Q2 2020 Zealand Pharma A/S Earnings Call
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I am welcome to your conference call this continue to stand by your conference. You're beginning to minutes. Thank you.
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Okay, ladies and gentlemen, thank you for standing by and welcome to the Zealand farmer results for Q2 2020 Cole at this time. All participants are in a listen-only mode after the speaker presentation. That would be a question-and-answer session to ask a question during the session. You need to press * 1 when you're telling me I must advise you that this conference is being recorded today are now like to hand the conference over to your speaker today marks. Kronborg, please go ahead sir.
Thank you operator. Welcome and thank you for joining us today to discuss feelings first half of 2020 Financial results. I'm head of investor relations and communication at 7 with Nico our Seasons chief executive officer direct Chief Financial Officer met Dallas and chief medical officer Adams feedback. The team will respectively provides business financial and development highlights from the first half of the prepared remarks will open the whole take your questions. You can find our first half of 2020 interim report the related Company announcement and additional supporting information on our website at 6.
as a company
In Denmark, our financials are reported in Danish crowns also referred to as Corona. He figures may have been converted to US dollars for convenience. I would like to find 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 communication flow application to update them except as required by law. Please refer to really filing for a more complete picture of risks and other factors with that. I will turn the call over to another internet.
Thank you, Matt. And thanks to everyone for joining today.
As announced last week Matt Jones earlier this month's as the head of investor relations and communication and we are very happy to have recorded such a strong and experienced professional life has continued to build the organization.
Do you think it's like three zero am has had a very strong first half of 2020 despite the unprecedented situation created by the covid-19 pandemic. I made significant progress towards our goal of becoming a fully integrated biotech Company by leveraging our Innovative pipeline to address unmet medical needs in metabolic and gastrointestinal disease.
No table in the new drug application for the iPad rescue pain was accepted in May and is under review by the usfda birth date of March 27th, 2021 as we wait an approval decision. We accelerated the build-out of our commercial team first through life of the very test assets and commercial commercial infrastructure, including the already marketed legal device.
And second with the Strategic Investments made to strengthen a commercial presence with the establishment of a new headquarters in Boston and the appointment of Frank Sanders on president of Zealand farmer.
With for late-stage assets. We also continue to execute on our clinical development pipeline.
I am proud to share that we now completed the recruitment of a first phase 3 trial of children we c h i
Fueled by the commitment to make a difference for these children and despite the extraordinary circumstances created globally by the covid-19 pandemic the team continue to deliver to allow us to meet or a goal that we had set prior to the pandemic.
finally
and the scoring up commercial preparation and development efforts is a solid balance sheet recently strengthened by an additional $657,000 billion finish gone through a direct issue and private placement the largest fundraise for Zenon ever as well as a 20 million-euro Milestone package from boehringer ingelheim glp-1 Agonist partnership program that was triggered in June.
Do I need to slide for?
I would like to take a moment to provide an update on potential areas of impact from covid-19.
Z. Continues to minister the covid-19 panoramic and take precautions to keep our employees patients business and clinical Partners safe.
We quickly adapted the way we work to keep our Laboratories open support our partners our community efforts and protect employees against covid-19 am continuing to provide patient care and maintain employees engagement and business community.
During the second quarter of this year several clinical sites post enrollment of new patients into trial to accommodate the pressure on the spittle systems caused by the initial phase of the outbreak.
However, we have seen a gradual reopening of new patient enrollment. We expect this positive development to continue over the coming months assuming that there is a continued reduction of the pressure on the spittle systems.
I'd like to actually extend a special thanks to the patients families and investigators who are joining a study trusting us kissing Jessica go outside and also want to extend a very big thank you to the Zealand team who kept the forming during these testing times keeping our own Laboratories and Key activities running.
I am particularly proud of the new employees who joined us earlier this quarter and braced organization added to a culture and for the work they did to Saddam continued access for patients to RV go wearable insulin delivery device.
And with that I will end over to our CFO Matt Dallas to redo Financial results for the second quarter of 2020. Thanks many well on Slide Five of our webcast DEC page. You'll see Zealand's income statement for the first half of 2020 and how it Compares with the first half of last year net operating result for the first half of 2020 was a loss of 230.9 million Corona thirty four point seven million dollars R&D costs, maybe relate to the regulatory efforts to support the NBA fine for the Desi glucagon hyper-rescue pin clinical development of data off on the cloud you type programs as well as in preclinical research activities.
Slide six illustrates our financial position and ability to support a growing business and then operating expenses shown on the left where 437.2 million Chrome 65.7 million dollars for the first half of 2020. You see that our cash position remains strong as of June 30th Cash Cash equivalents and marketable securities amounted to 1.65 billion Corona R. 247.2 million US dollars in Q2. We raised 657.7 million Chrome 99.3 million US dollars through a direct issue and private placement and in June. We also offer a milestone payment in the amount of twenty million euro from are boring legal partnership program moving to slide seven net operating expenses in 2020 are expect to be within the range of 905 to 1 billion Chrome. There's no change to the operating expense guidance and that's on May 14th of 2020 which reflected an increase.
420
Due to the completion of the asset purchase agreement for Blair plus which closed on April 2nd of this year the acquisition increased even Farmers Personnel by 110 employees in the u.s. And read the Vigo program to the z-pack good for you.
Total revenue in the first half of 2020 was 233.495 or 35.3 million US Dollars Revenue related to the FBI. Milestone was 149.1 million or 22.79 US Dollars net product revenue from the sales of the Vigo. We're a moment some delivery device During the period of April 2nd to June 30th was 58.19 Chrome or eight point eight million dollars with net product Revenue expected to be within the range of 150 to 175 million Corona for the period beginning on April 2nd and ending on December 31st, 2020 Zealand also expects revenue from existing license agreements. However, such revenue is uncertain in terms of size and timing is the only does not intend to provide guidance on such Revenue wage. Now turn the call over to our chief medical officer Adam seemed to discuss highlights more pipeline.
Thank you, man. It's like 8 you'll see our robust pipeline of peptide drug candidate for me to Pollock and gastrointestinal diseases off the first half of the year. You have seen significant progress across all programs. And before I go into more details and the basic program franchise and the vehicle type of short bowel syndrome. I would just like to share a few other highlights from the.
So you better pleased to see that the new handles the first patients in a phase two studies of 6906 and long-acting. The one off for treatment of type two diabetes obesity and match.
We are also seeing good progress in the preclinical pipeline, including our collaboration with addiction and complement C3 earlier. This quarter be announced a two-year research agreements Onyx. The equipment will enhance our ability to use Big Data artificial intelligence and machine learning in the discovery and development of next-generation peptide Therapeutics bath.
I wanted to work on franchise is presented on slide nine.
Starting with the adjustable need those pin program in March of this year. We reported positive face to data for prevention of meal is used hypoglycemia patience with post biotic hypoglycemia as previously shared. We have initiated the development of an adjustable need those pin allowing patients to solve administered as opposed to prevent or treat much more moderate hypoglycemia, and we are therefore now excited to announce that today that a phase II am trying for the prevention of intervening to is hypoglycemia and people with type one diabetes was initiated in June and this trend will expand the opportunity for the adjustable need those pain program, and we look forward to adding more updates as we progressed.
But it will home on artificial pancreas program. We now expect initiation of the pivotal phase three studies to slide into 21.
Mankirt that in spite of covid-19 beta balance has been able to complete the development of the eyelet device and achieved FDA acceptance appreciation of the phase three trials.
That also managed to screen all 440 patients in the pivotal including only bionic pancreas science and it's our understanding that doesn't of the first patients in a study is planned for later this quarter.
Completion of patient enrollment will guide imitation of the people to do home on artificial pancreas drive with basically Logan.
Moving to like 10 and an update on the high-profile rescue payment.
It's highlighted by Emmanuel.
Earlier in last quarter for the rescue payment was accepted by for review by the date of March 27tg.
And the hypo rescue pin is designed to offer patients with diabetes and effective treatment for severe hypoglycemia, and in the pivotal and cross street rods the primary and all secondary endpoints very successfully successfully achieved with a median time for blood glucose recovery after only ten minutes long and media and time to recover we have ten minutes was also demonstrated for Pediatric patients.
Moving to side 11 and our Airforce to change the life for Children and Families living with congenital hyperinsulinism by developing basically Logan home as an infusion pump therapy.
The goal here is to reduce or eliminate the need for intensive hospital treatment will reduce the frequency of dangerous low blood glucose the need for constant feeding off and to potentially delay eliminate the need for pancreatectomy.
You're running three three three studies in children with c h i coloring and eight spent from seven days to twelve years. The first is free. Trial is with 32,000 which c h i h 3 months to twelve years.
Which day rolling of the last station key and August we achieved and major milestone for the program the last patient last visited Stanford program, and we're happy to page concerned that results from this trial are expected later this year.
The 2nd Street line which isn't twelve children, which ehi from seven days to one year.
And here we are pleased to see that the first patients were randomized into this study in July and we expect all sites to be enrolling patients in the coming months.
Please move to slide 12 our lease candidate in the gastrointestinal franchise program is the title tag along. I think the two analog which is being developed in an auto injector with potential for convenient weekly Administration for patients with short bowel syndrome.
She knows how to show Down syndrome is a rare chronic debilitating disease affecting up to 40,000 patients across us and Europe and we believe that the attack retired has the potential to suck at an important new treatment option with a unique drug profiles. And once we get those in by auto injector, this is true results showed significant increases in certain and absorption following only three weeks of treatment with a good safety profile.
For the ongoing Tracy Drive. We are encouraged that a number of sites have been able to randomize new patients in the second quarter despite covid-19 restriction off as a new continue to Seaside. That would cost reports are now opening up a new patient enrollment. We maintain our guidance that we receive results from this month in the second half of Twenty-One. I will now turn the call to in annual please closing comments. Thank you Adam. Thank you, Matt.
20/20 is a significant to your president and I'm thrilled to see the progress. We are making on all fronts. We gained significant momentum on our own no doubt failure this year with the battery tested position. We accelerated transformation into a fully integrated R&D and Commercial biotech company Kettle a break continue to advance. It just sets into the final stage of clinical development and we strengthen our finances.
Zealand is growing and transforming every day. We continue to invest in R&D and the rubbers early pipeline standing from our Innovative peptide platform. We now have over 300 synthetic employees in Denmark and the combined and the company is on a positive trajectory.
We have delivered on our commitments and we are well poised to realize our ambition to have five products on the market by 2025. I am looking forward to the future month, and we've that we're now ready to take your questions.
Nadia please open the line for questions for meeting. Yes. Thank you. Ladies and Gentlemen We Now begin the question-and-answer session as a reminder. If you wish to ask a question, please press star one on your telephone. If you wish to cancel your request, please press the hash key. Once again, please press star one. If you wish to ask a question, and your first question comes from the lines of Michael from nerdia, please go ahead line is open. Okay? Thank you very much. And I have three questions is Michael from India so first to to the vehicle and the guidance and and I just seen your release that you comment that if you're not able to sort of meet with the stakeholders them obviously don't have an impact on on on sales. How should we understand that in terms of Beyond its a 2020 just to get a feeling for how long?
Which of of your efforts will go?
Going to continuing the the push on the Vigo product and then secondly on c h i maybe you just described sort of the the commercial perspectives on on on this Thursday in in in sort of in in Greater detail how we should try to to work with this on the commercial side. And then on the on the beta bionics just a feeling for life on the on the face three for the tool hormone how fast you expect it can can sort of be be initiated and started and and run as soon as it's it's going so we could see data perhaps off early late 2021 or something like that. Thanks a lot.
Thank you, Michael. Maybe I can take the vehicle and mapping that something as well to 8 and then Adam will take the next to but on the vehicle too early to tell I would say off the the results are encouraging but I think what's really I think the most more positive thing about legal knowing that you know, Q one was a 1/4 we're both capture the the sales you would actually under the battery test management and they were running through some stocking issues here to we've been running under this, you know, covid-19 pandemic situation. So it's just very easy very difficult to actually see what is the study, you know revenue from from the operations. Um, what's really encouraging is the the team now in the US has been fully integrated organization. We have a governance. We have actually leadership. We have hired a new president for the US and so there is a very strong momentum. They have embraced the the Culture Club.
And the company and the vision and the pipeline that goes with it as well. So I think that's what I was really looking for Less numbers but more about the momentum the engagement and as well the behavior of people and this is really encouraging of course, it's difficult to put on paper. But this is this is what I think we should focus on. Yeah, and this is Matt and for twenty Twenty-One. I mean, we're not going to comment on red expectations right now, but the the sales force, you know, there's duplications of call points with Viggo as well as the rescue pin launched so we would not anticipate, you know wage reduction in effort for supporting Vigo in in next year and it's more. Yeah. Okay, and that was also my my point because I was actually a bit surprised to see the vehicle is doing that. Well during the pandemic.
Yep. Okay. I can address the next two questions and CH actually not provided our company perspective on on the commercial potential and of course you can say one thing is we need to see the data from that. They see what I can say is that we're dealing here with children where there is a significant unmet medical need. And of course our expectation is with the program that we demonstrate that the address that need as also exemplified by the fact that we've been able to actually get patients in despite all the circumstances most often. The patient comes to all have decided to enroll also in the extension study suggesting that it's actually a treatment that is doing a difference to these stations. We have patience of being on treatment for more than a year. Now. So we we are you can say hopeful and and and very encouraged by the progress of this program with, Georgia.
I'm going to children being an also-ran indication. Of course, there's also opportunities for for for for having.
Sales around comes around the product because it is an indication. So the only guidance we can get this is and also rare product is a product which we believe will make a huge difference to the children if approved and that probably where we can go to on the commercial perspective right now complete the bionics here. We are seeing that the initiation of the sliding to $21 on the south side and what really we can say is extremely important for us is the first of all data X have managed to complete development of the eyelet. The the I is a commercial pilot that will go into phase three months, which is a major Milestone. They also managed to swing 440 patients in I think less than six weeks during the pandemic and now they're assume it's our expectations that they were randomized birth.
So they have it ready to get into the study. And as we have communicated all the time, we will not initiate that they they say three for the door home until they have completed that enrollment into their face wash so into that place, we sorry but they usually know so it really depends on the speed which which they can enroll these patients, but we are hopeful that it's it's it will be early Twenty One am sorry was that
Super. Thank you Michael. And the next question comes from the lines of Thomas Thomas powers from danske bank, please go ahead. Ask questions. Yes. Thank you very much, sir, a couple of questions for me as well. So so just on on a few gopal so so I'm just wondering if if there's any well in in regards to a pre launch preparations for this. I'm just wondering if you have started to to solving things with with pay us. And and if that's the case, do you have any feedback so far? And also I guess you're up for a mid-cycle review here next month. So I'm just wondering if is it fair to assume that you should you should not speak to any any at come on this one and then just turn into to to the to the emelin and lock it so that you can Co formulate with with move this move.
You do once so, I'm just wondering if this potentially could become part of the oil pipeline in the near-term. I may be looking for a different profile for for this candidate wage, and then maybe just lastly just on the flute sides. They were proven here, and I just wonder how does the Duke. I'm just wondering if you guys are still in for at least a 30% us patience in in that study and and if not any indication that could become a problem for the FDA. Thank you.
Yep. So on the iPad pre-launch activities the the team actually we have a full team working on it now. So marketing team medical Affair. We have a my sales in the Outfield. We have a sales team as well. But the I think the most important thing is that you know, they are actually we had and I think we I shared probably some of these data with you before in terms of public perception of drugs, you know preference by physicians prescribers, uh nurse has families and and patience, uh-huh big preference for the injectable route and you to injector vs. Jason vs. Nasal, but since now there is been you know, these new entrants we had not rerun these analyses and so we are actually running a whole batch of and that is including the access because the access actually picture has changed lately because of the new entrance so we are doing this work now dead.
At the same time we are actually doing multiple things like mapping the entire territories, you know, we actually run this Duty during the judicious Veritas we run this analogy to see what was the overlap between exact prescribers would be go and the the risk the risk UPenn. So we are completing these analyses now, uh, and and but we have a full team we are actually fully fully staffed and so people are actively working on all that right now. We we will share when later during the year. And again, we will not share everything because it's competitive intelligence, but we will share you know, what what what's relevant for for you guys.
Yeah, maybe I guess the follow-up and we have no indications that that would be a napkin reason for the for the for the viewing. I prefer on a million. We are still on a reality. We just receive all the recalls. So we have to evaluate this asset and will not be able to comment further answer that will be coming months. We remain excited about the Target and Thursday as many would be so so and we look forward to provide good or face when we have the tool overview of the date and swap the passenger side. We are we are we actually have seen em. Yeah and and number of viewers to randomize patients all they have started to to to communicate that they will be able to randomize again, but it still affects that most of the sites have been closed down 422 to whether we will end up having 30% of patients being Usef.
Will not be an issue as you also know, I mean with these situations are covid-19 and there are many things that we're allowed to to kind of go a little bit beyond value is normal things like this. So but we do not see any issues with if we would not have left a service with U.S. Patient in the time. Okay. Perfect. Thank you very much. Thank you. Next question comes from the line of Greg savanovic from Goldman Sachs, please go ahead and line is open.
Greg good morning. Good afternoon. Can you hear me? Okay.
Yes, we can hear you. Well, great. You change that name Berry the week. I've got two questions. Actually my first just I'm just trying to get a better gauge of what a potential hyperpower launch could look like in the past you've talked about what you've seen the market do with the bank introduction of to new entrants within the past year. I think you've said that you've seen kind of the market grow about 30% I'm wondering if if you have a latest kind of update on on what the heck it looks like right now and and whether there's been any inflection either up or down in terms of what the market is doing right now also with regards to a job that how you are currently thinking that the high-profile launch new might look like relative to the two other products in terms of kind of the slope of trajectories. Um,
And then my second question just has to go back to to Viggo and I'm just curious as to how much commercial intensity is not the right word. But how much commercial effort you are going to put behind that product. I know you provided guidance, but I'm just trying to get a gauge of how how much of a priority is or not in terms of driving sales rep. Thanks.
Yeah, so so the last data I I had on the market was that you know, there was a very fast inflection and growth of the market at at the lounge of like see me which I think grew by around twenty percent in six months. I think since it was rather flat. So the 20% growth was actually stabilized was still growing by 20% but didn't go further than that. And then uh, and then that's where that's where I stayed in terms of in terms of understanding the market wage actually needs to be correlated to data that I don't have because again, that's the work that was just mentioning Thomas before that. We are gathering which is what's behind. You know, these how much efforts wage is being put all the teams, you know on the on the other side still fully focused. I think it probably went from a a p-12 back to a p two or p 3 a.m.
Um, and at the same time we saw uh-uh, a disease awareness campaign being launched around hypoglycemia, which is really good because I think it's elevating the awareness for a need for you. So I I think it's it's a uncompleted picture right now for to understand the full Market behavior. However, I think you know the interactions we could still tell us that you know, there is a high awareness in the Nicholas we know for for the need there is a a big expectations for a simple solution injectable. And and so I remain confident that with the data we have provided the FDA that you know, we will be able to deliver a product that needs all these dead a preference for patients. Um, that's that's where we are in terms of how much efforts were planning to it will be actually as well somewhat linked to this analysis that we're running right now and again.
Adding a new head of the US helps a lot. I can tell you because uh before that the team.
Was actually everyone was engaged with it and we were spending maybe you know half of up time on it. Now. We have a full-time dedicated corporate management leader helping the US team focusing on the preparation of these high-profile Penn launched which for us is you were saying how the prioritize for us. It's a top priority. I mean, this is our first launch and this will be the only launch em until we bring thi so we will put all all the efforts and energy and focus behind this iPad launch.
next year
Okay, just just just to clarify with respect to hypo do you have a sense of how the market for the other two products has Fairfax in a covid-19 environment and just the other follow-up was just as a clarification. I was just curious about how much intensity the company might be putting behind we go next month. Oh on Viggo in in the human in the mix of the launch of hype about
Yeah, kind of yeah, yeah prioritizing. So in terms of activities during the covid-19 from the competition, I don't have the data. I don't know what's going on that's missing. The one information I have is that now there is should be marketing their auto-injector, but I didn't get any feedback from that either. So it looks like it's very quiet. But that's that's difficult to see there is numbers anyway, um and regarding the the Vigo, uh, you know, uh Synergy with a superb L as Matt said before there is there is actually a huge overlap in terms of call and you know, it's very simple for wraps to manage to products very simple, but didn't see the Eiffel Tower launch will be as long as every launch will be priority. It's top priority for us, but it's easy to carry two products.
Okay. Thank you.
Thank you. And the next question comes from the line of Alan car from didn't didn't and Company please go ahead a line is open. Hi, thanks for taking my questions about a couple of them actually coming back to the duel pump. You mentioned that there's a delay in the 21. Is it is it just a matter of the collaborator? They're having we're taking longer than expected to to enroll that and then also you mentioned the twenty patient phase two trial that you're starting with Daddy glucagon off a bit more about that. And what else you would have planned in terms of other opportunities for Ford as a glucagon. I know that you looked at bariatric surgery earlier too. So it's trying to get a feel for how broad you might go as a group. Thanks.
Desktop repeat that Onyx I think as with any other business covid-19 did have an impact on the timeline in the sense that they had to modify the engine only protocol and I and I think it's actually off an outstanding achievement that they managed to swing 440 patience during the day of the crisis us more than 20 sides and the only way to achieve that by introducing virtual screening protocols and stuff. So on and the same goes for the for the study the the randomization of the study that had to make significant changes to conduct the study in order to conduct clinical research across more than 20 sites in the US. So so it is I would say yes, it's a delay on the outside but on the other hand something that I think is extremely interested that they've been able to push through despite all these chances. So we we are actually as I said
Oh be notes really encouraged. Also by the fact that these opponents now have finalized the development of the trunk also during these times and and and basically ready to to to those pages or so, of course, it's always disappointing when you see if someone's the delay but on the other hand you see we actually see much more frivolous now because a lot of the risk has been removed from the program so that Thursday that is very good.
And the other program that was the the mini there was a program where we just started as a smaller place to study whether you do pay off a great replacement. So the opportunity to use a minute those aesthetic. We open instead of carbohydrates to to correct amount of moderate and you should see it as a broader scope as we as we also chatted our last call with an adjustable need those pain right now, which we would hopefully have in clinical trials within a reasonable time. And that is something we have been pursuing for some time. And we as I also said that my email isn't my opening those who look very much forward to share more life. And and what we intend to do with this program has a manual said Thursday. We have post-traumatic surgery hypoglycemia where there is an all-terrain indication that the clear need among these patients that that is one Avenue for this program. And then the other many patients with type one diabetes.
Do not yet have access to a door home on pump who could truly benefit also from a tent which could correct email tomorrow and hypoglycemia and situations where ingestion of carbohydrates and I am I could solution. So so we expect to talk more about that and I will then add lastly all the activities we have with a particular, specially when it relates to the minute those ten and so on Thursday actually contribute significantly to the empty to the file of the Google home owner of the bankers because we create both secrecy and safety data, which more of those has our particular brand new jersey assembly, and then we keep exploring, you know, all the for on-demand be those, you know for that if you get off at this product can can meet but we're still actually looking at regulatory routes to get you know, these these product to the to the to the market so not to calm but I think the phase two age
Throughout to read you know, if he could see these critical right now. Thank you for your question. Actually if I can get in one other one, I'm wondering about it and telmex your your deal with them. Can you have a good thing about how how you plan to leverage that collaboration specifically?
Yeah, so so it's basically everything that know how in in in handling big data and and that we will utilize more and I think it's coming back. I would say also a question that we get more and more and our peptide platform. And and our you can say we
I told my daughter about all these days assets, but the fact is it's also highlighted by manual in the introduction. We have a very very exciting platform here which we hope to explore and and we can same rich in Rich even more in the years to come and so you can say this is probably something you should expect to hear more about our airports in the pipeline and what we talked about before because I said thanks for taking my I just want to know we are we are discussing uh to Thursday. I can tell you an R&D day and this is where we will actually disclose a bit more details about this platform search so stay tuned, but we'll you'll get all the information when he waits for him.
And your next question comes from the line of it's from Google security. Please ask a question.
Great. Thank you for taking the questions just a couple of quick ones first on the Dual hormone pump. Are you able to provide any details on the design of the phase three, you know, he number of patients length of treatment. For the primary analysis, or I guess when we when could we get those those types of updates in a question on a c p 7570 if you can remind us of the potential advantages of of the Dual agonism and what the know the go, I guess know go profile for that molecule could look like wage advance that program. Thanks.
T v but we have already shared. I think some of the inside and the primary endpoint will be an hba1c. It's clear Thursday is also what if they still expects we will of course have continuous glucose monitoring on these patients and the devices connected to a CGM, but the primary endpoint is is is HBO package and we will it would be designed at the superiority tried every show that it would hold on set out to show that the Google home on a pump is superior to standard of care, but also Superior to a ninja it would it would and then of course, we also hope to show that we would even have reduced hypoglycemia the same time. It's going to be a 6 months prior client and then there would be an extension part to the study of another six months to connect further safety data because we're dealing with in a new chemical entities like that equipment for chronic treatment.
And we are we are aiming to include those children adolescents and adults from the goal in the in in the same study basis and the exact size. We we still need to to make it but they say the incident only study that is 440 patient wage. And they're the total hormone will be somewhat taken not that big. I guess it would be three arms as I said, so we have a pretty good idea walk around 6:31 during the week like
7570 to have the flu was also the place one later this year the program super excited about business. First of all in our preclinical animal models with X. Not only on the you can see it also in the disease models. We are trying to have some very good data off. The key thing here is we already have physical proof of concept by the fact that investigators have combined deal to do with everyone and she hasn't shown synergistic effects and the ability to reduce parental support. Our hope is that this knowledge, you will also be very effective on on the reducing the vehicle output which is a major burden for these patients and hopefully also improve the overall metabolic wage opponents is a pretty usage patients who actually have a disruptive influence in response because they get some demonstrations not by the oral route. So but the main thing will be dead.
On the traveling point we also have an infantry but then additional benefits and energy absorption and their style so and you can say they also you could only we only get a signal on those parametres from humans. Once we've done the page to started from phase one is basically as you know, a matter of showing that it's safe and you can get into it may not be expecting you if you go to
We have great. Thank you. Thank you for the update off.
And your next question comes from the line of Chess is away from Carnegie. Please ask a question.
Thank you so much. Three questions from my side first one clip a cat's I'd follow up and on the questions on the US recruitment. So just in general looking more Global have you seen any changes in recruitment in recent weeks or recent months? And I also recall that you had some sites not being open up yet have that change has to decide for example, it's really started to to other again just to get a feeling for the overall recruitment with with flip exercise. Then the question I'm we go again. I also took a lot of the guidance our case so $150 and seventy-five million in nine months. Is there any one else in that number or does it reflect the underlying nine months and and then again off course, can we just extrapolate that and say in a 12-month basis? The underlying number will be 1/3 higher and also follow up on vehicle aybak.
Of course that you don't give out a 2021 guidance, but with it so looking at the underlying drivers will be fair to assume that vehicle growth can can track and follow their growth in the underlying that we use population IEDs three to four percent of the vehicle and then just last questions on the program we have here with bringing in line with the iPhone 5 6906 given current timelines when to expect that we could actually see some phase three-phase to result. Sorry would be fair to assume that in the South part of 21, or is it the 2022? Thank thank you so much.
Could you take the data off when the endemic hit our our main focus was to maintain patience in the clinical studies that were already enrolled and this is what we were able to do very successfully took one thing was with this study. We actually have a very long sweet sweet. We have you optimized the pages before they were randomized. So a number of these patients also in the USA will put on trucks. Which was something wrong with Regulators. Meaning that we had been pulling up being a dead screen. And then we had to wait until the size could actually randomized and they could users that several of these sites dead us and also New York who had where we had to put the patients and trucks up they have now rear end up yet. Actually now enter my TV stations. So so that's that's addressing a group is the question. How are they opening up a lot of these Prasad?
Able to do that now. So how however it shifted its is a fact that we have. It's been Europe actually driving most of the randomization and do screenings in in the office. Especially I would say we have seen Denmark Germany France is standing on both very well now and and and the countries that have contributed so far. Also, you, are the ones where we still need to to you can say is extremely Regional some sites have been active all the time actually off some some sites have informed us that they expect to really be able to open up here and in August and early into September so
Yeah, so so so that's that's that's what it is. And and we we are actually encouraged right now. We've got to see if she got two two two sides being able to randomize new patients on Monday. I mean it is of course up to bi to communicate and when they have they solved I think it sounds probably say what you suggested. It could be a late twenty one is important but it is up to them to comment on that and and we don't have any insights Beyond dead on time.
Maybe on Viggo Matt. So if you look at the the vehicle guidance of 150 to 175 for nine months that's excuse to 3 and for Q2 with 58,000. So approximately a third of the range than that guidance. So it looks like I mean, we're not going to come in on how quarters just the the the nine-month themselves. I can't comment on a full-year number Q one was a pre-acquisition. It was Blair tossed incurred piece. They're not Revenue number audited numbers. They will not be reported in our financials in this manner and then looking at a 2021 it's a 00 early for us to publicly comment on growth expectations. We've only had the the acquisition just closed on April 2nd. It's just one quarter's worth of Revenue in the books. So it's a little little early there.
Thank you.
and your question
and the next question comes from the line of from Brian, please ask a question.
Yes, thank you. The first two questions were on Viggo and actually Matt's since you just said that we go with 58 in in life too. Probably the reconciliation is not correct on my site. I was expecting total revenue to be the twenty million dollars from bi and then the rest of ego, but I'm not sure it set up right there maybe something else but if the 58 is correct, then if we compare the 58 with the cost of good of a m e 8 million negative these brings us to gross margin of about 50% Is that correct? Anything one time one off in there or could we get the 60% gross margin going forward as being the right one? And the last question is on the the the alpha beta.
17 to Green inhibitor since Rush released this week the top-line results with naturalism AB, which well are mixed but somewhat disappointing and and a bit negative. Does it require more corrosion on your side before moving forward with your compound or is it good news as it clean up the the competition landscape off. Thank you.
Although let me address your Revenue questions right now right now, you know revenue is composed of three components. It's the bi Milestone, right? It's a legal product Revenue, but there's also we'd recognize revenue from our lifestyle partnership. So that's I think that's the completion missing and for the first half of this year. That was 26.5. So that's the that's the delta.
Right and then the gross margin you're correct is approximately 50% for the period and historically as a device that had a margin within that range. It's just again give you any forward-looking projections on gross margin for Vigo at this time.
Yeah, and then maybe on our way to 7.
The road program was of course an injectable. And what we're trying to do here is is to take a typical like an s27 which has been injected and to make that an oil. So whether it's good news or bad news for us that they fail and with regard to competition. I think it's hard to say because I think it could invent if we're successful with our all delivery of a molecule. I think that is that with that is transformative how to treat patients with inflammatory bowel disease. So I guess at that time we would just wish the market as as big as possible in order to capture. Yeah, I'll share that with a normal old therapy you have caused me to be cautious and we already know that in Chagrin biology is difficult. Our multi would have the same time and they already approved products. So so that gives us some confidence.
Thank you, and you follow up?
Hi there. Thank you for taking my questions. I just got a few left firstly the 2nd. Th I study would it be possible to or can you disclose how many patients had been screened and just can you confirm do you need data from both studies before you can file for this indication? And secondly, is it possible to provide any mortgage emeriti on the sales and marketing split regarding preparations for the hyperpower versus Viggo and that's it for now. Thank you.
Maybe if I just. C h i so we have actually randomized and those and completed the first few patients. So they have completed off and haven't seen and rolled into the extension study. We do not come in on the exact number. It is the first few patients. It's not it's not the most patient. And as I said also, we expect them both sides to randomize new patients in the coming months if it's real patient started, but again super encouraging that the patients have completed the study and have enrolled into the extension study wage whether we can file on one study or not. Ultimately. It depends on the data. I would say on our from our first study. It's something we were thinking about and we will also be in a dialogue on this but ultimately it will depend on the on the date and the strength of the data we have the the good thing is we have a lot of safety data because as I said before we have several patients will be indulging
And your next question comes from the line from Jefferies, please ask a question.
Wow, so so that that of course is reassuring. Yeah and on the back side. So so what we go and I Patel, you know, share is the because of the overlap of targets. Uh, they they will be sharing sales team and MSL teams, like medical field teams. They have a different marketing team. So we have different teams again to make sure that you know, they are focused on the analytics and on the the driving the programs for each one of these and then the other location of resource usually is based on position. So, uh primary position versus secondary position, so primary position wage recapture, you know around sixty seventy percent of the time and the and the and the costs are located to this shared resource and the and the second product will actually capture dead.
30% of the cost right now. We only that Viggo so hundred percent of the cost of the Investments. He's actually go.
I don't know if he answers you between terms of modeling at the moment. We're not breaking out sales and marketing between product lines and this will fly right is we start preparing for the c h i watch as well actually with positive phase 3 data, but at the moment, it's just kind of a bolt. Yep Zealand.
Okay, that makes sense.
Thank you.
No, thank you. And the next question comes from the line of David Lebovitz from Morgan Stanley. Please ask a question. But thank you very much for taking my life. I'm given that you're going to be launching desert glucagon into fairly uncertain environment and you can't be 100% certain wage what the marketing world is going to look like they're how is your team prepared to launch the product?
Given, it could be virtual. It could be sort of hybrid. It could be in person any thoughts on that.
Yes, very good question actually equals. We we don't you know, you know have a huge team and structure like, you know, some of big Pharma example is very easy for us to actually now invest in you know, this new virtual digital tools. So the team right now the iPad rescue team is actually focusing a lot on making sure that we have in place all these uh, you know, programs and tools available for the product at launch regardless of you know, if it's if it's still in the same situation probably likely and as I'm a I'm a optimistic guy, but probably like it will be actually I think in June next year or July next year will be in a much better situation, but I think you know, we are preparing for I would say a new normal and The New Normal is going likely to include some of these tools anyway off.
We are planning for it and we will be ready next year to pull that and one thing here to is would having a commercial team already out there selling Vigo their utilize these types of strategies in this new environment so that when the does Google on the launch, you're having a lot of the similar strategies, we have the experience. They've got a year, if one of the same wage in this type of environment, we will have a sales team that's quite experienced with the kind of the touchless model where need be
So actually the team has been running already with some of these tactics and tools for the last three months successfully in the field and they got a lot of attention because I think we were off the first company to actually Implement some of these and so so yes, I think we'll be well not only will have them but we will know how to use them as well.
Thank you for that and and one additional question is there I mean at this point given that the inspections for the for the submission are probably still far away considering that the FDA right now is not traveling overseas for inspections. Is there any thoughts on how you might manage that going forward if they continue not with them?
I think I mean.
They have introduced virtual inspection, so it should not be an issue.
Okay, sounds good. Thank you. Yeah, we went through so I know for the questions, please confirm.
Well, thank you. And as usual, we remain you know available for any follow-on questions, you know of of this line, but I think that's I think that's it that does conclude our conference for today. Thank you for participating. You may all disconnect speakers, please standby.
Yep.
Dead dead dead.