Q2 2021 Zogenix Inc Earnings Call
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Good day and welcome to the Zone <unk>, Inc. Second quarter 2021 financial results Conference call. Today's conference is being recorded at this time I would like to turn the conference over to Brian Ritchie lifestyle Advisors. Please go ahead.
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 <unk>, Chief Financial Officer, Michael Smith. This afternoon, <unk> issued a news release, providing a business update and announcing financial results for the 3 and 6 months ended June <unk>.
2021, 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 that during this call <unk> management will be making forward looking statements actual results could differ materially from those 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 in <unk> press release issued today and in the car.
<unk> SEC 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 day. This live broadcast August 8.2021, so Janice undertakes no obligation to revise or update any forward looking statements.
To reflect the 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 from <unk>.
License from here with you today to provide thanks on what continues to be an exciting on production Peter I just want to address as we further round commercial activities from consulting for basin growth.
So on development programs fall from Chatbot on other areas of our pipeline I will update you on later on during todays call.
So first I would like to provide a brief update on that on our commercialization of <unk>.
We continue to achieve significant progress around the launches of pretax Dravet syndrome, United States on Europe, where we see continued meaningful quarter over quarter growth the number of prescribers patients on Kentucky.
As well as net sales revenue.
And tougher addresses a large unmet need you have your day community by enabling more patients to achieve significance on last thing seizure reduction.
With physician interest remains strong we expect these positive trends to continue on.
As expected from our previous clinical trial experience patient adherence to touch on currency continues to be very high on discontinuation as loans.
Our first annual report submitted to the FDA confirmed that the <unk> process is working exceptionally well on that.
Robot Echo monitoring continues to show no evidence of other heart disease or pulmonary arterial hypertension patients.
Patients taking from Tesla.
During the second quarter as Covid restrictions begin to lift in many parts from U S.
Field based teams have more face to face physician visits.
Anytime since levels, leading to more physicians on this stuff educated about the benefits just from chancellor of the revenue process. So this.
June represented the highest monthly number of new patients referred to the Rems program.
This success in commercializing our first rare disease therapy, coupled with octave preparations for our next phase of growth and led to more complexity demands on our business I'm pleased to Air Force you announced the promotion of Ashish sorry, Good luck on exactly Vice President and Chief operating Officer.
She has been a critically valuable member of our executive team on as established on grown on commercial teams from the launch of <unk> tablets in the United States on in Europe.
In this newly created role he will be responsible for leading the company's commercial growth trajectory on global commercial strategic planning as well as on we're seeing pharmaceutical operations, which includes our CMC manufacturing oncology.
We look forward to further leveraging excuses expertise and talents as we pursue new markets and indications from the Falcon chatbot on preparing to Brian empty 16 transforms from market.
With that I'll now hand, the call on which we choose for further commercial uptake.
Thank you Steve on.
Turn to agility his new responsibilities and look forward to continuing to work with the exceptional <unk> operations.
Of transforming the lives of rare disease patients and their families.
With that I'm pleased to provide additional color on our commercial team's progress on commercializing <unk> in both the U S and Scott.
In the second quarter of 2021, we achieved $17.5 billion incentive on net product sales, representing 42% growth for the first quarter of 2021.
This includes <unk> on net sales of $16.5 million in the U S and too many on.
This significant sales growth reflects during design within the Gi community growth initiatives and continued treatment with <unk>.
As Steve noted with reported serious COVID-19 restrictions easing in the U S and Europe during the second quarter.
Sales and other customer facing teams were able to steadily increase in person visits with healthcare professionals.
At the end of second quarter, <unk> was able to meet in person with approximately 45% of their target accounts up from less than 20% in the first quarter.
Our experience on the seal is consistent with the recently reported figures.
Industry data for the neurologist sector as of June 2021 in.
In the later part of the quarter, we saw a direct correlation between these visits and new patients starting therapy.
By the end of second quarter or 860 patients have been prescribed from tablets and referred to the escrow that this reflects 160, new patients who suffer from the Rems program in the second quarter.
During the quarter.
More than 145 patients began receiving reimbursed commercial tenants.
Our retention rate for patients remaining on center flow has been consistent with our experience in clinical trials and the expanded access program for Dravet syndrome, with approximately 90% of patients remaining on therapy by the end of June 2021.
The number of unique prescribers increased by 22% to <unk> 90 on the first quarter.
Consistent with prior quarters.
Approximately 2 to 4 weeks to fill their prescription from the <unk>.
I'm on for patients as well.
So that's the broker that.
Collectively these are compelling metrics that indicate significant interest and principal on both physicians and patients as well as its durable benefit for patients and their families going forward, we expect steady growth in each of these key indicators, especially if the impact of Covid continues to decline.
We also continue to be extremely pleased with these with the payer coverage for free.
By the end of second quarter sales covering over 84% of U S. Lives had published a formal policy that covers <unk> absolutely.
On the parity with other anti epileptic drugs.
Having completed 3 full quarters since the launch of <unk> central and revealing the prescribing trends, we have decided to expand our prescribed work on this.
The majority of neurologists, who treat refractory epilepsy in the United States.
Our analysis indicated that almost a quarter of patients who have started from oxygen by these neurologist because its expanded list.
To cover the broader brought on targets on this and further accelerate the adoption of complete <unk> syndrome, we have begun an incremental expansion of our sales and other customer facing teams in the U S.
In anticipation of submitting a supplemental NDA for lgs net of this quarter. We are also finalizing preparations.
Conducting various market research studies and advisory boards to best understand the evolving needs of the lgs commodity.
Order to define our progress and go to market strategies.
We are also in process of finalizing on our health economic models and value strategies for engineers, who help facilitate discussions with payors beginning in the fourth quarter.
We anticipate that our launch preparation and the <unk>.
Previously discussed phase <unk> expansion.
Vision is to launch from Tesla in Lgs immediately upon approval in the first half of 2022.
Now transitioning to Europe, our first European launch of <unk> in Dravet syndrome in Germany is progressing well.
More than 150 clinicians are now unless you want to prescribe some deadline.
All clinical trials and expanded access patients have been transitioned to commercial tenants.
In France patients continue to prescribe.
We prescribe from tablet under the temporary use authorization on <unk> until the ongoing reimbursement negotiations are finalized.
We have made significant progress in our price.
Zinc and reimbursement negotiations in France.
In other major European markets, including Germany, the United Kingdom empty. Please.
In conclusion, we are very pleased with our strong sales growth in the United States and continued substantial progress in Europe, and the expanded on that expanding access often jetblue and other countries.
We anticipate continued growth in all geographies and look forward to updating you further as the year progress now I'll turn it back to Steve, but an update on our recent pipeline advancements.
Thank you Ashish.
Reinforcing the importance of Kentucky was a new treatment option. We were pleased to see a recent editorial in the journal of epilepsy <unk> behavior recognized from Tesla are setting new treatments for Dravet syndrome.
Joseph Sullivan from UCSF, Helen Cross from the Uk's UCL Institute of child Health on <unk>.
From the internationally you guys Scott.
Highlights the profound seizure reduction on positive facts on on exactly.
Exactly function achievements on.
Also raise the bar for assessment of future.
Refractory epilepsy syndromes.
This brings me to an update on the progress of our late stage development programs Covid Tesla on.
On <unk> 16, Turkey, 1 following a busy period of 3 highly positive type B meeting however, the FDA in June and July.
Most importantly, our pre NDA meeting with the FDA flow chocolate and Lcs was successful on collaboratively discussions around the details of our clients from Michigan.
We are on track to file a supplemental NDA by the end of this quarter.
As a group on the agency. We will include the results from our single randomized controlled trial on true open label extension studies to establish the safety and efficacy often talk about.
Yeah.
In addition, our submission will include clinical pharmacology.
Or pharmacokinetic studies on non clinical studies related to constantly <unk> on chronic toxicology.
The FDA also stated that the supplemental NDA may be eligible for priority review because it is part of the response to a written request under the pediatric research equity actual prayer.
The agency will decide on priority review classification.
Moving submission of a supplemental NDA.
Looking at additional potential indications for <unk>, we recently held a positive pre IND meeting with the.
<unk> for our newest true type of program and CDK on <unk> deficiency disorder or CVD true.
Finalized the design on proposed endpoints for an upcoming pivotal trial.
The FDA agreed that we should conduct a true on fixed our phase III trial to investigate the efficacy on safety Austrian Chancellor and controlling convulsive seizure frequency on a dose of 0.7 milligrams per kilogram per day versus placebo.
As a reminder, all of our prior phase III trials in Dravet syndrome. After U S were conducted has 3 on studies as per the agreement with the FDA guidance.
The FDA also approved.
Single randomized controlled trial could be sufficient to support a supplemental NDA in this indication on no.
Other pharmacokinetic or non clinical studies on needed at this time.
The R&D has been submitted to the FDA.
We are advancing rapidly with initiation of the phase III trial, which will include 40 patients per call.
We anticipate commencing enrollment later this year.
This encouraging regulatory progress regarding our programs announced you guys from <unk>.
D D highlight the broad potential of Fintech to have a meaningful impact on seizure burden in several cities.
Rita infant on childhood onset epilepsy syndrome, we are truly excited by the prospect of bringing this therapy to these additional patients in need.
Finally in July we held a very successful meeting with the FDA regarding the planned NDA submission for <unk> 21 in the mitochondrial disorder thymidine kinase 2 deficiency or TK treaty.
FDA agreed with US mission strategy, including that no new additional studies clinical or preclinical are needed for the NDA.
All studies for a regulatory submission are either completed or will be completed by the end of the year.
Regarding our filing in the EU, we are working towards a regulatory meeting by the end of 2020.1.
We are currently planning for an investor event in October where we look forward to providing more detailed information on Citrix Ritchie the disease on new empty 16, 21 clinical data, which continues to demonstrate a highly significant survival benefits on meaningful improvements in motor milestones.
Ritchie function each day.
And in reality in patients.
In conclusion, I want to reiterate that this tremendously productive quarter from <unk> as we further on commercial activities for Kentucky integrate advanced.
Advance a larger indication lgs unexplored, new applications for free tablets, such as CBD.
And Paula we are excited about the potential revenue 60 in 'twenty, 1 which expands our pipeline to address another rare often fatal disease with no approved treatments.
Let me hand, the call over to Mike produce from that review.
Thanks, Steve and good afternoon, everyone. Today, we issued a press release announcing our business and financial results for the second quarter ended June 32020, what we recognized $18.8 million in total revenue during the second quarter of 2021, an increase of 37%.
1.7 billion reported first quarter of the year.
This was a result of $15.5 million and product sales.
But in the United States 2 million product sales, it's been definitely in Europe, and $1.3 million related to our Japan partnership.
Total net product sales of <unk>.
A $17.5 million or an increase of 42% versus $12.3 million reported in the first quarter 2021, we recognized $1 million in total revenue for 3 months ended June 31, 2020, which consisted solely of the Japan collaboration revenue.
R&D expenses for the second quarter were $36.6 million, an increase as compared to the $34.4 million recorded in the corresponding period of the prior year SG&A expenses for the second quarter.
Excuse me SG&A expense in the second quarter ended June 2021 totaled $33.9 million compared.
Compared with $24.4 million for the second quarter of 2020.
The increase of approximately $9.5 million is primarily driven by the continued investments related to the launches that are ongoing or fintech on in the United States and in Europe.
Net loss for the second quarter ended June 32021 was $58.9 million or.
5 cents a share this compares to a net loss of $53.3 million or <unk> 96 cents per share in the second quarter ended June 32020.
We ended the second quarter with a strong balance sheet with cash cash equivalents and marketable securities totaling $390 million with that ill turn on.
Now 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. Thank you to signal for a question. Please press star 1 on your telephone keypad also if you are using a speaker phone. Please make sure. Your mute button is turned off to allow your signal to reach our equipment once again.
It is star 1 at this time to ask a question and will pause.
Everyone the opportunity to signal.
Yeah.
And we will take our first question from Paul <unk> with.
Stifel.
Great. Thanks, so much for taking my questions I appreciate it.
So a couple on the on the commercial side and then 1 follow up on that on this ramp.
Safety analysis, if you don't mind on the commercial side it looks like this quarter.
Sure patient adds on reimbursed drug lags slightly that patient adds to the rems on all which I think goes really were a little bit closer or very close to each other the past couple of quarters is there anything to that as it relates to kind of reimbursement delays or anything like that and then separately I was wondering if you could comment a little bit more on these trends you saw on June being your best.
Months, and whether or not that continued into July as well and then I have 1 follow up thanks.
Hi, Bob This is ashish I'll take both of these questions.
On the second so in terms of the patient as.
The lag is purely because they are in the funnel and that are going through the process of finishing vehicles are getting their insurance approvals. So I hope that gives you a little color.
And can.
Can you please repeat the second question again.
So you commented on <unk> being alright, Thank Steve commented on gene being the best months.
Guidance of adding patients to the ramps model I was wondering if you could just say a little bit more about that and then whether or not that dynamic continued into July if youre comfortable thanks.
Yes, so I think the dynamic purely depends on the COVID-19 environment and what.
What we have seen in July is a steady increase in the patient numbers.
And as you know in July we had at least a couple of weeks software COVID-19 related closures and restrictions and.
That has had a direct impact.
So what we had was a study at the patient numbers.
And we are expecting that as the COVID-19 restrictions.
On the various pods and we start seeing physicians face to face, we can see that direct impact in future weeks and months.
Okay. So July was better than June is that the point you were making.
But it was steady eventually is quiet that day.
Okay. Okay very good and then on that revenue safety analysis that was really interesting I guess, 1 thing that it seems like has slowed the adoption among practices that may.
We have not prescribed the drug yet it's still kind of lingering uncertainty surrounding cardiac safety is there any way you can kind of use these data and publish them given that you now have hundreds and hundreds of patients on drug and still are seeing clean echoes.
That's a great point of pool, yes, we all we are doing that.
In terms of moving ahead with further publications as we expand not only the number of patients who are on therapy the duration on therapy.
We've not seen any evidence of ph D or pulmonary arterial hypertension. In addition, we are getting paid.
Patients who are very willing to talk about their experiences on.
And so forth on also is there any lingering concerns about cardiovascular safety to have that discussion with families who may be considering from topics we are seeing that.
On Facebook and other other media and we will continue to reinforce.
On the safety often tough on the fact that we're not seeing.
Anything with respect to cardiac toxicity.
Very good thanks, Steve.
Moving on we'll go to Marc Goodman with Leerink.
Yes, I last quarter actually she gave us a flavor for how much usage you, we're getting Roger pay versus some of the off label. If you could do that again that would be helpful.
And then also can you give us a sense of the pricing.
Dynamic in the U S as well as what's happening over in Europe, just separately I'm, just kind of curious the pricing in the U S. This quarter versus last quarter, just what's happening there. Thanks.
Yes.
So mark I think from the Dias versus LG is I think the dynamic stays the same.
Last time, we said we had about 15%.
By the end of Q2 are we at around 20% of the prescriptions that are in the indications other than driving Ann.
The component of that is almost similar to what I said earlier on in terms of GSS.
Factory Epilepsies.
That is the day.
By end of the end of June.
From a pricing perspective, I think the pricing get stays the same because it is dependent on the dose and our average doses still at 5 by end of.
Q2.
So per patient day.
Some of the price.
And in Europe at this point in time, we are still at the German price, which is around 50% of the U S and that is both in Germany as well as in France, where we are getting patients onto the HEU and those are reimbursed at the German price.
As the negotiations continue.
Very advanced stage of negotiations in all of these countries that is France, Germany, UK as well as debt.
Denmark, and we are hoping to conclude then.
But again it takes anywhere between 9 to 12 months and deadlines and be able to comment on what we can.
And.
After those negotiations.
Thank you.
And next we'll go to your Atkins from J <unk> with Guggenheim.
Hey, guys. Thanks. This is Eddie on for you.
Can you give us a sense of what your modeling the cadence of the European launch to be it seems like Youre still on Germany, and France for now, but it's been a while since you've got an update on sort of what when those other countries can be expected to come online and then sort of separately do you anticipate sort of a COVID-19 impact in the second half to be different in Europe versus the U S.
And then can you just remind us how the gross to net is tracking.
Yes.
Let me take a first on around the cadence of.
Other launches and launches in other European countries. So as she said we won't be launching.
On countries until we have.
First on agreed to reimburse price on those discussions are proceeding very well.
So if we sort of assess where we're at today, we would assume that we will be able to move forward with the launch in France, where they were.
Reimburse price all over all really on in France.
You have on price in the United Kingdom.
Scott Scandinavia and Italy.
That's the cadence, which we would see.
Move forward either later this year or into early next year.
She is true.
From the gross to net I think it's consistent with what we haven't figured it out yet because eventually we will be somewhere in mid twenties.
Point in time, we are in the mid teens from a gross to net perspective.
And then can you just remind us.
About COVID-19 yet.
On the Delta there.
Oh, yes, so with the Covid I think with the desert variant. We have started it looks like we saw some closures and restrictions coming up in July.
That happened in both U S as well as in Europe.
And in Europe actually somewhere in I think in the month of May be complete shut down 5 in Germany for a few weeks.
And in July we have started seeing things open, but again it depends on the region and its depending on the individual skus quantities, but I would say at this point in time, it's mixed but we have started seeing the restrictions coming up.
Thanks for all the color guys Congrats again.
Thank you.
Now, we'll go to Jason <unk> with Bank of America.
Hey, good evening guys. Thanks for taking my questions.
I guess just as you bring in unique prescribers onboard just curious if you can talk to the official.
Efficiency.
The new prescribers and how quickly once youre getting new docs in the brand's certification.
These are becoming high prescribers for you and then as a follow up just on PK PD.
Maybe just a little color on what you'd expect for end of year follow up in terms of obviously, a very high unmet need indication.
I guess in terms of what's sort of the key outstanding questions be it either the extension study or the renal impairment data on that youre going to want to help clarify with the agency.
Okay.
From a take the first question I'll start with the unique prescribers.
And Jason we are focused on getting as many prescribers on board as possible getting them from satisfied.
Getting them to stock prescribed for patients.
Patients.
The timing depends on the individual prescribers, who are also in decision between the prescribed but on the family.
And they have an equal say in deciding whether they want to go on on mute.
And as you know in epilepsy, especially in this childhood refractory epilepsy.
Patients and the families don't want to think of anything that's going on at this point in time and they are fully on board, but at the same time, they felt comfortable that he again.
Managed that transition because any transition you do has a potential of getting the patient interest status epilepticus quite a worsening of the situation.
And I think that's best day time for us to and I guess, that's what we are seeing flow.
Turning to get onto the <unk>.
But in terms of physicians when we get them.
Satisfied I think they are they can get them satisfied primarily because they highlight that went on to patients that they wanted to prescribe and then they start talking to the patient about that.
And in terms of high prescribers.
As you can imagine usually it's always be hot leaders, who have a lot of patients will see more of that 10 to 20 patients.
I would say majority of them on already at the high prescriber side and as we bring in more prescribers. Those are the ones, who have said anywhere between 6 to 7.
Patients.
It's going to take step by approach to get the patients on therapy.
And you want to take on Tsi expenses, you're talking about Jason.
Jason I'll take your question on CK 2 G. So 1 thing to bear in mind here is that <unk> 21 has breakthrough therapy designation.
Which we've been able to utilize to have fairly frequent meetings, where the review division at FDA in fact, it's a route.
We view the recent likes to be.
Sort of kept updated as we make our various decisions on a on a program. So it's been very collaborative and very successful so with our last meeting in July we were able to clearly articulate what would be realistic to packages that would go into the NDA. So as I said in my prepared remarks.
A majority of the work is complete or nearing completion.
2 activities that are really driving.
There's a whole timeline is number 1 we.
With Mizzou Ho Securities.
Hi, good afternoon, and thanks for taking my question. The first question is related to a L. G. S. Assuming approval sometime or first half of next year because of the groundwork you have laid on dovey syndrome should we expect them that potential.
Really accelerated uptake or do you think this will be just a normal lunch and second there. A second question is Iran cash wrong way would you reminders where things are.
Thanks.
The first question on my.
Uhm, so different things on the question I think.
And Jesus average.
We are preparing for the launch and with that you send them to the rental expansion on that we did on on on that from.
Can you hold on just.
Neither friendlier from emphases, along with Willy's syndrome.
Positions of Sweaty will launch you should hang up on me a blue.
And as you know the Ngo's patient population to do that.
4 to 6 times to go to them that drove me.
Be approved drugs, we do know that Martinez has.
As before an NDA 4 Canucks alone and CVD, that's actually the first strike us on the review flow.
The FDA I think where we see from Tampa working is ready.
I've been able to at least on the basis of the open label trial nature, That's Doctor Dubinsky.
Generated and has invested initiative study really profound impact on.
On generalized tonic clonic seizures as well as other compulsive seizures. So we know we have designed.
Designed our study with assuming there will be a fairly large of track signs same effect sizes debates because they open labor day said with that we've seen in CVD reflect what we saw integrate when we first started on face free programs with from Tampa. So in other words, we do think that there's a potential for tablets.
Have a.
A big impact on seizure control within CVV.
Thank you.
Thanks for culture, Danielle Brown with Raymond James.
Hi, guys. Thanks for the question I guess, the first 1 I just I I think I missed the number so what what's the net number.
Number of patients on pay Jag at the end on the corner and then in private or the author provided the number of total dachshund Roldan Ranch curious at that number is as well and then finally, Mike <unk> <unk> big fashion on the sales and customer facing teams how should we think about modeling the stuff up and that's.
GMA going forward. Thank you.
Tried to shoot a high value. So simple so net number of patients at the end of the quarter.
[noise] I think net of Discontinuations, that's based on number would be around 650.
And then when you look at the total number of spots and build a number of stocks vanilla 740.
And we have like as you know we have that on 10% discontinuations, 90% retention rate.
And most of these have been happening after 5 months uhm trying to focus on Friday is priceless months.
In terms of total number of dogs. The total number of that's true prescribing is what you said is that on 1 of the nineties and that was a growth of 22% of all of the first order I.
I hope that answers your question.
Yeah, I'm wondering how that uhm differs from the total number docks and enrolled in the program I think it was 570 last quarter.
Did you have to 90 in addition to that or.
Yes, I would say it's half I was hoping you have on on 50 per cent of the physicians when I'm going into the Rams program on prescribing.
Okay got it.
Yeah.
Until he is he said this expansion.
You know, it's first of all just a little bit in front of where he would otherwise extended were really sticky and opportunity that we're seeing in the driven market second is.
He would have a standard.
I've seen is sales force as we approach locally.
<unk> margin L. Yes, free with a 6 month review March 31st approval.
And so so it's a little bit in front of that but none of material no. It's 20 people 2025 people more so than we have currently we've got all the other.
Activities on going anyways, changing our protein bar.
Putting together give the.
So.
<unk>.
Okay I see okay. Thanks, so much.
Okay.
And as a reminder, please press star 1 at this time for questions next we'll go to Tim look up with William Blair.
Okay. This is laughlin on to Tim Thanks for taking the questions Uhm. So I was wondering in terms of the persistent to you. It sounds like it's it's actually very hard about 90%.
She said that you just said that most of the patient could have just continue to have them started after about 5 months. So is there any kind of trends that you see in terms of why they're discontinuing alrighty will kind of color you can provide their that.
That would be really helpful and second of all and multiple abid appointment obviously covered restrictions.
Sort of coming back to the fore and as you expand.
From the the commercial rates for the new clinics, how should we think about the true potential.
Potential growth trajectory in the back off of the yeah.
Yep.
Lachlan banks on the question and then so persistence of your guidance 90% M.
Average is 5 months, but did you see the difference is anywhere between on on those side 5 and a high sat up to 8 months patient stay on that it would be before the discontinue.
And that trend is as expected because which sent up on that as you know it works, but it stops working.
And usually takes anywhere between the same 2.6 months for the nitration in the real world. So what we see is that patient start applying to go on debating 0.7 to the maximum dose.
<unk> out for a couple of months and if they're not seeing any effect than moving discontinue which is consistent with what you sign up can I could try it on so that we had it on to 1% on the base I'm just going to get because I did not see any benefit. So that's I think in line with what were you expecting.
That's what are you a second question on the Covid restrictions as we see more of them. This we will continue to make that first time I've been continues to make a fuss to get in front of that.
And with this expansion, which we hope to completed this court of am have that expanded team on board by but but starting on the queue for even though more opportunities to go in front of the physicians and we will have more of that kind of concentrated avs battle B B b.
To approach and so on.
Large areas because some of these restrictions can taken too faint and go out of effect pretty rapidly and the response time will also increase for us because they've done it brings when we can spot us on the traveling back S. So we expect that by that expansion, we'd be able to read.
Chapter more people in person as we started expanding and thank you people on board.
Okay. Thanks.
Okay.
Moving on will go to the case, but live with J M. P security.
<unk> greatest Roy on for Jason take for a squeeze on us and just a couple of questions I guess and it was supposed to call. So sorry. If this is my covered but that.
The phase 3 and C. D. D. <unk> did you guys have to make any allowances due to the expanded access program for <unk> and just to have art Biosciences gene therapy collaboration what's what's the status of that if if you're covered they just told me to listen to the replay picks.
There we haven't covered that so.
Thank you ride for your for your for your questions first with respect to C. V V. But we haven't made any combination oh the funding to access for from Oxford.
Uhm no we've been working very closely with the patient advocacy groups on experts in terms of humid sites to go to them, which on them to identify patients.
So we don't expect the presence about to have a major impact on grocery true that'd be able to enroll his trial Uhm Uhm you may have missed that this is a 2 on trial hold your patient or so a total of education should offers free program. So we feel comfortable will be able to erode on successfully and with respect to.
Several advise sciences as you know this is a an early stage collaboration looking really normal gene therapy approach for genetic epilepsies. It's we're still looking at the discovery mode in terms of during the appropriate uhm self as well as animal based on studies to come up with what we think is.
From appropriately Oh, Uhm, I am moving and Everything's studies things are going well, we have a great collaboration with them I'll Scream here is very excited about it and we will be more exciting to talk about it as we move into later this year on the next year when we have some some some you from experiments conducted so thank you for that question.
Raising trip advisor answers.
Okay. Thank you.
And next I'll go to Nina <unk> dark with city.
Okay. Thanks for taking my question, so uhm just for cutting through the discontinuation. So far can you how about whether those are still kinda, mostly coming from patients who were from top of naive you know uhm prior to having on a commercial truck first this patient pillows over from Coca child or extended access pro.
Graham.
And yeah, that's all thanks.
Yeah. That's it thanks for your question you know these are on.
<unk> by your patient so new new patients Gotta words, hoping it's supposed to feed tabla on <unk> clinical trial was funded access patients to sit on the survey. So I think it gets back to work uhm, but she said earlier.
If if if patients are finding <unk> dream tabla, the vast majority do not.
Benefit is just stay on for a long period of time on we've seen that.
Clearly in a clinical trial program and it looks like it's it's it's it's being broken on commercial experience as well.