Q3 2021 Zogenix Inc Earnings Call
Thank you for standing by this is the conference operator, welcome to the <unk> third quarter 2021 financial results Conference call.
A reminder, all participants are in listen only mode and the conference is being recorded.
After the presentation there'll be an opportunity to ask question to.
To join the question queue you May Press Star then one on your telephone keypad.
Should you need assistance during the conference call you May signal, an operator by pressing Star then zero.
I would now like to turn the conference over to Brian Ritchie of Life Science Advisors. Please go ahead Mr. Ritchie.
Thank you operator, and thank you all for joining us are Janet <unk> and its management team. This afternoon.
On today's call are Chief Executive Officer, Dr. Stephen Farr, Chief operating Officer, Ashish Gurrolla Kerr Chief Development Officer, Dr. Gail Farfel, Chief Medical Officer, Dr. Brad Galer, Chief Financial Officer, Michael Schmidt.
Good afternoon, So Genesis issued a news release, providing a business update and announcing financial results for the three and nine months ended September 32021. Please.
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 state.
Due to risks and uncertainties associated with the company's business.
These forward looking statements are qualified by the cautionary statements contained in <unk> press release issued today and the company's SEC filings, including in the.
Port on Form 10-K, and subsequent filings. This conference call also can change time sensitive information that is accurate only as of the date of this live broadcast November 4th 2021, So janet's undertakes no obligation to revise or update any forward looking statements to reflect events or circumstance.
Just after the date of this conference call now I'll turn the call over to Dr. Stephen Farr Dr. Farr.
Thank you, Brian and good afternoon to everyone and thank you for joining us.
I liked it to be shared with you today to provide updates on another strong quarter for subjects as we continue to execute on our commercial loan chatbot integration drill preparing for potential launch in the next car so syndrome and advance our late stage development programs approaching.
<unk> 21.
Positive momentum for the launches of some chatter in the U S and Europe continue.
Once again, we achieved a solid quarter over quarter growth in the number.
Prescribed resolved patients.
Our next chapter.
<unk> features.
In a moment Ashish will provide additional color perspective chocolate market dynamics, although these interim success and continued growth.
We also remain excited about upcoming opportunities to potentially expand your Tam.
The treatment option and other severe refractory childhood onset epilepsy syndromes.
Towards this goal in September we submitted a supplemental NDA to the FDA seeking to expand the label indication on can you talk about the treatment of seizures associated with Lennox <unk> syndrome or lgs.
On an estimated 30 to 50000 patients suffering from <unk> 19 states.
Notably the majority of patients who are uncontrolled seizures, despite taking existing approved anti seizure medications.
Also we are now getting close to starting our global phase III trial of <unk> in patients with CDK will define deficiency disorder or C. D D.
Several sites.
The good thing for us to begin screening patients and we anticipate the first patient enrolling in the study within the next few weeks.
Their phone furlough, Chief development Officer, who will provide more detail on both of these programs later on the call.
Loss during the quarter, we were pleased with the progress being made through regulatory interactions and ongoing development studies for the <unk> 16, 21 program on investigational substrate enhancement therapy for <unk> kinase two deficiency or <unk>.
Bret Taylor, our Chief Medical Officer will walk you through this progress in more detail on this call.
I also would like to remind you of our upcoming virtual investor event on November Th will feature presentations by key opinion leaders on disease overview, a natural history of Teekay, Judy and their experience with empty <unk> 'twenty, one as a treatment option for <unk> patients.
With that I'll now hand, the call over to Ashish Ashish.
Yeah.
Thank you Steve.
The continued solid growth for <unk> in the third quarter, completing our first year of commercialization.
All within a restrictive corporate environment and then single rare indication is reflective of the strong support we are seeing from patients caregivers healthcare providers and payers.
That support better with potential in multiple new indications and geographies provides us with confidence in Finfet plus commercial growth outlook in the short medium and long term.
Starting with the U S. During the third quarter or 130, new patients who had referred to the Rems program and 133, new patients started reimbursed therapy with Fintech.
This progress reflects a steady cadence of new patient adds similar to the prior quarters from this year.
By the end of the third quarter with 990 patients in the U S had been prescribed detlef and referred to the Rems program.
I didn't want to defend tablet therapy, all sort have been strong and remarkably consistent with our experience in the long term clinical trials and expanded access program.
Since launch the discontinuation rate is around 14% overall and 11% well they didnt go away syndrome patients.
We believe these rates are substantially lower than typically observed with other anti seizure medications, commonly used to treat refractory epilepsies.
We estimate that in the U S auto market penetration among eligible Dravet syndrome patients is currently about 15% to 20%.
Our internal research indicates that we should be able to increase the market penetration by at least three fold with time.
For example brand awareness among.
U S neurologists and let the allergist has almost doubled since late 2020 and is now higher than 80%.
To take advantage of this momentum we recently completed the expansion of our field based sales and medical teams by adding experienced professionals with deep understanding of the epilepsy market.
The field sales team is now considered to educate and support an expanded list of health care providers about Fintech lab in Dravet syndrome.
While it's still early we have already seen some positive trends with respect to increased physician engagement, leading to new prescribers in the fourth quarter.
We continue to be very pleased with the payer coverage for <unk> in both private and government sector.
Typically it takes two to four weeks for a new patient to receive sent up all at once that are offered to the Rems program and payer coverage continues to be strong with effectively all patients receiving positive and children's determinations.
During the third quarter, we supported the way community to various local and virtual events, including a unique center left photo diary contest through social media.
More than 700 care to give us participated in that event.
As you all probably know November it is epilepsy awareness month and this month our team is participating in more than 30 community U S votes, what Julie and in person to support and educate patients and caregivers.
In Europe, the launch of center in <unk> syndrome in Germany is continuing to progress where do you well how about a patient and prescriber base continues to grow steadily.
We continue to add new patients to reimbursed therapy in France through these temporary authorization of youth program and currently in eight additional countries two hour version ex access program.
We have made significant progress in our pricing and reimbursement negotiations in the major European markets with objective of reaching final determinations and executing commercial launches next year.
Following the submission of our F N b for Lgs, we are now ramping our launch preparations for this new and potentially significant indication for the Finfet plus.
We are conducting market research advisory boards and one on one discussions with health care providers caregivers and payers to best understand the need of the lgs community.
These preparations are already helping to Australia fine our go to market strategies and that along with our expanded commercial team will position us to launch <unk> immediately upon potential approval in 2022.
In summary, we are pleased with our strong sales growth in the United States continued positive momentum in Europe and preparations for the potential commercial expansion of <unk> into lgs.
We anticipate continued growth in all key geographies and look forward to updating you in the coming months.
Now I will turn the call over to Gil to share exciting new data on Fintech labs Gil.
Thank you Ashish.
I'll Echo the enthusiasm expressed by Stephen Ashish around our submission of the S. N D. A L. He has which was submitted on September 27, with a request for priority review.
If granted would set an S T. A goal to take action on the submission in six months.
A standard review would establish a 10 month review timeline.
The submission consisted of safety and efficacy.
263, lgs patients who participated in our positive phase III trial, which met the primary and key secondary endpoints.
San Diego submission also contain non clinical chronic toxicology and carcinogenicity studies and no new safety concerns were observed.
Furthermore, prospective assessment of cardiac balancing needs studies did not reveal any microscopic changes at any dose level.
Yes, we recently presented results from the interim analysis of our ongoing 12 month Phase III Open label extension study using tableau you know he has patients at the 2021 annual meeting of the child Neurology Society.
The results demonstrated that 10 Tesla produced highly statistically significant improvement in the frequency of drops features in the 247 patients enrolled in the extension.
The median reduction in drop seizure frequency was 39, 4% at three months and at 51, 8% for patients who were assessed over last 10 to 12 and the reductions at both time points at P values less than 0.001 compared with baseline.
Of the 170 patients evaluated in the interim analysis at most 10 to 12.
51, 2% reached a 50% improvement thresholds and 25, 3% reached the 75% improvement threshold, which is considered a profound level of improvement.
These results highlight the durable and positive effect long term in terms of the treatment and lgs patients.
To date, the safety profile of the Lgs study is comparable with the results seen in the Dravet syndrome trials and our experience in the post marketing setting.
This profile in conjunction with can tap the unique mechanism of action highlight.
I liked the potential Hudson templates to become a meaningful treatment option for lgs patients and their families, particularly considering the highly refractory nature of this condition.
I'd also add that we remain on track to submit a J NDA in Japan to Japan's pharmaceutical and medical devices agency by the end of 2021.
Now, let's move onto our newest seed capital program and CDK, all time deficiency disorder or C. D D.
C. D. D is a rare severe and highly refractory childhood onset epilepsy, and which patients experienced multiple symptoms such as gastrointestinal visual and sleep disturbances. In addition to treatment resistance seizures.
<unk> joined Illumina Foundation University of Pennsylvania, and other industry collaborators to support a three year non interventional study of patients with CVD characterized developmental trajectory clinical features of this disorder.
And a small open label study conducted by Dr. Orin Dubinsky NYU Langone Medical Center and presented at the American Epilepsy Society annual meeting in 2020.
Treatment with fenfluramine produced quite a bit of any meaningful reductions in seizure frequency and a 90% reduction in generalized tonic clonic seizures in a 55% reduction in seizures in a case series of six patients with CVD with a median treatment duration of five three months.
These initial compelling results form the basis of our decision to launch a study has been terrible and CVD patients and we anticipate the first patient will enroll shortly.
The placebo control fixed dose two arm trial will enroll 80 patients randomized to either Europe seven milligrams per kilogram per day, just tesla or placebo.
Husky and confirmed earlier this year in a pre IMD meeting a single positive randomized controlled trial could form the basis of a supplemental NDA in this indication.
With that I'll turn it over to Brad for an overview of our M. T 16, 21 program. Thank you Gail.
Made meaningful progress on our empty 16, 21 program throughout the quarter, expanding and enhancing our planned dataset that will be included in our NDA submission in 2020 choose among these additional data with an updated analysis of our primary efficacy trial study 101, formerly <unk>.
The retro study for the vinyls CSR that'll be included in the NDA.
The study's data continued to be highly compelling and consistent with previously reported results.
Primary efficacy endpoint for study 101, and updated survival analysis, using a time dependent Cox regression model showed that the difference probability of survival between treated patients and untreated natural history control patients was consistent with previously reported results highlight the template.
Yes.
Equals 0.0007.
In addition to this compelling survival benefit the majority of empty <unk> 'twenty one treated patients.
Also demonstrated clinically meaningful improvements in motor respiratory <unk> abilities with some patients requiring previously lost motor milestones.
The literature described and our clinical data is confirming teekay Judy is a progressive disease in all patients regardless of age of onset and that spontaneous improvements in motor milestones are rarely seen in this patient population.
We are continuing to make good progress on the clinical and non clinical studies for the NDA submission.
The timing for completing study one O seven which is a retrospective chart review study to collect a vital status of any untreated and treated patients in the U S and Europe.
Not involved in.
In our sponsored studies.
Has been impacted by the pandemic and has moved into the first quarter of 2022 from the end of this year.
We're now planning for a pre NDA meeting in second quarter of next year and an NDA submission in the second half of 2022.
In addition to our regulatory progress in the U S. We are preparing for a scientific advice meeting with the EMA.
First quarter of 2022 with that let me hand, it over to Mike Mike.
Hey, Thanks, Brad and good afternoon, everyone. Today, we issued a press release announcing our business and financial results for the third quarter ended September 32021 in the third quarter of 'twenty, one, we achieved $21 $4 million and definitely that product sales globally, representing 20% growth over the second quarter of 2021.
This includes can tap on net sales of $18 4 million in the U S and $3 million in Europe.
<unk> sales growth reflects significant interest for initiating some type of therapy, we continue to observe across the Dravet community.
We recognized $22 6 million in total revenues during the third quarter of 'twenty, one, which was an increase of 22% as compared to $18 8 million recorded in the second quarter of 2021.
Of the $22 6 million total revenue again, $21 4 million was in the form of product sales is in Tampa and $1 2 million was related to our collaboration with Novartis and Jaco for from Tesla in Dravet syndrome, and Lgs in Japan, our total revenue for the corresponding prior year period was $2 9 million R&D.
R&D expenses for the third quarter were $33 $3 million, a decrease as compared to $34 1 million recorded in the corresponding period of 2020. The decrease was a result of overall.
R&D operating costs, decreasing 24% to $26 $3 million and some operating costs and activities related to Tesla survey in late stage development programs are concluded.
This decrease was offset by a onetime $7 million charge associated with an agreement to amend our original licensing collaborations.
With regards to revenue sharing on our past and future collaboration with Japan, and Japan, sorry, with no bunching up.
As well as an increased investment in M. P 16, 21 development.
SG&A expenses for the third quarter ended September 32021 totaled $39 $5 million and this compares to $24 6 million for the third quarter of the prior year.
The increase of approximately $15 million is primarily driven by the continued investment related to the largest fund in the U S and Europe net loss for the third quarter ended September 32021, $68 million or $1 four per share.
This compares to a net loss of $60 million or $1.08 per share in the third quarter ended September 32020, we ended the third quarter with a strong balance sheet with cash and cash equivalents in marketable securities totaling $343 million.
That I will 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.
Yeah.
We will now begin the question and answer session to join the question queue. You May Press Star then one on your telephone keypad, you'll hear a tone acknowledging your request if youre using a speakerphone. Please pick up your handset before pressing any key.
To withdraw your question. Please press Star then two.
Our first question is from Paul <unk> with Stifel. Please go ahead.
Hey, Thanks, so much for taking the question I appreciate it I.
Good to see that new patient adds were relatively stable I guess the one question I had is just it looks like patient adds to the Rems program worse sequentially, a little bit lower is there anything behind that and maybe could you comment on just what you saw for demand throughout the quarter on a monthly basis and kind of how you feel so far.
In October if you're comfortable and then just seconds I would be curious if you wouldn't mind breaking out U S and rest of world. Thanks again.
Thank you for your question, Paul I'm going to hand that over to Ashish to address it for you.
Ashish are you on mute.
I'm sorry.
Bob.
So Paul for the Q3, despite the resurgence of Covid, the new patients that were consistent with the prior quarter and when you look at month by month, we have seen a consistent growth.
We haven't broken that out, but what we have seen is especially when you say towards the July and August when we had a lot of closures because of the recession, so far delta variant.
We did see a little bit that and I think that cognizant that we got but when you look at the raw numbers of 133 stocks.
The growth over last quarter.
It's been steady.
But in terms of U S and rest of the world.
Haven't broken down the patient numbers because as you know in Europe number are finding that are finding a number of patients actually is very difficult because of.
The regulations.
So every patient bubble that we are reporting is purely from the U S perspective hope that answers your question.
Yeah. Thank you so much Ashish can you break out U S and Europe in terms of Boston tablet revenues.
Yeah, Yeah. Paul This is Mike go.
Go ahead, Mike sorry, yes.
In the quarter 18, four was in the U S and $3 million was in Europe.
Great. Thanks, so much I appreciate it.
Yes.
Yes.
And Paul I think you had a question about what are we seeing during this quarter as much as we can say.
I just want to remind you that we did move forward with an expanded sales team.
Which became effective in the field at the beginning of the quarter, obviously, you'll take them a few weeks to get a bunch of entered into.
To start to have conversation with physicians, but we've been I think.
Very pleased so far this quarter without expanding team to increase physician engagement. So that's a very positive sign for us and we know that has led to new prescription so.
It's early days still are situations you can say that we feel encouraged about our expanded team is doing right now.
Okay. Thanks, Steve I appreciate it.
The next question is from Jason Butler with JMP Securities. Please go ahead.
Hi, Thanks for taking my questions just first one.
You're preparing the lgs launch can you just speak to any work that you've done with payers or plan to do with payers to get them ready for the label expansion and then on a M. T. One six to one can you just give us some context of any prior dialogue that you've had with regulatory consultants or kols in Europe, but given some.
Somehow the what the approval path could look like there.
And what Youre looking to get out of the scientific advice meeting.
Thanks, Jason.
I'll ask Ashish to take the first question and Brad will get ready to respond to your second one.
Excuse me.
Yep.
Yeah, Jason from the earliest launch as I said in the prepared remarks, we are doing a one on one as well as.
Advisory votes with their sense of Alaska every other stakeholder.
As al will outline on Monday may be a bit different with a different indication.
Whereas in the U S. We are looking for an indication for all patients in Europe. The EMA has been a little difficult and are requesting a little bit more data, especially with me adult onset patients. So it may be a different indication with a younger age of onset patients, but I'll be providing more information on Monday.
Just to add to that the majority of the patients that suffer from <unk> and in fact, I'm really offset so children as opposed to later onset and just reflects the fact, Jason that we have more data on young on central early onset we viewed from nature on site and that's really I think the issue that the EMA.
So addressing right now.
Okay. That's helpful. Thanks, and I look forward to the call on Monday.
Great. Thank you.
The next question is from Yadkin, So nature with Guggenheim Securities. Please go ahead.
Yes, Hi, this is eddie on for yacht.
Just a couple from me can you talk about what the potential risks are to the lgs filing like wise or even a debate around potential acceptance is there anything in the non clinical work that could create a risk and then.
Assuming approval and LG asks can you talk about the cadence of patient adds next year.
And do you think that will be affected by the level of off label use you're seeing and can you remind us what the off label use you're seeing in for <unk>. Thanks.
Thank you.
Would you like to take the first question sure.
You too.
Thanks for the question.
Well, we are unaware of anything in the filing that was such.
Such a risk.
We had a non clinical data are straightforward and those studies are complete.
In terms of the clinical data the same has happened we had.
Given the significant number of lgs patients and the feedback that we are hearing from the Cps.
In the sense that the data is meaningful for them. They are excited to have a novel treatment options.
And they are looking forward to have some top line in their toolbox because of these reasons ads and also the current treatments.
Inadequate to have a control.
Have seizure control.
We expect that.
That will not be a huge factor.
Thank you so much.
The next question is from Boston, We've made how many company. Please go ahead.
Hi, This is Robert on for Serge. Thanks for taking my question are you noticing any particular prescriber trends for tableau, thus far.
And then in terms of payer coverage should we expect any changes for 2022.
Jason I'll hand back to you again.
Sounds good.
In terms of prescriber trends Rohit, we see consistent increase month after month.
And as we said previously what we are seeing is that.
Physicians as we are connecting with them. They are as we educate them on the Fintech lab and the transformational efficacy in Dravet syndrome.
As they get comfortable with the process of the ramps as well as the impact zoogenic centrally they start using the product and once they start using the product it kind of snowball. Some that so we're getting good response from them and we are not only getting prescriptions from the pillar <unk>, but.
Currently available treatment if the therapies approved.
Yes, thanks for your questions I'm going to ask Ashish, you're going to take the first two.
Yes.
So as said I think in terms of the prescriptions from new docs as we add more physicians majority of them are community neurologist as you can imagine.
The all Lf Electrologist, who were part of our clinical trials and at the last centers that already prescribing the product cannot have signed up for the Rems program.
Every new prescriptions that are every new physicians that we are bringing in there coming from this covenant and neurologists.
And also from centers because.
Quite frankly, there are many centers.
There, we did not have access to physicians for <unk>.
A long period of time because of Covid I think slowly opening up and as we make inroads that we've seen prescriptions from that.
As far as your second question on the drop off.
Usually it takes around five months on average.
Ranges between four and six so the patients who have dropped off the try the product for at least five months between four and six.
And then the time to reach the maximum dose that they can tolerate and see the impact.
One great thing about enterprise that as you escalate the dose it will start working for you, but if it doesn't you will know that pretty quickly and I think that has been the range that we have seen and usually they stay on the therapy for that long and then they decided to drop off and majority of this drop offset because the product did not work.
For them.
And when you take that out.
The patients who have started the therapy there are still other therapies. So we have patients who started <unk>.
Last.
August when we launched the product they are still on therapy and we also have majority of the patients who are part of our open label extension and the <unk>.
Expanded access program still under therapy. So the average duration is much much longer at this point in time.
42.
I'll hand, it over to Brad.
Alright.
Hey, this is laughlin once again, thanks for taking my questions. So I was wondering.
Well it sounds like potentially several launches across the European market next year do you already have the commercial infrastructure, you'll need in those markets in place or you gotta be building.
You sort of get closer to the reimbursement decisions. There and then secondly, I was wondering for the C. D. K O. Five study are you comfortable sharing any details around the powering cause that and maybe somebody assumptions you use that.
I can take those for you.
Respect to powering we haven't route constantly talked about that but.
The type of hiring that we used for observation drawings.
What I would need you as opposed to the power that we needed for algae as the reason for that is that C. D. K O. Five is a moment genetic epilepsy very similar to Turvey syndrome, and we feel comfortable with the M. Equals 40 per group that had significance.
Answer just remind me of your first question again.
I was wondering which I think you said you had eight eight.
<unk> market in Europe reinvestment in fact, yes, if you already have the commercial infrastructure built adding those countries are you going to be building that out between now and when you are.
Yeah.
We're going to play in preventing went to stage approach. So we have.
Certain functions retro centralized.
An important for Europe based in mainland as in the UK and then we are building a presence in various countries.
And when the product becomes commercialized day.
So for example, today, we have a presence in Germany, where we've launched at the beginning of issues. You know we have about 10 employees in Germany and is probably the largest country offers to be will have in Germany.
So we will sort of buildup this country presences once we have reimbursement.
Proved.
Great. Thanks.
Thank you for your questions.
I see.
Describe is that were enrolled in the Rems program and approximately half of those were right.
Writing prescriptions poultry and topline.
Okay great.
Right.
Thank you for your questions.
Once again, if anyone has a question. Please press star one to join the question queue.
Our next question is from Allison <unk> with Bank of America. Please go ahead.
Hi, Good evening. This is <unk> Patel on for Jason Thanks for taking my questions. So first on the lgs filing for <unk> with a few weeks left ahead of the 60 day deadline to get priority review I just wanted to hear your thoughts on what degree of confidence do you have that you'll be granted the priority review.
And then I also wanted to ask with regards to getting new physicians Rems certified if you could quantify the number of docs certified at the end of <unk>.
And so it.
It looks like you had a 720 you just mentioned at the end of <unk>. So how likely are you to meet or even exceed the goal of 1400 by year end.
And given you've mentioned identifying and adding more prescribers cheered polyps as well and then finally on M. T. One six to one I just wanted to get your thoughts on the path for a market for that asset and what can you tell us about any data that we can expect that event next Monday.
<unk>.
Hey, Thanks for your questions.
If you'd like to take the Dow Jones' question sure.
As you know the granting of the priority review is an FDA decision.
And there are a number of other products that are.
Proved for Lgs, However, I'm listening to the patient community. There is still great unmet medical need among the community to have better treatment options and sometimes with a unique mechanism of action would provide a brand new alternative importantly, this study the lgs pivotal study.
Meets the requirements for the pediatric written request from FDA and the standard review time for submission in response to a pediatric written request is six months. So we believe that we would be granted or have a good chance of having granted the priority review timing.
Because of his response kind of characterization.
Hmm.
Sure.
Just.
Tracy.
I misspoke members 35 brokers in the Rems program.
Some of them over several years 'twenty at the end of September.
For Q3, but maybe the streets you can talk about what we're doing to increase the number of.
Prescribers entered the Rems program.
Yes.
Any data that we can expect at the event next Monday.
Thank you yeah. Thank you.
<unk>. Thank you for allowing me to advertise I won't give it all away, but b a K well one from you want some one from Europe, both who are investigators will be showing their own patient videos pre and post treatment, which are you will see when viewing uhm quite impressive in addition, I'll be presenting presenting.
Some non survival data, but in addition, as I mentioned to study one O. Seven is delayed till next year and also will be analyzing the prospective study one O. Two next year it'll be a lot more non survival data as well so a lot more to come to I'll be presenting in the Kols next Monday.
<unk>, a great day to coming out.
Thanks, Thank you.
The next question is Nina <unk> card with city. Please go ahead.
Hey, guys. Thank you for taking my question. So I was just wondering if you could clarify how many patients we're actually on drug actively at the end of September and then also if he could provide the number of total cumulative starts since launch out at the end of September that'd be great. Thank you.
This show I'm about to you.
Yeah, I'll take that set me that we didn't mention on the card the number of patients that we continue to add on a monthly basis, yeah patients and we will continue to do that in the foreseeable future. The focus is for us to get them on the top of the furniture and.
We know that once they are prescribed for.
Almost all of them if not every one of them gets positive determination and be unable to ship the product in two to four weeks.
Because.
In terms of the new patient starts I think that was your second question.
130 started in the in the queue treat and in terms of cumulative stuck that number is well over 860.
Perfect. Thank you.
Yeah.
This concludes our question and answer session I would like to turn the conference back over to Dr. Stephen Farr for closing remarks.
Thank you for joining us on todays call Im, particularly appreciate the questions that you address that you asked this as well I'm very happy to report on a strong quarter with growing to tell the sales the submission of the NDA for our second indication are close to initiating a phase III trial in a third indication for <unk>.
I'm also very pleased to cover empty 16th for anyone today I'm, especially excited to have our first mitochondrial disease focused investor event next Monday, I hope, you're all able to attend this meeting virtually.
Thank you all again and enjoy the rest of your day Goodbye.
This concludes today's conference call you may disconnect. Your lines. Thank you for participating and have a pleasant day.
Yes.
Okay.
Okay.
Okay.
Okay.
Yes.
Yes.
Okay.
Okay.
Okay.
Yes.
Yes.
[music].