Q3 2020 Eyenovia Inc Earnings Call

[music].

Greetings and welcome to I know the EPS third quarter 2020 earnings call. At this time all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad.

As a reminder, this conference is being recorded it is now my pleasure to introduce your host Eric <unk> Investor Relations. Thank you you may begin.

Thank you and good afternoon, and welcome to I know via third quarter 2020 earnings call and audio webcast with me today are I know Visa's, Chief Executive Officer, and Chief Medical Officer, Dr., Shawn I into that I know Visa's, Chief Financial Officer, John Gandolfo, and I know he is vice president of commercial.

Michael Rowe.

Earlier this afternoon I it'll be a issued a press release announcing financial results for the three months ended September Thirtyth 2020, we encourage everyone to read today's press release as well as I know he is quarterly report from 10 Cuprum. The form 10-Q for the third quarter of 2020, which will be filed with the FCC.

The company's press release and quarterly report will also be available on <unk> on I know via its website at <unk> Dot Com. In addition, this conference call is being webcast through the Companys website and will be archived there for future reference. Please note that on todays call, we will be discussing investigational products, which have yet to be.

Which have yet to receive FDA approval. Please also note that certain information discussed on the call today is covered under the safe Harbor provision of the private Securities Litigation Act, we caution listeners that during this call I know, we as management will be making forward looking statements actual results could differ materially from those states.

Good or implied by those forward looking statements due to risks and uncertainties associated with the Companys business. These.

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 Koby 19, pandemic and uncertainties arising from the U.S. recent U.S. elections.

Our estimates regarding the potential market opportunity for our product candidates and potential revenue from licensing transactions reliance on third parties, 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 clinical trials, including but not limited to the cost design initiation and enrollment which couldn't be adversely impacted by cobot, 19, and resulting social distancing Todd.

Timing progress and results of such trials.

Hi, I'm such trials the potential impact of COVID-19 on our supply chain, the timing and our ability to submit applications for obtain and maintain regulatory approvals for our product candidates the potential advantages of our product candidates the rate and degree of market acceptance and clinical utility of our product can.

That AIDS, our ability to raise additional capital our ability to attract and retain key personnel intellectual property risks and others are detailed in and qualified by the cautionary statements contained and I know be its press release and SEC filings, including the 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 November 10th 2020.

Nobody is I know the 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 that said I'd like to turn the call over to Dr., Shawn I into live.

From I know [laughter].

Thank you. Thank you, Eric and welcome everyone to our third quarter 2020 earnings Conference call.

During the third quarter and more recently.

We continued to solidify our business position through both new strategic partnerships and our proprietary clinical programs.

We believe that together these activities have positioned us for continued success as we ramp up our manufacturing capabilities.

And prepare for our first commercial product launch.

Starting with strategic partnerships to date, our business development partnerships have provided a total of approximately.

14 million of gross non dilutive capital in 2020.

With the potential to increase to approximately 100 million in gross non dilutive capital once you consider potential non sales related milestones.

As well as clinical cost savings or reimbursements.

During the third quarter, we signed an agreement with Arctic Division for the development and commercialization of micro pin for Progressive myopia and micro line for presbyopia for greater China, and South Korea.

More recently.

Well, we signed an agreement with Bosch help for my cooking in the U.S. and Canada.

These agreements build upon our long standing partnership with Sandra Pharmaceuticals, covering Japan, and the rest of Asia, and we believe provide further validation as to the value of our robust phase three pipeline and innovative Mike riddles delivery technology.

Our clinical programs, which are directed towards high value markets with the first in class treatment.

We have also made significant positive progress.

Our chaperone program for Progressive Myopia, which is being transitioned to ball shelf addresses at high risk pediatric market of approximately 3 million children into U.S., along with a potential value exceeding multiple billions of dollars.

The marketing, China, maybe equally large due to a patient pool that some estimate could be as much as eight times greater than that of the U.S.

Our vision program for improvement of near vision targets, the approximately 113 million presbyopia adults translating to a potential market value that we estimate that about $2 billion.

And our recently completed missed probably delivering positive phase three results as we prepared the new drug application for microscopic <unk>, Colombia may provide benefits that address a need for touchless comfortable effective and efficient triple dilation, you know world concerned about called mid 19.

The common thread among all three programs is our opt teacher my core dolls, IRET <unk> technology, the optics that we didnt touch lists.

Our digital health capability is designed for safer gentler and more precise delivery to give patients the best in class therapeutics they deserve.

With two strategic partnership.

Partnerships and pending Anda submission a unique program for presbyopia in late stage development as well as a platform technology from which we're working to develop new therapeutic indications.

We believe I know via is well positioned to enter 2021.

Significant momentum and a line of sight to milestones that could create incremental value for our shareholders.

At this point I'd like to hand, the call over to Michael to provide some highlights from all the strategic partnerships Michael.

Thank you Shawn and greetings from our R&D and Engineering Center in Reno, Nevada.

During the third quarter and also more recently, we executed on the strategy to out license, our technology and our micro line. The microbiome programs the partners, who could potentially provide greater commercial reach that we put on our own.

The first of these partnerships is with Arctic vision, a leading up the only company in China, who obtain rights to develop and commercialize both microbiome than microturbine in greater China, and South Korea.

The second more recent agreement is with Bausch else. They division a bell Shalom, who licensed the rights to develop and commercialize microport and the U.S. in Canada is important to note that we have retained the rights to both of these programs in Europe and the rest of the world outside Asia, including Australia, South and Central America among other territories.

Myopia is among the most common ocular disorders worldwide and are a leading cause of visual impairment and children.

In the United States Myopia is estimated to affect approximately 25 million children with up to 3 million consider to be a high risk for high myopia in China. The number of children a high risk maybe eight times higher.

Upon signing a licensing agreement with Bell shelf, we received a 10 million upfront payment and bell shelf assumed oversight and costs relating to the ongoing chaperone phase three clinical trial recall that the chopper on trial is a randomized double masked clinical trial targeting enrollments up more than 400 children between three and 12 years.

Stage.

The trial is assessing the safety and efficacy of low dose after being delivered than the opposite the Spencer for the reduction of progressive myopia apart.

The primary efficacy endpoint is the change in refractive error from baseline through 36 months.

Enrollment resumed in late June following a brief pause due the cobot Vijay.

Chaperone, there's a large long term trial and the assumption of the trial execution and cost by Bausch health potentially creates millions of dollars per year in savings for our company that we can channel into our micro line phase three studies as well as other development activities to evaluate new therapies, leveraging our micro dosing technology.

In addition, we are eligible to receive up to $35 million and payments from Bell shell based on product approval and commercial launch based milestones as well as tiered sales royalties ranging from mid single digit to mid teen percentages of gross profit on sales of Mike replied in the U.S. and kind of.

The Bell shelf transaction transaction can just 60 days after we signed with the Arctic vision agree about the rights the micro pipe as well as micro Biden in greater China, and South Korea together. These two agreements could represent potential upfront payments non sales related milestones and product and clinical development cost savings or reimbursements.

Approximately $100 million, we continue to evaluate other strategic partnering opportunities for additional indications outdoor territories as we believe partnerships could be an important contributor to our long term growth going forward now.

Now I would like to hand, the call back to Sean to provide an update on our ongoing clinical activities Shawn.

Thank you Michael at this point I would like to provide a brief update on our clinical programs before turning the call over to John through the financials.

Taking a step back for those of you who may be new taller story up to jet is I know it is proprietary micro dosing technology designed for optimal drug delivery to the eye.

It's utilizes my credentials are right print technology, similar to an inkjet printer and horizontal delivery to administer a physiological it compatible dolls to calling out the <unk> studies show that conventional eye drops can over dolls, the eye by as much as four fault, leading to unwanted side effects and unnecessary.

Over to access truck and preservative that can be harmful the opt to jet has been shown to achieve comparable efficacy to stardom eye drops and those that are approximately 75% less medication.

We believe both patients and clinicians are comfortable using d. off the jet prior studies found that 95% of clinicians and 88% of patients were able to successfully administered medication using opt to jet on the very first attempt. This compares very favorably to I. droppers, where multiple published studies have shown.

On that fewer than half of users are able to administer medications successfully on parts to them.

Importantly, the up to jet was designed we'd know protruding parts.

And cannot touch the ocular surface.

These are among the top the jets important differentiators, particularly in the age of COVID-19, given the ease with which the infection has spread.

Last quarter I summarized just a few of the publications highlighting the risk of called it spread you know last homology optometry examination room.

The standard of care Eyedropper was found to touch the ocular surface more than 50% of the time.

And in the typical clinicians offices for example, a standard Eyedropper sold dilating drops maybe use on literally dozens of different patients. This presents a risk whole cross contamination and an important issue that must be addressed by clinicians against the backdrop of the called the 19 pandemic.

D. opted jet has a reset delivery aperture as well as non gravity driven horizontal sprayed dispensation, which is designed for a more distant missed delivery.

In addition, we reported last quarter that the opt to jet appears to be qualified for preservative free multi dosing. So we believe the up to jet could address the cross contamination risk associated with Chad Droppers, well also replacing therapeutics that are delivered in single dose packaging, thereby cutting down on costs and waste.

Let's turn to our two clinical programs Michael.

Michael Unstoppable pharmacological addresses.

Microwave for presbyopia.

Beginning with micro stop our so called mid Columbia going forward based on our two positive phase three clinical trials missed one and two we continue to work toward submission of an M.D.A. by the end of this year.

Pharmacologic mid rise has been first to the dilution of the people that it's part of any comprehensive eye exam. It.

It is estimated that 18 million ounces based comprehensive in diabetic eye exams, and 4 million of standing surgical dilation performed annually in the United States and Pharmacologic Midrise is essential for diabetic retinopathy, glaucoma and retinal disease screening mid.

Mid Columbia with some to achieve mid rise is of greater than six millimeters in 93% of patients at 35 minutes pulse. Adults. This is clinically meaningful for both coffees retinal exam its all a surgical dilation.

If approved.

When it comes to you would be our first commercial product a critical milestone for Inovio Mitch.

Mitch, Colombia will introduce physicians and patients to the ultra dispenser and potentially generate incremental interest in the outage at four additional therapeutics. We believe this is an approximately 250 million market into U.S. alone based on interviews and cataract surgery statistics.

Finally, we could not be more excited about our phase three micro lending program for the improvement in near vision in people with Presbyopia Presbyopia, which is the non preventable age related hardening of the ocular lynch, causing the gradual off of the eyes ability to focus on nearby object affects an estimated.

130 million people in the U.S. and hundreds of millions more in China, where we've already licensed the product Arctic vision.

We believe that there are 31 million people in the U.S., who formed the sweet spot in the market for pharmacologic treatment of presbyopia, mainly those adults between the ages of 40 and 60 who are.

Otherwise never had to wear glasses before.

We anticipate initiating diffusion along studies this year with the first three out of the phase three data sometime around the end of Q1 of 2021 subject to any impact of carve it.

There is a growing interest in drug treatment for presbyopia currently the only option for dealing with presbyopia eyeglasses consequences or surgery, our own market research old high interest among our targeted markets for a drug treatment that could provide on demand improvement in near vision.

Mike line would be a companion product eyeglasses for those times when patients would prefer not to where I glass. It the market potential for an on demand improvement in near vision may be significant in the U.S. alone. We estimate this opportunity to be in excess of $2 billion.

Oh, a vision program will test two different doses of pilot Carping, a compound <unk> efficacy and improving your vision was validated once again, when our gun announced positive data from its clinical trials in presbyopia, a few weeks ago, what sets us apart in my opinion is the empty jet if micro.

The line is approved we believe our technology will facilitate accurate and targeted dispensing a pilot carping without overbuilding de <unk> as is common with conventional I droppers.

A century old technology used to administer other companies therapists.

We believe the increased portability comfort and safety offered by the opportunities that will be among key differentiators is our development program advances.

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

Thank you Sean now.

Now I would like to review our financial results for the three months ended September Thirtyth 2020.

For the third quarter of 2020, we reported a net loss of approximately $5.1 million or 23 cents per share and this compares to a net loss of approximately $4.6 million or 29 cents per share for the third quarter of 2019.

Research and development expenses totaled approximately $3.4 million for the third quarter 2020.

This compares to approximately $3.2 million for the same period in 2019, an increase of approximately 5.1%.

For the third quarter of 2020 general and administrative expenses were approximately $1.7 million compared with approximately $1.5 million for the third quarter of 2019, an increase of approximately 16%.

Total operating expenses for the third quarter of 2020 were approximately $5.1 million compared to total operating expenses of approximately $4.7 million for the same period in 2019.

This represents an increase of 8.6%.

It's important to note that the operating expenses included approximately $610000 of non cash stock compensation expense in the third quarter of 2020.

As of September Thirtyth 2020, the company's cash balance was approximately $22.9 million. This.

This includes net proceeds of approximately $12.5 million from a public offering of common stock that we completed in August which included the exercise of the underwriters over allotment option.

Factoring in the $10 million upfront payment that we received from Bausch out our pro forma cash balance as of today is approximately $31 million.

We believe that this is sufficient to bring our mid comedy Midrise product through the N.D.A. processing commercial launch complete I Presbyopia clinical program for Micron line and also prepare our pilot manufacturing capabilities for advanced suspension technology.

This concludes our financial statement remarks, now I'd like to turn.

Turn the call back over to Sean.

John.

Thank you John in closing, we're very pleased with our performance during the third quarter of 2020 and subsequent period, we remain on track to file an NDA by the end of this year and even approved plan to introduce our first commercial product in 2021.

We also have a second therapeutic that should be enrolling for its phase three study shortly in a potential men multibillion dollar indication subject to any impact of COVID-19.

And we expect our two licensing agreements with Arctic vision and bowel shelf.

To provide us with non dilutive funding that we can use to advance these programs, while potentially leveraging our dispensing technology into additional high value indications.

We believe were well positioned to achieve multiple commercial regulatory and development catalyst in 2021.

Aimed at advancing long term value for our shareholders.

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

Thank you we will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad confirmation Sean will indicate that your line is in the question queue. You May Press Star two if you would like to remove your question from the queue for participants using.

Speaker equipment, it may be necessary to pick up your handset before pressing the star key one moment. Please while we poll for questions.

Our first question is from E Shen with.

H.C. Hi. This is <unk> proceed with your question.

Hi, This is bought in dialing in for each and can you hear me okay.

Yes.

Hi, I would like to ask three questions. So beginning with vision trial is the company is still on track to initiate the vision trial or even to the Cobi cases are rising.

Yeah. This is a this is a good question we as of the latest Ah that our clinical operations group has a informed us.

Based on feedback from the sites are we have the sites already in the pipe and and being prepared we've gotten feedback that as of now we don't see any disruption to our timelines in the hopes.

Hopefully that will continue a I know the sites and the clinical.

Clinics of Optometry, and ophthalmology practices have really ramped up their precautions and Ah Ah that really adopted over the last few months.

Of course, we don't know how this new wave will unfold. So we remain cautiously optimistic and were monitoring the situation in direct communication with the sites.

So, we'll probably know a lot more in the coming weeks.

Understood. Okay. Next question do you plan to in license and old license additional candidate the next 12 months.

Yeah. So this is a this is something that its hard to again business development and partnerships is a FICO business. It takes time to evolve and the and again it took us a long time to to really develop the relationships that we have would Arctic vision and bausch scale.

There has been a lot of interest in our technology for even several years, but we've been very cautious in selecting the proper partners for that again, I I would probably not comment on on the which way this role Gol, what we're focused on right now.

Now and the best way, we can deliver value.

It's really to execute on the Presbyopia program and also on the NDA from Combi Presbyopia, it's such a phenomenal opportunity its its really a big big markets and particularly sold disruptive when we for the first time are able.

To do pharmacologic treatment. So we're really focused on or working in the trenches with our sites being able to enroll our studies. So that in Q1 of 2021, which is not far from today to generate phase three data and I think.

From what I know I'm sure, there's going to be a lot of interest in our programs and and of course, our management team and our board will evaluate all the options as well as the option, which is just on the table with such a big problem is for also I know via to.

Expanded commercial efforts from a mid Columbia, So again, we're evaluating that but that's the first thing is first let's.

Execute our program and led to deliver great phase three data.

And then of course, all the options would be evaluated.

I just had one final from me that's bombshells provided any update on the profit is on the chaperone trial. Thank you.

I can answer that saw enough yes.

Yeah sure go ahead.

So so bausch is nowhere in the process of transitioning a chaperone to bausch in the meantime, they're covering us financially reimbursing EPS for the work being done as of right. Now we are still managing the chaperone study and that study is progressing as expected.

So there's there's no update or change there from what we said previously we expect that study to be fully enrolled by the middle of next year.

All right that's it thank you.

Mhm you're welcome.

Our next question is with Matt Kaplan with Ladenburg.

Hi, I'm happy to take your questions.

Hey, guys can you hear me.

Yes about hot yes, yes, not great to hear and great well congrats on the progress during the third quarter looks very good wanted to dig into the [noise] Michael.

Michael line program, a little bit I guess, you know we view the program really is clinically de risk you know given the.

Given the positive results, we suppose results for appeal Carping from Al again, I'm impressed the Lps.

Can you give us a sense in terms of where describe the competitive landscape in presbyopia with products on the market or either [laughter] development and then what.

As Michael line really bring as a differentiating point Uh huh.

Oh right.

Yeah, Mike Yes, Matt this is actually a very very interesting question.

And it is so interesting because just a few weeks ago and it seems like other people are following that closely but a few weeks ago. We are we also were informed that allergan, which is developing a a pilot carping.

Formulation for Presbyopia had two positive phase three trials, so again as an off the mall adjust and what I know about pilot Carping and what we've seen with that drug through the years and underappreciated, but very well known or is that it has a very tremendous.

Ability to create a pinhole pupil a small aperture and extended depth of focus with extraction of residual accommodation to really enable near vision and we've never use that before and again, we weren't the first ones to be.

But to be a really a a cute about that I think all our gun.

Seems to also have appreciated that and they're leading the way with their phase two program. We're talking about an enormous space here 113 million potential users in the U.S. and the sweet spot of about 30 to 40 users into 40 to 60 age group. So.

We see that this would be a really great solution and treatment. So we are really tracking very closely what's happening in the space.

Obviously, all are gone as the first KMR or if it's something that we actually appreciate to some degree because they were opened a brand new market and and they're very good at that as we know we bought talks and other cosmeceuticals. So so I think it really validates the mechanism invalidate the compound and.

Oh and the part that we appreciate it the differentiated approach that we have.

Yeah, Alright, so Nike on up.

Yeah go ahead, Mike gets you to that but on the competitive environment.

I think you can sum it up for us in two ways.

You know if you're going to come into the market with somebody that is essentially a lifestyle drug which this will be you now that you need to fit within the lifestyle of the people who are actually use yet and you need to be well tolerated. Those are the two things you really have to hit out of the park and I think what Sean was going to talk about is with micro.

A dosing or would the after Jeff dispenser that is what differentiates us the micro dosing, we believe and we'll see what happens in our phase three study.

Should result in a better tolerated product both both from how the ice block as well as with the Broadway, which is known to occur at higher doses of plywood carping. So that would be in terms of tolerability in terms of acceptance, we know that the opera jet dispenser makes it much simpler for people to take the medication.

And that in case in point when we did market research on this product we had many people who were I make up who said well how is this supposed to work I can't put drops in my eyes Hum already made up for the day and I'm going out to dinner or something like that and want to use the product I don't want to have to do that I agree apply my medication that's for me.

Like that what's the opera Justin Spencer.

Can make easier for people and matched her lifestyle better Sean did I cover the two things you're going to yeah.

Yeah, Yeah, absolutely and again I'm not a footnote is if you remember we prioritize that program over glaucoma and now we actually feel justified in bad because of the opportunity and the timeliness and it's always come off the charts when Michael desk is the commercial marketing research. So we see high interest by.

Consumers and patients.

Thank you all right. Thanks, Thanks for that detail and I guess, maybe a question for Michael can you talk about your commercial preparations are where you are or for the I guess, it's now called me comedy a potential launch next year you Holly Indeed as Angela.

This year.

Yes. So our plan is you know we said we intend to file that ended at the end of this year.

We would start our commercial preparations are towards April may of next year, the idea, but hot but hide behind bid comedy is that we don't need to have a huge sales force to make make the successful. This is not a traditional type of pharmaceutical sell where you need to do samples and you need to be in the office.

Often then you need to get the formulary acceptance. This is essentially a diagnostic supply which means you go in you sell into the office and once you demonstrate for them what the really tremendous value proposition is for the product. In addition to two to it being faster for them potentially safer more cars.

Football not going to cost a whole heck of a lot more once you've made that sell you're done and you move on to the next big office. So that preparation could be done we believe by putting 12 very good people in the largest population centers and working from there and those are people, we would start to bring on board.

I would probably towards the latter half of the year in preparation for a launch in the fourth quarter.

Great well, thanks for taking the questions. Thanks.

Thanks Bye.

Our next question is what Len Yeah. Its stock stock partners. Please proceed with your question.

Well, let's just say that I guess.

After another call.

Oh, okay.

Maria Let's go to the next person.

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

Hi, Thank you hi, guys I was wondering so al again said that but that we will not any more detailed phase III presbyopia date until you know at least ARVO next year. So I guess, you kinda won't know what kind of pilot copied efficacy to kinda to kind of be on my side I guess I was curious.

If you're going to have the same primary endpoint as alcan did essentially near term vision, improving and then near term vision, improving without dispensation worsening and on what day. After the startup therapy would you be assessing that primary endpoint.

Yeah, So Jonathan the so for for our program.

We have a a distance corrected near visual acuity, which is pretty standard I believe this is what they have a swell in there.

And the distance corrected near visual acuity post dosing for us we're assessing that yeah through a three hour period after administration.

And so our study is really designed in such a way that.

We will be able to enroll and a very expeditiously assess the efficacy of our treatment because we're using that and were looking at the efficacy literally within several hours post administration, which is where our endpoint is.

So, yes, I'm looking forward to actually seeing their data as well and and seeing how the pilot Carping performed in an eyedropper.

By that time, I I would assume if we're talking our go up next year that by that time, we would have some of our phase three data as well and hopefully we will see what we've seen before in terms of the differentiation and the benefits of our micro like print technology, Michael do you want to add anything.

Yes, I would also add Jonathan that the way, they're looking at dose. He has a very different from ours I believe in their protocol. They were dosing every day, they're looking at it almost looks like a chronic medication. We're approaching this as something that you would use on demand. So you would literally only take these.

Ray from the opposite 15 minutes before you intended to make use of the product. So it's a different way of saying, where we think the struggle will fit and we just personally from our market research think beyond a bad model is much more likely to.

The fit with these particular types of patients.

I mean, you actually bring up another question do you think that you guys would have a different onset of activity compared Gallagher.

Well, you know I'm not familiar with their formulation. We know we have a pretty good idea of our onset of activity, which is like I said.

We think it's going to be working within 15 minutes or so.

Sit down on demand profile.

Okay, and I didn't quite remember what you said in answer to my first question, where you have that composite endpoint of your vision improving without distance vision worsening.

Yeah. So we will not have a we will have the data on both <unk>, we're not going to have a composite endpoint because that's not pre specified but we will have obviously, we're taking data on both the near and the distance of lesion. We don't have a composite endpoint in our clinical study.

Okay, and then lastly, I was just curious you know they'll be out first in all likelihood do you think you'll let their pricing weigh heavily upon your pricing decision or do you think the differential.

No the technology and the benefits there in.

Don't force, you really pay attention or pay much attention to despite it being a cash market.

Jonathan if they have a high price will be happy to take it.

[laughter] so either.

Oh, no that would be one way of looking at it one way to look at it but if they come out with a price that I think doesn't reflect the value that we're bringing I wouldn't let that impact us too much with like you have a price.

That I think is very fair and within reach for a we think about 31 million patients.

Who we're targeting these are people who have the means and there was never needed to wear glasses before in their lives. So there's plenty of them and at the right price, we believe they'd be very happy to use the product.

Okay. Thank you very much guys.

You're welcome.

As a reminder, if you would like to ask a question. Please press star one on your telephone keypad.

Our next question is what Stuart Grant. Please proceed with your question.

Hi, Sean.

Congratulations I fear for the <unk>.

Regulations on the Bausch health and Arctic vision deals those are awesome and it appears that the business is executing very well, but unfortunately the stock price has has been pretty stagnant why do you think the market is not recognizing the value and the Bausch health and Arctic vision deals and is the.

We're concerned about the lack of performance of the stock price.

[noise], yes that Stuart is a very very good and loaded question Ah, Yes, I think that it maybe the best way to address it is just giving my my perspective, which really doesn't oblige anybody.

We obviously expected this to be appreciated a lot more from a stock perspective or an appreciation of the value of the stock given how significant.

The Bausch transaction and the Arctic vision transactions are I mean, they're not only providing non dilutive capital today.

And up to 100 million of non sales milestones over the coming.

Coming years, but then potentially huge revenue a fairly de risked late stage programs.

Weren't there before and so it's a good question why we really haven't seen that I think our team made a very concerted effort.

To hold the press conference in really share with people the.

Details of our transaction and Ah, we actually felt very happy about the partnership.

But again going back into context I wanted to share.

If you'll remember several years ago, we have reported.

The results of our phase two trial in I O Pillorying pages 21, and that was a very significant trial because it validated our micro dose technology Dion pupil dilation.

And that date under really leaves the stub very much we had a subsequent great events from the Miss Twond and Mr. study as well as some of the additional milestones that weve reached including now preparing we are on the verge of launching a phase three program in one of the biggest indications hand off them.

LNG.

So it's really hard to explain I think we do have a shareholder base that we may want to reach out more I think everybody's distracted with the big biotech and new molecular entities and sometimes maybe people Miss the small players and let's not forget that we are really a micro cap Uh huh.

And as such maybe writing a much bigger programs that actually correspond to what people would expect from a micro cap. So this is not the first time I've seen.

Value up on appreciation so to speak and we put most of my private ventures in Texas. That's always been the case until you have the the major a result or or breakthrough or exit. So we hope people will will follow and C or the programs and the milestones that.

Coming forth, which a grade and we hope those are really end up in the in the really in the spotlight of I've walked the biotech and life Science success is because were very excited and our board is very excited.

About where the company setting and the fact that we do have now a balance sheet that has been augmented by those business development partnership significantly and provides is probably one of the best cash positions we've had before.

And if I might just follow up is it fair to assume that given the.

Upfront payments that were made that this fourth quarter at least for the quarter that I know you will actually be profitable.

Not on the PML basis, because for GAAP purposes, you need to defer the upfront cash payments. So when you look at our profit and loss statement.

You'll see that we included the upfront cash payment received from Arctic vision.

In deferred revenue on our balance sheet, and so we will not be able to recognize that until we provide clinical trial data to Arctic vision, which will be no.

12 to 18 months from now even though we received the cash so.

So it took us a nuances associated from a cash flow basis, you'll be positive cash flow for the quarter, but not on a piano GAAP basis.

Yes, correct exactly right okay. Thank you.

Thank you Stuart.

Our next question isn't Glenn Yeah, well stocked dock partners. Please proceed with your question Ah. Thank you very much I had to hop off for a bit. So I apologize. If these questions were already asked I was wondering if.

If you could compare and contrast, it get a little bit in your opening comments pilot carpino odd the allegheny's using it and the Gemini wanting to study in terms of the dose that using I think it was one dose and if you're using more than one.

Obviously the issue in the krona virus pandemic time that we're in a with the cleanliness I think is a major advantage and if there are any other issues in that regard if you want to comment on and then secondly, when bausch had there I recently, a reporting of their Q3 results. They talked about the fact that.

They felt they were really incredibly positioned in pediatric progressive myopia with a contact lens company agreement and then with you guys on the pharmacologic side and I was just wondering if.

Bausch is.

Devotion to the syndication is something that you think could lead you to your product to be one of the leaders in this of the various companies working on given their presence in ophthalmology and the fact that given that they're looking to both a ways of approaching that are they seem to be very dedicated thank you.

Very much.

Okay. Well then this a these are great questions. Its always so let me start with the second one and then Michael can chime in but again.

Regressive myopia right now, it's kind of like the anti VEGF and let's say M.D. before we developed Lucentis, Oh, which then became a $10 billion market. We're talking one of the biggest opportunities in ophthalmology and so it it's going to be a place where different technology.

She's in approaches will work and be synergistic.

In terms of the contact lenses that is a very hardware approach to the disease that requires the ability to put a call to class and where it and again, it's not for everybody.

And pharmaceutical treatment alone at night with an eye drop, particularly they could come in a very elegant.

Spencer with the my Kudos would probably be something that at least we believe it is much more germane to the general market now the good part is also that because they have very different mechanisms of how they address progressive may help you I think clinically one would be coming.

Let me open to the idea of using them together to even further influenced the progression of myopia and improve the outcomes.

Maybe I'll, let here Michael to chime in if he has any other commercial perspective.

No shot I think that's exactly it that that the people who are treating pediatric myopia want to have both options available to them there will be patients where they'll use boats.

And I think actually that's their preferred because they'd like to hit a the myopia as hard as they possibly can and as much as the the child can do.

So from Belches perspective, they are booking or to be the one stop shop with what they perceive as having the best hardware solution and with US are the best stuff pharmaceutical solution and I think even in the comments from Joe Papa.

He mentioned that he did think that was our dispenser technology that really makes the difference making it possible for these kids, who will be no medicating themselves for years to be able to take control of their own treatment and not even talking about the ability to monitor usage and with reminders and everything else that the dispenser can do.

[music].

So thank you yeah.

Great houses, so absolutely and to your first question and by the way just to finish I think personally I'm impressed and I think bausch has a very mature way of of blueprinting, the entire progressive myopia future and space and that's great that they have multiple ways because it's a big.

<unk> opportunity and if I were a big company I would definitely pursue multiple things that.

That aside to your other question on Tylo Carping again were very encouraged about Pyrocarbon, we actually know pyrocarbon very well it's been around for 50 years. So it's not surprising to us that Oh, we were seeing positive phase three results from another company like all are gone and we're now.

What's the price that's already done is the one moving into that space.

In terms of our dozing were using the 1% and 2% though.

Initially we were thinking to just do a 1%, but because of my credentials micro Ray print technology offers some very interesting.

Interesting advantages, whereby a higher dose with the lower total exposure of the cornea and the ocular surface with a targeted delivery can really enhance certain.

Parts of the equation and really inflect the therapeutic index, we decided to put also the 2% a small and and that will be part of our vision. One study. So we will it were very excited to see the data hopefully in a few months and share that with you and the wind or clinical community enough them.

Religion optometry.

And then lastly on mid con be how long do you think the FTC review process.

Would be is it going to be a standard 10 or 12 month review you expect from when you file.

Yeah, I think were assuming that it's really hard to believe today, where they're looking at extraordinary times.

But we have seen in all of our communications with the FDA a very proactive.

Approaching and time, timeliness, which has been really appreciated by our team.

We think we're going to submit very clean data our missed one Miss two studies were extremely clean and very very informative would clear efficacy and safety. So from my experience or a decade, plus a is the cleaner the data the more.

Our teacher lets you are asking for the FDA. These are you make their job and the better they can faster. They can perform so so we hope that will be the case and we hope also that they appreciate the advantages of this technology, we spent quite a bit of time really exposing it today to the fact that.

We have a touch less delivery with the with our recession, although that doesn't cross contaminated as much. We hope just by virtue of inherent intrinsic design at least that's what our care wells really appreciate so hopefully this would be all things that can really rationalize a.

Expedient, a process, but we're gonna be supporting them as needed.

To make that decision and get through their diligence.

Great. Thanks, so much.

Sure. Thank you.

There are no further questions at this time I would like to turn the floor back over to Sean I incentives for closing comments.

Well again that was a great very informative call a today hope and this concludes our call. Thank you again for joining us and we look forward to our next financial update in 2021 have a good afternoon.

This concludes today's conference. Thank you for your participation you may disconnect your lines at this time.

[noise] [noise].