Q3 2020 Zealand Pharma A/S Earnings Call

Dead dead dead, ladies and gentlemen, thank you for standing by and welcome to the Zealand farmer results 43 20 20 at this time all participants and they sent down the road after the speed your presentation. There will be a question-and-answer session. That is a question during the

Question you will need to press star one on your telephone. Also miss advisor to call is being recorded. Then there's the November 2020 and without any further delay. I will know off hand over the call to your first Speaker today. Mr. Match convert. Thank you. Do you spell that?

Thank you operator. Welcome and thank you for joining us today to discuss sealants third-quarter 2020 Financial results with me today as soon as chief executive officer in manual genetics Chief Financial Officer of Dallas and chief medical officer Adam Steve Burg, the team would respectively provide Business Financial and development highlights from the third quarter of 2020. As of the prepared remarks. We will open the call to take your questions about you can find our Q3 2020 interim report and additional supporting information on our website as far as a company headquartered in Denmark. All financials are reported in Danish crowns. Also referred wage earner. She figures may have been converted to US dollars for convenience. I would like to point out that we will be making forward-looking statements that are subject to risks and uncertainties these statements have added only as of today cause issues 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 with that. I will turn the call over to our CEO in any other language.

Thank you much and thanks to everyone for joining today.

As a well he's weathering it's eight months of the COVID-19 demek didn't, we continue to advance on our plans and commitments during a strong strong third-quarter?

We are preparing for first commercial loan for the Desi could I could tell Ricky Van for which we expect to receive notification on ussd approval in March?

We also continue to leverage our Innovative website platform for Less while advancing the clinical development of a late-stage pipeline.

Our organization has made significant progress this quarter and we are looking forward to several upcoming clinical and Regulatory Milestones which will support our mission of transforming page lives through Innovations and local Treatment Solutions.

On the key confront. We are excited to share the news of completion of the stays one eight people sending those trials with that secret. I'd previously referred to as long as 7517.

That is a long-acting glp-1 Agonist currently in development for short bowel syndrome.

In the trial that is decide which sounds to have a good safety into a rarity profile and we observe the half-life allowing for once weekly dosing.

Encouraged by these results. He cooperation immediately started building the first participant in the state one be multi multiple ascending those trials.

Oregon's program is the first attempt to advance a combination therapy for SDS stations, which we believe could represent the next generation of treatments month.

We also see progress in our late-stage pipeline including basically dragon in Continental hyperinsulinism.

recent

In the stage 3 trial is complete and we expect to report to apply and data in December.

Thi is an area with huge unmet medical need which is also reflected in the fact that both the FDA and the European commission granted orphan drug designation to that effect in this indication.

We are hopeful that don't if you get one can transform the treatment of this debilitating disease.

I am also especially proud of the amazing work by Avedon solid team and they are ongoing efforts to recruit the best talents from around the world together. We recently augmented of Global Medical Affairs function with the addition of the Daniel Bearer, G as head of Google's Affairs, and dr. David Kendall a senior Global Medical advisor both doctor's office building Kendal green sticky of experience in the global these days and we're delighted to have them on board and look forward to continuing to benefit from the expertise.

I'll financials remain strong and we continue to invest in difficulty in research and development and Advance our commercial organization in the United States. We maintain a financial gain expecting net operating expenses for the full year of 2029 of the fifty million to 1 billion.

I saw a commercial progress. We continue to build out or commercial organization in the US to book reports and marketing and sales of the vehicle variable engine delivery device and to pray for the high-profile received and launched we have now Rose commercial infrastructure in place and are taking steps for the launch of high profile as we await a decision on Thursday to approval from the FDA which is set for March 27th, 2021.

with approved with your first commercial launch as a company and the first that if you cable, which we hope will set the stage for future that if you get off in additional metabolic implications, including thi diabetes management and prosperity I put a senior

Of course pending for the vehicle trial results and subsequent regulatory approvals.

as you can see on slide for

Simply data shows that the US market for hypoglycemia rescue key is a projected growth value of around three hundred million dollars already the new products introduced. You're following many years without meaningful Innovation account for around 40% of the market.

And before I turn the call over to Matt to review financials in more detail. I would like to provide an update on the impact. We're seeing from COVID-19.

Despite the progression of the company and Associated shutdowns and restrictive Health Care measures. We have been able to preserve the majority of the timeline for warranty programs through the incredibly hard work and determination of the one exception. However is in fact the public has had on the phase 3 trial of zip advertised in short bowel syndrome where new patients inclusion and study program.

Rcma, I don't think we'll talk more about the plan that we can pack on our clinical trial and the steps. We're taking to mitigate these.

Why do we still we may still see the top-line results in 2021. We will need to see enrollment numbers over the next couple of months before we can provide a specific time frame to complete the study.

We are confident in the current timeline that we have advanced for all the ongoing legal programs including the installation of a phase 3 trial for that if you get home in the biomedical artificial pancreas Palm in 2021, overall, I am proud of the way we've kept our company labs and operations running despite the unprecedented Global challenges and with that off with any go over to our CFO mad at us to review Financial results for the third quarter tank. So many well on slide six. You will see Zealand income statement for the first nine months of the year off. Well compared to the same period in 2019 total revenue for the first nine months was 290 million Danish kroner or 45.6 million USD. This was driven by net sales of ego. Well face to Milestone payment triggered in June for a partnership agreement with boehringer ingelheim and revenue recognition related to our collaboration with it will actually on the net operating results for the first nine months was a loss of

449.1 million - 4 or 70.6 million USD sales and marketing costs maybe relate to the depot program the quietest part of the valeritas asset purchase agreement Maple. Well ID cost me and relate to the regulatory efforts to support the NBA filing for the high-profile rescue pin. So let's clinical development of Gaza glucagon and who pagli type programs and preclinical research activities off-site seven illustrates are strong financial position and ability to support a growing business through continuing Investments net operating expenses for the first nine months of 2020 with 714.5 million games corner or 112.3 million USD at the end of the third quarter of 2020. We had a cash position of 1.53 1.53 billion Danish, kroner month or two hundred forty point four million USD funding the company through several key upcoming Milestones turning to our financial guidance on slide eight and twenty twenty we expect revenue from existing license agreements dead.

However, since such revenue is uncertain terms of size and timing we do not intend to provide guidance on search Revenue an operating expenses is unchanged to the financial to the operating guidance announced on August 13th.

I'll turn the call over to our chief medical officer and head of R&D and Steve's Burgers discuss highlights from our pipeline. Thank you man. Cave type type drugs for me to Pollock and gastrointestinal diseases and with the say three read out. So can I think you are going to see H. I expected next month. I would like to Thursday. It's all about the disease and they have a comprehensive free program. So please translate tend to see a guy is an alter reality is affecting around $1,000 to fifty thousand new phones in the US m u every year it's a devastating condition-based side effects the unmet medical need issue and we believe the tragic event has a potential to improve management of History.

See slide eleven why you can see the comprehensive history program spanning children from age only 7 days to twelve years wage, which allows us to collect data across the patient population all participants.

Office continued a continuation in our own label extension study from which we will be collecting long-term data today. We have 29 out of 32 month sentence 517 109 continued in the extension starting the second Drive 17.03 is ongoing with three children having completed the time and also ended a long-term extension study. The expected safe to read out for the ladder is 20 21 on slide. So you will see that the same time and the key endpoint inside 17 109.

To be included in the time the children had to be between three months and twelve years of age and experience three or more events of hypoglycemia per week. Despite being a standard of care when enroll the children were randomized to receive eight weeks of basic rules on treatment as a subcutaneous infusion on top of standard account or thoughts continued for weeks of standard-of-care followed by four weeks treatment with that if you would run

The primary influence is the number of hypoglycemic events measures in the last two weeks of the first four week treatment.

And key secondary endpoints into fantastic tolerance time and range for glucose and clinically significant hypoglycemic events.

Need to be anticipating the top-line date from 7th December in case of a positive outcome. We plan to pursue a dialogue with regulatory authorities about a potential filing for registration.

So turning through our technical programs in short bowel syndrome on page thirteen.

Yes, it's a severe disease with a massive impact on Patients health and quality of life all things depending on prevention and donating to the two analog is being dissolved in an auto injector off potential for convenience. Leave the administration.

encouraged by the two weeks also shows

Increase in syphilis ocean following only three weeks of treatment with a good safety profile the pivotal phase three trials fixes that specificity a savior 1.53. I have to side with a primary influence evaluate the reduction in review parental support volumes of Baseline the 24

Estimation enrollment of new pages was impaired in the second quarter this year and why we observed increased activity over the summer. There was news sites and COVID-19 phone calls enrollment it again in the last month. This means that while you may still see the results and 21 turning up the data readout from the drive is currently on a certain.

In addition to your packet side. We are developing cervical side formerly referred to as a program named CP $75.70 that includes side is a potential Thursday class and don't happen to everyone and see if you choose the shelter currently advancing for the development of tools management of SES beyond what can be achieved guilty to to treatment. It may represent the next level of innovation in helping patients to further realize the full potential. You have to be patient.

Do you speak to a guy fourteen where you will see an overview of our phase one time W type the page not a singular sending those trial safety which address the safety and tolerability it healthy volunteers was completed in the third quarter and the product was found to be safe and well-tolerated in the trial and we observe the plasma Half-Life allowing for reproducing.

Yes, very encouraged to announce that based on the positive Phase 1 data the immediately initiated the page one be multiple sending those safety and stability track and even managed to build the first patients in this study here in early November.

Results from the trial I expected in twenty one. At which time we also expect to provide updates and the next development tips page that I will now turn the call to an adult for his closing remarks. Thank you again, and thank you, Matt.

15

twenty-twenty has been a significant to your position. I am pleased with the organization's progress to achieving our objectives in the first nine months of the year.

And even more so considering the challenges presented to us by COVID-19, which employees have overcome with strong resilience and great ingenuity.

Just makes me proud to be part of this unique company.

Encouraged by these results we continue to advance all our R&D programs as well as our us commercial organization and preparation for the anticipated launch. Am I to tell next year?

To deliver on our commitments to patients and remain on track to realize our vision of adding five products on the market by 2025.

Every day, we work towards fulfilling the significant potential of didn't and realizing our vision of transforming patient lives with that, but now ready to take your questions.

Operator thank you. Ladies and gentlemen, we will now begin the question-and-answer session again as a reminder. If you wish to ask a question, please press star one off and leave her name to be announced and if you wish to cancel your request, please press the hashtag. Once again, sorry, what should you reach the essay question? Okay, sir, our first question on the line with Michael Miller body from her Gaya. Thank you. Please ask your question. Thank you very much in couponing a few questions. First of all just took a vacation on the dash click on and nchi. So you've previously noted that you would file when you saw the readout of the second trial. I don't know whether I heard you correctly that you guys will know if you see good data, then you will engage with authorities and see whether you can file on this first trial just just a clarification on that and then and then secondly on the package.

But if you do see substantial delays to further enrollment do you have or do you see ways where you can do a an analysis on the patients that have already been enrolled and and trees or do you have to complete with full enrollment of the trial and hence? Just, you know, get past the the potential delays. Those were the two questions. Thank you.

Thank you madam. And I think of question. So if you start with the c h i first it is actually it is correct that once you see the date that we will have that opportunity to potentially file an only one study as you also show on the flight. It's actually a study where we can cover the age spans from the 3 months to 12 a.m. Yes, and we have a very broad representation of different age groups in this audience. And since we are talking about and also an indication and actually rather large study of thirty two children also highlighting the number of children you have in the extension study and I must to collect actually safety data for one and a half years from children. We would anticipate to month basis and discussions with regulators and how we could find on that study alone and maybe supplemental stories from the smaller children. But again, we need to see the data and then Thursday.

Bands from their correctly notice that is recognized as long as we have said all the time very very close with investigators cynical side and Regulators to see what we can do to address all the burden that they covered situation is good on on the central office policies. Of course, first of all to secure taking place in these studies, which we have very good control and then the quality of the data and trial and typically, I mean it is the page. You cannot compromise on getting the right qualities with with regards to other measures we could take to to potentially accelerate a timeline and so on this if we are exploring all options, and what we can say is we as we know more about when we will have resolved we will inform the market.

Thank you.

Thank you. The next question is from the line of Greg savanovic Graham Goldman Sachs. Thank you. Please answer your question.

McGregor your lifestyle open, please. Go ahead.

Thank you very much. Sorry about that. Good afternoon. Good morning everyone and thanks for taking my questions and congrats on the progress in the quarter. Just if I could ask a first question on Blue tide and on the slowing enrollment. I'm just curious if it is this more of an issue about being able to open up. Go trial sites, or is it really more of an issue of getting patients to those sites, uh in and you may have kind of addressed this in the last question, but what what are the um, you know, what what can you do to kind of get that uh to a place in terms of enrollment speed where you're more comfortable or is it simply we just have to wait until COVID-19 home away and you can get enrollment back up to where it needs to be.

Greg I think Adam will take this one again. It's a good question. And I think it's actually a combination and it's a little bit the same picture as we've discussed before we have to be at some sites are still have a Samsung. Uh, it wasn't down if you see a renewed fact as and so on this UK has been extremely tough. I mean by the Kobe situation and we have had a lot of those u.s. Headed to open up and we're still seeing some sites actually number of sites which are very active and others who are more careful and it's the same situation in Venezuela in Europe. I actually had sites which which can maintain activities and others who can so and that's why it's a very individual approach we have to eat site, but for some time we have a I mean you would also see that from other studies that enroll rolling patients over from from the pivotal part of the study to the extension time.

You are not able to do that because they local ethical committees and so on so that as a new study meaning that what seems just the you can say a technique technicality actually have time to study it and keep the pages in the in the main study also the title outpatient to roll into new studies, but these are the physical changes. We've been dealing with and decide investigators and we have overcome them as we've also same for all patients who already randomize it also secure new evangelization snooze screens throughout the. But it's just much more struggled by the science 540 and so on to be handled a little bit, but that's those things a little bit and is also has been among patient some we have heard patients who have been willing to come into the type of just said, well, we would actually be a few months until we get in because we now are concerned about the number of infections in our area and so on so it's a combination of both and that's where we are handling the situation on on so many levels that wage.

But we are you can say almost weekly dialogues with all the websites and so on to make sure that you always accommodate what they need. And and how how's the same thing? So we are working very diligently avoided the one thing we cannot compromise on the quality, but we cannot just open up the study and let go of the quality aspects of the data collection because Altima when we get the data it is down to have him come back to the starting to a table.

Where we have good quality data, if it is a register regular certifying that helpful. Thank you very much. Just the next question is on Viggo and I'm just curious as to as we start approaching twenty Twenty-One and maybe this is a question. Umm, I guess any of you can answer the question. How should we be thinking about Zealand, you know efforts in trying to drive future growth of that product and how much of a priority wage is it visa be all the other clinical trial activities that you've got going on is is the goal really just to maintain it where it is. Is it really to drive it going forward? Just wondering kind of how you're thinking about that?

It's it's a question. That's a question that you know are u s team right now is actually really assessing in terms of resources location and priority the whole the priority is basically on the launch. I mean, we're we're we want to make sure that you know, we successfully launched, you know, the first product it's the first launch for vegan, It's the first home loans for that if you get the first indication for this together, so it is really important for us to actually do the best we can on this one as you know, it's not very large indication as well with you a market but it is actually simply you know for us in terms of making sure that we do everything that we plan to do on. This one legal product is actually a great job with a new generation asset right now and you turn on the Eagles is a good dollar to get it's great as well because it gets our our team, you know facing wage.

So they are actually engaging with failures facing, uh, you know, the the the new post go viral swelled they are testing new platforms digital platforms engage in virtually resources wage. They are learning, you know, again a new map of the US or something that says, you know used to see reps and they don't see any more. So we are actually getting a lot of insight and Intelligence on this phone which allows us to redeploy according to this, you know our resource, but that's where where we are still doing the assessment of you know, how we prioritize resources right now. We really the only product that they have in their hands. So until we get positive approval from 4, I prepared with Japan Viggo is actually the product at the same as pushing.

Okay, thank you. And maybe just one last question if I could just on the earlier stage pipeline. I think you've assembled some interesting assets. Just wondering if there may be either any update you can provide now or if there's a time in the future that you could point us to where we might then be able to learn on how some of those projects are progressing wage.

Yeah, I think the one thing that we did highlight it is called and they said was the progress we've made with capital side. I was just want you to to of analog which is the development also for children. I think it has a very very interesting and promising molecule very actually manage to complete the face one day and in the end to 3 and then also start to multiple attending the office is actually a program that has multiple opportunities be honest. Yes, so and the profile of the drug so far what we've seen is is is very promising. So you should expect to hear more from data to mention it off earlier pipeline products. I would say with it with it by the end of two one or that area. That's that that is probably why you should expect us to 2 a.m. Most of them update and also an eBay where we can talk more about these opportunities as we have said we have we actually making good progress and some of these programs and and we believe we have some very interesting.

opportunities that could turn out to be

Also entering the clinic in the coming years, but that is for 90-day and that's the place to one that time.

Okay. Thank you.

Next question is from the line the palancar for medium and cold. Thank you a question.

Hi, thanks for taking my questions to talk about reparations for hyper pylon that from a CMC perspective any any risks around that have you completed everything you need to do around CMC. Do you think you'll be able to launch a hypo pal right after approval and then birth with respect to 75. 70?

What what is your is your plan to go straight to short bowel syndrome you hinted at other indications, but it's the plan after you finish the the Mad to do a phase two in short Bill. Thanks.

Yes regarding CMC and as you know, you know in the FDA reviews, you know, this is one of the area that has another screen T's. So we're getting off say around questions from the FCA so far. No, I would say signals of major challenge. I think it's working as as expected. But it's an area where they yeah, they they spend a lot of time in attention. We are we are confident where we are today. And I think it's progressing. Well related to display 78b. I don't do I did you say to that is an opportunities with 7570 and indications, but for sure when we talk about what we have seen also increasing for models and from the news combination studies that have been conducted by other investigators. It has a high potential in HBS. So that is our dog.

But we have to start seeing if we should go beyond that because we believe the mode of action at the tools, cause he's really could have potentially another education's all honesty s Public University one and still pursue component molecules and off and then yeah, you can come up with a number of indications where they would actually be a benefit. So again the twenty that aren't the next year is very would share more and all thoughts on these thoughts on what we do with the 25-17 and at that time we were also progressed further into the muscles. They need those study, but it is clearly a priority program for students.

Yeah, I was just asking because it seems like it with the phase three for Epic Loot. I'd carrying on I wondered if there was enough of a

You know the next next drug coming along for SBS not too far behind the first one. I just wondered how you were thinking about this strategically and that's a good wind down and you can say that of course you would have to do our page to study with 7570 before we would understand the proof differentiation potential with 7574 what we have seen so far also includes the study and so on it looks that it can provide very significant additional benefits also from the clinical testing approved combinations. But but of course writes that if it's dead it's based on a day-to-day to get the depreciation. It's not enough and not be so logical but that's all so excited about other opportunities which which we look forward with a small once you happen to find a little bit more.

Sure, and then took it to clarify the time for hypo pal lunch. Would would you be ready to go right after the Paducah date or would there be a lag by weeks or months?

I'm just to be launched ready at 8. So we our teams will be there. Trained the launch effective launch, as you know is taking few more wage, too because you get the label that you can pick a date. So we need to get the you know, this product, you know produced printed and and then the struggling the channels am also very so it takes you more weeks, but the plan what we can control which is launch Readiness the plan is to be launched with the active today for the team.

Great. Thanks for taking my questions.

Thank you. The next question is from the line of the roof from Guggenheim. Thank you. Please ask your question.

Thanks for taking questions. First one I guess is another follow-up to zp. 75-78. Just wondered if there are any comparisons you can make this far on on biomarkers of the cross between z b c p 750 tablet. I'd based on the former Dynamic and points you measured in the single is sending those study and then I have a second question.

let me think about.

Yeah, there will be like we we actually do not have the the full data on those yet. So so that will be again and probably something we share the scientific name.

Got it. And then on the door for my program if if first patient is those as planned in the insulin only trial and in the fourth quarter wondered if you could talk a little about the development sort of scenario timelines for the doorman pump trial and and when we could see that that data and and and whether or not a 2023 launch home for this program feasible.

Yeah, so it is the closing program that we have discussed before we hope to see that they filled out this year, but then communicated all the time. They wanted to initiate the only way it's going in that recall is not ours. So it has moved into next year but it's even well also Chad in the time. We are very confident in the in those time lines. And so we we still off 24 overs and and plan to get going to get it would be the bearings on the page streets early next year. We set that time. We should also have completed our interactions with the FDA off and so on those

And see what happened in coming months when they come in.

Monster we should be there is difference a friend also on those aspects but what I can say a lot of the timing on when we can don't suppose depends on how fast we can do with the fact that it's a six month study. So that kind of defines the time once you have a pasted on patient in so it will be interesting to see the speed with which page that I'm connected with the incident only started which is a 440 patient study where they managed to rent to screen all patients in in a couple of weeks or actually I think six weeks or so and that's what you get everything going and because they have to change and accomodate code situation. So if we can repeat that then you should expect to see some very fast progress. Once we start off with the I think the other aspects that we keep highlighting is that it's actually a very very good scenario to be and that that the items get tested in the industry knowledge

I know what to look on them. So they have the opportunity to just make some adjustments also to the protocol. It's a logistical earnings and so on. So we hope that we take learnings and wage and and the experience that that the team is getting right now from the engine only week. We will be able to maintain key once we get to the home.

I think you're sitting before besides and the patients are able to lower the best data plan that the bond and qualifications should be able to roll into our study as well. So that would again have to speed up recruitment. I got it. Thank you.

Next question is from the line of news according to codrington from Japanese. Thank you. Please ask your question.

Thank you for taking my questions already got a few that just first just back on the the artificial pancreas. I believe we have been expecting the wage. Um incident only Studies have started dating during three q and it now seems to have been thrust into 4q. I'm assuming that again is related to code that with lockdowns increasing. Is there a risk that could be delayed further. I do appreciate it's not your study. But if you have any thoughts on that and then just let the boots I'd just took a patients who are already in the study and and treated are they still able to continue there hasn't been any compromise to their data and if possible if you could give a rough percentage of patients that have been recruited I believe around in 1 Q it was around fifty percent. I wonder if we've made much progress since then and then secondly,

And thirdly regarding sales and marketing just how obviously there's been the ramp with Viggo and we're prepping for the daisy launch. There's looking in fact since one hash will be thinking about it relative to to this year. Thank you.

Let me see if I've got the dress the Troopers and you know, you kind of press the sales and marketing for five days into notes and see if you're honest and the gates and then typically to recruit page with the huge bag. Once they have done is they have debate and you can say updates to the code. Also exactly true. We have remote study in that they can do most of it's not all on the remote package which means that they should not be impacted. That's our understanding by the review sites and they have two pages already raised you to be randomized. So so so what we see right now, we don't have any concerns with them, but that's just

This is also the case that all the patients who will swing or randomized a word in the study. We were able to continue to price in the grass. And you also able to continue to provide you can see pictures of data quality making sure that we get the right measures in to to face our adjustments and here and so on with life, so this is the various occupation safety was to secure the quality of the day. So and that would be done extremely well built and there's not at all stations on the on the same as an example if we had to admit it to keep some patience and decided because specific sites would not allow them to build into this extension.

And so they will have to they have to save you under six months. And then the main study for those things. I can things we did in order to make sure we did not lose patience and maintain the Integrity of the data set up. So so we don't see anything there. We do not comment on specific number. It's on the equipment. But we are we are halfway in the studies which which we appreciate and I'm still around 39 lenders actively accidentally sorry. So so so we we we feel we are on a quick prediction because we also offer is going to be awkward.

Yeah on the sales and marketing team. I'm very proud of the team that we've got and the leadership positions have already been filled or will be filled ahead of the particular date.

with or without Kobe

Okay. Thank you.

Thank you.

The next question is from the line of Peter suggested from handle Banks can thank you a question.

Taking my question. I have a couple days won't be study in June Alpha. Can you move into phase two?

And secondly, we've talked about your expectations for ramp-up of have a pail sales and I think you indicated that we should expect a choice a slow launch and then I connect with an acceleration of that in that respect. I use a lot of comfortable with the I mean just a few numbers but nevertheless with the numbers that you can see if it was on page and Lindbergh, I concerns for around 100 million sales of next year and then two hundred Seventeen in in in the year thereafter, and I just finally if you could just remind us about the

The patent expiry put that you can Google.

Okay, so sorry, excuse me. Sorry.

Okay. 650. It's a blue.

7517 it's a multiple City and and it's going to be 10 to 3. So, what do you need to speak with you before you wind up in completely frame and and then you can finalize this area code you would be able to Saturday to study quite quickly after that. As you know, we say if you have access to data and roaming basis, so it's not that we have to wait a long time before we take decisions. But but again, this is this is where we plan to provide more updates early next year. Now faster that Monday to Thursday we have different plans per second key factors High including formulations and so on but the composition of matter patent

Dating the 26th, but then you would have to add up to five years extension based on what you can gain when you use your time with them. And so that was glad to take up into the third. So and then we let you know. We also have all in-stock basic nations in the month. So and then for the iPhone 6 on the high-profile, we have not issued guidance, um will really be issuing guidance in the near-term. We haven't gotten to the new padega. It's still a number of months away. So I'm not until we get through that point and then more commercial plans are outlined who we start kind of focusing on near short-term Revenue Expectations by the launch of that.

I can just have to find one before I popped back into the queue. What should we see it as a clinically significant outcome in the c h r i s. Thank you.

Yeah, we actually wait to come in to come in on that because of course, it depends on the day of the number five look like technical entertainment center way that they said the minimum wage to you in the week if you have 9:00 and you reduce that 225 that could be very significant and if you have three and you're only we do that by 1, I mean it's still significant significant but I mean either we need to see this very case and I have to pull over all of your that application when they enter the W I think for me as I said before one of the key other factors is actually require a secondary endpoint least we know for many patients and their caregivers they have to wake up several times a night to feed the children to get to it says no troops and soldiers

so if you can expand that one as well, that is one that would have a major impact on the quality of life of not only the patients but the parents and and and caregivers so

It's actually not just down to the primary and find it will be the totality of the data as they read out and and how they kind of communicate you will also see that in a nation starting with closest to reduce other standard of care treatment. And as I mentioned in my interview introductory notes, there's a lot of side effects with these things and and they had many patients are being dosed what you should use of those has it needs a way you can reduce that. That's another thing. So ultimately will be the Society of the days that will guide how attractive this treatment what encouraged us about is that so many patients that actually decided to stay on treatment in the extension study. And again, I just have to highlight. It's not just taking a walk every day is actually being on a pump connected to a pump 24/7. So so at least we encouraged by the fact that that people are saying the extension service

Thank you very much.

Thank you. Next question is for the line just for from Carnegie. Thank you. Appreciate your question.

Just one question a new slow into twenty Twenty-One. So assuming the uneventful or there's no hope it happens. But that attack is not pushed wage too much into 2022, but assuming that clip package outside is pushed into twenty-two can just highlight what new flow to expect in 2021.

Yes, so, I mean I think let's try to stick it in the order. So the I could tell you know basis on March twenty seven twenty one. We had to stop say too. So that did you decide 7517 a $21 we would as well as initiate phase three for the Bayou Bowl in 2021. Hopefully get the results of the countryside in 2021 the month and and and potentially some others from that we haven't discussed yet which is you know on the early of pipeline. So that's a shade food play. I mean, maybe I can just add you taken place to you and c h i a small children go ahead and study where we expect that fixed. Out and then

of course, you should expect updates on the editing program as well think that you can trade them and

yeah.

What can you do with the amulet program since you you have it in-house or now?

Yeah, but that's that's what you want to know.

Okay. Thank you guys. Thank you.

It seems like there are no further questions, please continue.

Well, then there's no more questions then I just want to thank everyone for attending and thank you for all your questions and and listening.

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

Dead dead dead dead.

Yep. Yep.

Yes.

off

Dead dead dead dead.

Huh?