Q4 2020 Zogenix Inc Earnings Call
[music].
Greetings and welcome to the <unk>, Inc, fourth quarter, and full year, 'twenty and 'twenty financial results Conference call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference. Please.
The press Star Zero on your telephone keypad as a reminder of this conference is being recorded I would now like to turn the conference over to your host Brian Ritchie with life Science advisors.
Thank you operator, and thank you all for joining US. This afternoon with me on today's call are Chief Executive Officer, Dr. Stephen Farr, Chief Commercial Officer, Ashish Agrawal of a car and Chief Financial Officer, Michael Schmidt.
Afternoon, <unk> issued a news release, providing and business update and announcing financial results for the fourth quarter and full year ended December 31, 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.
During this call <unk> management will be making forward looking statements.
The results could differ materially from those stated or implied by these forward looking statements due to the risks and uncertainties associated with the company's business day.
Forward looking statements are qualified by the cautionary statements contained and so <unk> press release issued today and the Companys SEC filings, including and 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 February 25th.
2021, so Genesis 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 very much Brian and good afternoon to everyone who's joining us.
Part of the challenges of the board for instance earlier towards the current people drawn by the global COVID-19 pandemic are increasingly with the euro today the share details of what was a current quarter of Europe's economy.
With the launch of the customer we are providing of important year chief adults and for many patients of the priorities delivering goods and very syndrome, and which is the result of many years of dedication and hard work part of our team and the clinical investigators and supported us along the way.
We're very pleased the progress of our U S launch the birds and the receipts will detail, we are seeing encouraging adoption of our existing and new prescribing physicians and patients.
As well the successful outcome from our discussions with commercial and government payers.
To provide optimal access to the spin southwest for operations.
Although the U S approval earlier in 2020, we were excited and December to announce that the European Commission approved the MAA for <unk> Chopra, who the.
Adjunctive treatment of seizures associated with Dravet syndrome patients two years of age and older.
We're pleased to report as of the beginning of this month and tougher.
And as commercially viable and Jeremy.
First European country Rolls.
I'll now turn the call over to Ashish for further details on how our launch is progressing and broker United States and Europe the changed over the years.
Yeah.
Thank you Steve.
As Steve mentioned, we are very excited about the positive momentum we have seen for the from Jetblue in the U S and now in Europe.
The physician and can't give her interest and awareness continues to grow at a consistent pace.
And the face of challenges and disruptions that the COVID-19 pandemic has caused to the dravet community and medical practices, we experienced a steady physician enrollment into the Rems program and new patient starts throughout the fourth quarter.
We believe this is the reflection of the significant unmet need faced by patients and families living with Dravet syndrome.
And the <unk> potential to provide transformation and durable seizure reduction.
There have been numerous reports of patients who have achieved a dramatic drop in seizure frequency and the reached the seizure freedom since starting on Fintech lab.
In Q4.
First full quarter of commercial launched and the U S.
We recorded $8 1 million and.
Net product sales for the finished up left.
At the end of 'twenty and 'twenty, we had 460 patients on reimbursed commercial therapy.
And as a reminder, as of December 31st nearly 500 health care professionals Catherine.
I'll, just start and Fintech, Netherlands program, and making the eligible to prescribe it picked up a lot.
This number is up 53 per cent compared to the number of registered physicians and the program at the end of third quarter 'twenty and 'twenty.
Also as of December 31st cohort of 550 patients had been prescribed pent up net and then therefore the the <unk>.
The Rems program, which included 336 patients who were new to <unk>.
Of these 336 patients 186 were enrolled into the apps in Q4.
We are seeing the reference of new patients into the Rems program and a consistent pace during the early months of 2021.
In addition, all patients who were part of a U S. Based open label extension studies and early access program were enrolled and the Rems program by the end of Q4.
As of mid February.
Proximately 95 per cent of these patients on.
And the reimbursed commercial product and the live.
And on track to receive reimbursed commercial product by the end of Q1.
Given that the revenue syndrome is notoriously refractory to multiple therapies and that's part of the approved label print of lives being added to patients current therapies.
Although the data is very limited we see that the most of the patients being prescribed the center of mass.
But already on three or more concurrent anti epileptic drugs and.
Including the branded and reimbursed see really therapy.
I am extremely proud of the work done by our team and helping patients and health care providers to access and tablet book.
And what physicians and caregivers have provided us with positive feedback on the Seamlessness and the ease of.
The old man and Onboarding process.
Currently on other.
It takes two to four weeks from the time of patient enrollment and the Rems program to the dispensing of the reimbursed went up a lot of prescription and.
As of December 31st approximately 90% of patients enrolled in the Rems program had completed their required of baseline echocardiograms.
We are very pleased with this onboarding efficiency, which reflects successful execution by our team.
With respect to access our discussions with the USPS has been extremely positive.
While it typically takes up to a year of post launch to establish full coverage. We are very encouraged by the positive coverage decisions. We have already received resulting in the health plan policies established in the.
They were of pent up not all the coverage of the approval through the medical necessity process.
By the end of 'twenty and 'twenty more than 85 per cent of patients enrolled in the type of advanced program, how do we see positive coverage decision.
And the remaining patients, but in the process of receiving coverage based on the timing of that enrollment.
This positive trend has continued in the early months of 2021.
And the ongoing Covid pandemic has impacted our launch and the ways similar to others and the industry.
Specifically it has had an impact on our teams ability to traveling and meet customers face to face.
The address this we are reducing the size of some large territories and adding four key account managers and one of the regional manager to mitigate these COVID-19 related travel restrictions.
While we cannot have the specific benchmark, while the pneumatic assessment of how the pandemic is impacting our launch efforts.
The data from Symphony Health and became.
And that in the anti epileptic class overall, new to brand prescriptions were down by approximately 35 per cent in the second half of 'twenty and 'twenty from the pre pandemic levels.
Now, let's discuss our progress and Europe.
On December 21st print of law was approved in the Europe for the treatment of seizures.
Associated with the value of syndrome.
And the approval of colors, all EU member countries as well as the United Kingdom, Iceland niches steam and Norway.
Following the approval we began the process of securing reimbursement for the doublet and major EU countries, beginning with Germany, where we can utilize the foot the automatic force to your reimbursement process.
We have also submitted the pricing das here to begin the negotiation process and the UK, France, Italy and Germany.
The support the centerpiece of launch of Germany, Our country office and Munich area is one of these stuffed with the leadership medical and sales team.
We initiated our promotional launch in Germany on February 1st with the first shipments of Fintech lab to patients operating during the first week of February.
In January of this year, we received it temporary authorization for the use designation from the French National Agency Force.
Medicines and health products safety.
This authorization provides access to commercial product.
And the patients in France the.
For the pricing and reimbursement negotiations are finalized.
We expect that patients will begin treatment with Fintech lie and France. During this current quarter.
In conclusion. This is a very busy and exciting time for the entire zildjian XT. We are extremely pleased with the significant progress achieved in the U S and Europe to date as we advance through 'twenty and 'twenty. One we expect continued strong physician and patient demand for <unk>.
Interest and that in both U S and Europe.
Followed the building on this momentum and solid foundation with the tablets.
And updating you assume.
Now I'll turn the call back the steep steep.
Thank you Ashish I'm very pleased of our commercial momentum and broker talk to United States and expect the builds on the initial success during this year.
As large server class of court launch from Europe.
Let me and I'm sure efforts flow through tough refrigeration, Germany, Japan.
As you May recall in September we announced positive top line results from our third global Phase III study of from software integration and draw which included patients from Japan.
The positive results from the study will support the journey.
Sure.
Sure.
And the third quarter of this year.
The corner of premium marketing authorization and tougher and Japan.
<unk> will supply of the manufactured for full commercialization for our distribution of partner the phone from Yahoo.
Non preferred store assortment of the country's largest and suffer indication opportunities let me Scott associate the word yes.
So lots of 'twenty was the year of significant progress of the sweep program.
You will recall in February of last year, we announced positive results from a pivotal phase III trial of this and Jeff and MTS.
Gross 36 and are one which will support from the FCA.
Your line of submissions for the treatments of this severe epilepsy syndrome, where nearly all patients experience lifelong treatment resistance seizures.
More expensive dates of some service newborn.
And were presented at the American Epilepsy Society, or yes, and the journey and.
In December of last year.
The results of Sugar, Kentucky retired and effective in the Houston generalized tonic clonic seizures or TTC.
This differentiating factor and GTE six was similar in magnitude so that the observed and all of your very phase III trials.
This is important because GTT seizures are recognized.
The primary risk factor for status epilepticus, and sudden unexpected death and epilepsy or sooner.
These data combined with a novel mechanism of action relative to other true of yes, some piece of the potential to physicians and Tumblr and important treatment option.
Lgs patients.
We're actively working on the supplemental NDA submission to seek a label expansion and the United States Hope and chocolate and lgs.
Ooh required studies from the submission of the Bruce and.
We have turned our attention to study closeout activities finalizing the data analyses and <unk>.
And the integration of long term.
We expect to submit the supplemental NDA and the third quarter of 2021.
Full of got rid of MAA submission and Europe per year.
Late last year. We were also very excited to see the promising initial results also tetra and <unk>.
The decrease.
<unk> deficiency disorder, or CBD from an investigator sponsored trial presented by the dock onto this the EBITDA yes.
And Sir.
The study the results show that patients experienced and 90% median monthly reduction and generalized tonic clonic seizure frequency.
And the 65% median months of reduction and <unk>.
Seizure frequency workers' comp, where it was added to the existing anti epileptic drug regimen.
Based upon these highly encouraging results and January we've announced that we were moving ahead with its phase III trial, all suite software and CBD.
We anticipate the mitre and the rest of your D&A.
Next quarter, we're paying the price on the program, which refer to EBITDA.
And once you begin and the second half of the year.
Now I'd like to discuss 76, and 21 are late stage investigational therapy for the treatment of our Micra Congress of United.
Hershey disorder caused by moving kinase two deficiency or <unk>.
The other two six and 'twenty one program is advancing with several studies ongoing.
The study one or two of the prospective safety and efficacy study has enrolled 47 patients.
The study one of the film.
The chart review studies, the captured data on <unk> patients treated with programs and the nuclear sites outside of our studies also continues to progress on enrollment has begun and studies.
One of six of your renal impairment study to support chronic dosing.
We continue to plan for an NDA submission and the first half of 2022 and in terms of submit for European approval soon after the U S submission.
As part of most of the development work, we have initiated various diagnostic screening projects to identify more cheaply.
And with clinical sites in United States, Italy, as well as other countries.
Finally, we announced in the December and early stage partnership which of our Biosciences, accompanied Premier Inc. Trna based gene therapies to discover and develop novel treatments with the goal of attrition the underlying causes of disease Dravet syndrome, and other genetic epilepsies.
This collaboration reflects our long term commitments to continue seeking solutions to help cash.
First of all of the lines of rare epilepsy patients and their families.
We recognized additional important unmet needs beyond seizure control.
The summary last year was an incredibly busy and productive year for the genetics.
Continues to grow as the commercial stage rare disease company.
With that let me hand over the course of Merck or the current.
The actual review of months.
Thank you and Steve and good afternoon, everyone.
Today, we issued a press release announcing our business and financial results for the fourth quarter and full year ended December 31 of 2020, which I'll now review.
We recognized $8 $5 million and revenue during the fourth quarter of 2020 net.
And the results of $8 1 million and product sales lifts and that blend and the U S.
And the <unk> 4 million related to our exclusive distribution collaboration with the punch and Yahoo burst and Tesla and Japan.
And we recognized $1 9 million and revenue for the corresponding period last year.
R&D expenses for the fourth quarter and $36 million essentially flat as compared to the $35 8 million recorded and the corresponding period of 2019.
SG&A expenses for the fourth quarter ended December 31.
2020 totaled $29 $2 million compared with $18 7 million for the fourth quarter of the prior year. The increase of approximately $10 $5 million was primarily driven due to continued investment related to the launch of <unk> and pepper in the U S, which began in the third quarter of this year and the preparations related to a commercial launch and.
The Europe, which is now ongoing.
Net loss for the fourth quarter ended December 31, 2020 was $72 million or $1.26 per share and this compares to a net loss of $56 1 million or $1 and 26.
Per share in the fourth quarter ended December 31 2019.
We ended the year with the strong balance sheet with cash and cash equivalents of March both securities totaling $505 1 million.
Please note we intend to file our 10-K pre market on Monday March <unk>, 'twenty, 'twenty, one and with that I'll now.
And I'll turn the call over to the operator to start our Q&A session.
Operator can you. Please open up the line for questions.
Yeah.
At this time, we'll be conducting a question and answer session. If he would like to ask the question. Please press star one on your telephone keypad, a confirmation tone will indicate that your line is and the question queue. You May press star two if he would like to remove your question from the Q.
Four of participants using speaker equipment and may be necessary to pick up of your handset before pressing the star of keys, one moment. Please while we poll for questions.
Okay.
Yeah.
Our first question is from Paul.
And what's the Stifel Stifel. Please proceed with your question.
Hey, Thanks, so much and thank you for taking a few of my questions Tonight and I appreciate it.
So hey, so a couple of and the one of the quarter I mentioned, a couple of and some of your 2021 commentary on the quarter was there any material changes in inventory and we're just kind of trying to get to this revenue number based on the patient data that you provided and then separately two questions on 'twenty and 'twenty. One one so ashish I was wondering if you could clarify.
And I and expand of the end of your comments it sounded like you kind of alluded to basically saying so far in 'twenty and 'twenty one the the pace of patient adds.
<unk> has been pretty similar to what you observed and <unk> and then separately you know one of the confounding things with modeling average price causes of the quarter is that EAP or kind of patients and the open label extension may already be pass the titration. So I'm kind of wondering now that you're through more of that what's your expectation for the Cade and.
So the average dose and things happen this quarter and kind of the following quarters relative to what we saw early and the launch thanks so much.
Thank you Paul and I'll just start with.
The.
Revenue and how that reflects back to patients who are on drug just recall rehab and specialty pharmacy distribution footprint type of work.
So.
And in reality.
And our.
Sales reflects the.
A drug that's being dispensed to patients and that's really.
And then were true buildup.
And I think the other questions you had on the U S.
The shift to address the expiring as of break this is Scott to do that and Ashish. If you want after other people aren't just said please go ahead and do that flow.
Sounds good thanks, Jim Thanks, Paul So yeah, what Steve said is correct in terms of the inventory, but its the cause.
We just have one specialty pharmacy and.
And everything that you will see and the sales you straight to the patients.
In terms of the commentary on the pace of patient patch and whenever that is correct. We see similar of patient adds as we have seen and the last two quarters.
And in terms of modeling average dose okay.
And again, it's very early but one thing I would say is all of the clinical trial and early access patients are now transitioned.
Almost all of the <unk> 95 per cent of them and their dose on average was <unk> 48, with the weighted average rate of 34, and a half kilogram and so I think that will stay consistent going forward.
And the new ones that are coming in we are seeing similar.
The dosing escalation scheduled somewhere between three and six months and again the data is so small and the first three months and particularly difficult to say if that trend will continue but from a modeling perspective I think if we use the same trajectory of three to six months back.
And that will be consistent with what is being seen.
Okay. Thanks can you are you able to comment at all of Ashish and just kind of.
I guess in the fourth quarter or most of the patients who are on therapy already passed the titration because of this.
I don't know, if you're able to clarify that but that would be helpful.
Yep.
And because the one thing I'll tell you is that if.
If you take that three to six months of anybody who would have come in the pipeline and say sometime in the October would be at the optimal dose the same by this month.
So that's the cadence if you want to model it that way.
Okay. Thank you so much that's helpful.
Just one thing to add there.
And of the labels and.
The form of our tight trading on a weekly basis, but what we've seen on the non expanded or early access program. I think is true for other drugs used to treat epilepsy physicians tend to titrate more slowly because the auditing the drive thru and existing regimen of drugs and they tend to garner more cautiously which is.
Why remodel of the three to six months of the Ashish described.
Makes sense thanks Pete.
Yes.
Our next question is with Marc Goodman from <unk>.
The B Leerink. Please proceed with your question.
Yes, Hi for 16 and 21 can you just review.
Where we are with some of the the gating issues to file and then when the past you've talked about there was a non clinical tox and dog study there was.
Productive talks you know all of the other things that you had not mentioned in your prepared remarks and the.
And then.
And.
And maybe you could just give us a sense of Hudson capital of just you know are all patients pretty much staying on drugs. So far I mean, I know it hasn't been that long, but have you have you noticed or heard of any drop outs. At this point I mean, it's been such a short period of time, but I'm just kind of curious about how retention was going so well and and the feedback just you know from the.
From the patient so far.
Yeah Colby.
The discontinuation of discontinuation rate, it's very small.
And so on the books and are also on the caveat that we're still relatively early and the launch but we're certainly encouraged of what we're seeing today.
And thats sort of reflects that what we see and broken all of our early access program and also and our long term open label studies, where we saw a very robust efficacy of response from a very low discontinuation rates and so hopefully we'll continue on the upstream.
Trajectory.
She has provided some feedback and theirs prepared remarks, but we are seeing maturing of operations are doing remarkably well, but at the.
The music and telco were not part of our clinical trials and and singing the.
And the same response of patients sort of clinical trials in terms of.
The dramatic reduction in seizures recall.
And no randomized control trials, we saw dramatic reduction and see it as even during the titration stations and so forth. So the net.
Peter on the surface very fast and we've seen a very durable response thereafter and <unk>.
So far we've seen and the same thing for patients who are coming to the Korean onto commercial product to our users and tougher.
Uh huh.
With respect to empty <unk> and 'twenty, one all of the Tox studies.
And on track some of it.
And nothing newsworthy and we're just doing what we need to do in order to be ready by the end of this year.
For the submission.
In 2022 is the tools.
So no issues from Covid slowing anything down.
No not on the non clinical side.
Continue to have to work around Covid, all three of our clinical studies.
Particularly the one or two which is the prospective safety and efficacy trial.
We had some periods lost share because of the Brian on international travel.
And as Couldnt get to study sites.
Able to for the most popular around the five and go into local offices.
Hospitals, where does the debt some of the assessments.
It's really being the biggest factor and that's in the program.
Program is really around the 31 of those here.
Thanks.
Thanks Mark.
Yes.
Our next question is from.
Getting the Sydney Zhang with Guggenheim Partners. Please proceed with your question.
Hey, guys. Thank you for taking my question just a couple from me and well can you remind us what gross to net as where you currently are and how should we think about.
<unk>.
G T and at the end of the shear and then and.
Terms of the I mean, I understand and you are early and the launch and maybe talk about the type of patients.
You are seeing the physicians still have to go through a generic epic out of before they can start on and tap like can you maybe give us a little bit flow.
Labor on the patient population.
Alright, Thank you, Eric and Mike maybe you can address the gross to net question and then ashish dress or yards and the second question of the benefits of arbitration.
Sure Yes.
The most of our.
Sales now obviously are in the and the United States yet into.
And the beginning of launched the gross to net.
Roughly now is a little bit under 20 percentage and the teens.
So to speak and it will inch up.
Towards the 20% number three.
And throughout the year it will be.
The contribution of mostly the United States for this year and.
And southern Europe.
Yeah.
Ashish.
Yeah. Thank you.
And your second question regarding the type of patients.
Yeah, the second metric.
And Mark I think.
The patients we are receiving is typical of any patients who already is on two or three or more different therapies.
What we have seen is the majority of the patients if not actually all of the patients are on at least two products out of more already.
And majority of them out of key and more.
And in terms of.
And then getting added of Fintech lab has been the mob.
And <unk> just gets added and that.
That is part of the label and then.
And that we haven't really seen anything the twin bed between the saying that hey, you have to try of one product of the other products.
Most of the policies that we have seen.
The primarily to the neighborhood, which is prescribed by the neurologist try at least one anti epileptic products and rolling and the Rems program do you are of course and does not exist.
Gross not exceeding 26 milligram per day.
17 of Fiat on stood up and call.
And one thing to mention is that the policies that we have received both on the Medicare as well as of the commercial side.
Fintech lines on parity with the other branded anti chemicals and backend loads of drugs, which is the really positive for us and the patients.
Got it I just shy of one more follow up the dishes and regarding the weight. This is regarding the price can you maybe remind us what percent of drove the patient do you expect to be on share of Bento plus 12 of them.
Cause I think those patients to receive and I think of half the door sort of little bit lower dose. Thank you.
Yep, so still the plan.
Is.
In terms of.
Usage of the product is very low is what we have seen.
And our clinical trial, you have seen a lot of them.
And in the early days that percentage is extremely low.
And again, it's another of anytime so.
Maybe we'll be able to give better number and out of there.
Three of four quarters once you have a little more robust set of data.
But from modeling perspective, I think right now the number of its pretty low.
Got it thank you so much.
Okay.
Our next question is with the Jason Butler from JMP Securities. Please proceed with your question.
And traffic, Jason and thanks for taking our question and just a couple of quick ones you guys mentioned before.
Essentially the phase II basket trial contingent on Covid, just wondering if you had any thoughts updated thoughts on that and then on.
60, and 21, Steve I think you mentioned a couple of sites and the U S and it'll lead to identify additional patient just wondering if you could provide any more color on that it sounds like the Pfizer opened are they have they found any patients and what are they doing and look for patients. Thanks.
Great.
Right right.
Basket trial of <unk>.
Just the recall we are post on that study last year because of the Covid pandemic and an inability to really get study sites up and running.
And as well as.
Moving to put anybody and.
Homes, where you are with respect to either of our T. More patients are being participating and the study.
But we.
And we.
The decided.
This year on the basis of sorts of investigator studies the continued last year.
The prioritize of phase III program, and the detailed <unk> deficiency disorder.
And it's interesting.
The board intensive phase II basket trial was to demonstrate where the product and they work.
Four months, whether or not rickards saw the normal form of development program, but we got the exact resolve the tigers the iron.
And assess the deducted parcels of the da Vinci XI and the data is so powerful we really wanted to move forward. The phase III program. We will continue to support investing initiated studies are going to look for signal.
And we haven't said, we're not going to do the phase two trial, but we are prioritizing the.
This moment of time and order put all of our best efforts and starting the the CBD trial.
From 16 to 21.
It's 30 days with respect to what we're doing to identify patients.
Okay.
Sure.
We have.
A number of different and extra day of software working on right now around the sort of screening projects.
Diagnostic advisory boards and market research and I'd, just say from Europe.
The partnering with diagnostic partners and also running some some studies to look for patients and various countries from all of that is going well and we do expect to.
Have a better understanding of the overall patient prevalence.
By the end of this year, and certainly and plenty of time before we submit the <unk>.
And the yard for Mtc and 'twenty one.
And also make the point that we are working with advocacy.
Advocacy groups.
And mitochondrial disease diagnostic groups and so it's really advanced and support disease awareness, but we think that's critically important and to.
To ensure the if we can GAAP of diagnostic tests, particularly to the from.
On the standard of neuromuscular and myopathy disease panels, we see the critically important and order too.
Really understand the overall patient prevalence.
Okay. Thank you.
Thank you.
Our next question is with the Ipi mine with Mizuho Securities. Please proceed with your question.
Hi, good afternoon, and thanks for taking my questions just a couple of I'm from Katla.
Would you be able to comment on how many unique prescribers.
And that have prescribed the feed tattler, we could mean, a mom and they'll stop day school I rent. So the good fight and then beyond that and if there is the typical lag time between the certification of rent to the first Scott.
Right and.
And the second question is around how should we think about the uptake trajectory.
And in Germany would it be somewhat similar to the U S. Thank you.
Thanks and sorry.
To ask Ashish to address your questions.
So.
In terms of unique prescribers.
I haven't broken out that number but what I can tell you is that we.
We are receiving prescriptions from the key centers that is the 450 physicians.
But can we talk about is the core group, which treat around 80% of the debate.
The patients.
The majority of them.
Part of this group and they out of prescribing and we have also received prescriptions from physicians and the community setting who may have one two or maybe <unk> got the of patients and we have received of prescriptions from that too.
Most of the city is the last time it is all dependent on the.
And the physician and the ability to get the patient and get the patient through the impact of process and.
And as we said the commented earlier.
And I think that the Covid situation, what does happen is that in many places where the reluctance of families to switch the medication due to fears of concern and this is what they had experienced in the past.
And especially things like diarrhea.
And would come out the other products, which related which net to potential hospitalization and and COVID-19 situation. They really don't want the pig that chance.
And then you also have the situation with this rolling state by state shutdowns and and.
January we have a lot of places which are of closed and that reduces the access and that's kind of of contributes in terms of when the physician will be able to get a patient and be able to put through the process.
On the trajectory to Germany, we got the divide it to two things one is the patients who are on the early access program and the clinical trial and of the new patients that have come and again.
And again, it's been just two weeks so it's very difficult to talk about the trajectory.
But one guidance I would say that.
By law in the Europe, one ski product and Jetblue and is the GM bust in these countries you have to transition pretty quickly. So we expect that that the early access patients and the clinical trial of patients will be transitioned to the commercial product anywhere between two two and a half months of six months.
And again, depending on the.
Timing and when they're able to do that and of the study visits but the early access program should happen.
In the span of three months, that's the timeline, we have seen with a lot of other products and I have no reason to believe the collapse of the same sort of indefinite.
Thank you Ashish.
Very helpful.
Yeah.
Yeah.
Our next question is from <unk> Ahmad with Bank of America. Please proceed with your question.
Hi, good afternoon. Thanks, so much for taking my questions.
Maybe one question on Dravet and and one on upcoming trials, yeah. So for Dravet and see if I was curious as to how your team is thinking about you know of the.
Early months of the launch you know what gating factor do you think is the most important right now it's a clear are in order of cat and I'm a little.
And we accelerate the.
The pace of the launch is that the Doctor awareness is it ramp is it the COVID-19 environment is the echo is it something else that you've been able to observe in the in the early part of the launch of plenty of kind of color on that would be great and then as it relates to L. T assets and you know the potential for sales.
And next year from from that indication.
Talk about any kind of differences there might be.
And for Lgs patients as it relates to you know way.
Wafer being underweight relative.
Relative to drive the eight patients and how that might translate and see what and average dose might be for an algae S piece of it if it happens to be the case that they tend to be underweight and little bit more often thank you.
And when.
The obvious question is anyway, and then the Ashish maybe you could take the question would seem out of us.
That's a launch and Dubai.
With respect to address the.
Our clinical trials.
Include more adults actually included adults.
So on that basis, the average stage and also the average weighted in those studies was higher than it was and.
And drew very and as a consequence of that.
And the high dose group, where we so.
Part of significant difference versus placebo.
It's a pretty large proportion of patients who are all of the maximum gross and 26 milligrams per day. So.
We expect that will also be the case for the.
And the ultimate commercial product, but because this is the disease is recognized and adults is gross children. You would expect the average dose to be higher because we're because of the average.
Sort of the average dose is higher because the way the cycles of the purchase of older.
Hopefully that addresses your question if it does then Ashish maybe you can take the other product is the <unk> question.
Thanks, Steve Yes, so it doesn't in terms of the gating factor.
And as I stated in my prepared remarks I. Thank all of our ability to execute once there is a prescription.
And the help the patients through vehicles through the reimbursement process.
And really proud of what the team has achieved and the investments we have done.
I think the biggest wildcard right now as the Covid environment, and how that impacts and how we are seeing that getting impacted on two fronts. One is RP and 72 to traveling and key customers face to face the.
And so you can do all of the limited things remotely and.
That does take time.
And also for the cash part of the patients and the families and their reluctance.
And accessing the medical facilities during this COVID-19 environment and I think that's what began and say the biggest one at this point and time.
And it is corroborated by the data that I shared in the prepared remarks lease up and the second half when you look at the all of the anti epileptic products. We saw the MBR of X is down by almost 30% 35%.
And we believe that and we have full confidence that as the things start opening up with the increased vaccination. We are already seeing a lot of facilities opening up a lot of places where we did not have of face to face access we are about getting face to face access. So I can just see this going up.
And the future quarters.
Okay, Thanks, Ashish about color and so it.
If the predictions about you know going back to semi level of the normal are true about the second half of the year should we expect to see and.
The meaningful acceleration of scrip trends and to wait.
Based on the east that.
We should but I don't have a reference point to say what it will be because we launched during the Covid time. So again, we will be and this launch more for at least a year are the board because the.
And I was sort of the physicians, we haven't been able to eat.
And the phase two.
The pace, we have done that on the zoom and.
So that's something I think we will continue to see the difficult to give guidance exactly what that will be because there is no benchmark at this point and time at least but at a pace.
Right. Okay. Thank you so much.
Thank you.
Okay.
Our next question is with Tim Lugo from William Blair. Please proceed with your question.
Thanks for the question you mentioned the effect of the cap on GTC of.
And one of the kind of signals of the FX positions of honed in on.
And then be able to draw that out and the label as you prepare for the filing.
And we'll see the KL fall kicking off and the second half of the year is that the study, which we should be able to see data from in 'twenty and 'twenty two.
Yes 2022.
Yes.
And with respect to.
The impact from GT series.
Most of them, if you like a pre specified and.
It was.
A post hoc analysis.
Unlike the of that Youll see that information, specifically and the label however.
However, we will remain true.
Visions and aware.
All of the that differentiate the fact, obviously through publications and we will continue to do that.
And interesting that this.
That's from GTC is we've now seen and <unk>.
Three different epilepsy syndrome installed and the today.
And lgs and also and CDK <unk> Scott.
And that's a dramatic impact on GTC is actually reflected.
Very good pool of the animal data of rehab as well and there's really a good correlation to what we've seen and.
And the extent of Michael any of our models and what we've actually observed and purchase so that subscribed the fire.
And in terms of your second question, Tim would you mind, just remind me again sure yes, the detail C D K O R. R.
Should we be able to see data coming out of that in 'twenty and 'twenty, two and and.
Maybe just general broad strokes, what the study will look like with beginning of the 0.4 and seven doses of looking a bit.
During the 50 patients.
All of that.
The going to be kind of similar to the historically run trials.
Yes, we're still finalizing the protocol and we need to oversee and share that with FDA and DMA and as I mentioned in my prepared remarks, so probably it's too early to tell you.
What the trial design would be like but I think it's safe to assume it will be very similar to what we did in <unk> syndrome and.
And because of the higher Frac size, and we did see and the open label trial of we do expect of the sample size will be the same debate so around 40%.
And so I think that sort of covers as much as I can say broker protocol to now.
Obviously, we will have more information as we go through the next several weeks.
In terms of from <unk>.
We'll take of the available next year, it's really too early for me to predict.
We haven't started the study yet we don't know most of the enrollment rates is going to the right. So it's hard for me to project.
Good day.
The first obviously is when we get the study of from running.
This year and we see the trend.
More appropriately inform investors and one that should start to see some data.
Yeah.
Okay understood. Thank you for the color.
Thanks.
As a reminder, if you would like to ask a question. Please press star one on your telephone keypad. Our next question is with Danielle Brill from Raymond James. Please proceed with your question.
Hey, guys. Thanks, so much for the kind of questions I have a quick follow up too.
The prior question Ashish, you mentioned that the EAP patients in Germany and.
The convert to reimburse Jive pretty quickly can you remind us how many patients you have and the EAP program and Germany, and then I'm also wondering what we should expect in terms of use and France and and <unk>. Thanks, So much.
Yes, Brian of if any of that.
You have to so that you and I think from an EAP most.
And just be patient.
And in Germany, and the approximate can be looking net stand 100. So I think that's the number we use and expect the conduits.
Pretty quickly.
In France.
It's very difficult to give the usage, primarily because the temporary authorization to use.
And is primarily part of physicians to apply and the.
Get the reimbursement.
And then start the process. So this is something which we cannot promote we cannot talk about of the amount of and I do that.
But we just got to make it out and they've been.
And that is the physicians have a patient that they need to put on.
And we do have a program they can but each of the medical team are they kept the rest of the central team and through that day will access the product so, but the spirit of difficult to project what utilization will be.
But what we do know based on the interest and that's why we went ahead and hospital of this authorization. We do expect that there will be the patients who will be accessing the product through this facility.
I see okay. Thanks, so much.
Our next question is with Paul Matteis with Stifel. Please proceed with your question.
Hey, Thanks, a lot of and taking the follow up I was just looking back at our notes and I might have the strong but I thought the lgs submission was supposed to be first half of our second quarter and it looks like its third quarter now am I right that that is a push and is there anything else to that that you can kind of help clarify thanks.
Yeah, Paul at the Hudson and pushed out.
It's one of the.
Basically.
So say the older studies are complete.
So we are now and the data analysis mode and.
As part of the preparation for the us and the areas.
We have to rely upon psychologists and vendors to do site visits for the study closeout as well as through a lot of the analysis for us and on the basis of the <unk>.
And sort of the timelines that we're receiving from Crows.
Best of the estimates that we will be going into the third quarter from the submission clearly we are focusing on ensuring that we can service the highest quality of San Diego time.
And if that moves into the third quarter, which we predicted where all of them working for us the best course of the journey.
Okay, Alright, thanks, Steve and I appreciate it do you do you of any expectations for the duration of the review.
For the SMB area.
Well.
It's sort of fiber fiber to supplement so and we've arrived at the priority review, which is the six month review clock or it would be.
The standard review, which is 10 months.
We will be doing all of SaaS to justify why the yesterday I should be awarded of priority review for this book.
At the end of the day, it's something which they need to determine and decided the congress as opposed to the.
And the recap.
So it's either six or 10 months.
Okay, Alright fair enough. Thanks, so much.
Thank you.
Ladies and gentlemen, we have reached the end of our question and answer session and I would like to turn the call back over to Steve Farr CEO for closing remarks.
Well. Thank you very much operator, and thank you to all of you for joining us on today's call.
We're obviously very pleased to share of progress over the past year as we've transitioned now to a commercial stage rare disease company.
Going forward to serve the gross and the year ahead, and we will providing further updates on our commercial and clinical activities throughout 2021. Thanks.
And thanks again for joining us on the call today and enjoy the rest of the these are the right now.
This.
Tonight's Conference you may disconnect your lines at this time, thank you for your participation.
Yeah.
Yeah.