Zealand Pharma A/S
Q1 2020 Earnings Call Transcript

Published: 14 May 2020

[Lani Morvan:]

Thank you and welcome to Zealand Pharma's conference call for results of first quarter of 2020. Participating in today's call are Zealand's Chief Executive Officer, Emmanuel Dulac; Chief Financial Officer, Matt Dallas; and Chief Medical Officer, Adam Steensberg. The team will respectively provide business, financial and development highlights from first quarter and subsequent comments.After the prepared remarks, we'll open up the call to take your questions. You can find the Q1 interim report, the related company announcement and additional reporting information on our website at zealandpharma.com. As the company headquartered in Denmark, our financials are reported in Danish kroner, also referred to as kroner. Key figures may have been converted to U.S. dollars for convenience.On Page 2, I will point out that we will be making forward-looking statements that are subject to risks and uncertainties. These statements are valid only as of today, and the company assumes no obligation to update them, except as required by law. Please refer to our recent filings for a more complete picture of risks and other factors.And with Page 3, I will now turn the call over to CEO, Emmanuel Dulac.

[Emmanuel Dulac:]

Thank you Lani, and thanks to everyone for joining today. We are pleased to share with you today the results of Zealand Pharma’s strong start in 2020. We are delivering on our commitments, despite the unprecedented and challenging situation created by the coronavirus pandemic. So despite the global health crisis, we successfully filed the New Drug Application with the FDA for dasiglucagon HypoPal rescue pen. This was an exciting accomplishment and the first NDA filed by Zealand for it’s fully owned countdown.We also announced positive results from the Phase 2 clinical trial with mini dose of dasiglucagon as treatment for postbariatric surgery, hyperglycemia. This could yet be another potential valuable treatment modality for this molecule and we are evaluating how it can supplement our development pipeline.We secured DKK 137 million or approximately $20 million in additional funding from a major U.S.-based investor, during a time when many investors had posed activity. Last but not least, we completed the acquisition of the Valeritas business. This significantly accelerated our efforts to build a U.S. organization, ready to launch four products in the coming four years. With the acquisition, we transferred 110 employees, systems, processes and the majority of supporting contracts to complete the foundation of our U.S. operations. This business continues to support revenue generating product, the V-Go insulin delivery device and is ramping up from the anticipated launch of dasiglucagon HypoPal rescue pen early next year. These achievements were made despite the rise of the global coronavirus pandemic.Page 4, highlights the areas where we have taken actions to mitigate potential negative impact from COVID-19. Zealand continues to monitor the crisis and take precautions to keep our employees, patients, business and clinical partners safe. We have adapted the way we work to support our community's efforts to reduce transmission of COVID-19 and protect our employees, while continuing to provide patient care and keep our business running.The impact of COVID-19 on our research activities as thus as being minimal, employees can work from home and they have been doing so, while those needing to work in laboratory facilities are divided into shifts to reduce the number of people gathered together at one time. Consistent with our announcement of April 2, we have continued our clinical trials while working with authority, investigators, trial sites and heroes to minimize site visits and ensure optimal trial follow-up.As a result of our team efforts, we have managed to maintain already enrolled patients in the ongoing CHI and SBS studies. Several clinical sites posed enrollment of new patients into trials to accommodate the pressure on hospital systems caused by the initial phase of the COVID-19 outbreak. But we are starting to see some sites reopening for new patient enrollment and Adam will provide more insights within the context of our development programs.Engagement with healthcare providers and patients, have been transformed, by leveraging virtual meetings, training and support. Commercial activities in the U.S. are focused on stabilizing business for V-Go, while ensuring a continued high-level of service and support for patients who have already been prescribed the device. Despite the pandemic, we maintain a clear vision of long-term goals. We continue executing on our aggressive strategy and our team stays focused to deliver on our promises.Turning to Page 5, I would hand over to our CFO, Matt Dallas to review financial results for the first quarter of 2020.

[Matt Dallas:]

Thanks, Emmanuel. On Page 5, you see Zealand's income statement for the first quarter of 2020 and how it compares with the first quarter of last year. The net operating result for Q1 was a loss of DKK 177 million. R&D costs mainly related to the regulatory efforts to support the NDA filing of the dasiglucagon HypoPal rescue pen, clinical development of the dasiglucagon and glepaglutide programs, as well as the preclinical research activities.An increase in administrative costs compared with the same period last year is due to higher consultancy and legal costs of which DKK 7.1 million relates to the acquisition of the Valeritas business and also new company headquarters and increased compensation expenses.Page 6, illustrates our financial position and ability to support our growing business. Net operating expenses shown on the left were DKK 171 million for the first quarter. On the right side, you can see that our cash position remains strong. As of March 31, 2020, cash, cash equivalents and marketable securities amounted to DKK 1.3 billion. In Q1, we received DKK 137 million in a private placement with a U.S.-based investor, not reflected in the Q1 cash as the anticipated milestone payment of EUR 20 million to be received after the first patient is dosed and the Phase 2 trial being conducted by Boehringer Ingelheim.Moving to Page 7, we are updating our financial guidance for the year. Net operating expenses in 2020 are now expected to be within the range of DKK 950 million to DKK 1 billion. The increase in guidance compared to the prior guidance of 2020, DKK 790 million to DKK 810 million is due to the completion of the asset purchase agreement for Valeritas, which closed on April 2.The acquisition increased Zeeland Pharma by 110 employees in the United States and added the V-Go program to the Zealand portfolio. In 2020 Zealand expects revenue from existing license agreements and the product sales of the V-Go wearable and delivery device. However, since such revenue is uncertain in terms of size and timing, Zealand does not guidance on such revenue.Now going to Page 8, I will turn the call over to Adam to discuss highlights from R&A.

[Adam Steensberg:]

Thank you, Matt.So on Page 8, you'll see an overview of Zealand’s robust pipeline. I will speak to our franchise programs on the upcoming slides, but here I would like to highlight the changes in our partnership with Boehringer Ingelheim. So in Q1 we regained the global rights to Amylin and we are excited about the amount of data provided by Boehringer and they are evaluating our opportunities with this molecule as we speak. This comes after a decision by Boehringer to focus on the development of now long-acting GLP-1/glucagon dual agonist. And we are very happy to report that glucagon is now recruiting for the Phase II trial with this molecule and to confirm that Zealand is entitled to a DKK20 million milestone when the first patient is dosed in this study. In addition, we are also very pleased to announce that Vienna has informed us that they intend to expand development of this molecule to also target treatment of NASH.On Page 9, you'll see the multiple treatment that’s added to – that we are pursuing with dasiglucagon in addition to the HypoPal rescue pen, which is in review by FDA for treatment of severe hypoglycemia and diabetes. We aim to change the life of children and families living with congenital hyperinsulinism by developing Dasiglucagon as a chronic infusion pump therapy for these children. Our first Phase III study with children aged three months to 12 years continues to making strong progress with patient enrollment, and we expect to have the last patient enrolled within the coming months and we can fill in our expectations to report the results of this study this year.For the second Phase III trial with 12 children from newborns up to one-year, we are also had that study ongoing and we have three other anticipated six sites actively screening of patients and ready to enroll. Driven by our ambition to transform management of Type 1 diabetes and reduce the burden of living with this serious condition, we are working with Beta Bionics to develop Dasiglucagon produced in the iLet bihormonal bionic pancreas. We believe that the results from the Phase II study announced last year demonstrated unprecedented glycemic control of the bihormonal iLet compared to an insulin only setting. And we are happy to see the progress made by Beta Bionics who have now started recruitment into their Phase III study with the insulin only device setting. As we continue to make good progress with the FDA and the bihormonal people to a Phase III trial, which is expected to start later this year. Finally, we are evaluating the potential of mini-doses of dasiglucagon as a novel treatment for patients who experienced recurrent events of meal-induced hypoglycemia following bariatric surgery.On Page 10, you'll see a summary of the top line results from the Phase II proof of concept study of Dasiglucagon in PBH, which was reported earlier this year and the trial demonstrated that small doses of Dasiglucagon were able to significantly reduce the time spent in serious hypoglycemia following a standardized meal in patients with this condition. And we are and remain highly encouraged by these results and we'll continue to explore the potential of mini-doses of Dasiglucagon to treat and avoid hypoglycemia seen in conditions such as PBH and Type 1 diabetes and look forward to provide further updates to the markets.Moving on to Page 11, here we review our program targeting treatment of short bowel syndrome. Glepaglutide is our long acting GLP-2 analog with potential for weekly administration in an alternate data, while we saw significant ramp-up in patient screenings across our nearly 40 sites. Early in the year several of these sites had to paused enrollment of new patients into the trials to accommodate the pressure on hospital systems caused by the initial phase of the COVID-19 outbreak. We are now starting to see some of these sites opening up for new patient enrollment and expect this positive development to continue over the coming months. That's our current estimate is that the interruption of the clinical – at the clinical site level has however caused results of the study into the second half of 2021.ZP7570 is a unique dual-acting GLP-1/GLP-2 agonist, which we believe represents the next innovation in the treatment of short bowel syndrome. We expect to have results from the single-ascending done Phase Ia trial here in 2020 and plan to initiate the Phase Ib, multiple-ascending dose safety and tolerability trial in 2021.With Page 12, I will now return the call to Emmanuel for his closing comments.

[Emmanuel Dulac:]

Thank you, Adam, and thank you Matt.I would like to conclude by and saying Zealand outstanding job of ensuring progress across our business initiatives. Our company and team has been one of the most resilient and positive I've seen in my career, despite an unprecedented period of external challenges. Our development pipeline has never been more robust. We have transformed into a commercial organization and are preparing to launch four products in four years. 2020 has been and will continue to be a momentous time for Zealand and we look forward to the prospect of the rest of the year, both for our company but also for the frontline healthcare professionals dealing with the pandemic today.With that, we are now ready to take your questions.

[Operator:]

Thank you. [Operator Instructions] So our first question is from the line of David Lebowitz from Morgan Stanley. Thank you. Please ask your question.

[David Lebowitz:]

Thank you very much for taking my question. When you look at the expense guidance for this year, I'm expecting that most of the incremental difference previous guidance and the last guidance, would we expect that to be falling under the G&A side of things considering the addition of the 110 I guess personally commercial side of things?

[Emmanuel Dulac:]

Thank you, David. I will ask Matt actually to address this question.

[Matt Dallas:]

Yes. The majority of the increase is all tied to sales, general and administrative expense as part of the Valeritas acquisition and 110 employees, all of which were commercial or G&A in nature.

[David Lebowitz:]

Okay. Thank you for that. And I guess given that the acquisition is completed I guess, what are the state of the preparations, obviously that's part of it that you are doing for a potential dasiglucagon launch?

[Emmanuel Dulac:]

So this one I can take. So we – we are done with integration of the existing systems, the existing processes. We are actually now starting to deploy, we would say a stronger organization. So feeding some of the gaps and that thing as well to not only to, get V-Go back to growth but as well prepaying the launch or the rescue pen. And so as a result, we are actually now engaged in multiple efforts on the marketing side to be able to ready our ops teams and on the medical affairs side as well as on the access side to ready the team for the launch of preparation for. So I don't know how to actually put – I would say a percentage in terms of time, but I think it's probably like a, right, a dig, a lot of time spent on V-Go and there's actually a separate team on the marketing side working, I mean, 100% of the time on the HypoPal rescue pen.

[David Lebowitz:]

Thank you for that. And I guess on the Glepaglutide enrollment, has that started to get back on track after delays of new patients or are there still some sites that are delaying the patients from starting?

[Emmanuel Dulac:]

Yes. I can take that question. So there are still sites that are not enrolling new patients as, as we also discussed in our last call, our first focus area was to adapt the protocol so we could allow the patients who are already enrolled or just about to be enrolled to keep them in this study and that we have secured. Then we have – we have protocol amendments and working according to updated guidelines. Then we have you can say on a side-by-side basis interacted with investigators and trying to understand when and how they will start to open up again. And throughout the period, actually we have seen some sites that have been able to screen a new patient, they’re randomized one, but – but clearly it was not at the level, I mean it has – it was the activity level was reduced significantly compared to where we were in January and February.What we're starting to see now over the last few weeks actually it is that some of the sites that have been asked to not randomize new patients into studies, they have been based on guidance from local authority has been allowed to now start recruiting again. So that's a very positive development. It's a – that we are seeing in Europe. It's a, I would say very much a country by country basis. What we are seeing in the U.S. it is depending on which States we are active in, where we will – some have actually managed to continue some randomization and material. So we are not where we were yet, but we are hopeful that over the next few months we will get to where we were.On the positive empty, you can say some of the, we have also discussed that former calls then it is a – this is a complex study and it puts quite a burden on the science. And what happens right now is that the patients who were already enrolled, they will of course complete trial participation, which means that once the sites are ready to enroll new patients, they will also have the hands to take care of these patients. So we are hopeful that that will maybe look at that to – you can say significant numbers of enrollment again in the coming months.

[David Lebowitz:]

Thank you very much for taking the questions.

[Operator:]

Thank you. The next question is from the line of Lucy Codrington from Jefferies. Thank you. Please ask your question.

[Lucy Codrington:]

Hi there. Thank you for taking the questions. I've got a couple. Firstly, would it be possible to see to this and what kind of – how, what percentage of patients have already been recruited into the Glepaglutide trial? And with the data being slightly delayed, is there still potential that this product could still be filed within 2022 or is that not likely to be pushed into 2023?Secondly, the Boehringer product, I guess is you still, do you still think first patient in could still be within this quarter given COVID-19 disruptions or could that be delayed? And secondly, on that product anyway to cross from the recent semaglutide data reported yesterday?And then finally, just on the V-Go device, just what your plans are for this product and how important it is compared to the rest of the pipeline? Thank you.

[Emmanuel Dulac:]

Okay. I will let Adam answer the first two questions. I'll take the V-Go, lasty.

[Adam Steensberg:]

Okay. As we just start with the BI question. So first of all, with the long-acting GLP-1/glucagon, where we announced the Phase II has been initiated, then you can say we have active screening of patients right now. So we would definitely expect a randomization and dosing of the patient very, very soon and within this quarter. So that study is actually actively recruiting and the data released by Novo, today on high dose sema, I think is a very impressive data set. They started at BI is running actually includes sema comparison. So that will at least give some opportunity to compare efficacy once we get the results from the Phase II study. What I would say again, what we are highly encouraged around is that BI is also now issuing NASH because if you look into the modality of GLP-1 and glucagon analog, it really is very interesting biology when it comes to the level.On clipper, I would say we have around half of the patients enrolled screened/randomized into the study when ended this period. And then so that's where we have to work from. And so you can say timelines as we communicate today. We pushed the expected results into the second half of 2021 based on what we've seen so far. But ultimately of course things depends on how the different clinics they get back in shape. But what we're seeing right now is actually a quite good momentum in that. I'm actually not clear – I cannot remember if you have a question on 7570. I think you should just take the leap now and then you can come back if I didn't address all the questions.

[Emmanuel Dulac:]

Yes. So on V-Go for us represent the first commercialized product. So I think we are learning a lot from it. At the same time this is a product which is commercializing the exact same target audience that we will be marketing our rescue pen – HypoPal rescue pen. So there is, I mean, anything we do right now V-Go has a synergistic effect with HypoPal rescue pen. So this is very important for us to learn actually from that.In terms of size, it's a – it's a small product, right now. What – what I must say is puzzling, is that I think each time you look at V-Go, I mean you can realize it's a very good product. V-Go demonstrated clinically relevant reduction in A1c with less incident, for example. It is actually a small product, it's simple to use. It's delivering both baseline as well the meal-time insulin in one product. It reduced number of injection. It's – I think it's been proven to be cost neutral with less injections, with better insulin control. So when you look at the data attached to the product, it's fully compelling, and I think there's a lot of work going on right now, so we don't have a full assessment, but I think it seems to be like, there is a lack of awareness of the product.There's a lack of adoption potentially versus the potential of the market. So we are learning and so we will provide more insights as we develop our knowledge around this product. But the good thing that again, we're playing in a field, this is exactly where we are going to operate with the HypoPal rescue pen. So it's all – right now it's all positive for us, and plus it provides us like a baseline revenue that is not huge, but that is not neglectable as well.

[Lucy Codrington:]

That's very helpful. Thank you.

[Emmanuel Dulac:]

Thank you, Lucy.

[Operator:]

Thank you. The next question is from the line of Michael Novod from Nordea. Thank you. Please ask your question.

[Michael Novod:]

Thank you very much. It's Michael from Nordea at Copenhagen. So – actually regarding ZP7570, maybe you can just give an update on the other thing, Adam, you were just about to mention it also in the light of, it seems like Takeda has decided to close down it's a TAK-681. Maybe, hopefully if you have any kind of knowledge about that would be highly appreciated. How you see that sort of pipeline market going forward?And then secondly on – again on V-Go, it seems like when you look at the underlying numbers from either Symphony or IQVIA that it's actually progressing quite stable. Is that something that you expect to work to continue throughout the year, maybe give some update on that?And then lastly on the dual-hormone pump, I can see you're still expecting it to start the trial in late-20. I fully acknowledge that you are sort of Beta Bionics screening patients, but isn't a significant likelihood that this is going to at least move another six months, and that means also the dual-hormone going into starting in 2021 instead?

[Adam Steensberg:]

Okay. Thank you. Maybe I can start by addressing a 7570 and then you have on 7570, we – as I said, we still expect to be able to report results from the Phase Ia study later this year. And as we've also discussed and as everybody is aware, it is a challenging time to do clinical studies, especially the first-in-man studies and Phase I – early Phase I study. So that is also in that light, you have to consider that we now continue to start the Phase Ib in 2021. You mentioned the decision by Takeda to close that long-acting GLP-2 program, which was in Phase I, and of course that we consider that very positive use for Zealand Pharma and I think it's also – I mean, of course we can only speculate why, but you can also put it this way, that we have a lot of confidence in Glepaglutide especially giving the current competitive market.So we also need to prioritize our resources in the right places. So that is a combination of all these things that, that are reflected here, I think the 7570. For the ZS program, I am personally extremely excited about the fact that the Beta Bionics has been able to start screening. And if you go to clinical trials that you can see all the sites involved in the insulin-only study, which by the way, I also decide that they're going to be involved in dual-hormone studies are actually recruiting right now.I think that's a strong sign of the commitment and the effectiveness with which they operate. And we've all the time set, the best study has to be added – initiated before we start dual-hormone artificial pancreas started. It is still set to start late this year, and as we have also said at Zealand Pharma, we are actually ready to support startup that study and we are not in a situation where we would change the guidance, because what we see with guidance right now is that they are actually able to see these patients and have the sites open as planned, so in a best case and a good case scenario, then they are also able to operate despite a consequence, despite of COVID-19. And of course with a device like they’re developing, it is helpful that it’s a lot of that can be handled remotely. So but, we are not changing our times, yes.

[Emmanuel Dulac:]

Thank you, Adam. As well, I would say that, you have to keep in mind as well that the patients, who are actually joining this insulin pump only, will be eligible for the next study as well, once they are completed. So that’s actually very positive for us as well, same sites, a bunch – bullies of patients that is actually pretty positive. And you had any...

[Michael Novod:]

Yes. I just on V-Go, how you sort of predict the sort of the weekly numbers to – it looks pretty stable actually. So it just to get a feeling of whether that’s sort of a stability we should expect to continue throughout the year.

[Emmanuel Dulac:]

Maybe that’s a question for Matt actually, who is looking at the numbers?

[Matt Dallas:]

The stability of the V-Go program, it’s hard to say right now. I mean, we like the program. We have faith in the commercial effort, right now everything’s a little hard to read based on outreach that the commercial teams can do. So it’s – we need to take a little bit of time and watch the progression.

[Michael Novod:]

Okay. Good, thanks a lot.

[Emmanuel Dulac:]

Good.

[Matt Dallas:]

Thank you, Michael.

[Operator:]

Next question is from the line of Etzer Darout from Guggenheim Securities. Thank you. Please ask your question.

[Etzer Darout:]

Great. Thanks for taking my question. Just a couple of – one questions, so first, I’m just wondered, given that this is the BI 456906 is a partner program. Do you have a sense of where we could maybe see the datasets that’s kind of informed the on sort of progressing to Phase II and sort of they are intend to expand into NASH. For the dual hormone, I think Beta Bionics starting to try recruitment is certainly positive. But maybe if you could give us a sense of what types of conversation are currently ongoing with the FDA and what kind of need to get agreement on prior to starting the Phase III program. Thanks.

[Emmanuel Dulac:]

Yes. So for – on the dual acting GLP-1/glucagon, it is up to BI to decide when to release data. And so we cannot comment more on that. The only thing as we have shared before is that we see a huge excitement in the Zealand and also it is a very strong signal from the BI when they are communicating that they are also going to push this forward in NASH. And we have all the time had a high belief in the data and I think there are other preclinical data available for other compounds with the same modality, which suggested that the mode of action of having both GLP-1/glucagon actually is something that can provide very significant weight loss, also more than what you’ve seen with single acting agents.And when it comes to the nutritional stages of a fatty liver then glucagon by nature is actually go into that liver from nutrition. So that is, I would say, that’s the evidence we can talk about right now. And then yes, I was ready to share the data from the lead molecule here. We cannot comment on that. On the dual hormone artificial pancreas and the interactions with FDA, we do not have updates to the market right now that we can share with, what we can share is that we are still progressing towards a single Phase III study and comfortable with the numbers that that we’re going to have in that study. And we expect to be able to provide, you can say at from trial design around some of this year.

[Etzer Darout:]

Great. Thank you.

[Emmanuel Dulac:]

Thank you, Etzer.

[Operator:]

The next question is from the line of Jesper Ilsoe from Carnegie. Thank you. Please ask your question.

[Jesper Ilsoe:]

Thank you so much. Two questions, one on NASH, and one on clear path. So on NASH, I appreciates all the comments you’ve made on the call. Just put into perspectives, on OPI, its running, but given all the things we’ve seen in the area with Novo reporting data, Genfit failing, it's just how you perhaps can see that asset in the current evolving competitive field in NASH, I know you haven't started the study and it’s very early stage, but just to give a sort of like your thoughts on this asset in NASH. And I also appreciate that again that the BI is running it and you don't have the data and everything, but just do you have any preclinical data on the compound as such to give you confidence besides the fact that GLP-1 has seen to work in NASH, that's the first question on glepaglutide?I'm just trying to assess whether we should expect the final Phase 3 data to the base case being in Q3 2021 or Q4 2021, because of course, this is a very key part of your story and there has been some delays in the past. You've previously the expected data May, 2020, then you expect it in H1 2021, I appreciate the impact from COVID and it's not in your hands, but it's just how bigger delay you've seen on glepa any color there would be appreciated. Thank you.

[Emmanuel Dulac:]

Yes, on the last question, I cannot specify more, because it actually all depends on how things are developing. Personally, I'm more positive now than I – that's what I said three weeks ago, because we are starting to see this opening at specific sites. And I think we all learning more around this, how to deal with this situation, but we cannot specify it more than what we have done with H2 2021.On the dual acting agonist for NASH, we have preclinical and there is also been published data on [indiscernible] once-daily analog. And I cannot speak for BI I can only speak from a Zealand point of view and perhaps my personal point of view is that, if we are normally – I would be very skeptical around moving into NASH as a company, because as you know especially if you have had an anti-bariatric[ph] agent in development for whatever disease and people have repositioned those for treatment of NASH because it's been such a hot area.While we are starting to see some very significant and great results out with the GLP-1 and the metabolic – addressing the metabolic component a little bit earlier than maybe when you start to address as a product, and I think I should mentioned that companies who have shown some promising data there, if you take a dual agonist and then mechanistic action of a dual acting agonist, probably NASH is the indication you should pursue with dual agonist because of the effects of glucagon on the label.And if you look into the preclinical data, we have published on obesity with a dual acting agonist, in my mind it beats anything else that has been published with other single acting agents. So that's why we feel that this is a potential future, we're not as we have discussed, we also understand that it's huge program and it requires a very committed player like BI is in that field. But so – but it's fair to say that from a Zealand perspective, we are really, really happy to see that they are also pushing this forward in NASH, because that is where we see very strong biology.

[Adam Steensberg:]

Yes. If I can add as well, Jesper, I would say that, the abandonment of the Takeda long-acting program clarify the story for the sites in terms of who they're going to be working within the fixture. And so I think it helps us in terms of being able to engage with clinical sites as we come forward with glepaglutide and they know that now it's going to be Zealand Pharma. And we have, as we say recent crisis behind so it will help us in terms of engaging with clinical sites and accessing clinical patients.

[Jesper Ilsoe:]

Thank you so much.

[Operator:]

The next question is from the line of Alan Carr from Needham and Company. Thank you, please ask your question.

[Alan Carr:]

Hi, thanks for taking my questions. A couple of them, Adam, quick around the V-Go and have all the supply chain issues that were experienced late last year by Valeritas and those all been sorted out. And then with respect to CHI, it sounds like you're close to full enrollment on the older kids trial, but can you give us an update on the smaller one in that the younger kids? And then the last one is around bariatric surgery. What's the next step there? What sort of trial are you all contemplating running there next? Thanks.

[Emmanuel Dulac:]

Adam, would you take the V-Go questions, I'll take the [indiscernible]?

[Adam Steensberg:]

Yes. So, on the CHI you're correct, we’re very, very close to have all the older children randomized into the study and we actually have them identified. So this is a matter of how to get them to clinic, so that looks very, very good. On the smaller children, as I said we have managed to get three out of six sites that are going to enroll patients into this study, activated and looks like the last site activated quite soon, that means on average they need to randomize two patients each. But since they are units, they have to appear to the clinic before we enroll them. And we have had active screening for few months now and we have had patients who are close to get in, I’d say but we do not have the first in yet.So I would say, it could happen any day. And then once – what we see is, since these are, it's actually on top of standard of care this study. So it doesn't impose a lot of additional burden on the sites, on the units, on the families. And it actually just provides an opportunity for these children's to get out of IV, glucose, et cetera. So it is a study, which we hope will not be impacted so much by the COVID situation. Now we assume this very, you can say dramatic and chaotic phase, where everybody had to adjust to how to work with COVID-19 around. So we are comfortable with that and we are managing to actually see progress.On the postbariatric surgery, next step is that, as I said, we will discuss with FDA and as Emmanuel has also highlighted several times, it is a program where we are doing a mini dose pen, so we actually have a pen that can give these mini doses. So you should see the development activities, we are going to do for postbariatric surgery in the totality of what we're doing with the franchise, meaning that we are also considering the next steps in the Type 1 diabetes with a mini dose pen, where we see a huge pool from patients and prescribers. So you could expect to see a broader development going forward within that pen – mini dose pen development.

[Emmanuel Dulac:]

Yes. And Alan, you will note that we are not calling the pen right now, the multi-dose pen our feature product. We're waiting to actually define a regulatory route for this product in the various potential indications. We can expect this product to be marketed. So that's why it's still, I would say in development I would say right now.Regarding the V-Go, I'm happy to share that actually the technical issues that led battery test to have their stock out and supply issue have been actually identified and solved. So the matter now that we are dealing with is, we are ramping back the production to the full capacity and we are actually supplying, we're starting to supply all the orders, delayed orders that we had so that we can get the stock back to full – again full orders. So this is a matter of weeks, but in terms of technical issues, remind you as well that this issue did not trigger a safety report to the FDA. It was just a capacity issue. So this is – I would say work in progress and we are – the supply chain and the supply team is actually working night and days to get the orders, to supply all the orders back.We have seen very, very happy customers seeing their stuff back and as well most of the patients had supply, so very few of them had a discontinuation. I think the team did a fantastic job to make sure that there was no holding during that period of time, so that everyone could have their supply as needed, but this is constant work. So we are monitoring it and we are working on it on a daily basis.

[Alan Carr:]

Right. Thanks for taking my questions.

[Emmanuel Dulac:]

Thank you, Alan.

[Operator:]

Thank you. Next question is from the line of Graig Suvannavejh, [Goldman Sachs]. Thank you. Please ask your question.

[Graig Suvannavejh:]

Yes, thanks. Good morning and good afternoon. And thanks for taking my question. I just want to focus on the dual hormone artificial pancreas program, certainly a really interesting program. And I'm wondering if the company plans to provide us a perhaps a more extensive view on how we should think about the commercial opportunity at some point later this year. And can you also remind us of the relationship that you have with Beta Bionics and kind of what the economics are in terms of whether it's the spend or on the backend on any potential, commercial sales, how that might be split out. Thank you.

[Emmanuel Dulac:]

Yes, Graig, thank you for the question. So we have that in works. I mean this better assessment and understanding of this opportunity is in motion. We have actually hired now full staff team for – and the leader for this new indication, which we didn't have before. And I think this is a top priority for the leader of this brand.The situation right now is that, we as well put a lot of resources on the integration and attention on the integration. And so I think we – for the last, I would say three or four months, we put a little less commercial attention to these dual-hormone pumps, a bit more on the regulatory route, discussing with the FDA on the clinical design. And so as a result, I think as soon as we have, I'd say and we're able to communicate the Stage 3 design of – you will have very clear understanding of the market potential for this product. So I know we have to wait a bit more to be able to communicate that openly, but I think it will be clear very soon.

[Adam Steensberg:]

And the collaboration with Beta Bionics, it’s a nonexclusive collaboration, but we collaborate closely and we have to do that. And then we – because we engage with FDA together and we're doing clinical studies together and you can say the cartridge that we are developing, fits exactly into the device. So it's a ready-to-use system, so it all adds to the simplicity. On the commercial space, we have not defined how to [indiscernible] there, but it is clear Zealand Pharma, as it stands right now are responsible for the cartridge.So selling the glucagon in a cartridge and Beta Bionics are responsible for the pump. And then each of our organizations are building commercial infrastructure. As you know, Zealand has now established a commercial infrastructure, but it allows us to work with other pump companies later and it also allows these brands to work with other glucagon providers later, if that would be some.So, yes, the very good news is that Beta Bionics hired their first leaders as well on the commercial side. So they are starting to deal their commercial presence as well.

[Graig Suvannavejh:]

Okay. Thank you.

[Operator:]

Next question is from the line of Thomas Bowers from Danske Bank. Thank you, please ask your question.

[Thomas Bowers:]

Yes. Thank you very much. A couple of questions from me just on glepa just a sort of a follow-up, do you have any impression on how many patients actually was screened just prior to the lockdown? So how many patients are actually ready to go on treatment right away? And then also glepa, is it fair to assume with the delay into second half, that BLA timing would be realistic for first half of 2022? And then maybe I missed it, but just help me understand on the V-Go, so the revenue impact for 2020, you have 25 million or 22 million in revenue reported from Valeritas after nine months in 2019. So can you just help me with some numbers on the full year 2019 sales and how should we actually model this into 2020? So it is fair to assume that maybe six months of sales and then flat growth is what we could see here for 2020? Thank you.

[Emmanuel Dulac:]

Okay. I get that with Glepa, I think it's, it's difficult for me to comment more on the glepa. I think what we have and that is sites that are completely ready. We have patients identified. We have a list of when and how they should be enrolled into the study. And we had, you can say a number of patients who are screened and we have modified the protocol so they can be randomized and they can enter the clinical side again. But it is clear that this has imposed an interruption to each of these sites, so but – and its coming back to this thing that we are seeing size now that the, when all this was lined up to happen in let's say March and April, and now we're trying to – and we're hopeful that we will now have in May and June, for instance, with these sites that have not started and that will be – as well will be June and July and others where it will be later after summer, for instance.So that is the role. And then what will then happen after that is, we need a second row of patient coming in a little bit later this year. So, that is – and so that's probably where we are there. And with regard to timing of the NDA, I think we will not have – we cannot be more clear than to say, of course, if we have results maybe early in second half of next year, then it could happen 2021, if we have them late in second half, then it will move into 2022 before we submit.And maybe on the V-Go question, maybe I will ask Matt to take the numbers.

[Matt Dallas:]

Sure. So with the Valeritas acquisition closing on April 2, of this year, we will record three quarters of product revenue for V-Go in Q2, Q3, Q4, due to the time, the transaction was completed, as well as the nature of everything going on with COVID-19 and just the transition of the business from Valeritas to Zealand. It is tough for us to give any guidance right now on the product revenue that we're anticipating for the remainder of the year. And we'll look to clarify that as we move forward.

[Thomas Bowers:]

Okay. So at least when we're looking at 25 million [ph] for the first nine months of 2019, it's not like we should expect any major deviations for that product in 2020. Is that factors your modeling on?

[Emmanuel Dulac:]

Again, again, Thomas, it's hard for us to say because within that COVID-19 was not part of 2019 and we're in the process of evaluating everything at the moment.

[Thomas Bowers:]

Okay. Okay, great, awesome. Thank you.

[Operator:]

No further questions, sir. Please continue. Hello, sir, there are no further questions you may continue.

[Emmanuel Dulac:]

Yes. Okay. So I just want to close by saying, happy we are to be able to engage with all of you actively, hopefully in live soon. It was a very good quarter for us. We actually are stronger as a result of being tested through the team through this crisis. No companies had this on their list of things to achieve, but I think we went through this and we met the – I would say the guidance that we gave in terms of execution.Again, this is probably transforming the way we're going to engage in the future, which is something we still have to assess, but I really look forward to be able to engage more and be able to share more of the achievements that Zealand is pushing to-date. And again, we're looking forward to a momentous year of 2020 for Zealand.

[Operator:]

Thank you. Thank you everyone. This concludes – the call.