Q1 2020 Earnings Call
Ladies and gentlemen, thank you for standing by and walk into the V Lab pharma results for Q1 21 at this time, all participants and listen only mode. After a dispute your presentation. There will be a question that actually session. You asked a question during the session you won't be the press star one gets a whole foam also.
As a bunch of the calls being recorded today Thursday before genes with major himself in interpreting and adult any forgive me I know like dad will be called your first speaker today Ms. slightly more than thank you. Please go ahead.
Thank you and what comes is even from conference call well results from the first quarter 2020.
Dissipating in today's call I ceiling, Chief Executive Officer, and then you all do not.
Chief Financial Officer, Matt, Dallas, and Chief Medical Officer, asking for.
The team well, respectively provide business financial and development highlights in the first quarter subsequent event.
After the prepared remarks, we'll open the call to take your question.
You can bring to Q1 interim reports the related company announcement in additional supporting information on our website, that's even pharma dot com.
The company headquartered in Denmark, our financials I reported in danger Crown also referred to as.
He figures may have been converted to U.S. dollars for convenience.
On page two I will point out that we will be making forward looking statements that are subject to risks and uncertainty.
And then a valid only as of today and the company assumes no obligation to update them, except as required by law.
Please refer to recent filings for a more complete picture of risks and other factors.
Page three I will now turn call over the CEO.
Thank you Lenny.
Thanks to everyone for joining today.
We are pleased to share with you today the results of that he didn't fall must trend stopped in twentytwenty.
We did you bring on not commitments, despite the disadvantage and challenging situation created by the corner somebody needs.
Despite the global health Crazy.
We successfully spine new drug application with the 50 fold. It does it you can I tell rescue pen.
This was an exciting accomplishments.
And the first India.
Sports fully owned come down.
We also announced let's keep results.
From the phase two clinical trial with media does or does he could get.
Treatments for diabetic surgery aggregate senior.
These couldn't yet.
Another potential that'd be able treatment modality. So this molecule.
And we are graduating how we can supplement or they love and pipeline.
We secured.
Hundred 37 million corner or approximately $20 million.
Additional funding from major U.S. based investor.
During a time when many investors had good activity.
But not least we completed the acquisition of the very tough business. These significantly accelerated died foods to build a U.S. organization ready to launch full products in the coming for years.
We acquisition, we transferred hundred 10 employees.
He said.
Crosses keys.
And the majority of supporting contracts.
To complete the foundation about you exploration.
These business continues to support or revenue generating product the Vigo inserting beat every device.
And he's renting.
From the anticipated launch of there that you could get them I put salary stupid early next year.
These achievements were made despite the rise of the global coronary artery some damage.
Page four.
Highlights the areas, where we have taken actions to mitigate potential negative impact from could be 19.
He didn't continues to money during the crisis and take precautions to keep our employees patients business.
And clinical partners safe.
We have it did the way we work.
To support our communities efforts.
To reduce transmission of could be 19.
And protect our employees.
Why continuing to provide patient care and obviously that's running.
These factors Coveas 19 on the research activities.
That's far being meaningful.
Employees can work from home.
And they have been doing so why do is meeting to work in laboratory facilities are divided into shoes to reduce the number of people gathered together at one time.
Consistent with our announcements of April 2nd.
We have continued clinical trials why the working we've authority.
Investigators.
<unk> sites and see a rose to me.
And ensure optimal trial sort of what.
As a result.
The team exits.
We have matched to maintain already enrolled patients in the ongoing get shy and SDN studies.
Several clinical sites, both enrollment of new patients into trials to accommodate the pressure on hospital systems caused by the initial phase of it could be 19 outbreak.
But we are starting to see some sites reopening for new patient enrollment and I will provide more insights within the context about development programs.
[noise] engagements with health care providers and patients have been transformed.
By leveraging this will mean.
Training and support.
Commercial activities in the U.S., all focused on stabilizing business legal.
While ensuring continued high level to savvy since you bought for patients who have already been prescribed the device.
Despite the founder.
We maintain a clear vision, although not long term goals, we continue executing on our aggressive strategy and our teams Facebook used to delever on the promises.
Turning to page five.
I wouldn't handover to our CFO, Matt that S to review financial results for the first quarter of 2020.
Thanks.
On page five you see Zealand's income statement for the first quarter 2020, and how it compares with the first quarter last year.
The net operating results for Q1 was a loss of 177 billion kroner.
R&D costs, mainly relate to the regulatory efforts to support the NDA filing the does it gone hydropower rescue pen clinical development of the does a good gone and got type programs as well as the preclinical research activities.
An increase in administrative costs compared to the same period last year due to higher consultancy legal costs of which 7.1 billion kroner relates to the acquisition of the Blair tops business and also new company headquarters and increased compensation expenses.
Page six illustrates our financial position and ability to support our growing business.
That operating expenses shown on the left 171 billion kroner for the first quarter.
On the right side, you can see that our cash position remains strong as of March 31st Twentytwenty cash cash equivalents in marketable securities amounted to 1.3 billion core.
The one we received 137 billion kroner in a private placement with the U.S. based on best or.
Not reflected in the Q1 cash is anticipated milestone payment of 20 million euros three received after the first patients dosed in the phase two trial being conducted by Boehringer Ingelheim.
Moving to page seven we're updating our financial guidance for the year.
Operating expenses in 2020 are now expected to be within the range of 950 million to 1 billion kroner.
Increasing guidance compared to the prior guidance 2020, 790 to 810 bank for its really the completion of the asset purchase agreement people their dogs, which closed on April so.
The acquisition increases even pharma by 110 employees in the United States and had the Vigo program to the zeal and portfolio.
2020, Zhou and expects revenue from existing license agreements and the product sales.
Terrible insulin delivery device, however, such revenue.
Uncertain times sized size of timing soon it's not guiding et cetera.
Now going to pay Jay I will turn the call over to Adam to discuss highlights from R&D.
Thank you Matt.
So on page eight you'll see an overview, let's see less robust pipeline I.
I will speak to our franchise programs and the upcoming slides.
Yeah, I would like to highlight the chances in our partnership.
Ingelheim. So in Q1, we gained the global rights.
And we are excited by the amount of data provided by.
Yeah, evaluating how opportunities is molecule actually speed.
This comes out that decision by the that's a focus under development on our goal I think everyone Nick on equities.
I'm very.
Very happy to report that.
Now recruiting for the phase two trial with this molecule that you can send that see that isn't tied to a 20 million euro milestone in the first patient is dosed in this study.
In addition, we are also their teach you announced that has informed us that they intend to expand development of this money Q2 also talking treatment of Nash.
On page nine.
You'll see that multiple treatment modalities that yet because shoeing. That's if you look on in addition to their habits I guess, keeping which is in my view by 88, the treatment of severe hypoglycemia in diabetes.
We aim to change the life of children and families living with congenital hyperinsulinism by developing that's gone as a chronic infusion pump therapy.
For these children.
Our first phase three study where children aged females to 12 years continues to making strong progress.
Patient and old man and he expects to have to last patient enrolled in the coming on and Reconfiguring our expectations with positive results. This study here.
But the second phase three trial with 12 children from newborn such a one year.
We also have pets study ongoing and we had three out of the anticipated six sites accidently.
Screening occasions.
And ready to undergo.
Driven by allowing patients to transform divestment of type one diabetes and reduce the burden of living with this serious condition working with pizza bionics. So basically we're going to use in the I did five homeowner bionic pancreas.
We believe that the results from the phase two study announced.
Yeah.
Administrative unprecedented sumit control, Okay, I'm, all I know it compared to an incident only setting.
And we're happy to see the progress made by Pizza bionics.
Who has now started recruitment into that they see study with the incident only device setting.
As we continue to make good progress with the FDA by Homo pivotal phase three trial, which is expected to start later this year.
Finally.
Yeah, I valuating the potential of many doses that you have done as a novel treatment for patients who experienced with current events of new and used hypoglycemia falling by adding surgery.
On page 10.
We'll see a summary of the topline results from the phase two proof of concept study that you have on TV age.
Which was reported earlier this year.
And the trial demonstrated that small those is basically work on.
We're able to significantly reduce the time spent in serious hypoglycemia. Following a center I knew in patients with this condition.
And he and the main highly encouraged by these results.
And we'll continue to extolled the potential of meaning it was just as you can work on succeed.
And then right hyperglycemia senan conditions, such as PD age and type one diabetes and look forward to provide further updates to the markets.
Moving to page 11.
Give me that you all programs targeting treatment of show passenger.
Hepatitis our long I think you the two analog potential to meet the administration in an ultra agenda.
While we saw significant ramped up in patient screenings across our nearly 40 sites early in the year. Several of these sites had supposed to enrollment of new patients into the tried to accommodate depression hospital systems.
Caused by the neutral phase of the cold 19 outbreak.
We are now starting to see southeast opening up new patient enrollment and expect this positive developments are continue over the coming months.
That's our current estimate.
And that the interruption ethics cynical clinical site level.
Hey, what goes through sauce study into the second half its 21.
C. P 35, 70, it's a unique acting kids get the two activities, which we believe represents the next innovation in sweeping up short bowel syndrome.
We.
Speak to that results from this.
Single ascending dose phase one eight trial.
Yeah, and Twentytwenty and plans to initiate a phase one multiple ascending dose.
Since I believe you tried and 21.
We paid so I will now we turned the colds in Monroe for his closing comments.
Thank you for them.
Thank you.
I would like to conclude by and phasing.
Outstanding job of ensuring progress across all business initiatives.
Our company.
And Tim.
Has been one of the most resilient and positive I have seen in my carrier.
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 full products in four years.
Twentytwenty has been and we'll continue to be more laments whose timing for xenon.
And we look forward to the prospect of the rest of the your goals for a company.
But also for the frontline healthcare professionals.
Beginning with the pandemic today.
With that we are not ready to take your questions.
Thank you mentioned that gentlemen.
I'm sorry.
Now please go ahead.
Thank you ladies and gentlemen, there's a lot began the question answer session again. That's a reminder, if you wish to ask your question. Please press star and when I get telephone and wait for it needs to be announced if you wish to cancel your request and spread fashion.
Against our one she Jewish to ask your question. So I'll first question is from the line David Lebowitz from Morgan Stanley. Thank you. Please ask your question.
So thank you very much for taking my question.
When you look at the expense guidance for.
This year I I'm expecting that isn't as most of the incremental difference between this guidance last guidance would be expected to be calling under that the DNA side of things considering the the addition of the hunger games 10.
Personal commercial side of homes.
Thank you David I.
I will ask Matt actually to address these question.
Yes, the majority of the increases all tied to sales general and administrative expense.
As part of the toss acquisition and a 110 employees all of which were.
Commercial or gene in nature.
Okay. Thank you.
And I guess given that the acquisition was completed I guess what are the state of the preparation.
Obviously, that's part of it.
You are doing for a potential does it look on lunch.
So just wanted I can take so we we all done with integration of the existing systems, you know the existing processes.
We are actually now no starting to deploy.
We see stronger organization, so feeding some of the gaps and adapting as well to knutsen need to you know.
Get beagle back to growth, but as well prepaying the launch of the Red Japan and so as a result, we are actually now engaged in multiple efforts on the marketing side.
To be able to redeem our teams and on the men across their side as well on on the exit side to ready the team for the launch of Ah preparation.
For so I don't know how to actually put I would say percentage in terms of time, but I think it's probably like a right, though a de <unk> a big amount of time spent on Vigo and there's actually a separate team on the marketing side.
Working I mean hundred percent of the time on the I thought of risk Japan.
Thank you for that.
And I guess on the a couple of tied.
Enrollment.
Has that started to get back on track after delays of new patients or there's still some sites that are delaying their patients who started.
That I can take that question, so that still sites that are not enrolling new patients.
As we also discussed at our last call. Our first focus area west to adapt the protocols will be put out the patients who are already enrolled or what's your thoughts would be in.
To keep them in this study and that yeah secured.
Yeah, we have by protocol amendments and working that go into updated guidelines.
We have.
You can say on that side by side.
Facing interacted with investigators and side just to understand when and how.
They will start to come up again and throughout the period. It actually we have seen some sites that have been able to to screen and you pacing.
Randomized, one, but but clearly it was not that they live I mean, it has it was activity levels at west reduced significantly compared to where we were in January and February.
Well, you're starting to see you know the last few weeks actually it was that someone decides that had been asked to not randomize new patients into studies they have been based.
Guidance from local authorities been allowed so now stock recruiting again, so that's a very positive development its a.
That we're seeing in Europe et cetera, I would say they must the country by country basis, what you're seeing in the U.S., it's depending on which states active in where we were some have actually managed to continue some randomization in the period. So.
So.
We are not where everywhere yet, but we are hopeful that over the next few months, we will get too.
On the positive and you can say.
Some of.
Yes, we will also discuss it from a.
Then it is a this this is a complex study and it puts quite a bit among the sites and what happens right. Now is that the patients who were already enrolled they will have caused.
Complete.
Tried participation, which means that once the sites rates when will you patient. They would also have the hands Tutsi cathy's patients that were hopeful that that will.
We will get back to two you can see significant numbers of involvement again in the coming on.
Thank you very much for taking my questions.
Thank you. The next question just from the line of Lucy contribution from Jefferies. Thank you. Please ask your question.
Hi, there. Thanks for taking my question Youve got a couple.
So I see.
It seems to this.
<unk>.
How what percentage of patients have already been with Cleated entity.
Okay, I trial and with the data being slightly delayed is that still potential of this product.
It could still be filed within 22, we thought like now like efficiencies.
23.
Secondly.
The bearing product and I guess.
Yes, so he still think cessation could still be within this quarter given and.
Okay that 19 disruption or could that be delayed and secondly on that product any way to costs from the recent stem the tide data.
Reported yesterday and and then finally, just on the Vigo devices. What your plans all for this product and how important is compared to the rest of the pipeline. Thank you.
Okay, I will let a Adam answer the first two questions I'll take the legal last.
Okay. If we just thought with that yeah.
And so.
First of all with it.
With that didn't want to work on long I can just want to work on.
As if that where we announced the phase two has been indicated.
You can say, we had active screening of patients right now so we would.
Definitely expect randomization and dosing of the patient they very soon and within this for them. So.
So that study is actually actively recruiting and there.
Data released by mobile yet today and high those say, Matt that I think is a very impressive dataset.
Started at the eyes running exiting foods say, Matt compared to.
Yeah. So.
At least give some opportunities if you compare if you can see once we get and the results from the phase two study what.
I would say again, what we are highly encouraged around is that that is also now tissue in mass because if you look into the bad it's yet to get into one and I grew up on analog.
Really it's very interesting bother to you when it comes to.
To the level.
Okay.
I would say we have around half of the patients enrolled screens as randomized into the study when he and his this period and then.
So that's where we have to work from.
Good.
So you can say timelines as we communicated today, we push the expected results answer the second half of 21.
Based on what we have seen so far but ultimately of course things depends on.
How the different Phoenix, they get back in shape, but what we're seeing right now is actually quite good momentum in that.
Yeah, I'm expecting lucky if you're not going to it but you haven't question I'm 70, 575, I think you should get kicked him even out.
And come back if I didn't address all the questions.
Yeah, so on Vigo for for US we present, the first commercialized product. So I think we're learning a lot from it at the same time you know this is a product which is commercializing the exact same.
Target well against that we will be marketing are.
Rescue pen hypothermia stupid. So there is I mean anything we do right now with Eagle has a synergistic effect with a very stupid. So this is a very important for us to turn down actually from that.
In terms of side, it's a it's a small product.
Right now.
But what I missed the first thing is that I think each time you Lukas Eagle you mean, you can read I, it's a very good product ego demonstrated clinically relevant reductions in eight once he.
We have less incident for example.
It is actually a small product you know it's simple to use it.
It's you know did you bring both the baseline as well that the mealtime insulin in one product it reduced number of injection.
It's I think been proven to be cost neutral weve less injections with better insulin controlled so when you look at the data attach the product it's pretty compelling.
And and I think there's a lot of work going on right. Now. So we don't have a full assessments, but I think it seems to be like there is not because of walnuts of the product there's a lack of.
Adoption potentially there's the potential of the market. So we are learning and so we will provide more insights as we as we develop you know our knowledge around this product.
<unk> Michael from entity in Copenhagen, So actually regarding said P. 70, 570, maybe you can just given update on that I think Adam you just say about two to mention it the oh so in in the light off it seems like to cater has decided to to close down it's a text 681, maybe.
Oh, who if you have any kind of you know.
Knowledge about the about that it would be highly appreciated how you see that the sort of a pipeline market going going forward and then secondly on a on again on V. go.
Like a when you look at the underlying numbers from either symphony or I.Q.V. that the it's actually progressing quite stable is that's something you you expect to where to continue throughout the year, maybe give some some update on on that and then lastly on on the jewel hormone pump.
Because he used to expecting it to to start the the trial in a in in late 20.
I I fully acknowledged that that you are sort of always by honestly screening patients, but isn't the significant likelihood that this going to at least move. Another you know six months and that means also the do homework going into starting in 2021 is good.
Okay.
Okay. Thank you maybe I can stop to.
<unk>.
<unk>, Yeah, and I'm 70 570.
<unk> I think we do expect to be able to report.
<unk>.
Okay.
This year and.
<unk>.
It's time to do clinical studies is basically person man studies and things one is one.
Oh.
That is also in that line.
Now.
<unk>.
There's one in 21.
You mentioned that you shouldn't.
<unk>.
Long acting guilty to program, which was one and of course that we consider that maybe positive.
<unk> I think it though I mean.
<unk>.
You can also put it this way that we had a lot of countries I think back inside it's basically giving the current competitive market. So so we also need to to.
<unk> our resources right phases. So that is that combination of all these things that that is that average.
75 seconds.
But it you have program.
I I personally extremely excited about the fact that.
Data banks has been able to choose dot.
Screening and they easy.
You can see all the sites involved in the in this study, which by the way also besides that they're going to be involved in it yeah <unk> studies.
Actually recruiting right now.
I think that's a strong assign the commitment and effectiveness with which they operate.
We have all the time said that that started it has to be how did you change it before we start.
<unk>.
It is still sensors dot late this year and.
We have also said then see then we are actually waiting.
Students who's important it's not that study and.
We are not.
Aging baby would change the guidance because we want D.C. would.
Right now that the I.C.E., which is just <unk>.
And so so in the best case and a good case scenario then they also able to operate is by <unk>. Despite uncle with 19 and of course with a device that get another thing is it is helpful that is.
That can be handled remote.
So so we're not changing all done yeah.
Yep.
Thank you and as well I would say that you know you have to keep in mind well that the patients who are actually join you Miss a insulin pump only you know we'd be digital for for the next study as well once they are completed so.
It's actually very positive for us as well same sites, a bunch, but budisa patients that's actually pretty positive.
Yeah.
On V. go how you sort of predict the sort of the the weekly numbers to it's 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.
Maybe that's a question for Matt actually.
Who is looking at the numbers.
The stability of the be go program, it's hard to say right now we we like the program.
We have faith than the commercial operas right now everything's a little.
A little hard to read based on outreach the the commercial teams can do.
So you know, it's it's we need.
Take a little bit of time and watch the progression.
Okay.
Okay.
<unk>.
Good.
Thank you <unk>.
Next question is found a lot of absurd the route from Guggenheim security thinking conceptual question.
Great well thanks for taking the question just a couple one questions. So first I just wondered you know given that this is the the.
The 456, I don't know six as a partner program do you have a sense, where we could maybe see the the the the data sets that's kind of in on the on sort of progressing to think too and sort of you know their intent to extend into mash Oh for the door <unk>, you know I think bit about unexciting <unk>.
Positive, but maybe they could give us a sense of what types of conversation are currently ongoing with the F.D.A. and what you know kind of neat to to to get agreement on prior to starting the phase three program. Thanks.
Yeah, so far.
I mean do what I can get the one to work on it is up to yeah I to decide when to read these data and and so we can not commenting on that the only thing as we have she had to go is that we see.
Huge excitement.
And also isn't very strong signal from yeah I. When there are communicating that they also going to close this board in in Nash and then and we have all the time had to high in the in the data and I think that other preclinical data available.
Oh.
Other compounds to weight, the same with energy, which suggests that said.
The mode of action of having both get one and grew up on actually is something that can provide very significant weight loss also more than once again.
Acting agents and.
When it comes to the.
Nutritional stages of okay fatty liver and by nature is actually [laughter].
Into that label from from the tuition so that is.
I would say.
That's that's the that's the evidence we can talk about right now and when.
Yeah, the eyes ready to share the.
Data from the need molecule here, we we cannot come in and then.
On the.
And they do at home or not sufficient pancreas in there and the interactions with <unk>.
We do not have updates to the market right now that we then we can see <unk> that we as stupid question to wasn't single C., three study and and.
To go with the numbers that that vehicle and you haven't destiny.
And we expect to be able to provide you can see and so I'm trying to design around some of this year.
Great. Thank you.
<unk>.
The next question is from the lineup Gisbert also from Carnegie thinking to censor question.
Thank you so much two questions one on this and one on clipper so unless I appreciate all the Commons you've made on the cold.
Just just sort of into perspective, I know P.R., it's running it but but given all the things we've seen in the area with nobody polling data ginseng failing. It's just how you perhaps can can can see that s. It.
In the current evolving competitive field in the S. and though you haven't started.
Well the space, but just to give <unk>. So it's not like your thoughts on on this s. It an s. and I'll also also appreciate that the P.S. running it and you don't have that they don't have to think about what else do you have any preclinical data on the on the compound shots to to give you confidence besides the fact that.
That'd be one has to.
Work the in S. that that's the first question <unk> <unk> <unk> <unk> I'm, just trying to to to to assess whether we should expect to the final for three days to the base case being incomplete. So one or two thoughts are sort of what because of course this as a very keep.
Part of of your your story.
And there's been some delays in the past two previously to expect to say that they 2020, then you expected H., one short and 21.
I appreciate the impact from covert then they snow then you'll have but it's just how big it then they you've seen on okay, but any thoughts.
I call. It there would be agree says thank you.
Yeah.
The last question I I cannot speech <unk> because it it actually all depends on how things are developing.
<unk>.
Personally I'm more positive now than I, that's why I said three weeks ago, because we have time to see these opening at specific sites and I think we all learning more round is how how how to deal with the situation, but I can we can must be five more than than what we have done with h. 221 on they and they do acting.
Equities for Nash, we have preclinical and it's also been published data on a on a former lead l. once they.
Analog and I cannot speak for yeah, I can only speak from the ceiling point of view and pass my best Moot point of view is that if we.
Normally I would be very skeptical around moving into Nash as a company because as you know, especially if you have had an enter for our product agent in development for whatever disease that people have we'd persistent those so cheap enough and ask because it's in such a hot area.
Well, you're starting to see some very significant and and and a great results I. We did you if he wants <unk> addressing the meeting volley component little bit earlier than maybe when you start with <unk> and I think.
You mentioned that that companies, who have shown some promising naked man.
You take it <unk> <unk> <unk> <unk> <unk> <unk> <unk> <unk>.
Probably Nash is d. indication you should issue with it.
Because of the effects you look on unbelievable.
And if you look into the <unk> and we have puppies on obesity, we'd we'll acting equities then in my mind. It beeps anything else that has been published with the single <unk> agent. So that's why we feel.
This is a potential future way not as we have these guys. They also understand that it's used programs anyway. The class a very committed at play here like yeah I. It was in in that field.
But so but it's sad to say that from a scene in perspective, you really really happy to see that they are also pushing this board in mesh because that is why we see goes wrong about it.
Yeah, if I can add as well, yes, I would say that the.
Abandonment of the second that long acting program clarify the the story for the for the sites you know in terms of <unk>, who they're going to be working leaving the future and so I think it helps us in terms of being able to engage with people sides.
As as we come forward weekly petrified and they know that now you know it's going to be <unk> and we have as we say 70 550 behind so it it it will help us in terms of.
Engaging would keep both sides and accessing equal patients.
Thank you so much.
The next question is from the line of Alan Carr for meeting then company thanking conceptual question.
Hi, Thanks for taking my questions.
A couple of them quick around a veto him if all the.
Supply chain issues that network experience too late last year by <unk>, if those all been sorted out.
Then with respect to see H., one it sounds like you're close to.
Fall enrollment on the older Kids trial, but can you give us an update on the the smaller ones.
The younger kids.
And then that the last one is around geriatric surgery.
<unk>.
What's the next step there what do you what sort of trial you well contemplating running here next thanks.
And then would you take that people questions I think it'd be good idea yeah. So on the on C.H.I. are correct yeah.
I have all the older children randomized into this study and we actually have to my they define so it's these amount of how to get things you can make so that that looks very good.
The small children as I said, we have we have made it we have managed to get three out of six sites that are coming from rotations into this dog reactivated ending and hooked like the nice size activated I assume that means an average they need to randomized to patients each.
But since then units they they have to appear to the Phoenix.
Before we involved and we have had screening for for.
For Pizza, a few months now and.
We have had Asians, who chose to get in I will say, but we do not have the first in yet so so funny.
Would say.
It could happen any day.
And then once we what we see is since these are.
Should be on top of standard of care. This this study so it doesn't impose a lot of additional burden on on on this ice on the D. needs.
On the families and it actually just provides an opportunity for these children to get out of I.V. glucose et cetera. So it is a study, which we hope will.
Not be so.
So much by they come with situation now that we have to Miss you can see dramatic and chaotic phase where everybody had to adjust to how to work with Kobe 19 around so.
So we have yeah comfortable with that and we are managing to actually see progress.
Yeah on the <unk> next it is that as I said, we will discuss with 68.
As as him analysts also highlighted several times. It. It is a program that we had doing a need those pen. So we actually have a pain that can give these meetings is so.
You should see the development activities, you're going to do proposed by adding <unk> of what they're doing with the franchise mean that'd be a also considering the next steps in the type one diabetes.
I think with Amigos pen, let me see a huge tool from patients and despite those so so you could expect to see a quota.
A ford within that and need those dependent development.
Yeah.
Will know that we're not we're not cooling the pen right now the milk you do spend our feet product Oh, <unk> winning to define regulatory route for this product in in the various you know potential indications. We can we can expect this product to to to be to be knocked. It. So that's why it killed I would say.
In development everything right now.
Regarding the Vigo.
Share that actually the technical issues that led a battery test to have their.
Talk you out an issue by issue I I've been actually I don't decide and solved so the the matter now that we are dealing with we're renting back the production to their food capacity.
And we are actually supplying which was starting to supply all the others. The late order is that we had so that we can get this talk back to to again food holders.
So this is a matter of a of weeks, but in terms of technical issues.
You as well that this issue did not trigger a safety report to the F.D.N. It was just a a capacity.
So so this is I would say work in progress and we are supply chain and the supply T. music. She working you know 910 days to get the others to suit by all the others deck, we have skin very very happy customers seeing.
There's talk back and as well most of the patients had supply. So very few of them had these continuation nothing the team did a fantastic job to make sure that there was no holding during that period of time. So that everyone could had you know their supply as needed, but but this is constant work. So we have money.
Entering it and and we are working on it on a daily basis.
Right. Thanks for taking the questions.
Thank you.
Thank you <unk>. Thank you finish answering a question.
Yeah. Thanks, good good morning, good afternoon, and thanks for taking my question I, just want to focus on the door hormone.
Artificial pancreas program certainly are really interesting program and I'm wondering if the company plans to provide us.
Perhaps a more extensive view on on how we should think about the commercial opportunity at some point later. This this year can you also remind us of the relationship that you have with better by on accent kind of what the economics are in terms of other suspend or on the back end on any potential.
You know Ah commercial sales how that might be a split out. Thank you.
Yes, Greg. Thank you for the Gershwin. So we we we have that you know works I mean, these better assessment and understanding of these <unk>. This is in motion we have actually hired now food you know these test team.
For a and the leader for these new education, which we can have before and and nothing but she's a a top priority for for that either of these brand.
The 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 we for the last two I would say three four months, we put the Beatles last you know commercial attention to these you hold on palm it'd be more on the regret to reroute discussing with the F.D. on the people design and and so as a result to think as soon as we have we see.
And were able to communicate the the state redesign of the you you will have very key understanding of the the market potential for this product. So I know we have to wait a bit more types of people to communicate that openly but I think it will be you will be here very soon.
And the collaboration with Asian Bionics, it's an unobtrusive collaboration, but we collaborate closely and.
We have to do that and that and we because we engage with F.T.A. together and we're doing clinical studies together and you can say the context that we are developing fits exactly into them to the device. So it's a it's it's if they did you use system that so it all adds to the simplicity.
Under commercial commercial space, you have not defined how to work you believe that but if it is clear that they see the environment.
Right now I'm responsible for the <unk>, so selling that blew up on in a cottage and be device are responsible for the for the.
Each of our organizations building commercial infrastructures as you know she minutes now established a commercial infrastructure. So.
But it allows us to work with other companies.
It later and it also allows you to the eyes to work with other work on provide as later if that if that would be some.
So.
Yeah. The good good very good news is that <unk>, hi, or their first leaders as well on the commercials side.
So they are they are they're starting to deal you know, they're a commercial presence as well.
Okay. Thank you.
Next clustering is from the lineup slowness Bauer from dance can bank. Thank you can set your question.
Yes, fingering watch a couple of course from from me just on a on leave huh.
An impression on on how many patients actually was screens just prior to the to the to the knocked down so so how many pages.
Right away.
And then also.
<unk>.
<unk>.
Second tough, though that's a really timing.
First half off 22.
And then maybe I missed it but but just told me on on stand on on the vehicle. So so the revenue impact for twins twins.
3 million.
2 million in in revenue reports from from from a notice often nine months in in in 19. So so can you just told me with some non bus on on on the 40 or 19.
Sales and and and how should we actually model this into.
22.
Maybe six months of sales and then flat. Both is is what we would see here for for 20.
Okay, if I, if I, just topically, but I I think it's actually it's it's difficult for me to comment <unk> I think what we have that.
Sites that are completely.
<unk>, we have patience identified we had at least when and how they should be in the audience with the study.
And we had.
You can say a number of Asians, who ask we who are screened and we have modified the protocol. So they can be randomized when they can.
Clinical side again, but but it is clear that.
This has imposing interruption to each of these sites so.
But and he's coming back to this thing that we are seeing site now that.
Oh this was lined up to to have them in in let's say March and April and now we are trying to and we hope to that they will now hadn't in in May and June for instance would with these guys that have not the other than that will be a that's well we'll be June July and others, where it will be maybe that.
So I'm Gonna for instance.
So that is.
They were all and then.
And have them after that is we need a second row Asian coming in a little bit later this year.
So.
But that that is.
Yeah and that so.
It's probably where we are there and we got to timing of P.A.P.L.D.A. I think we will not have you 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 in 21, if we have them later if they can have then it will move into to.
22, before we suddenly.
And maybe on the Vigo question, maybe I will ask maps to take the numbers.
Sure so.
With the <unk> closing on April 2nd.
This year, we will record three quarters of product revenue <unk>.
<unk> in Q2 to three Q. for.
Due to the time the transaction was completed as well as the nature of everything going on with Cobin 19, and just the transition of the business from Blair toss Two Zealand it it's tough for us to give any guidance right now on the product revenue.
We're anticipating for the remainder of the year.
We'll look to clarify that as we move forward.
Okay. So so at least when when we don't have to 23 million for for the first one for a month off 19. It sounds like we should expect any major deviations for for for this product.
<unk> again again.
<unk>, it's hard for us to say because within that.
Coping 19 was not part of 2019.
And we're in the process of evaluating everything.
Okay. Okay. Okay.
<unk> further question Sir keeps continue.
Mm.
<unk>.
Yeah.
Hello, Sir during <unk>.
Yeah, Okay. So I just want to close by thing you know happy we aren't to be able to engage with all of you.
I'm actively hopefully lied soon.
It was a very good corner for US. We are we we are actually are stronger as a result of you know being tested through the teen and through these crises no companies had these you know on their list of things to achieve but I think we we went through.
<unk> and and we met the I would see the the guidance that we gave.
Execution.
He.
Again, this is probably transforming the way we going to engage in the future, which is something we still have to assess but but I really look forward to be able to you know engage more and a and be able to share more of the achievements that <unk> is a is pushing today.
And again, we're looking forward to Oh moment too you know you're for 2020 fuzzy them.
Yeah.
Thank you. Thank you everyone.
Concludes I think these cool.
So that <unk> participating in the hall disconnect.
Mm.
[music].