Full Year 2020 Zealand Pharma A/S Earnings Call
[music].
Ladies and gentlemen, and thank you for standing by and Black and to Zealand pharma lease as Foskey for trend.
At this time all participants are in and he said.
Right.
After the speaker presentation that would be a question and answer session.
Just a question during the session you will need to press star and one on yet.
I must advise you that this conference is being recorded today and I would now.
And I like to turn the conference over to you and Mike.
My T O debt piece.
Please go ahead.
Thank you operator, welcome and thank you for joining us today to discuss sealant as full year results for 2020.
And Matt Dallas, Senior Vice President and Chief Financial Officer At Zealand.
With me Today are Zealand, President and Chief Executive Officer, Manuel do back and Chief Medical Officer, Adam stands for.
After the prepared remarks, we will open the call to take your questions.
As you can find related company announcement and additional supporting information on our website Zealand pharma Dot Com I'd.
I'd like to point out and we'll be making forward looking statements that are subject to risks and uncertainties. These statements are valid only as of today and the company assumes no obligation to uptown and 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 President and CEO Mary you want to lock it.
Thank you Matt.
And thanks to everyone for joining today.
This is a very special moment and you didn't.
Pharma.
As we are approaching all could you send day.
The vision of something that started 22 years ago.
And he doesn't format grew first from a small research lab.
And to a globally recognized on.
R&D developments focused organization.
2020 was a pivotal year as we added another page to the rocket.
To fully leverage the value of our pipeline, we added commercial capability to our company.
And became fully integrated global biopharmaceutical company.
And the level rarely achieved in biotech.
2020 was a challenging year for that.
Well.
But we kept executing on our vision.
And research we.
We made huge progress and the field as pet. Thank you all for key.
And cooking on bakery.
On targeting and understanding of the root causes of many for.
Obviously untreated disease.
With the support of our research engine.
And I've got Paul and.
Thank you.
We are we are advancing new and better treatment options.
People living with a wide range on.
And large unmet medical need.
In the coming weeks and then that's what you've got going on between vector and peripheral T range may be approved by the U S FDA for the.
Treatment of PDI for good yeah.
And people with diabetes.
One of the most you have complications of diabetes.
And he got approval, we are fully committed to execute on even first independent credit launched in late June.
In anticipation of the potential debt you could get go on coupon and we have built out for royalties from this organization and the U S through the acquisition of better read that.
We are and experienced U S. Commercial team, we gained significant metro E and commercializing the Nox at igo, Wearables and seeing the light and we kept.
And indeed by hiring highly experienced and talented leaders and prepare us to execute on our vision.
If approved.
As he forgot going yeah.
And we'll be the second product commercialized by you know and the reason to have five commercialized products by 2025.
Also in January we raised 749 million bad as corner of new capital.
As you can see the largest kept on rate in the company and victory.
Leaving us well capitalized as we.
We continue to develop our commercial capabilities, while progressing multiple program.
Across our robust pipeline.
Oh, well the need and peptide drug discovery and design.
Have you done throughout our pipeline.
Lucky for lesson and both late stage trials and preclinical testing.
All of which have the potential to transform the lives of patients we've picked up on gastrointestinal and even though the G E.
We have made good progress in both on late stage and early stage program.
And that's when you'll see the dynamic R&D day in which we also detailed about our earlier stage as it.
And we'd now carries over to our head of R&D and doesn't seem good.
I'll discuss as he does 2020 clinical milestones.
Adam.
Thank you Emmanuel.
And please go to sniping on besides.
And.
'twenty 'twenty.
What's a transformative year for Sina and finest pipeline and we continue to deepen our leadership and peptide drug discovery and development by expanding if you Pudic focus of our early pipeline to include obesity and associated metabolic diseases and we also brought forward new candidates for inflammatory bowel disease and other.
Chronic inflammatory diseases within the Gi franchise.
If we start with as you can look on and then we have tissue and multiple opportunities to improve patients' lives through different product between attitudes and.
And later this month as Manuel mentioned, we expect the approval of that he can walk on ultra and Jay country for syringe for the treatment of severe hypoglycemia and diabetes.
And this would be based on three phase III trials that all demonstrated a median time to recovery from hyperglycemia as only 10 minutes.
As Manuel and Dirty shoes, and they just going to be our first potential loans other product that had been discovered and fully developed by our team.
On slide six you can see that basically work on phase III program for congenital hyperinsulinism and ultra rare indication caused by defects and the pancreatic beta cells.
As already reported the first phase III trial did not meet the primary endpoint.
Other hypoglycemia was reduced by 40% to 50% with debt should go up on as compared to standard of CAD zone. When we assessed this pipeline did continuous glucose monitoring.
Also we have said that as you look on treatment should be safe and well tolerated and importantly, 31 out of 32 patients continued into the long term extension study.
We are conducting additional analyses and engaging with regulators on.
As you discussed the results of to try and while we await the outcome as the second phase III trial, and neonates up to 12 months of age, which we expect later this year.
Please go to slide seven.
And 'twenty Trenching, and we continued our strong collaboration with beta bionics on the ILEC Bionic pancreas device, which utilize and stats you can work on and we expect to initiate the phase III trial and the second half as this year.
The study will enroll approximately 350 of adults and 350 children with type one diabetes.
And were the primary income outcome measure being HVA, one see superiority of the buyer for mono islet considerations or what day.
Interesting only configuration at week 26.
On this program has been designed to demonstrate the clinical outcome of fuselage and as you can look on in the pile them on I. Let me I was just the insulin only islet why do we will also compare the results to intensified usual care and a third.
As you can see on slide eight we have been broadening our pipeline of therapies to target obesity and non alcoholic stats for hepatitis.
Which we can see the key value drivers for the future Zealand.
And alongside our patent appearing on English and we progressed to clinical development to pharma to you. If you want to walk on dual agonist and 2020 with the initiation of the phase II tried and true diabetes and shortly we expect to initiate phase two development and obesity and Nash as well.
On slide nine you can see our two late preclinical assets and development for obesity, both of which have shown attitudes weight loss potential when co injected with tier one and Alex and we anticipate starting phase one trials with our amylin analogue and later in the year.
Yeah, and expect to bring our keep analog into phase one next year.
In addition to the advancement of all makes of pilot programs. We have also made significant progress on the clinical development of our gastrointestinal candidates and recently announced some new preclinical assets.
Please go to slide 10.
So paclitaxel is all along I think the Q and I, along with an effective half life, approximately 50 hours, which is being developed and an easy to use disposable ultra and character to simplify its administration.
As announced at the on D Day last week, we are progressing with patient enrollment for the pivotal phase III trial, which evaluated once and twice weekly dosing of escalator.
[noise] versus placebo for 26 weeks and we expect the resource as this time next year.
On slide 11, you can see the updates on debt pizza side, which as our follow on molecules for treatment of short bowel syndrome last year, we completed the phase one and a trial, which demonstrated a plasma half life of 120 hours and humans.
Well as he would be too mainly stimulates intestinal absorption capacity. He has he went and slows down and sit and then let's see let's eat that and actually contributing positively to enhance absorption.
And we therefore believe that debt you could tie it has the potential to take treatment of Sps for the next level and get patients one step closer towards regaining full.
Autonomy.
The phase <unk> trial, which assessed multiple ascending doses of static as aside.
What dose weekly is on.
And with the second dosing cohort being completed.
Turning to the early inflammation pipeline on slide 12.
And expanding our research activities into IBD and other inflammatory diseases as we believe the peptide and medicines represent a great opportunity for new innovation and the inflammation disease space. This area has been dominated by the antibody drugs for many years.
Programs, we are progressing towards the clinic represent high profile as peptide targets. We are currently advancing our selected caterer 1.3 block on into IND, enabling toxicity studies with an eye for IBD as the first indication and are also progressing on alpha four beta seven inhibitor, which has the potential to be our first ever.
And all peptide as an ex the molecule has been designed to have relevant all bioavailability.
Lastly.
We have made great progress and the collaboration with election, and pharmaceuticals, and the development of our complementary tweak peptide inhibitor.
We have selected the candidate molecule and and now progressing this molecule into the next.
Page of development and.
And with that I would like to turn on one of the call to our CFO, Matt Dallas to walk us through our Q4 and full year financials.
Matt.
Thanks, Adam on.
Slide 13, Youll see Zealand's income statements for 'twenty, and 'twenty and how it compares from 2019.
Total revenue for the year was $353 3 million Danish kroner were $54 2 million USD. This was driven by net product revenue of the V go wearable insulin delivery device as well as partnership revenue from our collaborations with BPI and Alexia on the net operating result for the year was a loss of 792 4 million Danish kroner, but 121.
And 1 million USD sales and marketing costs, mainly relate to the commercial infrastructure and the U S to support V go while R&D costs relate to our late stage clinical programs.
Slide 14 illustrates our financial position and ability to grow on growing business through continued investments net operating expenses for 2020, one point O 9 billion, Danish kroner, but $166 9 million USD and.
And of the year, we had a cash position of 1.2 dollars 6 billion Danish kroner for $192 2 million USD funding the company through several key upcoming milestones.
Turning to our financial guidance on slide 15 and <unk>.
'twenty one we expect revenue from existing license agreements. However, since such revenue as uncertain because of size and timing, we do not intend to provide guidance on as much revenue.
Net product revenue from the sales of our commercial products as expected to be 220 million Danish kroner, and with a range of plus or minus 10% as compared to 2020 net product revenue of $161 3 billion Danish kroner.
Net operating expenses from 2021 are expected to be one to five zone in Danish kroner with a range of plus or minus 10% as compared to 2020 operating expenses of one point on 9 billion Danish kroner and.
With that I will now turn it back from anywhere.
Thanks, Matt.
As Matt outlined we arent as strong position financially.
Which is crucial as we head into these critical next few months.
We used the 35 March 27 date in sight.
We are already ahead on commercial preparation.
And pending approval, we will be ready to execute on our first product launch.
As product from our own research and.
And first indication for <unk>.
And as you could get from franchise.
As I outlined late stage program milestones and R&D advancements.
As we covered in detail at our R&D day with us.
And exciting in any year.
But I am, especially proud of our talented employees for a call.
Fishing and the knee.
On a global pandemic that presented unforeseen challenge.
It seems that GDP and commitment to changing lives.
And with the next generation of peptide therapy.
As the reasons need and he is positioned to become a high performing commercial organization.
As reported by our World Class Research and gene.
And on track to deliver on our vision of offering.
And I've commercialized products by 2025.
Thank you all for listening.
I will now turn it over for questions.
Ladies and gentlemen.
A question and also cash.
As a reminder, as you used to ask a question. Please press star and one on your telephone.
Wait for your name to be on.
Please.
And by the Q&A queue, Thanks, and I'll just take a few moments.
And he can see on request a piece for us.
Once again, ladies and gentlemen piece for us.
And actually.
Yes.
And your first question comes from the line of Michael and I have watched from God Damn. Please go ahead. Your line is now open.
Yes. Thanks, a lot first a question to our financial guidance and the product sales so.
Just trying to get a bit more flavor also on on how you see the trends moving forward for for Veeco, because if if you sort of landed.
<unk> to 'twenty.
And as he said most I would assume as it assumes a significant decline and in V go sales and also and in that connection.
Regarding the the real launch of of Hypo Pal, how fast we actually expect to be able to be.
In the market with hyper pulp are pending the approval on and they did and they.
Did it much.
Yeah, I guess that that was actually is.
Thank you Matt.
And Michael Matt do you want to take this question.
Question on financial guidance sure.
Yeah, so on the financial guidance as.
As we communicated on our earnings release day, I think the plan as the launch for the Daus and glucagon auto injector and pre filled syringe to be late June of this year our.
Our guidance on our revenue was 220 and net product revenue as it is a blended number but we're not breaking out.
And the split between them just based on the fact that we're even ahead of right now that the <unk> date for the hydropower or for the sorry, the Prefilled syringe.
Yeah, but it will be thanks, I need to be as whether its sales force that will support V go through throughout the.
But as if that's it that's for.
I assume that debt that you sort of see a decline and and what would drive that decline is that because you are moving all the other fits into our into the prefilled syringe or how should we how should we see this.
Yeah, I mean, I'm not sure I would say, it's totally the climb and did a 161 last year.
There are efforts that will be.
That will move towards the pre filled syringe, yes.
Well, so kind of changing.
Yes sales model with and within that.
And again I think Michael it's a blended.
And whether you talk yet, but I would say that all for crews to and so you're all focused.
And is on commercial excellence, we are building the company to allow us to launch pretty much one product every year from now to 2025. So that's really the focus and I think the proof is in the pudding. We have to really look at what's important for us which is making sure that we can execute on this.
Launches and and.
And so that's why this first launch starting late June is.
It is critical for us.
Okay, great. Thanks.
Your next question comes from the line of Greg as Silvana.
From Goldman Sachs. Please go ahead your line is open.
Yeah.
Hey, Thank God. Thank you for taking my questions and just.
Got a couple please.
And maybe just picking up.
On the last questions around the launch of other pre filled syringe, maybe if you could give us.
A sense of where are we and that market right now given the.
For Lilly and <unk> and <unk> launches.
How do you think those launches have impacted.
The growth and the market I think on the R&D day, you said the market as maybe has grown 10% for those two products launched perhaps where you would've thought that the.
And the growth would've been a bit more robust and then 10% and you know what.
Additionally, do you think that you will.
Either can do or need to do to make a pre filled syringe and you know you know.
As successful.
A successful launch and so that's kind of my first question.
And then just.
A second question I have has to do with Emmanuel your comments around you know.
Having a company with a commercial capability of launching a product.
Every year until 2025 can you just remind us specifically, which products you are pegging to each year just want to make sure that we're thinking about things the same way that that you are.
And then my last question, maybe for Matt just going back to the financial guidance any way for us to be thinking.
You know, perhaps directionally as we go through 2021, and how we should be thinking about R&D and SG&A. Thanks.
Yeah.
Yeah Gregg on your on your first question regarding the market.
I believe you need market.
I think you know the plus 10% growth you know during what for.
And for two novel T as being introduced during a COVID-19 year I think it's a it's actually.
Not that we are we actually of course, just like pretty much everyone listened to as well.
And I are all competition as you know conference and they mentioned that this you know the impact from Covid and 2020 for them during their physical launch operation was.
Impairing their ability to really measure the impact for this market I think what's really interesting and this market change is that these are new novelty have actually did you keep taken around 30% to 40% of this market in a year and the house Stein for any key.
Which is a very nice conversion assuming that you know this is a very table, even episodic market, which hasn't seen any innovation in the last 20 years. So there is some ER.
Prescription habits from from prescribers and some expenses from.
And from the patient. So this is a very very interesting you know shift in the market.
And I think this market will likely continue to grow and will likely continue to convert to these novelties. So I think for us the timing is right.
On the launch your I said pretty much year. After year. So we are we have the goal to have five commercialized products by 2025.
I'm, assuming you know and again were hopeful that we get you know a good response from the FDA, we would be launching.
One this year and and then we have three to go through 2025.
And so yes, we have few products and late stage that we hope to be able to bring to the market.
And this in this same period, and and and and you know the and I E.
Ph I deliver a dual and non pump we have the multi dose as well, but Ah yes.
Yes, I think you know we are pretty much looking at these products as.
Those debt will actually helped us achieve these goals in the next and the next five years for years now.
And on your last question and then.
And yes, you got it.
Yeah. So so Greg if you look at our 2020 numbers. It was a 55 for sides of our spending was R&D, 45% was SG&A.
The sales and marketing component of that SG&A and 2020 was only for three was only for three quarters as the Blair class acquisition happened on April 2nd.
And what are you looking out for that 2021 number as you're going to have a full year impact for the sales as well as launch costs that helps.
Okay.
Okay. Thanks, so much and I'll get back into the queue.
Our next question comes from the line of Jesper <unk> from Carnegie. Please go ahead and that is happening.
And so much just also to follow up on Michael's question on the guidance on the definitely work on.
And so can you first just confirm that you will launch both HIFU and the Prefilled syringe late June so that do not end up like Cirrus with I guess first loans the pre filled syringe. So just whether you can confirm debt.
And then I'll have a follow up afterwards.
Yes, yes for we hope to be able to launch.
And launch these two presentations, yes, okay.
Okay Cool and then just on the timing. So you say late too so as debt.
And two or three months out so as that through the pandemic him doing face to face promotion is it due to production capacity constraints. So why too intense for loans late June and why not say April and May just do it you'll get that thank you.
Oh.
And that's just the nature of the operations when you get the response from the FDA.
You know it takes two to three days for the FDA to post your label are we need to print labels packaging a sheet.
Sheet distribute and.
And then at the same time, we can actually operate we can operate.
And right from the get go.
With our people in the field in parallel as you know trying to engage prescribers and and and so that's you know week as it prescriptions, but for US you know what we define as launch is when the drug will be India and of patients and so it takes it always takes few cubic's operationally to get there.
And why we are we're extremely precise a maybe a bit more over it but that's actually as a reality.
It will be late June launch for us okay.
Just on your on net sales guidance also so whether you use coupons on this and that's a clue on loans and as Thats why you say solar implicitly only.
<unk> generated limited as it move on sales and try and 21.
So will you have any revenue from debt and flew about noise as mostly say coupons through built up there a prescriber base.
And at this point, we can't comment on the breakout or the gross to net assumptions on any of our programs for 2020 one commercial programs.
But I'm going to use our coupons on this launch.
Again, we can't comment on that given us and we're not even as the Paducah day, yes.
Yeah.
Thank you.
Sorry, yes.
Our next question comes from the line of David.
David Lebowitz from Morgan Stanley.
Please go ahead.
And then.
And I. Thank you for taking my question.
And by June I'm, guessing and I guess, how high touch and do you expect here.
<unk> operations to be and.
And.
Given the nature of the product how high touch does it actually need to be to be able to get an effective launch.
Yeah.
Yeah.
And we cannot comment on anything related to commercial operations.
And as as we still are expecting.
A response from the FDA on the approval and so.
So I think you know based on what we know from the market.
As the market, where you know there is a need for novelties and and we know that the expectations are very high for for thing, which.
Solution that will simplify patients' lives and we'll bring them and potentially better if he gets he but again on our own products, we cannot comment on the commercial.
Operations or the commercial make predictions on commercial and commercial you know.
They are new killer product before it's approved.
And with respect to the congenital hyperinsulinism ism data coming up.
And given that the first trial was not successful.
What is the I.
I guess the regulatory approach do you do you see a path to approval with with the first trial and not succeeding as the second trial does happen to succeed.
Yeah and Adam.
Do you want to take that question.
And if we looked at them.
Yeah, sorry, I was on mute and she also explained that there on the other day our approach from here will be to discuss with FDA. The totality of evidence for it as you can work on and.
And then.
And the ongoing second phase III study uses a different primary endpoint. So that as these are small children, who are in the hospital, having IV glucose infusions and wants to stay out of hypoglycemia and the endpoint as the ability to be less dependent on IV glucose infusions. So so we are hopeful that we will meet the primary endpoint and that stuff.
And then of course, we will use the evidence from the first starting from the continuous glucose monitoring debt, which shows that as 50% to 50% reduction but also the fact that we have so many children, who chose to actually still be on treatment and now for some two years later and the evidence that we have connected and the long term extension study.
So that will be our approach and then.
It's still our ambition to have this product and.
Ultimately approved with the FDA based on that as such entity of <unk>.
Evidence, but as he also said with it now needs to have the second phase three study readout later this year and then.
You can say, we can be much more clear on on expected timing.
Thanks for taking my questions.
Okay.
Our next question comes from the line on really got you and Ken from Jefferies. Please go ahead.
And.
Hi, there. Thank you for taking my question as I've, just got a few left and.
Firstly and.
Just wonder if you can give any update on any potential ex U S plans for hydro power off as areas as products as recently appraised and yet.
And then secondly, and I believe there as OSA commented and.
Feedback from the FDA and debt.
Developments and exercise induced hypoglycemia will be more straightforward and pastes bariatric high pace.
And they're also planning to start phase III by the end of the year and.
And why might that be and.
If he has and so and I'll say, how quickly do you anticipate and could potentially get to phase III for one all day to these indications and.
And then lastly, and I know you can't you're not.
Forecast any milestones that could you outline any possible losses that you could receive without giving tickets and Keith.
Yes, hi, and.
And for your questions so regarding the rest.
And the rest of the world or ex U S market opportunity, we're still working on it right now it is actually not very clear from from from the information we have gathered exactly what the potential is in.
And these markets for for distributions.
So we actually are still working on it and.
Of course for us.
And the opportunities open and we are actually working on it right now we are as well looking at it and the scope of the pipeline, we have which as you know it's not one product launch, but it's a succession of for this launch so I think it makes actually the debt.
For potential opportunities.
And the bigger of course, and the and so we are we're looking at it and the in the whole totality of the pipeline and.
So as.
And as soon as we are ready to communicate on it we will but we are actively working on it now.
And yes.
Yeah.
The next question Evan.
Okay, I can address that need those concept and we also she had a little bit on that so you can say we are also pursuing both exercise induced hypoglycemia and post bariatric hypoglycemia.
And so as these are two parallel routes the interesting thing and as far as soon as debt.
Both will actually use the same injection device as a weapon.
And a doable and multiple use pen, which we already have stepped up and which we expect we will take into clinical studies later this year.
And that Penn will actually take the cartridge that we also use for them.
For the dual hormone artificial pancreas pump like we are working on with beta bionics, though that product as also ready and will be actually ready for phase III studies later this year.
On the next clinical step for both of these indications and we expect for actually do outpatient study as in PTH and exercise and she was typo.
This year, so we will do too.
At least two studies a phase III study two to.
Our sales how true to use this.
Concept.
And the best way.
And what I would also highlight is that.
As she looks.
So basically were abandoned and we have completed the chronic tox. We have continued the carcinogenicity studies and all the supporting activities, we have the cottage ready for phase III studies. So.
All of that I think should each of having tasty for we can embark on phase three on the clinical evidence so for.
For the technical up as basically a rating.
From the clinical experience, we just need a few more studies before we would feel confident and how to best address this unmet medical need and these two situations, but we're moving forward as steadily as Manuel has also set.
As you can say the upside opportunity as that could actually needs to two additional approvals and within the next five years. So.
So we but we we feel that we are progressing and the right way on day without exercise induced hypoglycemia as easier than PVH I think that that depends on how you do it at a normally for a rare disease.
Like P. D. As you would expect less patients but for of course for <unk>.
And product.
He was product and type one diabetes, you would expect to have significant patient exposure before you can get it approved.
And we will get that from a biomarker studies.
Which would be extremely supportive of the day exercise and she was mini dose pen as well so.
We hope to provide more guidance on our next steps debt say, what we're going to do and next year.
With regards for phase III et cetera, and later this year.
Okay.
Yes.
And next question on the partner on the partnership milestones, we have not disclosed the tiers of milestones with either <unk> on deal.
What I'll say as that as a milestone with either partnership were to become eminent and that's when we would make that announcement.
Including the financial component.
Yeah. Our next question comes from the line of.
And from Guggenheim. Please go ahead.
And then.
Great. Thanks for taking my question, just maybe assist things up a little bit on Adam we saw some interesting updates from our recent oral integral and molecules.
Do you have any kind of projections on on win and I'd.
And it could be on file.
Good for you or integrin inhibitor already plants and sort of accelerate preclinical development based on on what we've kind of seen recently.
Yeah. Thanks, Thanks for the question and it is of course also interesting from our and to manage our you can see some of the progression made in this area and so for hot.
As for beta seven and EBIT. So we have not provided guidance for when we will start the phase one study, which of course means and it will not.
It will not happen this year and we would have talked about it but and but we are progressing steadily and and I think what is important to us and that as what you will also know should notice for all our programs also if you look on a historic perspective, and just that'd be once you have it right from the start because then you have much less issues and the and when it becomes extremely.
So we are we.
We are walking that extra mile here and they start to make sure that we get things right before we put a question and answer their clinic and especially the winter that when you have to do with oral molecules you don't want to take too. Many other peptides you won't don't want to take too many penalties because it's super expensive when you get further into development, so that as our focus right now and as.
Actually it goes along with that you can say, what we also announced last week that we will.
Step up our focus on all therapies and the future.
Because we really think we have and etch here combining not only our peptide design capabilities, but also all the supportive activities that as that are needed in order to get there.
As the Pep side, but also the formulations to the level, where they can actually become attractive drugs and not just research tools. So I cannot give you I'm sorry, I cannot give you a more specific date.
But we are encouraged by seeing the development and the area and we truly believe that as a huge opportunity here for <unk> and also going forward at all.
Peptides in a in an area, where we have traditionally seen and.
Antibodies and small molecules, sometimes for them to actually make it all the way.
And so on specific binding and so on.
Okay, great. Thank you.
Our next question comes from the line of Joseph strength from.
Please go ahead here and any salary.
Hi, everyone. Thanks for taking our questions.
Wanted to ask sort of a general strategy question on debt.
GAAP.
I believe as side here.
So is it.
You mentioned that you did.
As a long acting flip one for two and.
Potentially.
Potential development and Sps and.
And the other indications, but is it as it is certainty that you would develop it and Sps are sort.
A follow on to slip.
Given that you have a once weekly arm and that.
But trial or.
I guess, what's the prioritization.
What indications you would develop for us that before.
But as yet either.
Highest priority and we do when you look for other indications first thank you.
I think theres no debt.
And then do you want to take the clinical side of it and I can talk about some strategies around.
Yeah, Oh, yeah. So first of all and maybe yeah I will just address first of all we haven't very very strong commitment to SBS as you know we've been in this space for a number of years and have and deep.
Deep you can say commitment to actually take treatments for the next channel. We are extremely confident and I would eat molecule with labor that that's a moving.
No.
Tier two and I can actually.
As a great potential for patients, but we also acknowledge like in obesity and other indications if you truly want to take them at the Sis like Sps to two.
And next level, where you were looking into complete enteral autonomy for instance.
And so patients become completely independent and for instance support problem.
Probably we need.
To attack more than one.
And <unk> receptor and that's why we are extremely excited about the tactical and tied because it is addressing two.
Which looks to be two important aspects of the disease. So in that sense I would say we are committed to the Sps Eh community. We also as you notice that there is actually a great opportunities for other indications for which we have not discussed yet, but which with a molecule that that he could actually play a difference so that as probably one.
I would say and what we also said as that may be more clear on this guidance later this year and once we have the phase one data and then what did you.
Yeah, I just wanted to say that.
Draw a parallel between these as key.
Keith as you get tight.
Create the French fries and malnutrition.
So we're very excited to have not one for the two and it's a deep and draw.
And what kind of with the question from Lucy earlier on the geographic and opportunity I mean.
Of course, it creates a lot of opportunities for us.
And these are the different indications on different geographic and now we have to prioritize investments we have to do.
Business cases, as well, which allow us to advance investments, where we can actually sustain them for a long period as time and grow in this field, so the excitements around particularly tight and the lithography and combine it.
Is the possibilities are enormous.
And in SBS and beyond so we just need to prioritize actually now, but yes, very exciting times and and programs.
Thank you for that for your question.
Yeah.
Next question comes from Dan and I know.
And what it does from kempen.
Your line is open.
And.
Hi, guys and thanks for taking my questions.
Our first question is on the.
On your current sales force can you remind us on the size of your current sales force and a world. This number increased significantly and assuming a hypothetical approval.
And the second question would be on the on the dual hormone pump phase III trial and collaboration with debt to be on X.
You indicated that the start of the phase III program.
Be expected towards year end.
Can you remind us how long you would think it would take for such a study to be conducted from from the start until one day that gets reported thank.
Thank you.
Okay.
I'll take the first one and then and then we will take the phase III on build on income.
And on the sales force I mean, I would say you know sales force is limiting its a.
Bigger and and get more complex on only the sales force, we have extra the healed and myself.
<unk> access people, we have it should be.
Trainers, who are supporting as well for so the combination of these team as actually are aligned with the guidance.
Guidance numbers, we communicated before we're not.
We're not planning to add.
And more bodies are we on.
All right sized now to be able to handle a potential launch for the rescue pen.
And and I'm just wanted to talk about the Jerome on comp.
Yeah, So if I'm on pump for phase III studies.
The primary endpoint as the 26 week, so every patient and that the last patient who as randomized will have to be and for 2006 weeks before we can.
Chose the database and then reported results. So that gives you a half a year and then you have to add time, it takes to randomize to screen and randomize the patients and debt that.
And that of course as the unknown right now and I think a good and you can say benchmark as is how fast the beta bionics is randomized into the Haynesville and the only people. So study, which is ongoing and that's a 440 patient study.
And.
What they had expected as I think treat for four months as two randomized dose for for longer than 40 patients across 20 clinics and we have more clinics and this study plus the upside that we can actually randomize patients who were and the interesting, though and stuff as well.
So we expect quite rapidly and randomization and once we get the study going on.
And and then as a six month study.
Okay, that's very clear on thank you.
Our next question comes from the line of day tested from on the spot.
Ken.
Go ahead and that is happening.
Yeah, Thank you and pick pack and I'll have a couple of questions left.
First one is just touch again on the guidance as it is fair to assume that your guidance as risk adjusted for the probability of approval.
And.
Of hydropower and.
And secondly in respect to your election Coker and collaboration.
Have you've been in contact with people et cetera from Astrazeneca and potential with our due diligence on this particular call.
Collaboration product.
Thank you very much.
Yes.
So on the I think and the first question and maybe a matches and actually too about the guidance guidance on the second question and I, just want to clarify Peter which collaboration on you're talking about.
Are you on election.
Alexia I think Alec.
Okay, maybe not supposed to actually address that.
Questions.
So the first one as the guidance being on a risk adjustment on the guidance and.
And what I'd say as right now it's it's it's a blended number and it's and it does factor in.
Kind of a mid tier scenario.
That makes sense.
I think and electrical.
And then and Emmanuel if you want to comment on whether or not on astrazeneca.
Yeah, well that's the.
Yeah and.
And again on this one we've been asked because you know there's and the ongoing discussions between two companies not to actually comment on the as a key.
Ongoing discussion, what we know and what we can communicate is that we are.
Very happy with the compound we have advanced and the and we are actually encouraged by the reception and the discussions ongoing but again, we cannot comment on.
These two companies.
Activities right now just because of the sensitivity sensitivity of there.
All of their discussion.
Okay.
And thank you.
Our next question comes from there and I know Craig Silvana back from Goldman Sachs. Please go ahead and anyhow.
Okay.
Okay. Thanks for the follow up questions. There just housekeeping in nature and I've got to their very short.
First as could you remind us of what the status as of the potential I believe it's a.
Last payment from Santa Fe with regards to the prior collaboration you had with them on.
And I think we had modeled perhaps a payment in 2020 and and just wanted to get a sense of.
Whats the latest as a comment around that and then second.
This is really about your beringer angle on collaborations have you got your.
For six sorry for five six and 909 compound, which is referred to and the press release, but and the AR and the deck and I've seen it and the passage of for referred to as nine O. Six I just wanted to make sure I understood just pharma.
Ah numbering question perspective, as at 909 or nine effects. Thanks.
Yes, Okay, well that's a second question on work addressed by other them. Shortly Max do you want to talk about Sanofi.
Yeah, So there's $15 million and gross milestones for.
From that collaboration as a 5 million tranche.
Tranche and a 10 million tranche and those are not the net numbers that come back too soon on this I can't give you good guidance on the timing because they are tied to accumulative sales and I don't have I'm not we're not the sales engine for that so.
It's hard for me to provide any clarity on when we would incur those.
Yeah.
So Greg. Thank you. Thank you for reading our press releases.
I guess as it up and do you think that's why I said its 45, six 906 debt should be the right number so sorry, if we've gotten as long and one of these.
Okay.
No.
Thank you.
Okay.
Thank you.
As we can probably correct on this on the what's supposed to it. Thank you.
And our NAV.
At this time. Please go ahead.
Yeah.
Uh huh.
Okay.
So for that question.
Okay.
Alright with that we'd like to thank you all for attending and all of your questions moving forward to connecting on future announcements and updates.
Thank you.
And thank you.
And could this cool. Thank you very much then.
That does conclude our conference for today. Thank you for participating you may on disk.
And net.
Okay.
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