Q1 2020 Earnings Call
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Ladies and gentlemen, thank you for your patience I'm pleased to see the standby your conference call will be getting an approximately two minutes. Thank you for your patience and please standby.
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Good afternoon, and walking to care Therapeutics first quarter 2020 financial results Conference call.
All participants are now in listen only mode.
There will be a question answer session at the end.
Please be advised said this call is being recorded it carries request.
I'd like to turn the call over to the care team. Please proceed.
Good afternoon. This is Jack held to connect with Stern Investor Relations and walk into care Therapeutics first quarter 2020 financial results an update conference call.
It is really in the basketball just after four P.M. today, you can be found on our website at www Dot Cara Therapeutics Dot Com you may also listen to a live webcast a replay of todays call on the Investor section of the website.
Before we begin let me remind you that statements made on today's call regarding matters that are not historical facts are forward looking statements within the meaning of the private Securities Litigation Reform Act 1995.
Both of these forward looking statements include statements concerning the expected timing of the data readouts from the company's ongoing clinical trials.
As a result ongoing clinical trial tightening a future regulatory and development milestones for the company product candidates.
Excluding the company's projected timeline could that submission of its first M.D.A.
Utensil for the company's product candidate could be alternatives in the therapeutic areas investigated and the company's expected cash reach because such statements are subject to risks and uncertainties actual results may differ materially lead from those expressed or implied by such forward looking statements.
Risks are described more fully in Cara therapeutics filings with the Securities and Exchange Commission, including the risk factor section of the company's annual report on form 10-K for the year ended.
Summer 31st 2019, and other documents subsequently filed with or furnished to the Securities and Exchange Commission.
All forward looking statements made in today's call speak only as of today on which they were made care therapeutics undertakes no obligation to up such statements reflect events that occur or circumstances that exist. After the date on which they were made participating on today's call our dr. Derek Chalmers her president and CEO.
Mr., Rick Macabre BP and head of accounting I'll now turn the call over to Dr. Commerce.
Thank you Jack and good afternoon, everybody and thanks for joining us today, so our first quarter on recent progress in many ways.
Eliminated and positive topline data from our time to global Phase three trial of cursive injection and hemo dialysis patients, which we announced a few weeks ago [noise].
We were and continued to be very quickly to observe a robust sustain bounty correcting for six to pursue the injection in these patients that was consistent with what we observed there first you at phase three trial or one trial.
With positive results from both our phase three efficacy trials in hand, and a large safety database ready to go we're not focused on preparing our in D. and we indeed, we remain on track to submit ER and the second half of this year.
Before we go on I'd like to command the entire caring team.
We're delivering this data set on time.
During such a challenging period.
As the cold with 19 pandemic houses all.
Team has continued to demonstrate great flexibility and dedication in order to advance our clinical development program.
And our commercial preparations in keeping with our original timelines.
As a result of the pandemic, we have implemented several clinical and operational measures to prioritize the hell.
Safety all patients.
Our employees and study investigators.
To minimize potential disruptions to our ongoing studies.
These include such measures are adopting answer piece for remote monitoring visits Andrew mall source document verification for clinical trials.
I will note that like many other companies the rate of enrollment and our ongoing clinical studies has been affected some walk in response to the time damning. However, almost all of our study sites, who made open under enrolling patients.
And we are fortunate I forget you clinical timelines remain on track and of course, we will continue to update you should there be any changes to these expected milestones.
Lastly, we did have sufficient clinical supply of both pursue the injection and or pursue though we are in close contact with our clinical and commercial manufacturing partners and we believe that future supply will continue with minimal or no disruption.
On the overall operations sites of care team is working very efficiently and a virtual setting we're continuing continuing to monitor the progression of the time, Danny guidelines from state and federal government. So we can quickly adopt her business operations should that be appropriate.
So on today's call I'll provide an update on each of our program and our expectations for the rest of this year.
But first I wanted to provide a quick reminder, on CRE soup as broad onto quirky mechanism of action, which is in contrast to other modalities focus on blocking one specific who ran to Jim.
So the action of courses on terminal and if you double immune cells looks through lease up a range of nerve sensitizing molecules out where the Jones and pursue that directly diminishes. The stimulation of germinal dermal sensory fibers you fibers all of that downstream from the action.
Religions and assessed do the going all and anti inflammatory effect and that is what we believe prove it provides for anti corrective activity.
Regardless of the initiating pathophysiology, whether that's chronic kidney disease or chronic liver disease or some dermatological conditions.
So let's begin with our lead profile for pursuing injection in human dialysis patients with CKD associated provide us.
That's just the patient population were approximately 40% to 50% of patients.
For moderate to severe crew and it's clear significant unmet need with no therapies currently approved in the U.S. or in Europe.
Our pivotal program is presently concluding.
And that includes four phase three studies I town, one U.S. efficacy trial, which where that plus the top line data last year.
Tom to our global efficacy trial, which we had a positive topline data last month.
And to open label safety trial.
Hi, I'm wondering can too were designed to investigate the efficacy of pursuit of injection at a doses 0.5 micrograms per kilo versus placebo administered three times a week. So that's after schedule by offices sessions.
12 week treatment period.
And each efficacy trial included a 52 week open label extension phase for safety.
In April that I've already mentioned, we were very pleased to report plus the time to topline results analysis of the primary endpoint demonstrating cursive injection significantly because it's intensity with 54% of subjects achieving at least a three point improvement and war such intensity compared to 42.
2% subjects in the placebo group.
So the key secondary endpoint, 41% of subjects treated with SCUSA. The achieved at least a four point improvement more such intensity compared to 29% and the placebo group.
And although we Didnt achieve statistical significance center to quality of life and points as measured by the skin index and the fight etch self assessment skills. Additional analysis of each of these results that indicate that pitching intensity related demand in both scales were significantly right.
So that's consistent with the improvement we reported in both the primary and key secondary endpoints.
Because of injection was generally well tolerated with the safety profile that was consistent with kind of one and with a prior clinical trials and the program.
Moving onto our safety studies in the program. We currently have safety database in line R&D feeding I see H. guidelines for and then do you submission with over 1500 total patient exposures, including more than 600 patients having completed six months of treatment and over 300 patients completed.
One year of treatment at the therapeutic doses.
So we are confident we have sufficient safety exposures to support our NB submission.
We believe we're well positioned this amount is strong and be a package to the yeah. Yeah in the second half the year as you may recall, we have breakthrough designation for creative and injection for this indication. So we'll also be applying for priority review.
As you know we plan to commercialize pursues injection in the U.S. and we've already established commercial license agreements and other major commercial markets, including Japan, South Korea onto a European Union.
And the E U we have a collaboration with before Fresenius, which allows us to leverage the broad reach of Fresenius to dialysis patients across the continent.
Working with our partners that before Fresenius, we plan to submit for marketing authorization approval.
Yeah may shortly after we complete began be a submission.
And the U.S., we've established a co promotion and profit sharing agreement with Seaport Fresenius.
Specifically within Fuzziness clinics.
Which allows us to leverage the nephrology focused expertise is booked resilience and VR and which we hope will build momentum for the adoption of cruces injection upon launch.
In terms of our commercial preparations we've established and continue to execute on a cross functional launch time, we already established a national MSL group at Kara and they've been working hard to increase awareness of the CKD associated provides us a through disease education.
Beyond that we've begun to prepare all of the necessary steps to potentially launch pursue the injection and 2021 and that includes establishing commercial manufacturing agreements and planning for senior sales marketing market access hires as well as laying the groundwork for our sales force activation.
Post Andy.
So again, we're very pleased with the M.D.A., enabling come to results in the Cabot team is working extremely hard on finalizing or indeed package for submission later this year and we'll continue to update you on the timing for that on their commercial preparation and the coming quarters.
So let's move onto our pipeline programs focused on oral Priscilla and start with our lead program in pre dialysis CKD patients with moderate to severe provide us.
In December last year, we reported positive topline results from our 12 week phase two trial evaluating the safety and efficacy of three tablet strengths of oral Cressa 0.25, 0.5, and one Mick taken once daily based on not data we identified the one make tablet strength as the Doe.
It was level to take forward and to see three.
With that hemo dialysis population, who I just like the significant proportion of pre dialysis CKD patients.
Based on providers related growth prescription data up to approximately 7 million people diagnosis.
CKD here in the U.S. about one third are currently receiving some started treatment for through items and these treatments are typically generic antihistamines coding to see rights neither of which effectively alleviate the provide this burden.
Certainly not in the long time.
There's a significant opportunity for oral cursive as a novel therapeutic approach in this population and were keen to move to a registration program here as soon as possible.
With that in mind, we do plan to hold an end of phase two meeting with the F.D. and the second half of this year to enable initiation.
Pivotal phase three program.
As many of you know we're also currently evaluating oral because of a and ongoing phase two trials for a topic dermatitis and paying rebuild <unk> College I just PVC.
Atopic dermatitis as of course, one of the most common chronic inflammatory diseases with prevalence rates of 5% in adults and approximately 25% in children.
Right assistant defining symptom of atopic dermatitis with a point prevalence estimated essentially 100%.
And then a similar fashion to seek they'd be associated provide us current treatments across the 80 patient spectrum, particularly the mild moderate disease area. So sharp consisting of topical corticosteroids tank goes on he has to means or indeed antidepressant. So our ongoing phase two trial is designed.
Two randomized atopic dermatitis patients across three tablet strengths of oral care Suva again, 0.25, 0.5, and one make it can twice daily versus placebo in January of this year. We made two adjustments to this trial, we expanded the enrollment signs from 240 adult patients with moderate usage.
Right us approximately 320 patients and we incorporated an entry conditional harvest investment and to the design to be conducted after a cop smartly, 50% of the targeted patient number complete designated 12 week treatment period, and I'm happy to core that we're on track to complete the interim.
Statistical analysis, and then next number of weeks before the end of second quarter.
We also continue whether phase two trial more acquisitive in PBC patients with moderate to severe provider.
Right just as a common symptom a call assassin liver diseases with 20% to 30% of patients experienced and provide us, but where the prevalence of up to 70% in patients with PBC. That's a reminder, this is a 16 week trial designed to evaluate safety and efficacy of one make tablet strength of or because of the taking place.
Clearly versus placebo in approximately 60 patients.
I'd like to add that nearly all of our studies things for the two phase two trials remain open and we continue to enroll patients although the rate of enrollment has slowed somewhat due to the pandemic.
We're also expanding clinical site as were able with the aim to report theater from both trials before year end.
So to wrap up 2020 hats off to a very good start with compelling consistent pivotal data from our two trial. We're on track to submit our first Andy a progressive injection later this year.
In addition, we expect major progress with our oral modality of pursue though as we work to finalize the phase three program for pre dialysis CKD patients I agree that data and the phase two trials in both the topic dermatitis and PVC.
So with that I'll turn it over to Rick to cover the financial results for the quarter Rick.
[noise]. Thanks there.
As a reminder for the full financial results for the first quarter 2020 can be found in our press release issued today Thats the merger closed.
For the first quarter 2020, we reported net loss of $28.9 million or 62 cents per basic and diluted share compared to a net loss of $22 million were 56 cents per basic and diluted share the same quarter of 2019.
The first quarter 2020, we recognize revenue of $8 million related to the before collaboration agreement compared to $4.2 million during the same quarter in 2019.
Moving from the sale clinical compound was approximately $100000 into first quarter, both 2020 and 29 team.
For the first quarter 2020, we reported R&D expenses of $33.5 million compared to $23.6 million from the same period of 2018.
The higher R&D expenses in 2020 were primarily due to a net increase in clinical trial cost increases and stone stock compensation expense payroll related costs conferences and travel and related costs.
Julie expenses were $4.6 million during first quarter 2020.
The 3.9 million in the same period of 2019.
Increasing 2020 was primarily due to increases in legal and accounting fees stock compensation expense insurance cost franchise taxes in payroll and related costs. Those increases were partially offset by decreases travel and related costs. Other income was $1 million in the first quarter of 2020 compared to $1.1 million in same period of 2000.
Thank you.
As of March 31st 2020, or cash cash equivalents marketable securities totaled $179.8 million compared to $218.2 million.
As of December 31st 2019.
The decrease in the balance of cash cash equivalents in marketable securities primarily resulted from 30.3 million of cash used in operations, partially helps offset by $100000 received from the exercise of stock options.
Turning to our financial guidance based on projected cost for clinical gold and plans and timing expectations. We expect to the current cash cash equivalents in multiple securities as of March 31st 2020 will be sufficient to wonder operations into the second half of 2000 2021, not accounted for any potential milestone payments under the existing club.
Operations I'll now turn the call back over just the acuity.
Ladies and gentlemen to ask a question you would need to press star one on your telephone.
Withdraw your question press the pound cake.
Please standby, we can probably Q and a roster.
Our first question comes from Jason Gerberry of Bank of America. Your line is open.
Hey, guys. Good evening and thank you see my question.
First question for me just given the covert dynamics and where you are with your atopic dermatitis. PBC study is either study from a topline perspective, a greater risk getting pushing 2021, just any color you can provide and that would be helpful. And then.
Second question is protective Ivy course Suva.
And then ultimately wondering how you model and think about patient adherence to therapy.
With this treatment and as you think about there the RCT in the open label extension studies, how you think about the proportion of patients who will be lifetime chronic therapy, those that will potentially drop off or gets shorter duration therapy. Ultimately how do you get at a average days of therapy for patients just curious how do you think about that for.
On the model thanks.
Yeah. Thanks, Jason on the first is also on the Cobrand effect. So as I said, we have noticed a slowing and enrollment and both the 80 trial on the PBC trial and you know in both trials we are actively.
Moving to enable novel clinical sites that can help make up for some of that so so far in terms of timelines, where we're not going to all of those that's the said the interim comes when were.
50% through on the H D, 50% through the entire and targeted patient population there and we're gonna have the interim and then that I don't want six weeks to Vanda. This quarter. So we're we're on track with that and you know based on the interim unless you know that's an interim the somewhat more adapter.
Then we've used in the past and that we will have the ability to increase sample size on a targeted those though.
Specifically, so what's in your space coming on board, there and where we are in enrollment, which as you know it slowed but it's not certainly not deal.
Here here in our current sites that we think we can still see topline data.
Later in the year, but clearly we'll adjust about PBC is the same way, we're trying to I'd novel sites, there and that's been hindered a little Judah the president environment, but you know dates are opening up and that should help that should help to get these sites up and running so the minute we're still.
On track to keep that data.
This year and then on the on the IB pursue the four for patient adherence you know I think we discussed us before in terms of hesitations views us.
Symptom that's been numerous studies on the us with very large patient samples and and consistently the rate provided us as their worst symptom associated with with with hemo dialysis CKD, which is remarkable on itself, but at that level, where as moderate to severe on any of severe.
You know effects on quality of life, perhaps understandable, so really we're gonna see patients on therapy long time.
This is a GPCR ladies mechanism when we start supplying I can attest to that target you're going to see a diminished response biochemically. So there's going to be honest therapy long term to treat that provide us and.
You know is we think it's an advantage in the feedback we hear from patients and investigators. It's an advantage that we had minister that's at the point of care. So they don't want to think about another medication unless you know they're heavily tilted burden. So we think without getting up three times a week really isn't bolus you know another lever.
Finished their dialysis session. There bolus pursue Buddy go home to get protected from provide US began decent nicely you know these stopped scratch and they have some sort of social life.
I think they're highly motivated to keep that up and so I think it's kinda longer term therapy, and I think the penetration rates and to this population would be and will be significantly higher than you'd expect in a normal.
You see type environment.
Even related to Sears symptom on general these patients really up to.
Come to the dialysis clinic, and they're highly motivated to treat the conditions I think there'll be a high penetration and to that.
Patient is there are different.
Just as a follow up because in the phase threes, we've seen more more shorter term exposure, but is it your sense that the open label extension should mirror, maybe the discontinuation rate seen in the in the shorter term RCC trial.
And that might be good indicator for the proportion of patients who will go on and can be adherence to a chronic therapy regimen.
Yes, I mean that isn't possible indicator that's true we've certainly seen a large percentage of patients from the RCT portion have moved on to the the open label. So there's the motivation there to go on and take the maturation when she does a good sign.
The people would like to continue that and the discontinuation rate do not have that's one of the interim safety extension for I don't recall that being significantly different than what we've seen and the RCT portion about which is also good sign.
The patients want to maintain their medication for that treatment. So very high percentage meant that the RCT into the open labels on both those.
Safety extension that and I should say, we're winding down and all of those safety.
Trials right now and concluding those so those are wrapping up and again getting back to cool.
Influence I think it was a combination of good planning from our clinical grip going to presciently, putting in these esso piece to deal with close in Dundee databases.
Thank you know a little but a good fortune that we were wrapping up many of these trials just as a ton damages ticking up but we're in good shape forget and all of that data from all the safety trials.
Kind of great. Thank you.
Yes, Jason.
Our next question comes from David Amsellem of Piper Sandler Your line is open.
Oh. Thanks, So just had a couple of questions. So wanted to get your latest thoughts on how you're thinking of.
About pricing, particularly wanted to get your thoughts on pricing overall szuba here just for a refresh us on how you're thinking about what kind of analog you're using.
And then this is somewhat related to price, but to the extent and you have a real signaling atopic dermatitis and and you try to access that market. How do you think about how that influences your view on the probably for the product and.
How do you think about step two is in terms of what patients are gonna go on first than what they could be forster before they can access.
The reagent thanks.
Thanks, David.
Yes, so on pricing.
So obviously a little early.
Be thinking about price points, you know, there's going to be a number of variables to consider there as we go out developed the develop the oral and these somewhat different markets of course.
No you're well aware of Entresto event injection, where.
We are part of the yes, our deep fun thing reimbursement and as you know there we're going to have a two years to dapa at PNM. We you know we're actively engaged grew up is actively engaged with CMS to.
Create some sort of pass some clarity regarding cost the doctor reimbursement there. So that's ongoing and we are.
Confident we have good engagement, there and we think we'll get some.
Some answer as to how Thats going to proceed on the oral of course, the vast majority of a pre dialysis patients or commercial insurance and certainly in a d. so they're going to be commercial insurance. So that's a slightly different beef there and you know.
As you know this is the first in class.
Hopefully will be the first the label for treating moderate to severe provide us with an oral medication here. So you know I think a reasonable analog might be other long term symptomatic treatment and and again I think a differentiated pain drug or maybe a reasonable analog.
To look out there, although there are still as an argument as a large unmet need we'd be a first in class and not usually commands a premium pricing, but you know I'm highly differentiated non abuse, the bull less of usable and drugs that right there.
You know and 810 12000 per year on launch there hasn't been many recently.
I'm not maybe the bottom end to that Mark and then at the top end highly differentiated oral dermatological medication might be a tesla.
And that's getting you and the high teens 20000.
Annually, so thats a conversation we just don't have enough.
Information yet to think about in great detail, but those might be the kind of bukantz would be thinking off in terms of the H D market and I think you and I discuss a couple of times. There I mean, I think I think thats sorely missed on an oral medications to treat the primary symptom and as you know any topic, John the vast majority of that focus.
Nation that mild to moderate and those mild to moderate patients are really not candidates for biologics there.
Both from a patient perspective, and from a pair perspective and paying for that so you know I think the only staff through in it one way to look at it but it may be a combination here, probably topical corticosteroids and the mild to moderate population there.
And then of course that there comes a practicality to find that twice daily and then there's a long term issue with that also so I'd imagine that makes it the only thing we see a happy with this and this you know easily usable oral medication twice a day to.
Really systemically reduce right it would be would be the next line therapy.
We have imagined.
Okay. That's helpful and regarding aided just a quick follow up do you.
Intend to commercialize that you're so far is that something you'd look to find a partner for.
Yes, so you're really looking for Canada.
Last fall projections here David Grant.
A few years there are so I think are starting to come in as.
We can easily handle.
<unk> said, we can accommodate launch and the the IB product and the dialysis population that's something as you know that is manageable and we think we've got a good partner and before Fresenius that will help us without launch and we think.
That's something that we can accommodate.
And we think some very very attractive product.
Of course, when we move to.
The larger throughout this market and as you know there are some.
20 million or so scripts broadly in the U.S. annually across all patient populations and that's a big or not.
For the small well the car as the crack a right now so at that point.
Most likely we look for a strategic.
Partnership when we get there someone with an established salesforce with the appealing and that some.
You know very attractive structures that are being employed and have those commercial relationships have been I've been set up so I think it's most likely and when we get that we look for some sort of strategic arrangements and that really depends where we are in terms of revenues from our.
Our launched Ivy product and how do we feel about that but most likely will that for some strategic.
Alliance on the larger oil market.
Alright, thanks there.
Thank you David.
Our next question comes from Chris Howerton of Jefferies. Your line is open.
Great. Thank you.
Hey, Dave So I think for me. It was just really quick question. So in the past you've described the aspiration is certainly for oil pursuant to just get a broad anti pruritic label.
So just curious again, if you could walk us through.
You know potential approvals and single indications and how does that translate to a broad just anti pruritic label.
Yeah. Thanks, Chris.
Yeah, I'll look as I said at the beginning here, we think we'd get a mechanism with this drug where we're not focused on one specific to religion on one specific site again, maybe elevated in a specific clinical population.
It's been widely accepted for many decades.
You know peripheral Kappa receptors when activated can diminish see fiber activity century fiber activity very very effectively and and so.
As that final conveyor of the signal from from the from the epidermis and the dermis.
Then we should have a mechanism it should be brought the applicable now there's some good evidence for that obviously, we think the evidence spares that were highly effective in CKD associated provide us some good evidence from the Japanese drug this on the market there they can treat liver diseases to see the pricing obviously those of different profiles in terms of elevated site.
Thanks within those patients that's evidence that ray, perhaps we're thinking the right way and then you know we kind of looked at it the way that people in the past have looked at the at the pain medication regulatory approach not not I should sit around and specific guidance the best probably for providers and pain as you know to get that broader.
Legal you would satisfy the division that you had activity across these various sub types of of pain from inflammatory to neuropathic to festival can we talk about it at the same way here and you know our clinical development groups done a great job and strategically thinking about that's in which patient subgroups.
The useful to add to the argument right now we have endorphins disease.
Provide us with CKD and C.L.D., but clearly moving on to dermatological, if you like local inflammatory.
All right us with a topic and we may look at some other subgroups and provide some information and these other areas that are quite prevalent perhaps perhaps neurotoxic trying to send so the ultimate case to be missed areas with that data in hand that shows activity across all these various physiologies then.
I would make sense to have the broad label and I haven't set that we think we're in a great position with seeking ideas you and I have discussed before in the.
If we when we move phase three programs forward here, we do have a large number of seats exposure is already available from a intravenous inclusive and action.
Ground, which would make sense to reference as part of this up pivotal registration program. So that's certainly something we'd like to engage the FDA west and that would save as you know a great deal of.
Time in terms of developing but in the fourth exposures and perhaps is another new there to have a diminished requirements in terms of efficacy trials also so it doesn't make sense to to start with will quickly into some large unmet need.
The could get is that label as fast as your time, but clearly if there's a.
Signals, we hope and any topic, John that's that's obviously a very large.
I met need there that we'd also like to push quite quickly when we get in there. So that's the idea develop in very efficient populations that the ultimate conversation, that's probably not the primary conversation, but the ultimate conversation with the oil would be get up broader label there for moderate to severe providers.
Okay.
And I apologize I should know this but I just wanted to.
Are you expecting advisory committee for the IP formulation of course are though.
Well that's.
I've no information on that's fine that's something that they'll decide upon on reviews, yeah I.
Imagine, it's a novel chemical entity, there might be a higher likelihood for that but we have no information as well.
Okay. Thanks, Okay, well. Thanks, yes, thanks Les I appreciate you taking the question.
Appreciate it thank you.
Our next question comes from Annabel Some Mimi of Stifel. Your line is open.
Hi, This is avatar Jones on for Annabel Tonight.
Two questions regarding come to firstly have you had an opportunity to pull out any of the additional secondary endpoints.
Such as the Completive response.
And secondly have any of the come to patients rolled into the open label or extension studies and if so what percent would you see there. Thank you.
Thank you avatar cuts Tokyo.
The answers here pretty sharp no we haven't actually done any.
Additional analysis on that and to assist the course of a dedicated but smaller force had moved onto close enough that I mentioned some of these safety database is we really need to get done.
Our team to get done for endear submission. So so we haven't yet done extensive sub analysis and all the other secondary endpoints other than and we mentioned that somebody come to call. We did lose and tends to the quality of life that countries. We did look at the individual domains and there and confirmed that we didnt have statistics.
And reductions in the providers related demand on both those.
Quality of life skills, So that's reassuring and ties in with what we've seen on the prime is but we haven't had a great deal of time to get through all that that we will be projecting at presenting on data later in the year.
At the nephrology meeting in the fall so that will be additional sub analysis that's presented.
That's presented there what's your second question over time.
The second was on common to patients rolling into an open label, a what percentage of patients their head had rolled until than they.
Yes, no is high in both count wanting captures a high percentage of patients that don't have the precise number in front of me, but it was a high percentage that rolled forward entered that open label studies and both of those studies around not right now.
Okay.
If I could squeeze one more in there I'm just a little could you provide a little color on your preparations for commercialization.
With.
The core Suva in dialysis population.
Yeah. So yeah, that's something we've been working on for a while actually so.
As I said on the call Weve already established we're expanding actually our national MSL group.
Here are camera under the guidance of our CMO Jochen listen we're working more can to broaden our key oil universe increase awareness of CKD associated riotous.
They've been working harder, establishing regional and national advisory boards and their sponsor main strategic education opportunities and putting CMV symposia. In fact, we had one recently at the NTS spring clinical meeting in March and we as you know where I'm presuming and increasing.
Because of a publication footprint, we publish calm one in the new England Journal at the end of last year, and you'll see continuous publications through it last year and preparation for lunch or MSL team is.
I wish going up in active on the.
Commercial preparation.
A broadly we've already initiated things like state license thing processing and application. We have established manufacturing agreements with major cm AWS you got commercial scale manufacturing enabled we are currently screening and hiring senior commercial hires and sales marketing.
In market access.
So all of that is underway and.
Constantly and developing and preparation for 2021 launch.
Excellent thanks, guys.
Thanks Avatar.
Our next question comes from Alan Carr of Needham and company. Your line is open.
Hi, Thanks for taking my questions a couple of them.
You can get your latest thoughts on.
Phase three strategy for.
The oil formulation CKD.
Trials and that sort of thing and maybe size thats changing from.
Previous speculations and then also around yeah.
He was partnerships.
Oh, yeah in Japan and over in Europe.
<unk>.
What is your expectations in terms of.
Revenue stream from a milestone payments from them.
In the near term I think it's looking at small single digit.
From the.
To Asian ones, but you have some regulatory milestones.
The fourth resilient wasn't tied to a submission.
So I don't approval.
Thanks Alan.
Yes, so so.
Well, let me take the second the first is clearly.
More more or less speculative easier to deal with the factor so yeah in terms of.
Wrapping a stream from the various partnerships first of all of them or design. So we.
We see appropriate royalties, which are mostly tiered by by sales, but they're all double digit.
Starting starting in a reasonable double digits.
All of them other than the Korean also ask commercial milestones fill into them.
You're right in terms of regulatory milestones and completion of the M.D. are also a set of milestones we've said publicly before for before presuming that 30 million.
Related to regulatory and this approximately another you know.
Several million and milestones related to our agreement and department, we sheet and with C. D in South Korea.
So that's kind of the revenue stream there in the near term.
With before Fresenius, we have approximately 440 million and commercial milestones on top of.
The royalty there on X.U.S. stale. So so that's also significant and there is a commercial milestone associated with the.
With the MRO you. She agreement also so those are also broker.
Is there really milestone the $30 million that.
Is that one or is that multiple milestones.
That would suggest approval.
Yeah like that.
No that's related to approval on the U.S. and approval in Europe.
And that's the 30 million non fee for convenience.
And then.
On the phase three oral yeah, I mean really the same answer.
As we had last time to great position, we're in now with our phase two data in hand. This that we now have a set of empirical data that we can model to make sure we size that phase three oral trial appropriately and you know we discussed this last time.
The unusual aspect of the phase two Ole data was at a higher placebo response.
And certainly higher than we've seen and the the Ivy trials and hemo dialysis patients in our thoughts there were a couple and we think we can make amendments to the design that can address those couple of thoughts one was there earlier stage patients than they have more labor I'll provide us. So we can have longer ramp periods being more careful make sure that right.
Assessment would be something we built our into a design.
Pithree designing and.
We're going to move from a three to one randomization to straight up one to wants about a long should help.
In terms of placebo response, and then we're not going to use any station I should know a reasonable number of those sites for use in the phase two Ole trial had previous experience with tresiba either from the chime one trial a phase two trial. So we think there might be some expectation biased built in there.
So use engine Oversights is an obvious solution or a few other things were going to.
Teaching to consideration to try and help without placebo response, but nevertheless taken on critical data and modeling if you like a worst case scenario, which as you know the beautiful thing about running stage development programs as we have data real data to model on so we can take that.
Variability, we saw there and taste and simply model that for phase three study and assumed the worst case scenario for the best and as you know we like to checker assumptions on these larger trials that we large trial, we've run for the last.
Three years, we've incorporated an interim assessment that 50% completion and that really as a terrific indicator of whether your assumptions are correct. In fact in all three of the latest as those interim assessments, we had the primary endpoint and so and so we got that we're going to deal with it and so.
That's why you know I think I've said before it really depends on a conservative we want to be on a per assumptions, but at a reasonable conservatively I mean, I don't have the numbers right in front of I do recall that says and you know the 202 sets of very reasonable you know sample size cookbook to get a very good hiring.
On that or not trial. So we're in a great position to the two design not trial.
Separately.
Are you thinking one or two I think any before that there might be two phase three more I'm thinking one, but it really depends where the FDA thinking. So you know I think there's the case to be made for one here, but obviously, that's a decision we'd have to.
I have in consultation with the FDA has you know we have many many exposures in CKD patients and and so there may be a case.
You know, but that's the conversation for the FDA and then at the decision on that.
Okay. Thanks for taking my questions.
Hi, Alan Thank you.
Our next question comes from Esther Hong of Janney. Your line is open.
Hi, Thanks for taking my questions.
So with Ivy courses or potentially launching 2021.
Followed later by other potential approvals for all courses that can you talk about patent protection other types of protection right now it looks like on current patent expiry is through 2027, and so that kids between six to seven years of current patent protection. So.
Sounds like applications have been filed can you speak about those the status of Doe tapping into its been granted or they close to being granted any update there. Thanks.
Yes. Thanks. Thanks. After yeah now you're correct, we have composition of matter pounds that do run through 2027, but recall that with that extension on those.
So with hatch Waxman on that we go to 2032, which you'll get his or her to 10 years on the market if you like.
Both with Ivy and that I would suspect with oral for force label, there, which would probably be a year behind the IB.
But you're also correct we have multiple other.
Application. So we've built several fences around us them IP estate related to usage and they're also patents related to specific formulations as part of that but Brian and to the 20 Thirtys.
Mid to late and so and so we felt was much protection around that as we can but we will get the benefit of hatch Waxman. So we'll get our full 10 years on the idea in the oil.
Great. Thank you.
Thank you after.
There are no further questions like turn call back over to the care team.
Great. Thank you Michel so thank you everybody. Thanks for participating in today's call I also want to thank at the whole powered team. Our study investigators all at the patients who continue to participate in our clinical trials and we certainly look forward to updating you again very very sense would be syfy healthy everybody. Thank you for calling in today.
Uh huh.
Ladies and gentlemen, this concludes today's call.
Thank you again for your participation you may now disconnect have a great day.
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