Q4 2019 Earnings Call
Greetings and welcome to the Zogenix fourth quarter in full year 2013 financial results conference call at this time to pinpoint any listen only mode.
A question answer session will follow the fall presentation.
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As a reminder, this conference is being recorded.
Now my pleasure to introduce your host Brian Ritchie. Please go ahead Sir.
Thank you operator, thank you all for joining us this afternoon.
On today's call, our Chief Executive Officer, Dr., Stephen far Chief Commercial Officer, Ashish Agrawal car and Chief Financial Officer, Michael Smith.
Addition, chief Development Officer, Dr., Gail Farfel loss will be available during the Q when they session.
Good afternoon, Zogenix issued a news release, providing a business update and that you financial results for the fourth quarter and full year ended December 31st 2000 <unk> [noise].
Please note that certain information discussed on the call today is covered under the safe Harbor provision on the private Securities Litigation Reform Act.
We caution listeners that during this call Synergetics management will be making forward looking statements.
Actual results could differ materially from no stated or implied by these forward looking statement due to risks and uncertainties associated with the company's business.
These forward looking statements are qualified by the cautionary statements contained Genex's press release issued today and the company's FCC filings, including in the annual report on form 10-K and subsequent filings.
This conference call also contains time sensitive information that is accurate only as of the date of Thislife broadcast.
March 2nd 2020.
Janet's undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this conference call now I'd like to turn the call over to Steve.
Thank you Brian good afternoon, striving to be joining us on todays call.
Very busy an exciting time, it's renting trekkies a pivotal year for all these are all programs and the company.
Starting with synced up Intravase syndrome, basically the phone calls from last year.
You know Andy partner, what a six month priority review.
Last week, the FDIC studies or extend through the period for the idea or three months to June 20 cents French fries.
The new but do for talking thanks, a lot of yes, you're trying to review additional information submitted by subjects in response to a recent requests from the up here.
The additional information provided here do you agree datasets to conduct.
Sensitivity analyses on the efficacy outcomes from a to cover studies completed in July syndrome.
Our own analysis is shown in the phase three data or very robust so the sensitivity analyses.
In addition, the teachers crack was not related to sacrifice safety profile. Moreover, there's been no mention or possible Advisory committee from the FDIC. During these San Diego review process.
As a reminder into your application was based on data from two pivotal phase three trials with your racing grow on their interim analysis and ongoing open label extension study or where they study 50, no three which at the time included 232 patients treated for up to 21 months.
Yeah.
Oh, the pivotal trials met the primary endpoints in all key secondary measures with high statistical significance.
Tell all doses resulted in rapid clinically meaningful reductions in convulsive seizures went participation stable on t. after treatment regimens.
During the fourth quarter results from these people to raise studies were published in the fall into procedures journals nonsense Java neurology.
We remain very confident the data supporting all I'd be a submission I know for once you're continuing to work with the agency. They complete their review along with some new timeline.
Importantly, the robust reductions in convulsive seizures observed in the Rocky ride control trials. We're also sustained in the long term open label study and Interbody syndrome, which as I noted earlier, including patients on therapy for up to 21 from us.
Results from an interim analysis of the same already study when it comes off stage in Q1 last year includes a total of 330 patients with immediate treatment duration of 445 days, where the range of seven to 899 days.
In 222 patients treated one here.
It was a 77% decrease in medium, mostly convulsive seizure frequency right penetrating the fact that means 10 to 12 versus baseline.
I'm 40 to 52 patients treated for two years.
And decrease in monthly convulsive seizure frequency at that time point was 83% compared to baseline.
[noise]. These impressive data along with a portion of patients clinically meaningful upfront season reductions in seizure frequency will be presented at the American carving a royalty I don't want BJ interim so in April.
Other presentations at this meeting will also feature pentathlon.
Including reports on the real World and stock that's no ongoing U.S. expanded access program.
Early results from an open label Piven study or fenfluramine safety and efficacy in sense why were Sandra.
Well, let me look ahead to the but you've been talking things. We are continuing without precommercial activities are planning for a potential launch in the United States in the third quarter this year.
She's it's X. I can tell me more about our plans into moments before about though let me also I think we're also focused in on the M&A, hoping checkpoint interface.
Reveal the review process is consumed in Europe I should be system review is and that assessment of our application towards a final opinion this year.
With that let me go haven't turned the corner with Rishi Parekh, all commercial readiness activities.
He'll be followed by Mike who will cover off for quarter four years running 19 financial results and then I'll provide an update on the restaurant development pipeline before opening up a QNX G.
Thank you Steve good afternoon, everyone.
We haven't been able to ensure that scholarship program I mean.
Well that we intend to be ready to launch hockey.
Yes.
We are what I thought he was constant theme in place and have recently hired and onboard at key account managers in national accounts team, yeah, it'd be customer supporting documents delivered comedy anticipation services to our.
Which has caused zogenix sanchez.
These out experienced professionals will have considerable experience in that and they see this epilepsy and specific any time et cetera.
We have been discussing with Bayer educating them on the significant unmet need that exist in the topic I mean.
[laughter] conversations today, we have they see if any positive reception as we've been continued to engage with passed through the first time I'll be here.
Product manufacturing supply and distribution partners.
Ready to launch in July.
These block is uniquely positioned to ensure the most efficient access the front step that for the greatest number of patients at lunch.
We have committed to ensuring patients who need to have not able to access.
If effort.
It was an exemption lapa personalized service does tend to have not patients get dealers and physicians.
So as an accent is a single location for why do you get Oh, let's start with support system for families and healthcare providers throughout the team and fulfillment process.
Specifically it will include.
That is laid back you had to coordinate does would work with the calculus and healthcare professionals to the stock and the continuation austerity.
You must have been disappointing to have kind of kept professionals I can't give us.
That's administration, including got with vehicle process, especially if you follow.
We continue to engage with the member stuff that up let's see communities, especially Tony community, So, but I missed at that means we.
We are grateful for that I can you support and increase my sort out efforts I programs as we have made to potential approval effect.
In 2019, we also launched a disease education.
I imagine Si dot com to educate and brand awareness to the needs of patients.
Let me turn now to Europe, where some of them activities are underway at the bottom European country limit preparing for the potential launch effect.
We have moved a deep but to consider when experience in Nevada, Caesars and epilepsy, and yes, such as market access and marketing.
We have initiated discussions with has got a part of these definite country, especially I think has economic models.
So far we have had many positive engagement and feedback competent let us in all major European markets and we will continue these conversations in 2020.
We already have experienced medical evidently teams in place all across Europe, and we have recently said that country offices and local leadership in the United Kingdom, Germany, Italy in Hot.
In summary, we opened a bit and ready to launch definitely not group. So that we can bring this potentially transformational atrophy for patients who so desperately need it.
With that let me handle in a positive like quite a financially.
Mike.
Thanks is huge and good afternoon, everyone.
Today, we issued a press release summarizing our financial results for the fourth quarter in full year ended December 31st 2019, we recognize 1.9 million in revenue during the fourth quarter of 2019 and as the result of our March 2018 collaboration with a bunch of Yacov for Fintech, let intravase ingevity those yes for Japan.
No just recognize no revenue for the corresponding period 2018.
Total R&D expenses for the fourth quarter were $35.8 billion.
An increase of 20 from 23.6 million in the corresponding period of 2018 is largely attributable to the expanded clinical trial activity led it to the ongoing phase three development as well and LG, yes.
<unk> expenses for the fourth quarter and it.
So $18.7 million and its compared with $11.3 million for the fourth quarter of the prior year. This increase was driven by continued investment in preparation to prospectively lots to TEP love for the treatment are based in Germany, U.S. and in various countries in Europe in the coming years.
Net loss for the fourth quarter ended December 31st 2019 was $6.1 million or dollar 26 per share.
This compares to the net loss of 22.4 million or 53 cents per share in the fourth quarter ended two that December 31st 2018.
Net loss for the year was 419.5 million worth a lot a 9.7 $4 $74 per share compared to a net loss of 120.9 million, where net loss of $3, a 27 cents per share in the prior year.
We ended the fourth quarter with cash cash equivalents in marketable securities totaling $251.2 million, which assuming approval. We believe are sufficient resources first to execute on watch Devlin trace and John support our planned operations for at least next 12 months with that I'll turn the call back over to Steve.
Mike.
As you shouldn't be a I can be advancing all aspects of off in Tempur program integration drugs and look forward to the target action date for the idea of June threat defense This year.
Last month, we were delighted to announce positive topline data from a third pivotal phase III clinical trial for example.
He 60, no one a global phase III clinical trial in 263 patients without yes.
Studying critics patient that you need ages or two and 35 years, we see it should remain uncontrolled well on one or more anti epileptic drugs or.
The study met its primary endpoints of showing a highly statistically significant reduction from baseline in the media Percentrange in monthly drop seizure frequency compared to placebo.
As we've mentioned before LG asked is a rare and severe form rep say arising from multiple different causes make it is notoriously difficult to treat overseas are often be highly resistant to existing therapies.
Importantly, they all else, yes patients will at some point I've tried and failed multiple agencies.
Therefore, there continues to be a significant unmet need and algae, yes.
Based on the results of Oh from studied 60, no one has.
Been tough when the show efficacy effect size comparable to many other currently approved algae has treatments.
Therefore, we believe that fintech, but with its differentiated pharmacology guys unique mechanism of action.
Has the potential if approved to become a meaningful that'd be options for physicians, who treat patients with refractory out yes.
From a revenue starting points under the assumption of an approved anti <unk> chocolate for Turvey syndrome, we do not anticipate any further pivotal safety and efficacy studies will be required for supplemental India, India for an expanded label indication out yes.
To support this supplemental submission, we have concurrently completed or a well underway in conducting several phase one clinical studies unknown clinical toxicology studies.
We intend to meet with the FDA later this year to confirm the content of the SMB or which will determine the timing of our submission.
In addition to LG Hassinger basin drone, we Oh, we have initiated an exploratory phase two study.
I understand the country's sticks of additional where epilepsy disorders in separate cohorts and evaluate whether even tougher is safe and effective versus placebo in these patient populations.
The study protocol has been finalized and we are currently seeking I'll be approvals are proceeding with opening study sites.
Yes.
We now expect your ROE first patient in this phase two basket study in the second quarter, well targeting topline data from the fastest growing cohorts why we ended the year.
In addition, real sponsoring investigator initiated studies in several orphan epilepsies syndromes sure, which a microphone could you try to stock up for the treatment of sunflower syndrome, and see the okay five deficiency disorder.
Next I'd like to switch to M. T 16, 21 of our investigational therapy for the treatment of a devastating unfrequently faithful mitochondrial do you native tissue soda.
I think Chinese to deficiency or Teekay too deep.
M.T. 16, 21 is an oral fixed dose combination treatments.
The oxycyte cutting on Deoxi, starting with the answer serves a substation hospitality to restore mitochondrial DNA to overcome difference is caused by this disease.
Enrollments at the study one or two a prospective open label study involving patients from the retro trial was completed at the end of January.
Good progress is also being made towards completing the non critical.
Nonclinical enter your enabling studies on finalizing the product manufacturing requirements for the idea.
I T 16, 21 house breakthrough therapy designation, United States and Prime designation in Europe.
We have a meeting scheduled with yesterday in early Q2, I look forward to providing an update regarding future plans on the regulatory submission timeline once we haven't changed the appropriate feedback from these discussions.
We can take you expect to hold is simply meeting where they may later this year.
So with that we can I could begin to keep an eye session. Operator could you. Please open up the lines for questions.
Certainly well now begin ducking your question answer session.
If you like to be placed into question Q. Please press star one of your telephone keypad, a confirmation Tony Blair indicate your line is in the question Q.
You mean prestart too if you like to <unk> question from the Q.
For participants using speaker quite maybe be necessary to pick comprehensive before pressing star one.
One moment please poll for questions.
Our first question today is coming from Pullman teams from Stifel. Your line is that life.
Great. Thanks, very much you're taking the questions.
I wanted to ask one of the PDUFA expansion and then one on some of the data you just shared on EWP extension can you clarify what types of sensitivity analyses you think the agency.
On the phase three trials and maybe you can just give us a little bit of context as to why you're confident that this isn't really a big deal for Approvability and maybe secondarily why you're comfortable that the agency isn't going to arrive at any sort of different conclusion as it relates to the differentiated effect size you appear to happen.
Right and then second on the long term extension data you just presented I was wondering if you could just give a little bit of color on the retention rates, you're seeing at one or two years in your extension study and any additional color just as it relates to safety and how that's holding up thanks. So much.
<unk>.
Uh huh.
That's cool appreciate your questions I'm on the Oh, the sensitivity analysis that all several analyses that we have conducted and I'm sure, which the after they want to conduct as part of that sensitivity.
Work as well what I will say, yes, that's the dates oh incredibly robust to any sensitivity analysis. We conducted that's the point, where we're not seeing any shift in P values I'm very very small very small differences and and quite estimates so.
Well, we don't think there's really anything that the FDA go into uncovered sure, but we have not already seen and we've been able to establish that are they said, though very robust. So I think that probably addresses your first question.
On the second question the retention in our phase three been open label is still very very good are we seeing the majority of patients still remain open label. As you know we are moving patients over to a study 90, no one a which is a a which is a a another look like Boston.
Study, where there's less study that's around 85% retention. So we feel good about oh from a safety perspective, we really see nothing and the open label extension. That's any difference what we've seen in the randomized control trials, where you quoted are indeed in the safety data cut that we presented last year.
Yes, which forms the basis or integrated summary of safety in the idea.
And that also includes no patients I'm has a as Bob or heart disease or cutlery.
Right.
Yeah.
Great. Thanks, so much Steve appreciate it.
Thank you pool.
Thank you. My next question is coming from Marc Goodman from his review.
Hello.
Yeah can you just give us a sense from the commercial spending what was done in the fourth quarter and how we should expect 2020 to play out a you know given you don't have approval, yet and and then second of all just come come back to your first second and just tell us what exactly where where are we on that can you give it.
<unk> <unk> to find the time, a little bit more carefully.
Then and what you had mentioned this just happening this year. Thanks.
Yes, yeah.
Go ahead Mike.
Hi, Mark.
Yeah. So they tend to be activities that are conducted or in this past quarter. We've continued to do a lot of the research in helped pulled a lot of discussions with like me that community. The physicians Payors Oh, we're ramping our.
Dialogue with payers obviously your initially.
Anticipating at a mid year launch so a lot of those activities in the six month. The launch window that we were executing on we've also been fortunate to be able to dial up a fair amount of participation in EAP, which resulting activities.
Sounds strange to ask DNA in the context of hub activities and other things that were preparing for with respect to I will distribute the product through specialty pharmacy in the United States in Europe, So getting a lot attached that's trends there. So that was a lot of the a digital spend we have this season.
Mentioned onboard our core group of Oh pacing.
Facing ER physicians.
In in this coming.
And this 2020 year, where you've got kind of set plans for that into our expanding.
Subsequently finalizing our infrastructure there so I think it's.
It's one of the you know we've talked about this markets. It's one of these things where it's a rare disease launch. It's a net 50 people plus in the United States across inside and outside 2025 person.
External face and Salesforce so its.
A fundamentally cost that would be similar for that kind of structure that we would be anticipating for the year and then for Europe, you know where basically our base case right now off of a timeline that is.
Similar to happen dialects. This timeline there and so we do a lot of crap activities organize in the big countries that we want to go to but ours.
Since we're not going to be expecting a decisions till later in the year. This year. You know those are mostly activities from a commercial product perspective in providing product to that will start up in the early 2021.
The 50 people can you give us a sense of how many have been hired already how many were in the fourth quarter, how many gonna be in the fourth quarter first quarter.
So why wouldnt be happy [laughter], that's in the U.S. the attack on what should the team has been.
Yes, so that savvy better.
[laughter] bedding for launch in the only bought up the Q2 and have that people is already in place yeah, we'd like to see as we get the approval to expand mosquito too.
Thanks.
[noise]. Thank you. My next question is coming from Daniel Brims from Piper Sandler Your line is our lives.
Great. Thanks, Thanks for the questions guys. So a couple I guess, we'll follow up to Mark first for the EM and Ts NPL decision if I remember correctly you had.
Indicated at one point that the decision to come this quarter can you remind me why it's not expected now until later this year.
What the go and then and then sorry can you off we're talking about your approach in the U.S., but that you're 20 feel base right I think are targeting 1500 dock.
You know how did you identified though what gives you confidence that you can probably just the market with that number of people. Thanks.
Yes, I can tell me <unk>, Alaska, she used to take the second part, but before that I can sort of take you through.
The <unk> as you know is there there's no could do for equivalents in Europe with respect to the reveal of elaborate a bit of various clock stops along the way.
We're up right now with a with the.
Hey, it's that we are anticipating that they want a two questions are coming up.
Towards the end of this quarter, so that would be the next time, where are we will see a their feedback from me it from the reviewers and that we'd have a better estimate of what the timing would be a round.
It's trying to see it should get paid time no. The reviews in Europe do trade, we think a little bit longer than they have in the United States historically.
We think that's I would timeframe that we're all Israeli no different to a number of other drugs that being a.
A proof recently, including one and let the next customer Dravet syndrome.
I'm not sure if you take an excellent. Yeah, then I think the intense so do you know what else I guess I talked about.
Taking a step back you ought to look at it and they do they syndrome focused activity.
Which is they have condition yeah, we have done over the last few didn't want.
Why do people into research as well as profiling <unk> a work in the U.S. and what we learn from the community as well as some of the physician strategy of the page slot being different Tri band was diagnosed.
In these have epilepsy centers, yeah. These measures community centers and that's how we came to this athletic them. This stuff system. That's accurate data that you mentioned.
I wanted me I'm also not at the same time. He is looking yet it's based on some of the new what are the ones that have happened in last took that latter half yet we haven't looked at how the patients have been found that teacher in any of these may says if that gives us confidence that after launch at least in first year ago 18.
We will be able to connect with all the patients who had been I didn't get side and I mean, she did they cannot product that can offer yeah. As time goes by we believe me expanding yes to see because they're not hofh patients who are diagnosed or what not miss diagnosed and we believe that not up those out in the U.S.
And we'll be focusing on if what are those as you move into the large process hope that answers your question.
It does thanks very much.
Thank you Doug. Thank you. My next question is coming from Serge Belanger from Needham and company. Your line is not wise.
Hi, good afternoon.
A couple of questions for me.
On the update of the a Andy a review for Dravet syndrome that that was delayed you talked about the F.D.A. request for additional data, but can you provide us.
An update on the CMC component of that review has there been a an inspection in the manufacturing side at this point.
And then my second question is related to the upcoming supplemental filing for.
LG, Yes, you can elaborate on some of these additional phase one and.
Non clinical trials that will be required for a for filing.
Thanks.
Yes, I said.
Oh, let's go to take your second part with respect to the CMC elements of the review we have certain needs I've had unaddressed CMC questions are these since the yeah I preapproved stretches not occurred at this moment rescheduled to be very soon.
And let's just take the second part we try to L.D.S. filing we are completing some of the typical profiling. So.
Specifically hepatic and renal dysfunction profiling clearance of the driver as well as some of the preclinical studies, where drift werent deferred for need your may filing specifically long term carcinogenicity any developmental and reproductive toxicology studies and so those have been ongoing and they'll be included.
In any LG s. filing.
[noise]. Thank you. My next question is coming from Jason Butler from JMP Securities. Your line is alive.
Hi, Thanks for taking the questions I tend to come back to the 1900 open label extension study can you give us a sense of how how many more what proportion of patients you've now transitioned over from 15 out three and then just in terms of getting IR be approvals for that study can you talk about <unk>.
Variance with moves the move to less frequent echo monitoring thanks.
Thanks, Jason.
That's good to talk about the less frequent monitoring them how was the Ibiza dressed up there in terms of or the open label extension we are.
Moving patients over once they have completed a this study 50 notes rate and if you look at the numbers in total between 1900 and since you know trader Joe's.
Oh, that's who had approximately 219 enter vacations in both those studies.
On the rather some because those currently in 19, hundreds when moving them over as they sort of and a study 50 anniversary.
And just follow up I'm I'm not aware that we've had any we like we made a question which were addressed I'm not aware that we've had any.
Concerns that have prevented the transition from Asia.
Three to 900, it's a large process there are many sites in many countries involved so it's proceeding.
Yep.
Great and then just one more for me on 16 21 could you just lay out scenarios scores from both the from a planned regulatory meetings, where in the U.S. in Europe.
Yes tough for me to say, yes in out years right now, Jason I really would like to get the other side of the a the meetings with the FDA.
Our assumption going into the meeting is that we have generated sufficient clinical data with respect to the efficacy or we are continuing to collect safety data a in study one or two as I mentioned in the area and then we also need to understand snow.
To be a level of Oh.
Nonclinical data as well as CMC data is required for the NDA submission. So I think we feel a lot better about giving some guidance on that when we get the other side of the ft engaging.
Okay, great. Thanks for taking questions.
Thank you Jason.
Your next question is coming from your kids and half from Guggenheim Partners. Your line is that right.
Hey, guys. Thank you for taking my question just a couple on the preclinical side could you maybe talk about the preclinical studies, especially with regard to put the carcinogenicity studies that have there been submitted.
For drug me, what would be the gating factor from preclinical perspective for L.G.S. I'd do it or do you have to complete those studies five to the submission and what the status is and then I have one more fun off.
Yeah. Thank you.
So the the cost studies that we started.
In relation to I'm, assuming that so these studies may be required for the original supplemental in D.A. for LG, yes.
Do you have to Yang where we're prepared for these to be deferred for unapproved drugs right.
So they don't required for the the fall and winter grade and again as you know.
We have conducted to Cogs studies are well ones come just completes the other is still ongoing one is in a six month transgenic mouse or on the other is a two year cog in roads.
When we are I would sort of when we discussed with Sta, we're really trying to determine exactly watts information around viscosities needs to be submitted as part of supplemental book just rather not you could just sumit with one robin to Cogs studies working off the U.S. yeah.
And what access for example, a draft sports you've reported as opposed to the finals.
<unk> plus send data so those type of.
Questions. A response of those questions will help us and sort of an hour down what is the the a timing for an sndk for L. T S.
Okay. That's helpful and then on on the balance sheet side of it looks like a thing you raised maybe about 50 million in in Q4 can you maybe can farm.
That's true was there to get an ATM and then talk about you know your comfort with the balance sheet now you know what level, you'll need to maintain going into the launch and also if you can talk about the pricing range that we should be thinking about now that you have both trial they announced yesterday Dan.
No it's up to Mike.
Oh, I can yeah, we ways around $40 million to $43 million in Q4 or are they getting that we get a shelf that we had act is and he did or most of that fit for all the activity. After we got mushrooms is of acceptance of the India.
We have financial say about a quarter billion dollars Inter bank account at this point and given the size of.
The Oh launch teen in infrastructure needed being somewhat efficient, we're very confident that we've got the resources, we need to put to that or for that or for that and our other operations for the coming here.
We are you know you got the data on LG yesterday confirmed a lot of the things that we've seen in Germany with respect to getting some robust response with a number of different patients that have a.
A disease that's classified in that syndrome.
We didn't have the same level of responder rate that we saw in Germany, though we did see some are really significant responses in the context of a they're a very difficult to treat disease that doesn't have a lot options in a isn't necessarily your broad refresh refractory epilepsy.
Okay. So our pricing strategy is going to remain consistent.
Today in that we are looking to appraise the product off the value of the Dan informed on ongoing basis, but there are discussions with payers in the community.
Okay.
Thank you.
Thank you. My next question is coming from Difei Yang from Mizuho Securities. Your line is that one.
Hi, good afternoon, and thanks for taking my questions just a cop Paul I'm not that no.
Any deals at the scene so they could you comment.
Oh, what how should we think about.
I'd of Africa C O for the Oh, yes patients.
And then formal bad with a quick financial question with regards to watch what should we assume the on deep I'm right 2020.
Thanks to say I'll take the first party question hundreds of micro good REIT question.
We don't have a when we have not reports or any data yet a long term dates and no G.S.. So well tend to be something that we'll go talk about when we see those data overtime. So we are.
Very excited about the data were showing a for a long term efficacy intervention, how it's how durable responses and I think that's emphasized by the latest cut to be up when you actually talked about today. So we obviously don't know what it isn't out yet at this moment in time, but.
I will certainly reports on that as we have the they did but the data moving forward.
[noise] like doing right.
Yeah well.
Yes, given specific guidance with respect to line item operating costs for the coming year today.
Well.
Well not have material changes or context of nobody's any large swings up or down.
With respect to our offerings [laughter] this year.
Okay, I can say, though.
Yes. Thank you.
Oh final question on the.
For the L.D.S. study.
When should we be looking for additional data on additional detailed breakdown analysis for the phase three these out somewhere between two and where do you plan to prove that.
That's or something that we would like to do this year and I think I guess at the end of the old is probably the most realistic conferences to consider the effect.
Thank you for taking my question Mike. Thank you.
Thank you. My next question is coming from Tom Google from William Blair. Your line is that wise.
Hey, this is lots going on for Tim Thanks for taking the questions I'm I was just wondering.
Yeah in the FDA interactions you've had thus far has the rems program at old being solidified or if you made progress there and what does that look like at the moment what are you expecting the rents for rental look like and then.
In light of the current events I believe you only have one supplier fenfluramine in the UK. So you just talked about how you're thinking about sort of supply chain risks.
Moving forward.
Yep. Thanks for your questions with respect to regimens, we did I propose a rams are in the a and the I. I think based upon the but the fact that be.
To date has been extended to do try to Fred predicts anticipate.
That was rems discussions actually picking up over the next month or so would it be all gas.
In terms of the supply chain, Yeah, we have.
Supply a manufacturer Oh fenfluramine in the United Kingdom is using our patented method or actually producing a highly purified long or fenfluramine.
And so we are mitigating our risk around the single supply by ensuring we have capacity. Another side, we've got supplier and we also have some risk mitigation going around the drug product as well. So what you would expect a company to do this looking not only to mitigate risk and supply chain.
But it should have adequate capacity for future indications, we're doing all those things today.
[noise]. Thank you.
Thank you.
Thank you as a reminder, that star one to be placed into question Q1 moment. Please only poll for further questions.
Our next question is coming from Michael Higgins from Ladenburg Thalmann. Your line is that was.
Except for Hi, guys. Thanks for taking the questions I'm just a follow up on earlier one about their card studies when you talk with the FDA, but the to your current study did they say the results we need to be included in the San Diego.
Not discuss directly.
It was not discussed are actually it was just heard or need terminate anyway.
And and far LDS based on the timing we.
Well at least for the six month than we assume finished you here will be it wasn't clear yet.
Okay, and then just a follow up in some of the questions earlier regarding the you efficacy analysis by the FDA has that had an impact on the European review not quite sure from what you've said thanks.
No. We don't believe it has an impact on the European tier we've actually conducting the sensitivity analysis.
For both European regulators as well as for U.S.U.S.S.J. likes to do their own. Another season, we've conducted we submit to those that assessment to do that.
Okay. Thanks, and then last one any feedback from the payers on how after dialects. This fared in how they see Fintech blues role and those are vacation.
Oh hundreds machine.
Yeah, Mike I think the feedback we have received based on our discussions he is very positive fly the clinical profile and the efficacy that trend up last shown in the pervasive.
Oh, we're also focusing our discussion on the unmet need in the interplay syndrome, yeah, I'll get that if he likes it kept an eye because I.
Can't really fulfilling that need.
In terms of other products I think go.
I think it won't be appropriate for us to comment on that those feedback.
But at what we do understand not only from the fast but also some of the community is that given did exactly nature up this ambition and given the seasonal Florida. There is a need for different had a piece and we expect back when we launched it when you get to use cannot build.
Great appreciate it thanks guys.
Thank you thanks.
Thank you we've reached end of our question answer session Oh, let's turn the floor back over to Dr. far for any further closing comments.
Oh. Thank you operator, thank you for joining us on todays call I'm very pleased with milestones we've achieved its running 19 allowed us to further develop fins have watched on starts transforms oragenics into more diversified rare disease company through the acquisition of M. T 16 training for 21.
Looking forward to an exciting get ahead as we work towards becoming commercial stage company focused on providing therapeutic solutions to patients their families. So thank you for again for joining us on our call today and enjoy the rest of your day.
Thank you that does conclude today's teleconference. You may disconnect. Your lines. This time and have a wonderful day, we thank you for your participation today.