Q1 2021 Zogenix Inc Earnings Call
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Please standby the conference call will begin momentarily we thank you for your patience and ask that you. Please remain on the line. Once again, please standby the conference call will begin momentarily.
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The defense.
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Greetings and welcome to the <unk> zinc first quarter 2021 financial results conference call during.
During the presentation, all participants will be in a listen only mode.
Afterwards, we will conduct a question and answer session at that time. If you have a question. Please press the one followed by the four and your telephone.
And any time during the conference you need to reach and operator, Please press star zero.
As a reminder of this conference is being recorded today Thursday may six 2021 and.
And now I'd like to turn the conference over to Brian Ritchie of 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 Segro, the car and Chief Financial Officer, Michael Schmidt. This afternoon. So again ex issued a news release, providing a business update and announcing financial result.
For the first quarter ended March 31 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. So again ex management will be making forward looking statements.
Actual 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.
These forward looking statements are qualified by the cautionary statements contained in <unk> press release issued today and the company's 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 date of this live.
Cash.
May 6th 2021, so genetics undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this conference call now and that could turn the call over to Steve.
Thank you, Brian and good afternoon, everyone.
Very pleased to share with you today and to provide updates from what has been another of exciting executive quarter for the agenda.
Despite the operational challenges for all of our the ongoing pandemic of commercial launches of free cash flow for Dravet syndrome, and the United States and Europe continues to progress well.
As Ashish will describe shortly and we are very encouraged by the steady growth of adoption by both existing and the prescribing.
Prescribing physicians and patients by the continuing positive dialogue and commercial and government payers with more physicians gain experience with Tesla and more patients reaching the effective dose we see a marked increase in the new type of prescriber base and the beneficial impact of dosing trials.
We will now begin to see an increase of the ability of our field based teams and travel and meet with physicians and other health care professionals.
The results we are looking forward to the positive impact of this will have on our commercial activities and other.
Price of our business I'll now turn the call over to Ashish for further details on power launches are progressing and the U S and in Europe Ashish over to you.
Thank you and Steve I am very pleased to update you on our team's continued strong execution of the center for that launch in the U S.
And the share with you details of the early momentum we are gaining in Europe.
And the first quarter of 2021, we achieved $12 $3 million and picked up a lot of net product sales.
Couple of net sales and the U S $11 3 million and $1 million in Germany.
This strong performance reflects the significant does that within the commodity.
And the ship and continued treatment with Fintech and map.
We have been really pleased with our ability to sustain this momentum despite significant COVID-19 related headwinds and and the U S weather related disruptions that impacted the most of the country in the beginning of the year.
We continue to expect higher adoption and long term use of <unk> increase.
Increased as more physicians gain positive experience treating patients and as Steve noted the impact of COVID-19 begin to diminish.
And the U S growth and the number of healthcare professionals and the rolling into the Rems program. The initial step and indicator of physician interest and prescribing for tablets and remains robust.
By the end of Q1 Approx.
570, Hcp's, we're satisfied and add Rems program with the majority already prescribing for Detlef.
More than 90% of these prescribers are new.
Is that did not participate and our clinical trial, our expanded access program and reflecting the broadening interest and prescribing <unk>.
During the first quarter of 151, new patients for their prescribed the Fintech lab, which brought the total number of Rem threat foot and per.
The <unk> patients in the U S for just over 700.
This is a 27% increase since the end of 2020 and.
Importantly, we saw a consistently increasing the rate of new patient the reference month to month from January through March.
We're extremely pleased by the strength and expect to see continued growth throughout the year.
By the quarter and March 31, the number of patients receiving reimbursed for <unk> and the U S grew by 35% to more than 560 patients.
More than 90% of this growth in Q1 was driven by patients who are new to <unk> and the.
First come to the state of the final participants transitioning to commercial therapy from our open label studies and expanded access program.
We continue to be extremely pleased with the payer coverage and access for Fintech.
By the end of Q1 sales covering more than 75% of U S light had.
Published if portable C to cover for that lab as.
As for labor and on parity with other agents the.
And the rest of plans covering it true prior authorization and medical necessity process due to the rare the prevalence of <unk>.
Syndrome and that covered population.
Additionally, we successfully completed the coverage the verification process for all patients during the month of January reinforcing the absence belief in Fintech plus Therapeutics, Inc.
Since launch the majority of principle of prescriptions in the U S have been written for the patients diagnosed with dry eye syndrome, but we're also seeing some patients prescribed and enrolled and the Rems program for other funds of Cvs rare epilepsies bye.
But at the end of Q1, the percentage of prescriptions written for seizure disorders.
The NPV of syndrome was in the mid teens.
We also see increased physician confidence and titrating patients to the effect of those related to patients wait and see.
One of the production and tolerance current.
And prescribing patterns indicate that approximately 55% of patients for each of their effective dose by the fourth month of the treatment with the remainder of reaching by six.
The average daily dose of winter plus following titration is similar to what we saw in the expanded access program, namely approximately 0.5 milligram per kilogram per day.
Although it is still very early and our launch.
Mentioned rate continues to be very high at 93% and <unk>.
Distant without experience in the expanded access program and clinical studies.
As vaccination rates in the U S increase and the restrictions ease.
More of our customer facing teams have been able to schedule in person interactions with the Cps and their staff.
We believe this positive trend will continue into the second half of the year, making it and it easier environment for us to interact with the physicians patients and families who are now considering treatment with <unk>.
Bruce seizure.
Transitioning to the Europe, our first European launch in Germany is progressing very well.
And the first few weeks after the mid February launch more than 50 clinicians had enrolled in the controlled access program to become eligible to initiate the <unk> therapy for their patients.
In Germany and perhaps.
And similarly, 100 patients and participating in our open label extension studies and expanded access program the.
These patients have now and process of transitioning to commercial therapy.
Progression, we expect to be completed by the end of June.
In France patients have now being prescribed and tablet under the temporary user authorization, our Apu and as we discussed earlier in this year ex.
First of and deadline, France will be under the <unk> program until reimbursement negotiations are finalized.
Pricing and reimbursement negotiations across made the major European markets, such as the United Kingdom, France, and Italy are progressing well.
In April we launched these nodes and ex access program to further expand the availability of center of plate to physicians in the other parts of the world where local regulations allow.
And this also includes some European countries the reimbursement has not yet been established.
We look forward to supporting more of TPS and patients in need for this new program.
Further the reflecting strong global interest and Fintech lab in Q1, we entered into an agreement with the medicine pharma to make sense and the label for patients and Israel.
We are now working with our partners to prepare and file the <unk>.
And going to cheat and reimbursement documents for a per.
Ruble and covered us and Israel.
To conclude we are very pleased the that more patients are now benefiting from treatment with <unk> due to our strong growth in the United States progress in Europe, and the addition of new programs and partnerships and other countries.
And we anticipate continued momentum and we hope the worst impacts of pandemic fast and we receive pricing and reimbursement approvals in additional European countries now.
Now I will turn it back to Steve Steve.
Thank you Ashish for the Great progress next I'd like to update you on our pipeline, including free cash flow prospecting of larger indication opportunities for ex gas process and drove royalty as.
As well as free tablets, which are great.
True.
Our community of patient advocacy discussions reinforce the lgs remains one of the most challenging epilepsy.
And the many lgs patients dose after and the new treatments for this.
And therefore, we're excited the on track for of planned third quarter of 2021 submission of a supplemental NDA and the United States profit share for next year.
Followed by an MAA filing in Europe for the fourth quarter.
Both of our high priorities and significant milestones for us in 2020 of oil.
As part of our preparations we intend to meet with the FDA during this quarter for free.
In terms of the Amy Chang to confirm discussions and agreements from our earlier and the phase III and.
And to align all of the final electronics industry structure.
And Paolo we were excited to report new clinical data for the tougher.
And obviously, you're asking the podium presentation at the recent <unk>.
And <unk>.
These results from our pivotal clinical trial of Lgs.
Show the profit and product of two charters for patients with proceeds the software I believe behavior emotions and accomplishments the.
And non future findings complement earlier phase III data and us.
Demonstrating the <unk> significantly reduced drop seizure frequency and notably the frequency of generalized tonic clonic seizures.
A primary risk.
For the sudden unexpected death and epilepsy for sooner.
We believe these data combined with a novel mechanism of action relative to other approved therapies for this.
Turning to free capital as a potentially important new treatment option for lgs patients.
The clinicians we have engaged and advisory panels reinforced the seizure control as the primary treatment growth for Iot area of any patient who received a non growth troubles and could be candidates for treatment.
And treatment.
While the conditions indicate they would likely tried and true for all of the refractory lgs patients, but also stated that they may place a tightening of the treatment algorithm for patients who experienced a high number of generalized tonic clonic seizures, and <unk> and other ways the at risk of Sudan.
And I'm, turning to free tougher and Japan, we remain on track for our planned NDA submission for Dravet syndrome and later this year.
Separately the loss of 33 patients with the randomized into our Lgs studies.
Which of the <unk> requested to enable the comparison of responsiveness and Japanese patients. So the multinational data from study 60 of our work a broader phase III trial.
In addition to Dravet and Lgs, we're also making great progress around the planning of our phase III trial, and Tampa, and CD carryover price deficiency disorder or CDC as the.
Reminder of Doctor for intravenous ski at the NYU Langone Medical center larger share of compelling data from sales investigator initiated study of several patients with CTD.
We plan to discuss the final protocol with the FDA during this quarter and expect to begin enrollment of patients into the study and the second half of the year.
As you can see we are of significant growth plans for fintech.
To complement these objectives, our intellectual property position for two channel was further strengthened last quarter for the tissue of true.
Further the U S patents and the Orange book. This brings the total with the patents for fit samples and chat with the part of the expertise ranging from 2033 the 2039.
Now I'd like to discuss ft, $6 41, our late stage investigational therapy for climate and kinase two deficiency or teekay to the.
And Im excited to report our continued progress of you bring the therapy forward two of patient population with no approved treatments.
Leveraging of data demonstrating.
Demonstrating benefit and for morbidity and mortality and Teekay choosy, we will pursue and indications encompassing all patients and our FDA Friday.
Based on our discussions with the EMEA and Europe, we will pursue and initial indication for patients with early onset disease with the goal of making this drug available as soon as price.
The later onset represents a minority of the coloration and estimated 20% of all of <unk> patients, which is only recently being recognized and interest.
The other offset patients represent the largest group of patients and those with the clear high unmet need and.
Untreated disease and in front of childhood onset of patients often results and lots of developmental milestones and made progress rapidly to respiratory failure and death.
Yeah.
All of our studies required for all of the records submissions are advancing as planned and we.
We remain on track to submit an NDA for <unk> and 'twenty, one and the first half of 'twenty to revenue too.
MAA for European approval shortly thereafter.
And Carlos Roger Government work, we are pursuing a range of activities to identify patients and better characterize teekay two day.
As with many of mitochondrial diseases teekay to the is significantly under diagnosed and.
And the setting of clinical suspicion of the disease <unk> is easily of definitively diagnosed by genetic testing.
We are therefore engaged and in three important areas of work.
The development of disease awareness and medical education programs to drive urgency to get the genetic tests.
The approach of partnerships to improve access to non cost testing and to ensure teekay <unk> genetic testing is present, all testing panels and scientific and market research to understand and characterize the impact of this disease of patients caregivers and families.
To conclude this has been a very productive and exciting quarter suggests as we ramped up commercial activities profit and Tesla and continue to advance clinical and Gregory programs for 2016, 21, and the new free charter indications so with that let me hand over the quarter, Mike for the financial review.
And.
Thanks, Steve and good afternoon, everyone. Today, we issued a press release announcing our business and financial results for the first quarter and then March 31 2021.
I'll now review.
We recognized $13 7 million and total revenue for the first quarter of 2021, which was an increase of 61% as compared to the $8 5 million recorded in the fourth quarter of 2020.
This increase was the result of $11 $3 million and products. The other thing Tesla.
And I would state 1 million and product sales lift and capitalize and Germany and $1 3 million related.
Through our exclusive distribution collaborations and the punching yaacov for Finn <unk> for Dravet syndrome, and Lgs and Japan.
Total net product sales of some capital of $12 $3 million and increase of 53% as compared to the $8 1 million reported and the fourth quarter of 2020.
And that was $1 2 million and total revenue for the three months ended March 31, 2020, a year ago.
R&D expenses for the first quarter were $31 million of decrease as compared to $33 $2 million recorded and the corresponding Q1 period of 2020 SG&A expenses for the first quarter ended March 31, 2021, total $31 2 million compared with $21 3 million for the first quarter of 2020.
The increase of approximately $9 9 million was primarily driven by the investment related to the launch of <unk> and Tesla and the United States and in Europe, and the preparations related to the commercial launch and other countries forthcoming and Europe in the coming year.
Net loss for the first quarter ended March 31, 2021 with the.
The $5 $6 million or $1 per share. This compares to a net loss of $25 8 million or <unk> 54 per share and the first quarter ended March 31st 2020, we ended the first quarter with the strong balance sheet cash cash equivalents of marketable securities totaling $435 million.
With that I'll now 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.
If you'd like to register a question. Please press the one followed by the four and your telephone you'll hear of $3 on profit technology request and for your question has been answered and you'd like to withdraw the registration. Please press the one followed by the <unk> III.
One moment please for the first question.
Our first question comes from the line of Paul Matteis from Stifel. Please go ahead.
Hey, thanks, so much as always for taking the questions. Obviously appreciate it.
So a couple of a couple of on the commercial side, it's encouraging to hear that you had more in person interaction.
And the pandemic range is there any way you can quantify that what percentage of the face to face meetings, a day and virtual versus in person personal over the past month or two and are you seeing any increase in volumes as a byproduct of that and then separately on lgs. Just ahead of the pre <unk> meeting I was wondering could you just set the stage of.
Little bit of this is just more administrative or do you feel like you still need to kind of get a reaffirmation that of single pivotal can serve of the basis for our pilot. Thanks. So much.
Thank you Paul let me take the of Jeff's question first Ashish, if you could get ready to address all of commercial question.
Regarding <unk> and this is the standard Lisa.
Part of the development programs of course, an NDA and.
I think we like all of other sponsors and really take advantage of as much time as we constitute certain true to be upfront service.
Of the FTAA loaded and share of its absolute clarity for the eventual NDA.
NDA submission to the.
And sure the reviewed remains hopefully on track.
So this.
And as we've mentioned in the past we've had really good interaction with the FDA at the end of last year around the critical packages and the non clinical package and really got agreements for what that was the <unk>.
And so this is more administrative and more reaffirmation of trimming.
Of all of our previous agreements.
As I mentioned, it's standard it's helpful for programming for US. It also gives us the opportunity for the gas and initial feedback on what would be our proposed label for <unk>. So there's a lot of upside for going forward and they take and it's not going away.
Great. Thanks.
But with the negotiation.
Yes.
Paul.
Most of the in person interaction hasn't been a recent trend and loss cannot for weeks and that in terms of quantifying and I'll give you primarily of quantitative models.
And I'll say more than the 60% of two thirds of five key account managers have been able to go out in the field and.
And karla and their physicians.
And certain pockets and the country with <unk>.
Allowing the.
Pharmaceutical industry and that's to come in and so those are kind of still the stake kind.
Kind of off limits, but we are hoping that they will stop opening up because we are getting the appointments.
The other thing I would add is we have been doing the got and starting.
And towards the end of March.
We have been about different programs and person instead of.
Research and person, we just did a huge.
And <unk>, which was the candidate someplace else and parser. So all of these things kind of going towards the <unk>.
A positive trend and we are expecting that that trend is continuing with the patients coming and visiting the offices and the offices, allowing more patients to come in because as you know and some of these chronic conditions of the offices.
Wanted to continue with the telemedicine and because of the COVID-19 risk, whereas the vaccinations and increasing we have seen that and almost every part of the country. So more to come up back one.
Okay, Great and would you mind, just finally, just quickly quantify and with gross to net was in the quarter.
Yeah, I can take that.
And I call Tonight.
And it's in the teens.
So.
It's been.
And then and there since we started I think for eventually we're going to be we think eventually once we get the full patient population and over a year post launch will be.
The low twenty's, but it currently out of a little bit lower than that because commercial is coming and willow.
Other than.
And the pace and the.
Public Poles.
Alright, Thanks, Mike Thanks, everyone.
Thank you Paul.
Okay.
Our next question comes from the line of Marc Goodman with SBB Leerink. Please go ahead.
The Si.
One can you give us just the sense of the average price per.
<unk>.
Who are on the therapy.
First question second question is.
What kind of color can you give us about how April spin and just the first week of May just trying to get a sense of.
Of how things are going relative to.
And the last time, and then and lastly, you mentioned that off label was I think you said, 15% this quarter what was it last quarter. Thank you.
Yes.
Thanks Mark.
I'll provide a little bit of color on.
Sort of what's going on this quarter and then Ashish if you could take the question on average price and also of the non pervade.
Patient and so we're seeing as well so just very simply and I think it follows.
She said and the previous.
The previous question.
We've seen.
And a nice increase and rates of patients per month.
Over months and.
Q1, so in other words for you have more patients come into the revenue milestones and in January and we're seeing that trend and the early part of this quarter as well so.
And I think the chest.
The results so for.
Ashish of talk of that.
Earlier.
And with that I'll hand over to Ashish.
Yes, Thanks, Dan.
In terms of the average price for on therapy.
I'd say it continues to be the same because again, we are and the first year.
But we are having more and more patients now getting towards that 0.5, the average dose knowledge around the <unk> five.
If you translate that into annualized and cut out and how does the 9000.
That would be going forward could it be.
In terms of the patients on the indications other than 12 eight.
<unk>.
And that's not.
The overall since the launch.
Okay.
Hi, good afternoon. Thank you so much for taking my questions and congratulations on the quarter.
I'd be prepared to file for the lgs.
Application wanted to get your thoughts.
On whether you think that this is likely to get and accelerated past two approval and some other examples of some CNS and other therapeutic areas. There has been some recent filings where expectations might've been set to accelerated and F. D. A has grants of the standard review so wanted to get your thoughts on that and then I have.
The follow up.
Sure.
I appreciate the question.
Alright.
And.
And.
For the grocery on them.
True.
True.
For sure.
And the the most basic and phone.
Well we.
The.
The.
For.
And syndrome true despite the Scott.
February of drugs.
The Bill of November.
Which of the learning channel.
Physician.
The full name patients.
Well, so we do.
And he was.
And tried a mood board of of the policy review of it.
And.
[noise] dress already of those yes.
Per cent too started review, which would be true.
Unless you know instead of.
And just.
And by the Ocean.
We will do our best to to move forward with the furniture.
Okay, great. Thanks for the color and then as it relates to the launch maybe and she's can provide some color on how exactly like how important is it.
To be you know on formulary for a doctor to feel comfortable writing of script.
Perfect coupler is it the case that even if it's not on formulary and of doctors at this point of feel like day, I understand what kind of pay for work they need to fill out and that's not of right limiting factor for them.
Yeah of business day.
What was the cause.
And that's gonna wait time of day second at all and so.
<unk> and.
This particular space and you know and where the seasons prescribe what is the best for the medications.
And they may have the conversation and the interaction for you ever had.
That particular hasn't really come up.
The other thing to add that is we do have the surgeon extension, which is really geared up to support and the the office stuff as well as the physician into the entire profit.
And the stuff that is really experienced and manage of this process for the credit refuses and sofa and.
And my prepared remarks, we have had really good success and.
That becomes the reference for <unk> for the physicians to look at but also the comfortable.
This product will and go through the entire process within two to four weeks and the the patience and get the therapy.
Okay, and if I could please and the last question for patients better Onboarding better and.
The profile of the pieces for you know, what's the sense of them have already kind of the dialect.
And.
We haven't broken that out of input as you can imagine most of them would have tried.
And something else what I can share with you is that we have seen for an average of around two four.
Different and battle net.
The drugs that day out on and on a very worst case, we have seen up to 10.
And as you know current.
Couple of gifts added to the third of theme. So even if the patient is on one of the C V D product orders of any of the other products for.
And and get added to that and once the patient established and then they will start looking get okay. What else. They can do in terms of and have you seen.
The overall product for them.
Okay got it. Thank you so much ashish.
Thanks.
The day.
Yeah.
Our next question comes from the line of Danielle Brill with Raymond James. Please go ahead.
Hi, this is the meal on the for Danielle. Thank you for taking the the question.
Uhm.
<unk> can you help us understand and what percent of patients that are involved and rooms and the up on the net reimbursed Oh God, you're asking because the clinic last quarter, you have 550 patients enrolled and rooms and this quarter you have.
60 of patients and pays for.
Does that imply the 10 efficiently normally the rooms sexually the.
Prescription drug and the <unk>.
Thank you.
She shows for us.
And explain the difference between the top.
And the rugs and describe your.
Yeah. So in terms of when you have somebody look at the patients go and get on the top of the family and I'm getting the embers therapy.
You want and look at the absolute numbers and of 151 of the top of the fun of come out of 145, plus at the <unk> at the.
The end of the front of cause if you recall at the end of two for we had around 415 patients on the reimbursed therapy and.
And 550 patients who have just and rolled into the program.
Yeah, and it takes around for two to four weeks and I just say for it is for the week, so you're going to have that lag and stations come on to the therapy and it has come into the Rams program, and then the and and receiving the reimburse therapy.
I hope that helps understand the kind of a.
Question there.
Thank you very much for it.
Okay.
Thank you for him.
As a reminder to register for of question is personal one followed by the for and your telephone. Our next question comes from the line of Tim Lucco with William Blair. Please go ahead.
Hey, this is laughlin on the 10th and thanks for taking the question. So I was wondering how should we think about the change and productivity of the sales reps.
Get more and more and policy interactions compared to the sort of virtual or digital well, but we've been and.
And and the second question, if I may yeah, and within the the Red and certified doctors you have.
How many of the potentially eligible patients that I have therapy, so most of them and sort of trial with one or two of patience before it expanding to the rest of the of population all of the day on behalf of for Ya.
Patients age.
Yeah.
<unk> Yep.
Yep.
Black and thanks, I'll start with the second question of the first.
The.
What day of seeing is in terms of physicians, who of Proscribing. They are not only or the top leaders for also the community physicians and as you can imagine if you have possibly the who have lots of more patients.
They are writing a lot.
And we have but that's it within the if not the majority of many of most of the the patients have been looked around for a center for that.
And will you have community physicians can I can tell you the the setting up the quite the remarks, almost 90% of prescribers.
Coming from the community physicians, who are not part of our of chemical trial and the.
Expanded access program and there'll be of seeing multiple prescriptions. So I think it's both.
Most of it is and again some of the places where they may not have it and for all of their patients of all football the patients because they haven't seen them because of the COVID-19 part of because of the restrictions of the families of food not feeling comfortable going into of health care of setting or even trying something else because of the COVID-19.
And any challenges that they may have the debt.
But that kind of leads into your first question I don't have a benchmark to talk about what change will be because we launched within the COVID-19 I think the only benchmark I can go back is to what we saw part of the of bad anti epileptic class where the.
You too Brian prescriptions, and the COVID-19 environment went out of the most up to 35 to 40 per cent.
And we.
We will be doing every other effort to go back and and go through every one of the the.
The physicians, who have the other patients to educate them and.
Make sure that they offer the product to the patients.
Oh and thanks, Thanks for the call.
Our next question comes from the line of your team Sunia with Guggenheim Partners. Please go ahead.
And you guys. Thank you for taking my question did not at the press one for I was pressing one by star. So sorry about that okay. A couple of questions for me in terms of the the total sales is there any European and component to it can you tell us how much once per se and what was the number of in Europe. So that's the number one.
The second question is just trying to get a sense of.
Cadence of new patients add going forward and also trying to understand the dynamic and Q1.
Cause I think I should just didn't mention that there were some left the R. E P patients that.
Where added and Q1 of that got the drug and Q1. So it seems like the dinovo patients are the less than 150, so there seem to be and it seems to be a little bit less than the last quarter. So just trying to get a sense of what the exact number of Ross for the novel patient and how should we think about Kid and is going forward and thank you.
Yeah, I can I can I can take the store.
Sure.
Just on the second question the first of all respect to the craziness of the day.
Patients it was actually 152.
And do you want to know the original.
The earliest of patients for already and the rash.
For a.
85% of the over the over here.
The last year.
And the.
And the remainder where the.
And this is this last quarter and where are they.
The north.
They are already and the rest of and all kinds of against the the fish.
And is correct.
With respect to trading so the guy was just.
Reiterate for us.
From the earlier.
The overall.
Thank you we saw of him.
Increases the race and.
And what we expect and continuously goes for this.
Of course.
And the total sales of.
12 23 million sales.
The last 0.3 of the service and the United States and a million was in Europe.
Got it and then and I understand and it's very early and the launch any color on the compliance or the discontinuation Red and then maybe if you can comment on what the average wait for patient that you're seeing for drove a of patients.
And.
The show of due to the address yes.
Yep I'll start with the average wait for the average wait for your seeing is consistent and what we saw in the expanded access broken out of our qualified kindergarten. So you get the range of that about the average right now is 35.
And the compliance as I said of the push the the persistence and the and I said, if I prepared for about.
Definitely it is around 93% at this point in time, so 93 per cent of the patients who started that's still on the penalty.
And again, it's very early but and that's as you'd know yet the and the.
The X, one and access as well as clinical trials.
The discontinuation of around 10%. So we expect that we will get the but right now I think the of seeing of great results patience I think riches of some bad of benefiting and then they of staying on the product.
Great. Thank you very much.
Thank you thanks for the question.
The last question comes from the line of Nina, which retail guard with the city. Please go ahead.
Hey, guys. Thanks for taking my question just for the question around the.
[noise] cardiac monitoring and you know I guess at this point you have some patients who have been on commercial truck for six months. So they would essentially be going now for.
<unk> six months kind of Echo I guess, how has that been going and have there been any kind of issues in terms of of getting patients and for the six months ago and.
And it's not proving to the kind of or is that kind of proving to be as smooth as the the baseline that kind of have been going ex.
One of the fish.
Yep, Honey and I think it sounds of the cardiac monitoring of of the second that goes exactly as you said, it's been going smooth and.
We haven't had any the that's that's the any challenge of static and patience and told that families and all that and as you know we have the really robust those and extension program, which really the mines the individuals.
Sales on top of it we stay connected with the physicians and.
And we have many patients a lot of patient and sometimes you know some of the expanded access and the clinical trial of patients who went on to the commercial therapy. They already had the record some time back in the past six months. So we have a lot of patients who have gone through and the second Nicholas.
Again, even since the one last year.
And every one of them have been able to get it in time and without any challenges.
Gotcha perfect. Thanks, and I guess, if I could just have one more question quickly than on the just kind of going back to the piece of the new star and say Thank you know.
Thinking about the number of patients that were yet to kind of start on commercial drug rather than kind of and number of patients that were and the Rams and said no I think I calculated and the fourth quarter of their about 160 or so some type of naive new starts in fourth quarter and this quarter. It seems like it's closer to 100 and just given the there were some piece of.
And still starting to <unk> can b E T and the only I guess, how how should we think about the pace of new starts from here in terms of aware of that number. It should go understanding that you know like you guys have said there is this month of the month increase but and what's a reasonable number of new stuff.
And and.
And we finished queue for we had total around 100 and between 150 of 160 and it's about the same pretty much the same number and cute one although we had the the impact of severe impact of the COVID-19 pandemic through the holidays and the the January of year, and and I'm sure you're.
And I'm familiar with there are the reason restarting where people on and off in January to set and pay of programs and whatnot. So you had your typical January of starting and we saw increasing throughout this quarter of month to month, and then also the increasing and and keeping up.
With increases and to this quarter as well so you expect to be.
That increasing and the the capacity to for it to.
The less challenged by COVID-19 and also for the balance of the year too. So it was great to see that we were able.
Be able to come through this quarter and what is the standard Lee and uhm lower demand quarter of lower start quarter because of of of January impact and to maintain the place that we were on and increase it and by the time getting through the end of the quarter.
Okay. Thank you.
There are no further questions on the phone line I'll turn the call back over to you.
Thank you very much operator.
Joining a for today the past quarter like like the.
Of course and incredibly good for us we're continuing to focus on the pricing.
The program.
Free Tomorrow, if you will be critical retrieve it off of the patients facing Sierra and that medically. So really look forward to Brian you refer other updates of art for the strike. This year. Thank you for the Guy for joining us on a call today and enjoy the rest of your day Bye now.
That does conclude the conference call for today and we thank you for your participation enough for you. Please disconnect your line.
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