Q3 2020 Zogenix Inc Earnings Call
[music].
Greetings and welcome to the geologic third quarter financial results 2020 conference call. At this time all participants are in listen only mode brief question and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad as a reminder, this conference is being recorded.
It is now my pleasure to introduce your host Mr., Brian Ritchie of Lifesize Advisors. Please go ahead Sir.
Thank you operator, and thank you all for joining US this afternoon with.
With me on today's call are Chief Executive Officer, Dr., Stephen Farr, Chief Commercial officer, She said well the car and Chief Financial Officer, Michael Smith.
After <unk> says that actually issued a news release, providing a business update.
And announcing financial results for the third quarter ended September Thirtyth 2020. Please note that certain information discussed on the call today is covered under the safe Harbor provision of the private Securities Litigation Reform Act.
We caution listeners sector. During this call Synergetics management will be making forward looking statements actual results could differ materially from those stated or implied by these forward looking statements due to risks and uncertainties associated with the company's business.
These forward looking statements are qualified by the cautionary statements contained in <unk> press release issued today and the companies actually see filings, including 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 this live broadcast November night, 2020, genomics 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 and good afternoon to everyone joining us today.
I'm very pleased to share key updates from what has been a truly exciting quarter preserved trucks as we continue our transition to a global commercial stage rare disease company.
As we announced in our last quarterly call the lontra itself, but for the treatment of seizure the Sochi Winter basin drilling United States began on July the 27.
In the short time since then.
Experienced commercial team has made impressive progress make itself available to do you estimate commitments.
The significant studios a good feedback received from physicians caregivers and patients during the first three months of the rest of world, which has increased our excitement about the future of successful pretty tough luck as a new treatment option for everybody syndrome patients and their families.
Ashish will detail today, we have seen strong physician adoption.
Excellent execution of operations within all principal <unk> Rems program.
So driving structural services, allowing for a seamless enrollment transitioning our initiation of patients the peregrine, including many who are you just getting tougher.
In addition, we were pleased to receive a positive opinion from CHF three in Europe on October 16 recommended approval, Oh, I'm married for pretty tough Winter Barre syndrome.
Accordingly, we continue to ramp up our preparations for a potential European Roadshow can talk about in the first quarter of next year.
I'm not very happy to turn the call tertiary so I've got a couple for color and details on how the launch is progressing United States onto an uptake on launch preparation in Europe, Ashish or would you.
Thank you Steve as.
As Steve mentioned, we are very excited with the success and momentum we ought to see in the front half my lunch.
Enforcing its potential to provide transformational and durable future production for a more complete basin central how well they syndrome patients.
This is particularly noteworthy given the challenges and the disruptions to everyday life that the corporate Bipin pandemic continues to cause.
Despite the significantly alter and watch.
Oh, what I'd have aspirations have enables our teams to get excellent traction and deliver solid condition business.
On the spec so far to U.S. commercial everybody come off of your sons are running as expected.
As a reminder, we have 20 key account managers and Dan and myself in the field, who are driving patient and physician education for what's truly had in Boston.
Comprehensive patient support Black Swan Zogenix Central is doing an outstanding job of providing support to patients and families who are either stopping sent up lots had a peak for the folks died or transitioning out of lot of clinical trials or expanded access program.
Why do we got Lucky I think I'd be quoting standard metrics yet in the early days of the launch.
I would like to provide some specific color on the momentum we are experiencing in the initial launch.
That will help them, but could it be up more than 360 clinicians how does endorse can defend up love them spoke about and computer the certification process. This.
This is it this is the first step in patients ability to access a double about that's only them certified to clinicians can describe the therapy.
During the third quarter with approximately 200 patients with prescribers went up about and but all in the Mems program to become eligible to receive tend to be well.
Well, what 50% both these patients were neutral for double that's.
Why is the other strong support from our clinical trials and expanded access program.
We are on track for probably some disbanding clinical trials have expanded access program patients to commercial product mix people six months.
Our experience to date indicates that the big up to four to six week from the Bible space and that own bread and butter. That's broke it out but this one think off you go what effect does not prescription.
At the end of September we had approximately half of the them. So that all patients on the reimbursement coverage on the reimbursed commercial gotta be his last majority off the docket in September.
With respect to reimbursement we are highly encouraged by the positive responses to front up a lot from commercial and government payers.
To date, we have met with the kids were those blogs, representing more than 80% of covered lives in both commercial and government sectors.
Well it typically takes six to nine months to wouldn't be established commercial coverage policies for stopped moving.
We have been able to get strong traction and have a whopping wholly positive coverage determination from both the commercial and government they have segments.
We believe this reflects the plugs unique efficacy profile as we lap the suppose indicating that Caesars for board about 80% of W.P.. So I bought controlled on existing therapies.
So as I said in receiving positive go what is good neighbor pharmacy discrimination from Baird.
For the summer and ask you would have also noted the seamless meds can be eased off or onboarding process.
One is 45 to physician prescribing went up not be somebody them at all and put 'em screw it up and the gift you work out what kind of gone back with those any central part.
<unk>, BCS and product information and services, including reimbursement Kim.
Cardiocom scheduling support.
Despite the Corbett 90 brand to make approximately 90% of the patient <unk> patients come to work in the Rems program as of September Thirtyth.
We completed the required baseline echocardiograms.
That's the scheduling a company somebody echocardiograms has not impacted our ability to onboard patients. Good if it doesn't appear to be.
As I stated earlier big.
Picks up to four to six weeks from the initial contact to the dispensing of commercial product. We have seen this timing of on boarding vary depending on the patient's location and a specific goal with my husband and wife.
Once the impact of core with Bydureon Subsides, we project that this four to six weeks timeline will be reduced.
Now, let's discuss our progress in Europe.
Following the news of a positive opinion from your jumping on October 16th.
For Tobey pretty soon here do you have an older. We expect a final decision on all the marketing authorization application by the year end.
[laughter] authorized print that must be approved for use on European Union member countries as well as United Kingdom, Iceland Lichtenstein had thought of it.
But we had why didn't you tell me. We would then begin the process of securing reimbursement for a friend Doug Amazing new countries.
We intend to launch went up about four in Germany. Shortly after the approval in the <unk> automatic force do you have the reimbursement process and im proud of them work to finalize it negotiated price.
To support the planned launch we have established office in Germany, and have the leadership medical and sales teams already in place.
Our key account managers are being trained and we'd be ready to launch went up a lot if approved in the Q1 off next year.
We have a robust you wide distribution program that will implement the regulatory requirements. We believe will be included in our label and when should be safe and appropriate to use up went up.
But it wouldn't bother me did I hear it all so that's.
That's perfectly in the United Kingdom, and Denmark, we have begun discussions with the 11th healthcare authorities, who understand that these unprepared 11 submissions to secure reimbursement.
In conclusion. This is a busy and a very exciting time for the I've got to go to an extent we.
We are extremely pleased with the early launch it it does have significant progress achieved in the U.S.
As well as the bulk of the advances made towards the potential approval and launch in Europe next year.
We look forward to building on this initial strong commercial foundation, what's that done.
Now I'll turn it back to Steve Steve.
Thank you Ashish Ashish described to really thrilled with the law firm can shop, United States, but all preparing to begin to see the country launches in Europe next year.
We receive approval obviously by the end of this year.
Additionally, with respect to our development program, which we announced positive top line results from our first phase three study open top information draw in September.
Results corroborated these highly statistically significant convulsive seizure reductions seen in earlier multinational phase three studies, often suffer interbody and this whole study was supposed to be JV, a submission in Japan funds for the third quarter of Twentytwenty well.
As a reminder, commercialization and distribution are pretty tough entry is covered by our exclusive distribution agreement with Nippon sheet younger.
Undeveloped agreement signed in March 2019 subjects will supply product to the patriarca retains responsibility for completing the clinical development programs.
Regulatory submissions for chocolate Interbody syndrome.
Skus, though syndrome or else you guys.
Turning to our Trs, we conducted a type C meeting with the FDA in September.
To be working on a supplemental on T.I. I said to you before pretty tough it out.
Yes for submission in the second quarter of 2021.
We anticipate submitting for approval and Ltvs in Europe in the third quarter of next year.
Before I move on from the telephone I would like to note. The significant problems, we will have once again.
No American unless I see you're worried yesterday, which will take place virtually from December fall through December.
Results from several studies often suffer will be highlighted in nine separate presentations, including analyses from our phase three studies now so yes <unk>.
Three your update on long term safety and efficacy Interbody syndrome.
The real world experience from the U.S. expanded access program is racing drones amongst others.
In addition, I'd say, yes, we're pleased that don't have already commenced in college focus on results from an investigator initiated study of the use of some sort of range to treat convulsive seizures in CDK <unk> Friday's deficiency deficiency disorder or C D.
Encouraging preliminary results from this study were recently presented by Dr. Dubinsky of these syndicated Oh, sorry forums for instance, French your major.
We're also commensurate to explore it does help us it's up to us and other genetic that's not to say several things.
I look forward to initiating the phase two basket study once the pandemic environment permits us to do so.
Now I'd like to switch to empty 16, 21, our late stage investigational therapy being developed through our subsidiary focused set of users for the treatment is probably my Jakavi Odeon Angel tissue disorder caused by many times to the efficiency or T.K. two G.
I'd say 60, 21 is an old fixed dose combination treatment.
Serves as a substrate in house I'm sorry.
We sold probably mitochondrial teenage French.
The goal of this promising therapy, it's a treat to progressive often fiscal deficits remotes are <unk>.
Spurred free underfeeding functions, but characterized this disease for which no approved treatments currently exist.
Following these things with health authorities in the second quarter.
We believe we have a clear path, we're bouncing all development program for T 16 trends as well.
This includes the continuation of study one or two a prospective safety and efficacy study on T. 16, tricky 147. She takes you repeat patients 55 of whom transferred from the earlier Retro study study one on one.
Separately in response to it I see requests we want to initiate a chart where you started to go the other data to support the survival analysis in T.K. to the patients maybe treated with chemical grade. The Oxycyte you deem the oxy fund to be outside of the motor starters.
We also anticipate initiating a phase one really intense study in early twenties 21.
We continue to expect the old takes our free potential and the submission will be available by the end of trenches for anyone with a plan to finding a first call for trench reisinger.
We intend to seek European approval soon after the rest submission.
Right.
Moving onto Mike for his financial review.
Thanks, Steve and good afternoon, everyone.
Today, we issued a press release announcing our visit the financial results for the third quarter ended September 32020, which I'll now review recognize 2.9 million in revenue during the third quarter of 2020. This was the result of 1.5 million of products. The other thing Kaplan, the U.S. and 1.4 million.
In revenue related to our exclusive distribution collaboration with the punching up perfectly engine. They syndrome in L.G.S. in Japan, we recognized point $6 million in revenue for the corresponding period in the prior year R&D.
R&D expenses for the third quarter were $34.4 million.
An increase of approximately 6 million from 28.4 million in the corresponding period of 2019.
And this increase is attributable to the modest increase in spending in our phase three old yet study 60, no one well.
On the expenses related to M. T 16, 21, and an increase in personnel and R&D operational costs, all partially offset by a decrease in spend in our survey syndrome program. That's.
That's DNA expenses for the third quarter ended September 32020 totaled $24.6 million compared with $15.8 million for the third quarter of 2019, an increase of approximately 8.9 is primarily driven by the continued investment.
To the lots of pent up in the U.S.
Which began in the third quarter and for the preparation for wager prospectively launching in Europe. During the first quarter of 2021 net loss for the third quarter ended September 32020 was $60.1 million or dominate your share. This compares to a net loss would be 90.5 million or $6.75 per share.
In the third quarter ended September 32018, and we ended the third quarter with a strong balance sheet with cash and cash equivalents and marketable securities totaling $525.2 million.
No in late September we closed on an offering of 2.75% convertible.
Senior notes due in 2027 for the aggregate net proceeds of approximately $222.7 million.
This financing allows us to robustly supported him back in the launch of contactless interface in Germany in the U.S. as well as the planned launch in that indication you.
It was claimed lots is an L.D.S. in both the U.S. and you weren't picked up a lot.
And empty 16, 21 for Teekay too deep.
With that I'll now turn the call over to the operator dark you Anita.
Operator can you. Please open the line for questions.
Thank you well now begin the question and answer session, if you'd like to ask a question. Please press star one on your telephone keypad, a confirmation told will indicate that your line is in the question queue. Please press star two if you'd like to remove your question from the Q4.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.
The first question is from Paul.
A T.S. stifle. Please go ahead.
Hi, This is Alex on for Paul Thanks for taking the question and congrats on the quarter.
First question on sort of the different type of launch so far on that 50% of the 300 patients that are enrolled in the rents that are on commercial drug could you give us a sense of the proportion of those that are on Oh, you're the expanded access program and I have another follow up thanks.
Hi, Thanks This is Dave.
If I answered your question correctly, you were asking a question about the up at the top of patients in the clinical trial expands access program.
Yeah.
Yes, I I would say up until September Thirtyth, if we were able to move over to.
Jos a bank sponsored access patients first and then a clinical trial patients will follow a reason for that is that a patient store in clinical trials, obviously needs to happen in the study visit in order to be compliant with GCB practices at various sites and that's one of the reasons why it takes a little while longer to move the clinical trial operations over a us.
She said, we certainly expect to help move them over within the next three to six months.
Our the just to clarify the majority of the patients actually on commercial drug from the EAP at this point or or not.
Ashish would you like to address that.
Yeah definitely some exciting yeah, what we said is out of those 300 half of them, but you yeah, how about them.
On the commercial product.
So I wouldn't say, it's my daughter people that live top off the bottom the commercial products I hope that clarifies.
Okay.
And then a question on El G.S. could you provide any more color on your recent FDA meeting and any more additional steps prior to the Escondida submission. Thanks.
Yeah, so the the yesterday meeting confirms.
Our development path and time lines towards the supplement the submission I'm ready to be that's a major question meeting was around the two year Carcinogenicity studies as you know we started some time ago and whether they would be required for submission on enbrel form.
And we now have agreement with the FDA, we will but they all required for submission and those studies currently any reporting stage. We will have filed reports available in Q1 of next year. In addition, obviously won't be.
Same thing.
A longtime safety analysis of our ongoing studies 16, a wonderful form the basis of a summary basis or I should say the summary of safety for <unk> and <unk> as well as the efficacy data that came from Oh about same study. So we essentially have everything that we need either.
When we pull pricing all of our speech would pricing be ended its contract.
Great. Thanks.
Yeah.
The next question is from Mark Goodman SVB Leerink. Please go ahead Sir.
Hi, This is rolling on the line from Marc Goodman I. Thanks for taking the question I was curious thinking about the European launch in first quarter could you give us some guidance on what you expect in terms of SGN I spend how that might uptick as you launch country by country.
Oh, She's just lay out for us I will start I guess with respect to staffing for European launch and then Mike you might be talking about yesterday after that so what would be your ashish.
Thanks, Tim So don't I think it's Tom So first Janet.
We already thought the Germany, we already have the team in place. So we don't we do get a lot see any more people being added that yeah.
Yeah and in terms of adding more people to keep you only depend on then we even received the younger sweat.
As you know it can take anywhere between nine months to 12 months after the approval in individual countries.
But our plan is to continue having these conversations we are ready to make all the submissions that's going as we just see the approval yeah.
And we will be bringing on the.
The same Steve, but the key advantage at the at least 18 months before the expected up pretty well off that he imbursement.
Yeah, the muddy Christine as you know is already on the ground and we have had medical treatment for some time, so I would say that wouldn't be the Easter in jail for ramp up well with 2021.
Like anything else.
Oh, yeah, so on the.
You know the the question on the expense items were not guiding 2021, the expense levels like class at this point. So you can expect us to be launching on a country by country basis, though and so there is a.
She's noted substantial amount of personnel that weve already put in place.
Now in Europe and in Germany.
Great. Thanks, I have one quick question relates to the day lunch in the U.S., what kind of feedback are you guys getting from prescribers.
Completed the online Rems sign up process and how smooth this out then for their offices.
Yeah, I'll ask Ashish to try to start with where you are on it.
Yeah sure well I think the feedback so far has been very positive the process is very seamless for both.
Physicians as well that's part of the patients.
We have anecdotes so.
That's bought the segments come at all in coupon on that I phones caught on the tablet.
We had basic electronic even de signatures are done through electronic process that we use verify the processes. There. So I think that process has gone very smoothly. So so far the feedback has been very smooth as when a seamless.
Got it thanks.
We have a question from your team Tunisia Guggenheim Securities. Please go ahead.
Hi, guys. This is Eddie honestly, yeah. Thanks for taking my question. The first is a further new patients that had been the getting the scripts that aren't from the EPA or the clinical trials do you have a sense of what the average weight of those patients in the dose and those new scripts and then can you also let us know what your gross to net and the inventory levels were for the quarter. Thank you.
Yeah I'll take the the the first question, maybe Mike you can to everybody for a second.
What I will say is we're not going to go into details on the average weight and a a patients in the dose that we've seen over the new patient can control when everybody else is doing a little ones, where I can tell you is that I think that we've seen in the first two this launch is consistent with our expectations on assumptions that.
We used a moment basis, what it spends in the expanded access in clinical trials. So there's been no surprises I think it appears to be out as we expected.
Okay.
Yeah. This is Mike can you repeat the second question.
Just wondering what your gross to net was for the quarter and if there's sort of any inventory a level that you want to talk about that might be helpful for us understanding launch their launch.
Sure Yeah, Yeah, we're well, we're not talking about the growth in that actual percentages, because it's really early and not reflective of where we could go based on the the patient make up what is going to get people in different animal incorrect level, but long term, we have said we'd expected to be 20 units.
I'm 20, 25% to 30% in terms of growth in that.
For the product so yeah that still that's still holds.
We.
We are.
We were modeling young U.S. model is one where there's very very little inventory called specialty pharmacy. So there's a high degree of.
Call it none of transparency or fidelity of water and sales end user sales are and what we're recording we're recording when we send it to the specialty pharmacy, but there is very little inventory that they will.
[noise] Oh, great I appreciate that is there any sort of.
Prior authorization issues that you're seeing like or is it pretty standard and what you expect what you expected going into that going into the launch.
Yeah, we've been very encouraged.
Where the coverage seems so Paul.
Everything has been covered her label is she said.
So no step edits being mandated Oh see everything is per label. So we feel good about that and she said anything you want to run just a.
Oh, no I think that go with it.
No Steve that compares to 30, I think we made sense to the labeling yeah, and we haven't had any but that's.
We haven't had any challenges there.
Great. Thanks for taking my questions guys.
Thank you the next.
The next question is from Danielle Brill Raymond James Please go ahead.
Hi, guys. Congrats on a watch and thanks for the question. So I just want to make sure that I heard the first question correctly.
So I'll start there, but he said over 300 prescribed over half of those are now so let's just say how about 150 new prescription.
I'm not rolling over from the prior study of those how many unique prescribers habits, you know written scripts that are.
Sure I think the.
Yeah, I think that that's done if we hadn't bought terrorists.
Kind of giving guidance on how many prescribers have prescribed but you can imagine that most of the new prescriptions that are coming on from the centers that will be at a focused on bad they do have.
So Michael Kelly.
Patients and that some of them are from India, but we also see a lot of prescriptions coming from that physicians, who were not part of a lot of clinical studies horribly access build yeah I'm really impressed.
Impressed by the efficacy that's the product to like.
I see so are you getting prescriptions outside of your targeted 450 to 500, Sunrun and then a follow up to that how many of those centers have you engaged with either in person or no.
Since launch thanks.
Yeah, So again, specifically segment wise, Vietnam, breaking out that information at this time back in.
Dan So visiting B centers.
Well, it's the thought of it for 50 that is good man, but that doesn't mean, we're not calling got off the other physicians because we had a calling on all the physicians, but the where the focus is mainly on the biological group, but it's got to be said about the whole system.
And how does this have been both I would say, though in person has a lot has changed the added more channels and it all depends on the particular geography and the situation in the job.
We have had to play so it's very personal budgets have been possibly.
And there are some places that are only de telemedicine has been possible. So I would say we started that on 50 50, and that's a major goals have either.
Either way, depending on the covert situation.
Maybe on the follow up visits that we do that they generally happen under telemedicine.
One important thing to remember here Daniel is the theme that we have a we have hired really experienced people in epilepsy. So they do know these offices. They do know people in the offices as well as the physicians and that has been really helpful. And also instrument in really generating the enthusiasm can they think that the physician.
But at the same time educating them remotely even if the in person what's not private label.
Understood. Thanks for the question.
Thank you Tony.
The next question is from the pay Yang Ming Xu Hill.
Hi, Good afternoon, everyone. This is Alex on for Difei, Thanks for taking the questions.
Could you could you describe the cadence of new patient additions outside of the expanded access an open label extension studies over the quarter and how do you expect that cadence to evolve into the fourth quarter.
Just a quick one for me, we're not going to right, we're not going to talk about what's happened this quarter or other than to say that we still feel very encouraged by the way, which this launch as a move forward in the first few months do you want to think about kids.
In person soon in.
Third quarter Ashish.
Yeah, I can make one comment cheered Alex that guidance. That's as you know we launched in on the 27th of July.
And after that once we start to be that's true information and education, what the offices I think we started getting prescriptions starting in the month of August and do you have the stocking up or be a lot shedding beak information on what the cadence on a monthly basis looks.
Like but as you can imagine has the patients are coming in as we go through the process, so taking them getting to be a cope.
Yes, the all benefit verification process and that can take up to four weeks and in some cases up to six weeks. Yeah, you start getting patients on therapy and as I said in the prepared remarks, a majority of the patients that have got on the pet upbeat. They have got them to be in September. So I think that should give you guidance.
In terms of how we are looking at it.
Okay, great. Thank you and do you expect to provide guidance at some point next year.
Oh My God, we are we thinking about to right now we don't have any and the any firm plans one way or the other right now because it's so really we want to make sure that I mean are we understand exactly how this is moving forward.
But certainly we will make a determination as we got into the 2021.
We will have a full quarter of experience Oh God.
Okay, great. Thank you.
As a reminder, if you wish to ask a question press star one on your telephone keypad that star one.
We have a question from Serge Belanger Needham. Please go ahead.
Hey, guys. Thanks. This is a piano for search I think you mentioned that there's about 80 million covered lives across both the commercial and government plan. So could you give us a break down of that I guess, how much is the commercial.
Versus how much is coming from the Medicaid side.
Yes.
Yeah. So let me clarify that got done what we said is we have been we have reached him make presentations to payers to cover.
80 million lives yeah in terms of breakdown of you're not providing GAAP, but you can imagine that the games all the usual lodge fares as well as the large Medicare programs yeah.
As you can see and do you have talked about this earlier.
Oh, we expect that the banamex based on the analog stuff out there and the drilling space what ended up listing space.
But I'm, 55% to 60% of the patients wouldn't be a word on the Medicaid.
Programs, such as the state Medicaid programs.
Yeah, we.
We see the similar bottom coming out in how we are approaching the behave space given how we prioritize and connect with them.
Okay. Thanks, and then on the rents enrollment to dispensing I think you said about four to six weeks I guess could you give us any detail as to what you know what's accounting for the bulk of that timeframe I guess, how much is traveling to getting an echo versus you know how much time.
Ms needed to get a coverage determination. So any details there would be appreciated. Thank you.
You're supposed to stress though.
Yep.
So he said it's up to four to six weeks and depending on the situation. It can be no. That's it can be even TV apps that can be even less than that and it can go up to six weeks. So its a wage.
In terms of exact buying how much. It takes I think it's very difficult to make a trend because it's where do you actually have the number several small.
But I can give you a process once we have the patient enrolled into the trends and therefore to the hub.
I think both the things started badly in terms of a scheduling a nickel and getting a nickel.
Which can take time and we have seen that some places it's going to happen in the weeks. Some places it could take up the TV because as you can imagine depending on the local situation.
Even if the flight he at Echo cardio graph place closer to where a patient lives. They do not have the appointments of unable not because of the cold weather situation. They may not be accepted.
One thing to remember here is these are really really very sick children and I was sick children and as you know 80% of them are not controlled on the existing medication and as they are making a decision to go on immunotherapy and all these things that are coming into the plan.
Coming into play that that takes the time. So we have had success is where we have seen.
Since coming on board and less than two weeks and we have seen in some places where there is a huge corbett im glad I meant that they haven't been able to get equal appointments. So it could have taken up to five to six weeks. So that's the range or what you're looking at but in terms of specifically how much of that going how much is the.
But you got a lot of men, we haven't separated that out can haven't provided guidance on that.
Got it thank you for the details.
The next question is from Thomson Ahmed Bank of America. Please go ahead Sir.
Okay. I think that's me hi, guys. Thanks for taking my question, maybe a topical and forgive me if you've already answered that part I just wanted to get a sense maybe about how long do you think it'll take orphan Hap love to have more of a permanent because they.
And then within formulary would you consider the work that's being done now up to to get permission from from insurance provider and that's one of the main.
No not in and the speed with which patients can get access to it in top line and I'm wondering if you think that is going to eat.
In coming quarters.
And then the second question I had also field, but high treason do you have any sense of how tight reason is working in a real world setting that's far compared to on the clinical study. Thank you.
Thanks to the answer your questions.
These are ones Rashid.
Yep.
So Colin let me start with the population and then I will come to the pharma living so that that May sound again, it's been just two weeks or months too early to talk about how we have seen good maybe once we have to see bonds and few more shipments then we can really see the tread habit.
But based on our experience an early access program before.
We firmly believe that it's the experience and the other one is not going to be much different than what we saw in ERP. They took anywhere between three to six months for us to try to do the most effective dose.
In terms of family the decisions that we have received so far they are to the label yeah.
Yeah, and as you know, but the Johnson syndrome, you lets you have and the VR label is that you have to have a print up lives added to the pedal piece and then I'll clinical trial and the diagnosis of Tableau syndrome, you have to have failed at least two or three different therapies if not more.
So given all that surrounding.
We are not seeing that getting reimbursement ought to getting your formulary decision or even a policy determination has a bottleneck to get access to the Fintech lab and so far we have been able to secure that access so well get the conversation, but the base, but there even though.
What is your terminations that we have these kids have been consistent with that label.
Excuse me are there are there any further questions from bank of America.
We have a question from <unk> to Google William Blair. Please go ahead.
Hey, this is lockman on for Tim Thanks for taking the questions.
So I was wondering you mentioned that you're there about 360 Rem certified physicians I assume a large portion of that sort of trial investigated the liberal.
It rolled over in gold certified I'm given to have patients on their can you just kind of give any insight as to what proportion.
Both those physicians all trial investigators versus news addition weren't involved in the trial.
I guess related to that are you sort of touched on it earlier, but among the the new patients are new to brand patients.
Any sense of how that sort of splitting out between the physicians that are already out.
Several patients on drug from trial.
The new positions.
I can start she's can take over I just want to upset the frame we talk about 360.
Patients enrolled in the Rems program No. We had approximately you were less than 50 sites United States conducting all our clinical studies. So they got put into perspective, but we clearly see positions were enrolling <unk> Oh clinical trial respond to that access programs.
She's river.
Uh huh.
Yeah, one think I lied lacking is that in terms of seeing the prescriptions for new patients.
We are seeing them from everyone not only from the clinical studies and as Steve said the mix at less than 50 physicians, who would have bought off the or what are the early access from the clinical trial you.
You got lost a majority of people, who have signed up for our programs and who are prescribing.
They were not part of that program.
[laughter] [laughter] congrats.
Chris Ocull.
Thanks.
There are no further questions at this time I would like to turn the call back over to Dr. Stephen are for closing comments.
Well, thank you operator, and thank you for joining us on our call today.
We're very pleased to show successes progresses, we are start to grow up commercial rare disease company developing a refreshing new salaries to address significant unmet needs.
These fibers these patients their fathers, we look forward to providing you further updates on our commercial and clinical activity as we move forward. Thank you all again for joining us on our call today during the rest of your day.
This concludes today's teleconference. You may disconnect your lines at this time and thank you for your participation.