Q4 2020 Eyenovia Inc Earnings Call

[music].

Greetings welcome to I know the fourth quarter and full year 2020 earnings call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation the trend.

Anyone should require operator assistance during the conference. Please press star zero on your telephone keypad. Please note. This conference is being recorded on.

Now I'll turn the conference over to your host Eric Whitman you may begin.

Good afternoon, everyone and welcome to <unk> fourth quarter of 2020 earnings Conference call and audio webcast with me today are I know, the Chief Executive Officer, and Chief Medical Officer, Dr. Sean Yeah on Sheila and I know, it's Chief Financial Officer, John Gandolfo, and I know he is.

Chief operating officer, Michael Rowe.

Earlier. This afternoon I had no via issued a press release announcing financial results for the three and 12 months ended December 31, 2020, We Inc.

Encourage everyone to read today's press release as well as I nobody of annual reports on form 10-K for the year ending December 31, 2020, which will be filed with the FCC within the next few days the Companys press release and annual report also will be available on <unk> website at I know of.

<unk> Dot Com. In addition, this conference call is being webcast of the company's website and will be archived for future reference. Please.

Please note that on today's call, we will be discussing investigational products, which have yet to be Christie, which have yet to receive the FDA approval. Please also note that certain information discussed on the call today is covered under the Safe Harbor provisions of the private Securities Litigation Reform Act, we caution listeners that during this call.

Paul I know the management will be making forward looking statements actual results could differ materially from those stated or implied by these forward looking statements due to risks and uncertainties associated with the company's business.

These forward looking statements are subject to a number of risks, including risks related to fluctuations in our financial results volatility and uncertainty in the global economy and financial markets in light of the evolving COVID-19 pandemic.

Our need to raise additional money to fund our operations for at least the next 12 months as a going concern our estimates regarding the potential market opportunity for our product candidates and platform technology and potential revenue from licensing transaction.

Reliance on third parties of the ability of us and our partners to timely develop implement and maintain manufacturing commercialization and marketing capabilities and strategies for our product candidates risks of our and our licensees clinical trials, including but not limited to the cost of design initiation and enrollment which could.

Be adversely impacted by Covid, 19, and resulting social distancing timing progress and the result of such trial of Trialed trials.

The potential impact of COVID-19 on our supply chain, the timing and our and our licensees ability to submit applications for obtain and maintain regulatory approval for our product candidates the potential advantages of our product candidates and platform technology the rate and degree of market acceptance of and clinical.

<unk> of our product candidate and platform technology, our ability to attract and retain key personnel intellectual property risks and other risks related in the and qualified by the cautionary statements contained by it contained and I know the its press release and SEC filings, including its most recent annual report on form 10-K and subsequent.

Filings.

This conference call contains time sensitive information that is accurate only as of the date of this live broadcast March 25 2021.

I know via on.

Undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this conference call, except as may be required by applicable securities law.

With all of that said I'd like to turn the call over to Dr. Shawn I answer that.

Yeah.

Thank you, Eric and welcome everyone to our fourth quarter and full year 2020 earnings conference call.

During the fourth quarter and more recently.

We made significant progress towards advancing our proprietary clinical programs and becoming a recognized leader in the field of ophthalmology.

Most notably we recently announced that the FDA accepted our new drug application for <unk>, our proprietary fixed combination mydriatic for potential use in the over 80 million comprehensive eye exams.

Currently conducted each year in the United States.

If approved not only would meet the combi be the FERC microdose ocular therapeutics applied with our proprietary high precision smart delivery system the off the debt, but it would be it would transition into a commercial stage company.

We have been given unexpected due for date of October 28th 2021 form of Combi and if approved we believe we can effectively and efficiently market in the combi with the small and highly targeted field sales force in combination with the specialty pharmacy network.

Michael will elaborate on this shortly.

We also announced earlier this year that the.

First patient had been the dollar vision of one phase III clinical study evaluating all of the proprietary pilocarpine formulation micro line, which has also delivered via the app to check for the improvement of near vision in patients with presbyopia.

I'm happy to announce that vision, one is now fully enrolled and we're on track to deliver top line results in the second quarter of 2021.

As a reminder price.

The appeal of the age related hardening of the islands', causing blurred near vision. The vision impairment typically begins after the age of 40 and is often corrected with eyeglasses of readers contact lenses or surgery. We believe micro line has a significant market opportunity in that it's estimated of presbyopia affects more than.

113 million people in the U S alone.

Recall that our third clinical program microbial for the reduction of pediatric myopia progression has been out licensed to Bausch health in the U S and Canada. In addition, we have our clients of microphones as well as micro line the Arctic vision in greater China, and South Korea to date. These partnerships have generated a total of approximately.

At least $16 million of upfront and milestone based non dilutive life on seats with the potential to increase to approximately $100 million in gross non dilutive capital once the potential non sales related milestones as well as clinical cost savings of reimbursements of taken into account.

Would one NDA accepted the second phase III program now initiated and fully enrolled that's why with several of our robust development partnerships with ophthalmology leaders established I'm very pleased with our progress from last year and believe we have entered 2020 of along with significant momentum and line of sight the multiple potentially Bob.

Creating milestones.

At this point I would like to kind of the call over to Michael to provide some highlights from our Combi program Michael.

Thanks, Sean.

Shawn indicated we recently announced that the FDA has accepted our NDA from mid Combi, our proprietary mydriatic agents administered via via our Microdose array of French or MIP technology, upon which our opt the jet dispensers base.

The current standard of care for pupil dilation requires multiple eyedrops given at least several minutes. Apart. This can take considerable time and often caused both discomfort and drug overflow prior.

Researchers found that there's many of US 90% of eye care providers reported that they encounter situations, where patients skip the comprehensive eye exam, because they do not want to undergo an uncomfortable pharmaceutical pupil dilation procedure. So.

So we believe there is significant need for an improved process of pupil dilation to help make sure that everyone, who should have a comprehensive exam is more willing to get one.

Additionally, in the age of COVID-19, there is greater sensitivity to the usual practice of sharing conventional droppers of pupil dilation medication across the number of patients the.

The Combi was developed with the goal of providing a touchless fixed combination microdose formulation designed to improve the hygiene related to the process of pupil dilation and improve the efficiency of the process. The optics of is designed with no protruding parts, which may help prevent accidental touching of the ocular surface to help reduce.

Use the chance of cross contamination between patients.

The Maccabi NDA submission was based on the phase III mist, one and mist two studies in these two studies of fixed combination of Microdose tropicamide, 1% and feed all of that from two five per cent of ophthalmic solution met the study's primary endpoints and was shown to be safe and effective for pharmacologic mydriasis.

Approximately 94% of treated eyes achieved six millimeters or greater dilation of 35 minutes post installation advair.

Adverse events were infrequent with fewer than 1% of <unk>.

Patients reporting blurred vision reduced acuity photophobia or installations like paint the.

The study results were recently published in the peer reviewed journal therapeutic delivery and are available online and in open access format.

We have received an expected <unk> date of October 28, 2021 from a coffee and have the kind of measure of the investments in our U S. Commercial infrastructure, we are designing our commercial launch of the combi the be highly efficient if and when we receive that approval.

To take a moment here and explain what we mean by inefficient commercial launch of the Combi.

Mid continent, the diagnostic pharmaceutical Houston eye exams. The product is not prescribed the individual patients nor is it dependent on formulary acceptance or reimbursement. It is typically purchased by the practice on behalf of all doctors in that practice.

And through our recently announced the agreement with episodic would be distributed through a streamlined system, making use of e-commerce and real time sales data if our commercial launch of successful it would eliminate the need for a large conventional sales force and detailing which can in some cases require about 100 salespeople and.

Related infrastructure.

We expect our launch on the other hand to be led by approximately 10 account managers, who will focus on the largest practices on the largest population centers of the U S and expand further once those practices have incorporated mid combi into their process with our planned commercial launch we estimate that we can get to approximately 50% of the pace.

The volume in the U S. By the end of 2022, we plan to have our sales force launch day ready. So we can work on capturing our addressable market as quickly and efficiently as possible.

We also are exploring partnerships with organizations that already have significant reach and presence into these offices to augment the work that our own account managers will be doing.

It is worth highlighting that we believe the value proposition of the comp each of the ophthalmologist or optometrist is very compelling on it.

Comparable cost of what Theyre spending today with the use of the Combi doctors can prepare of patient for a comprehensive eye exam faster than conventional mydriatic drops potentially resulting in reduced patient chair time, and greater office throughput. This couldnt term turn improve the practices bottom line, we believe the copies.

Value proposition, coupled with our targeted distribution strategy will help drive the success of our commercial rollout Needless to say we are excited about the potential of been combi to disrupt what we estimate to be approximately $250 million market.

We look forward to meeting with the FDA later this year if approved the copy would be our first commercially available product and a significant milestone for our company.

With that I'd like to turn it back over to Sean.

Thank you Michael.

As I did last quarter I would like to take a step back for adults, who may be new to our story on.

Two Japanese all of proprietary micro dosing technology designed for optimal drug delivery to the line. It utilizes microdose array of print technology similar to an inkjet printer and horizontal delivery to administer a physiologically compatible sells to the cornea of the line.

Studies show that the conventional eyedrops can overdose the eye.

The as much as force called.

Leading to unwanted side effects and the unnecessary exposure to access drug preservative that can be harmful. The <unk> has been shown to achieve comparable efficacy to standard I dropped the oldest with approximately 75% less medication. We believe both patients and clinicians are comfortable using the app the jet.

Prior studies have found that approximately 95 per cent of clinicians and 88% of patients were able to successfully administer medication using up the debt on the first attempt.

This compares very favorably favorably to Eyedropper, where multiple published studies have shown that fewer than half of the users are able to administer medication successfully on the first the 10th.

Before turning the call to John to review the financials I would like to conclude with the review of our Phase III Micro line program for the improvement in the near vision in people with Presbyopia.

Presbyopia, which is the non preventable age related hardening of the ocular lens, causing gradual loss of the is the ability to focus on nearby objects.

An estimated 113 million people in the U S.

In the hundreds of millions more in China, where we have already licensed the product of the Arctic vision.

We recently announced the initiation of the vision of one study and anticipate data sometime in Q2 of 2021.

We plan to follow this up with the initiation of vision to potentially by the end of the year subject to COVID-19, and other factors in which we intend to test the higher dose of pilocarpine to further assess the.

The tolerability and determine if the reason adult depend on the response.

There is growing interest from drug treatment for presbyopia currently the only option for dealing with the presbyopia, our eyeglasses consequences of surgery.

Our own market research showed high interest among our target market for a drug treatment that could provide on demand improvement in near vision.

The core line it would be of companion product to eyeglasses for the.

Those times when patients would prefer not to wear eyeglasses the market potential for an on demand improvement of near vision may be significant.

In the U S alone, we estimate this opportunity to be in excess of $7 billion.

Pilocarpine is the compound whose efficacy in improving near vision of Hasnt been the well documented.

What sets us apart from the competition and my opinion is the optic trial.

If micro line is approved we believe our technology will facilitate accurate and targeted dispensing of pilocarpine without overdosing di <unk> comment on with conventional eyedropper.

A century old technology used to administer other companies therapy.

We believe the increased portability comfort and safety of.

<unk> by the <unk> are among our important differentiators as we advanced our development program.

This is a very exciting program for us and we're pleased to have initiated enrollment in vision of one.

I'd now like to turn the call over to John to review our financials John.

Thank you Sean.

Now I would like to review our financial results for the three and 12 months ended December 31 2020.

But the fourth quarter of 2020, we reported a net loss of approximately $4 $2 million or <unk> 17 per share and this compares to a net loss of approximately $5 $2 million with 31 per share from the fourth quarter of 2019.

For the full year 2020, net loss was approximately $19 $8 million or a loss of 94 per share and this compares to a net loss of approximately $21 $2 million from $1 47 per share for the full year 2019.

Revenue for the fourth quarter on full year of 2020 was $2 million. This revenue represents a milestone payment related to wear of exclusive collaboration and license agreement with the Arctic vision.

Which was announced in August 2020.

We did not recognize any revenue in days of the fourth quarter of full year of 2019.

Research and development of expenses totaled approximately $3 4 million for the fourth quarter of 2020, roughly flat with approximately $3 3 million for the same period in 2019.

For the full year of 2020, R&D expenses decreased 6% to approximately $13 3 million and this compares to $14 $1 million for the full year of 2019.

For the fourth quarter of 2020, G&A expenses were approximately $2 $1 million compared with approximately $2 million for the fourth quarter of 2019, an increase of approximately 5%.

For the full year of 2020 general and administrative expenses increased 7% to $7 $7 million versus.

First is approximately $7 2 million for the full year 2019.

Total operating expenses for the fourth quarter of 2020 were approximately $5 4 million and this compares to the total operating expenses of $5 3 million for the same period of 2019.

This represents an increase of 2%.

Fourth quarter of 2020 operating expenses included approximately $656000 of noncash stock compensation expense.

For the full year of 2020 total operating expenses decreased 1% from approximately $21 million compared to $21 3 million for the full year 2019 'twenty.

2020 operating expenses included approximately $2 5 million of noncash stock compensation expense.

As of December 31, 2020, the company's cash balance was approximately $28 $4 million. We believe this cash balance of cash received in the first quarter of 2021 from the milestone payment as well as Warren exercises the sufficient to last us into the middle of the first quarter of 2022.

And will enable us to bring on the copy of the dry on the.

The dry from products through the NDA process and commercial launch in addition to completing the <unk> clinical program from Micron line and preparing our pilot manufacturing capabilities for advanced the standard technology.

Concludes our financial statement remarks, so I'd like to turn the call back over to Sean share.

Thank you John Thank you.

We're very pleased with our performance during the fourth quarter and full year kind of 'twenty and subsequent period to summarize our key highlights of today. We anticipate on October 28, 2021 could do for date for our mix from the NDA, which gave approved gives us the.

Our first commercial product.

We're rapidly advancing our phase III Presbyopia program in an estimated multibillion dollar of indication and anticipate data from our first of two phase III studies in the very near term and our licensing agreements with the Arctic vision and Bausch health are progressing well and continue to offer the potential for meaningful development and the regulatory bodies.

On <unk>.

Non diluted funding that if realized we plan to use to among other things expense and advance our pipeline of novel Therapeutics, leveraging our <unk> technology.

All of them.

We believe we are well positioned to achieve multiple commercial regulatory and development of catalysts in 2021 aimed at creating long term value to our shareholders.

That concludes our prepared remarks, we would now like to open the call for any questions operator.

At this time, we will be conducting a question and answer session. If you'd like to ask the question. Please press star one on your telephone keypad. The confirmation tone will indicate your line is in the question queue.

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One moment, please while we poll for questions.

Our first question is from Tim Chiang with Northland Securities. Please proceed with your question.

Hi, Thanks.

Sean with the vision one study.

Addition to the primary endpoint.

Are there any secondary outcome measures that you.

Measuring here in the study.

You'd be able to present any of that data.

In the second quarter as well when the.

The study of compute.

Yes, so I think it was a little faint tahira I'll guess the your question just the repeat it for everybody I hope everybody can hear it is the.

Whether we have any additional endpoints. In addition to the primary endpoint of the wider we're collecting the other data.

And yes. The answer is we are collecting a lot of data we have secondary endpoints of exploratory endpoints with swell.

This trial will provide a wealth of data for us.

As you know this is a phase three phase three study with two doses.

We are really anticipating the data to see how that the.

Does the with the op the jet.

We will be able to be quite informed from this vision of one study before we proceed with the vision to study Les.

Later in the year. So yes, the answer is yes.

Now to your question about when we'll present the data.

We will just have to.

See how how that parts of the with our publication strategy.

Of course Oh.

This probably will be done in synchronization with our registration efforts and probably not ahead of that.

I see.

And maybe just one follow up.

Kind of the mid con the produce the data I think you guys.

Announced that today September 28th.

You know at what point do you think you'll need to bring in the.

The sales of the specialized sales people.

We'll probably be most likely in the in the third quarter or will it be.

Before that.

Yes, so I will let Michael Yeah, I'll, let Michael it's related but I think one of the of parts of his presentation today was really to educate folks on on really how we plan to launch. This this is not of launch where we act on our goal of Blackstone with 80 reps, partially because this is the knock EUR.

Traditional commercial so the beauty, where it's prescribed one by one from one doctor to one patient, but we have some really.

Mass purchasing distribution advantage it's here.

And this would allow us to do it all the way the professional sales force and really do it in a very cost effective way most people probably think about a commercialization in ophthalmology typical to other companies, where you would have to really bring in a big cost overhead. We are not looking at that this may have.

On down when we go down towards micro line.

A few years later.

Where this would be justified, but mid combi as of really perfect way to introduce the technology Prime the market and at the same time to do it in a very cost efficient the way. So maybe Michael you can answer that in more detail.

Well the only thing I would add for Tim is that.

We don't anticipate bringing antibody on board before August.

And they would be here on.

August September start to be here August September in preparation for the approval.

At the end of October and we would be using that time to work with them and our medical affairs people.

To educate potential customers on the technology, so that when we do get the approval it becomes that much faster for us to get the uptick.

Okay great.

We look forward to seeing the data in the second quarter and Michael the line.

Thanks very much.

Certainly thank you.

And our next question is from Matt Kaplan with Ladenburg. Please proceed with your question.

Hey, guys. Thanks for taking the questions.

And congrats on the.

The recent progress.

Just starting off maybe a question from Michael.

As you as you're kind of nearing the day for day at the end of October can you give us a little bit more sense in terms of your recent agreement with adverse on on how that fits into your marketing plans and commercial client strategy for the the Combi.

For the on the launch.

Yeah, and thank you very much for the question.

What we're doing is all under the the philosophy, because we wanted to be as efficient as possible and not build up.

In the infrastructure of that that.

Of that we're not going to have the feed.

So the idea of with ever Sun is that they can take over things like invoice.

Invoicing and billing and customer service and shipping and basically save us from having to have those things in house. So basically what we will keep in house or the the key account people because we believe they need to have specialized knowledge about the technology, which of general sales force with.

<unk> not have and they can do a better job of that but everything else. Once that product is ordered in the b all online use credit cards again to keep it as simple as possible.

That will go through episodic so basically outsourcing that entire section of what we would normally or what the company normally would have in house, we won't have to build on ourselves.

Okay.

Do you see yourselves force kind of initially having kind of a very hands on.

Approach in terms of teaching the doctor's offices to use the device.

On an approach it that way.

What's your strategy there.

So the strategy is it would be hands on it doesn't take a lot to educate them on how to use the product and takes about 15 minutes.

But we do believe you need to be able to touch and feel it.

Two to really get the best experience with the product. So the idea would be that our key account people would go into the practices and work with the technicians, who most often they are the ones who actually do the pupil dilation in the office managers. They are the ones that do the ordering and the doctors in the on do have the final say, but they would.

Go in there they spend a lunchtime showing them how the dispenser works and what the advantages are and how to use it and then they'd likely leave one for.

The revaluation for three or four day, so they can actually use it on 75 patients.

And then come back and hopefully because we'll be delighted by then complete the sale.

Great Thanks and.

And then maybe a question for Sean.

Anticipating the potential success for.

The micro line and the isn't one Kevin given the pilot cartoons success.

And the syndication are ready.

What are your plans for of vision to the vision two study.

And how that should take shape in terms of maybe timing and then any differences you're foreseeing versus vision one.

Yeah, Matt. So this was the this is the very good question and maybe its in terms of background. If you remember initially even before Covid. We were planning to do vision of on envisioned to at the same time I think COVID-19.

This intermediate at that plan, a little bit and also when we looked at it it actually made sense.

To learn from vision, one maximum we can and then apply it to vision two because again this is a really new indication.

There is a whole lot of companies rushing into that we know there were two positive phase III studies from.

Allergan Abbvie in with the same compound, but we haven't even seen data yet. So I think we wanted to take a more measured approach, where we really learn step wise.

The plan here is really to get quickly comfortable with the vision of <unk> data in Q2 of next year of Qsymia and very quickly by the end of the year in raw with Paragon initiate enrollment of the <unk>.

Vision two study.

And again vision, two will not be materially different.

From vision, one we're still looking.

For the indications for on demand improvement of the near visual acuity. So a lot of the endpoints will be the same.

We made down select the dose from the vision one dip.

Depending on the results. So I think it will be hard to say exactly what we will do accept that it's gonna be very very similar we hope that this will be of positive study and would allow us to launch of vision to promptly by the end of the year and if that happens I think we will be able.

To execute very similar to vision, one ginger and her team did a phenomenal job in the midst of Covid pandemic site closure and.

And everything else, we were able to launch the study operationalize it execute in fully in the Raleigh as we disclosed today. So I think that we're gonna be looking hopefully for a very similar cadence of very prompt the enrolment.

We have so many patients I mean, that's the beauty about this indication there's just so many patients available, it's such a big opportunity and patient population and patients and science of ecstatic about not just the being able to be.

Free of hardware and changed the treatment paradigm for Presbyopia day really ecstatic about the new technology, where you don't have to have the overdosing to the eye redness and really use the very antiquated paradigm with the.

With the Eyedropper to you something very modern and smart so I think for US we don't foresee any issues.

We design and push the button to launch of vision to hopefully by the end of this year to really get very quick results provision too as well.

Great. Thank you and now definitely impressive execution by our clinical team given the backdrop of the pandemic. So congrats on that.

Thank you Matt.

Our next question is from Jonathan the Astral with Roth Capital Partners. Please proceed with your question.

Thank you I was wondering even though you were talking about mid comedy not being sold to individual patients.

Is there any way that it could somehow still be used off label in amblyopia.

Do you expect any news from that setting.

Right. So when you say mid Combi.

Used for amblyopia.

The first.

The company will never.

On a really encourage off label use in any.

The way.

The second I think.

The politically today the way amblyopia is treated is by.

By use of atropine.

Not by use of a fixed combination.

And the lesson of Tropicamide.

So again, we don't really know I think that.

The response to meet Combi.

And to the technologies is huge people really don't understand how.

How game changing that is for the eye exam.

Today, which hasnt changed in almost 100 years.

And transitioning from two or three drops to a single pray that the.

It really kind of alleviate a lot of the discomfort.

And problems with patient of experiencing that.

I'm not I'm sure doctors and people clinicians out there who are very creative may find different applications.

Certainly I know via will support them.

In that as the throw a registration pathways such as the part of the lifecycle of expansion, we fine but for now we're really focused on on the market and when the Michael says, it's the $250 million market. It's the $250 million market, assuming we're really on parity price parity with the.

With the conventional paradigm and were not dramatically moving the price target, which which may be very different once we have a very successful product and we find out of that debt market can be reenergizing of major way.

And after all you have to sell mainly dilation is happening every every year here, but who knows what the conditions were suggesting we'll certainly be listening to the marketplace out there.

Yeah.

Actually how clear have you been with what Youre pricing your initial pricing will be from mid comedy.

Yes, Michael do you want to address that.

Yes, so and thanks Jonathan.

No that.

With doctors are spending of our officers spending now for the the two drugs that they currently use is somewhere around a dollar per dollar in the half.

For patients and we've said that we're going to be very close to that we are anticipating of price of about $100 of cartridge and a cartridge.

Should treat at least 75 patients so from an out of pocket expense for the practice it should not be an issue.

Okay. Thank you very much guidance Youre welcome.

And as a reminder, if anyone has any questions you May press star one on your telephone keypad doing so ensure that you join the question queue. Our next question is from linear free which Doc Doc partners. Please proceed with your question.

Thank you very much and I think this is the first conference call that you've had since.

On the promotion of Mr wrote the CLO. So I just wanted to commend you on that new responsibility for him.

My question is when we get the results from vision, one we'd be getting results similar to the Allergan endpoint of improvement of near vision in low light conditions without a loss of distance vision or will it just be a subset of that.

Yeah the land.

And again, it's a really timely congratulations on that we're very excited about the grades of responsibility.

Well from Michael and then that's the great I'll, just let him answer that question.

[laughter] alright, thank you doctor of Doctor.

The results that we're going to have available in the second quarter will be top line will be very similar.

Two the results that have been presented by Allergan and we're also going to take a special look line.

On the side effect profile.

We have a strong history in clinical studies of demonstrating that by using our technology you can get similar effectiveness and much better tolerability and we're hoping and looking forward to being able to see that in the presbyopia trials one of the things that's held back pilocarpine.

As an eye drop for presbyopia is that it's known to have a a brow ache or headaches side effect of about 20 per cent of patients and we believe in our market research shows us that if we can significantly improve on that.

You would do a lot to encourage the uptake and eventually choosing the microdose products our product in the off the jet over a traditional eyedropper.

Yes, I think the.

On your dosing.

As I.

I think on either side of the Allergan dose, but you deliver last I was wondering of pilocarpine. The two doses you've chosen I was wondering if you could comment on that and secondly, I think that it's an important point given that there is a non medical.

Need.

Core of Presbyopia.

Presbyopia drug and there are alternatives that can be used such that if the patients are experiencing.

Any discomfort of any consequence, the very likely to revert back to eyeglasses or contact lenses.

I think the that bears.

The great understanding thank you.

Yes, certainly on that second part we would agree that people don't want to pass the field types of their reading glasses, all of the time, but they're not willing to trade that off for the.

On the potential of the headache or a rally so we're looking forward to coming in.

Pretty clean on there and as far as the dose itself.

We did one per cent and 2% because we wanted to see if we could push up efficacy without.

Without reducing the Tolerability and we think we can do that we didn't choose an intermediate dose.

Because unlike with eye drops we don't have to worry about being substituted with the generic medications. So if I was an eye drop and I have a 1% pilocarpine for presbyopia.

Easily be substituted with of 1% pilocarpine thats used in glaucoma. So to avoid that I will go to of 125 per cent for example, pilocarpine and that's how I get around that from a substitution point of view, but because we cannot be substituted in that way, it's not something we need to worry about.

Great. Thank you.

Thank you.

Yeah.

We have reached the end of the question or section and I will now turn the call over to Sean the Angela for closing remarks.

Yeah.

Okay.

That concludes the call today, Thank you again for joining us.

We look forward to our first quarter 2021 financial update in May.

And I hope everybody has the good afternoon. Thank you.

Okay.

This concludes today's conference and you may disconnect. Your line at this time.

You for your participation.

[music].

Okay.