumor. And if you combine that with checkpoint inhibitors that limit the immunosuppression, you can make that T-cell response much more effective. And hopefully, we can increase the number of people who actually respond, who are currently not responding with checkpoint inhibitors by combining with the vaccine. We have initiated a Phase 2 study in non-small cell lung cancer in combination with KEYTRUDA. We also plan to next year initiate a bladder cancer study in combination with dysenteric. We still have plans to initiate at least one more Phase 2 study, which will again – will be a combination study. But we are continuing discussions with multiple partners on the potential combination and also that indication – and that third indication. Slide 14, just talks about some of the animal data that support this combination approach, so the various cross aero showing the growth of tumors in animals. On the left hand side of the black graph these are the control animals that are injected with tumors and you can see the tumors universally grow to a size that eventually would kill the animals. In the blue, we're treating the animals with two checkpoint inhibitors targeting PD-1 or LAG-3. And here the majority of the mice, while the tumors do grow are controlled by that treatment. The third graph, the red is a treatment with cancer vaccine, you can see that the tumor growth is modified compared to the control, but all mice to come to the tumor growth. Whereas on the far right hand graph or the green graph where we combine both vaccine and the two checkpoint inhibitors, we get a very robust control of the tumor growth and all mice survive. And as I said, while we’re not anticipating such a clear cut result in the clinic, it’s certainly does support combination. That a vaccine can stimulate those T-cells but only own will struggle against the immunosuppression both the tumor and the immune system. But if you combine it with something that can block that immunosuppression, such as checkpoint inhibitors, you have a synergistic and much more powerful treatment. Slide 15 talks about Brachyury. Brachyury is another tumor target which we are encoding in our platform of MVA fowlpox. Brachyury is a transcription factor involved in the epithelial to mesenchymal transition, which is a bit of a mouthful. But basically the process that’s in metastasis or the spreading of tumor cells. So Brachyury expression is hardly correlated with metastatic disease and multi-drug resistant tumors, so it represents a very good tumor target. Our Phase 1 study that’s already being conducted by the NCI with MVA Brachyury component shows that in 38 patients with variety of different tumors, this was highly immunogenic and we could generate T cells against Brachyury. On Slide 16, the next step is to actually conduct a Phase 1 study looking at also adding a booster with fowlpox encoding the Brachyury gene. This will be initiated in the coming weeks and will generate obviously the safety and the expected enhanced immunogenic that we expect. And following that we plan to initiate a Phase 2 study next year in a rare cancer called chordoma in combination with radiation, and that will be starting mid of 2018. And in parallel, at least one of the study is planned to be conducted through the National Cancer Institute, which will be another combination study most likely with the checkpoint inhibitor. So Slide 17 gives you a snapshot of the anticipated milestones to come. If we stick to RSV obviously we will be initiating the booster study in the coming weeks, that data will be available first half of next year where we will be initiating the human challenge study. While, we will have discussions with the FDA on the trial designed for Phase 3, we will also get that topline efficacy data towards the end of next year, and also in 2019 we will then be moving into Phase 3. Within the mean, we expect the readout of our ongoing Phase 3 early next year, which is positive, which we anticipate will lead to a BLA filing and approval hopefully in 2019 we will be awarded a Priority Review voucher. CV301, we have a lot of exciting milestones coming up, will be the Phase 2 lung trail will be continuing. We will see the Phase 1 data of CV301 in OPDIVO, we’ll also then start seeing some of the early objective response rate and progression free data in late 2018, early 2019, will be initiating Phase 2 study, which is TECENTRIQ in bladder and we should start seeing objective response rate data from that trial in 2019. With Brachyury, we will initiating the Phase 1 with data early next year leading to the initiation, the couple of Phase 2 in mid of next year, one chordoma which will be in combination with radiation therapy, and the second, an undisclosed indication, we will also be a combination of study for perform by the NCI. With PROSTVAC, we do have ongoing combination studies, most notable with BMS, new checkpoint inhibitors and we’re legally awaiting to see whatever we can build on the exciting data that’s James Gulley already presented, and that data will becoming now, as probably in the first half of next year. So with that we can move for Q&A. So operator, would you open up the line.
Operator
Thank you. [Operator Instructions] And we can now take our first question, Chad Messer from Needham. Your line is open. Please go ahead.
Chad Messer
Great. Thanks for taking my question. And my thanks always for that thorough overview. In quick passing, I heard in the opening remarks, that there were some unexpected rests of world sales for IMVAMUNE, I know this is not traditional been a big part of the revenues, but there had been some – just one of you could comment on what those where and – are you having any conversations with other governments or entities that would give you some hope for better prospects in the future.
Ole Larsen
Hi, Chad, it’s Ole. Thank you for your question. When I mentioned the rest of world sales, it is so that we are only guiding on sales that has been secure, so of an sign contracts. And what has happened during 2017 is that we saw a minor contract with Sweden and we have also in October seen yet another exercise of an option from the Canadian DOD, so that’s basically what I’m alluding to is some of these contracts are accounting through the year, where we did not have a sign contract, we made our guidance. And we of course, in dialog with several countries, as it is, a lengthy process, we are trying not to guide too much on this, because it is with a lot of uncertainties.
Chad Messer
Okay, understood. Thank you.
Operator
[Operator Instructions] We will now take our next question from Peter Welford from Jefferies. Please go ahead.
Peter Welford
Hi, thanks for taking my questions. First take just on the 006 trial, I appreciate that this is – this is not necessarily that relevant. But obviously this trial has been getting from long time now, and now date has been pushed into early 2018. Would you just give us bit more clarity on to rationale for that as to – why we should anticipate data a little bit later then initially planned? Just the secondly that on the RSV study, I want you just talk through how he was thinking about the booster. Is it that the boost doses again that you looked up before will be used again and it will basically be a run device powerful boost to half not to or how do you go by investigating the effect of the booster as the potential impact by atopic dermatitis. And then finally, just on PROSTVAC, I guess you presume that you got more day to in-house now from the prospect trial. And I was just wondering whether you are willing at to make any more comments on that, and equally whether there are any decisions yet is to when and where those data will be presented. Thank you.
Paul Chaplin
Thanks, Peter. So the first question related to 2006 and yes, it is a lengthy ongoing study, due to the complications of where we had to perform it. But the delay in the readout is nothing serious, its related to actually a change in reagent in one of the assays. So it’s a very minor change in timelines and we do expect it to come out early next year. And we don’t really see that timeline changes material and annoying my view not really material. In terms of the booster, yes you’re correct, we are going to be evaluating both doses. So if you remember from the Phase 2 results, we concluded based on immune response that wasn’t really a significant difference between the two dose levels. And that by single vaccination seems to be good enough. Obviously what we are tying to evaluate now by including both doses is that a difference in terms of the longevity the response between the two doses. And that in pueblos will be answered by the booster, which we will be administering. So basically half the subjects in each of the groups you received the single vaccination will be reenrolled and provided a booster shot of two different doses. Regarding PROSTVAC, yes of course we are still data mining, and yes, of course we have more clarity on what the data is, but we’re not going to comment on that now. We’re looking to present the data at a Scientific Congress. We haven’t finally decided our math to give away the lead investigator, but we are looking to do that early next year.
Peter Welford
Thanks. Just follow-up on a more general question. Given the CapEx broaden to fill/finish given obviously the U.S. government contracts this to some extent for more back-end loaded., I guess is obviously the work on that goes on et cetera, and given the CV301 trial that are starting. And I guess is there any comment you made regards to the cash flow profile of the company, you’ve managed to cash preparedness relatively stable over the prior years, but it seems now that we’re going into 2018, 2019 we likely to end up here where we’re all going to see cash burn over the next few years. And well within your front-loaded capabilities, is there any steps or any thoughts or things around that or are you happy to see that profile change? Thank you.
Paul Chaplin
Yes, I’ll try and answer that, an easy one, I can see all of the CFOs are desperate to answer, but I’ll try. So basically, yes, we are going to be going into a period of cash burn. So we’re not guiding for the coming years, but we’ve said it, not said it today, the 100 million bulk will be split between 2018 and 2019. Again we’re not guiding on our R&D burn, but we’re saying that basically our R&D activities are continuing at the same sort of levels you’re seeing in the past, and of course, we are investing in addition as you mentioned into the fill/finish. So yes, we are going into a cash burn scenario. We believe and we know in fact, we have sufficient cash to execute on both the investment and also the chemical strategies. So it’s not that we are going to be need in more cash. But yes, the cash profile and the revenues and maybe the breakeven is also you’ve been use to see is going to change in the years ahead.
Peter Welford
That’s great. Thank you.
Operator
[Operator Instructions] And there are no further questions at this time. I would like to turn the call back for any additional or closing remarks.
Paul Chaplin
Thank you everyone for attending the call today and for the questions. So thanks very much. Bye.
Operator
Thank you. That will conclude today’s conference call. Thank you for your participation. Ladies and gentlemen you may now disconnect.