Q4 2019 Earnings Call

[music].

Ladies and gentlemen, thank you for standing by welcome to today's program I eat Nokia Inc. fourth quarter 2019 earnings conference call. At this time all participants are in listen only mode. After the speakers presentation. There will be a question and answer session. If you'd like to ask a question. During this session will be the press star one are you telling.

Phone as a reminder, takes program is being recorded and now I'd like to introduce your host for todays program, Alex Lobo from the with group. Please go ahead.

Good afternoon, and welcome to I know of U.S. fourth quarter and full year 2019 earnings conference call an audio webcast.

With me today are Dr., Sean I actually I noticed Chief Executive Officer publisher, and Chief Medical Officer, John Gandolfo, I never be as Chief Financial Officer, Michael Rowe I know gets vice president of commercial.

Well here. This afternoon I know they issued a press release announcing financial results for the Fremont and full year ended December 31st 2019.

We encourage everyone to read today's press release as well I know he has an annual reports on form 10-K, which can be filed with the FCC.

The company's firstly a annual report will also be available on I know this web site at I know you're dotcom.

In addition, this conference call is being webcast to the company's website I will be archived for future reference.

Please note that today's call.

We will be describing investigational products, which have yet to be received FDA approval.

Please also note that is there any information discussed on this call are covered under the safe Harbor provision on the private Securities Litigation Reform Act, we caution listeners that during this call I know, there's 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 at the company's business.

These forward looking statements are subject to a number of risks, including legislature fluctuations in our financial results in stock price, particularly given market conditions.

I made the potential and the potential economic impact of covert night gene I need to raise additional money to fund operations or at least the next 12 months has a going concern.

The potential impact of the clubs.

A lot of Irish endemic honor supply chain risks of our clinical trials, including but not limited to.

The cost design initiation and enrollment, which could be adversely impacted by the Corona vivus endemic and resulting social distancing timing progress and results of such trials.

The timing and our ability to submit applications for obtain maintain and maintain regulatory approvals for our product candidate.

The potential success of our Reprioritize pipeline any projected cost savings related try reprioritize pipeline, our estimates regarding the potential market opportunities for product candidates the potential advantages of our product candidates.

Right and a degree of market acceptance of clinical utility of our product candidates.

Our ability to timely timely developed and implemented anticipated manufacturing commercialization and marketing capabilities.

And strategies for existing product candidates.

Our ability to identify new products, our ability to attract and retain key personnel intellectual property risks and other detailed in qualified by the cautionary statements can take I know via press releases I guess, you see filings, including his most recent annual report on form 10-K and subsequent filings.

This conference call contains time sensitive information, but an accurate only as of the date of the slide broadcast March 25, 2020, I know, we 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 laws.

With that I would like now to turn the call over to Dr. shiny onshore.

Thank you Alex.

And welcome everyone to I know vs fourth quarter and full year 2019 earnings conference call.

29000 wasn't successful year for I know via as we continue to validate our patented Piazza print delivery technology.

And that's we Reprioritize, our late stage pipeline to focus on high volume indications.

We believe now represent an approximately $7 billion total market opportunity in the United States, where the company.

Earlier in the are we successfully completed our Microsoft Phase three missed one and missed two studies for pharmacologic Midrise says, which have further validate our novel approach to treating from in back of the I conditions.

That's what what's paved the way towards the new drug application submission to the U.S. food and drug administration later this year.

Furthermore, the initiation of all micro pin phase three study for progressive myopia represented a significant achieve I'm lucky here.

And we hope to complete patient enrollment by the end of this year, although the impact of the Corona virus from Danny could result in a do like.

We were also very excited to introduce our third phase three program micro line for Presbyopia.

As we Reprioritize, our pipeline to focus on high volume indication.

We believe our on demand treatment of presbyopia represents tremendous untapped potential.

And we're working diligently to initiate the faced many vision trials in the months ahead, although the trials could also potentially be impacted by call. It nine Kim.

As we continue to rapidly advance our late stage program. We were also very pleased to expand our scientific Advisory Board with the addition of professor Mark Bully more in April Jasper.

Both brings a wealth of scientific academic and practical experience in visual sciences, COMETRIQ childhood, myopia, and presbyopia and we look forward to leveraging their experience as we advance our product candidates to the clinic.

Today I'm going to highlight our success with the phase three trials for Microstar review of the progress of the rest of our exciting pipeline.

And then hand, the call over to Michael to discuss our commercial development strategy.

But before we begin I want to pick a few moments to discuss how cold it might be might impact our company.

Well, we sort of the number of components from Asia, our supply chain for clinical product has built even leads time.

We believe or not currently address.

That said, we also depend on third party contract vendors as well its clinical and business partners, where it expanding impact of the Palm then Nick on the business environment, both locally and globally would have an impact on our business.

We're closely tracking environment enrollment in our ongoing clinical study, that's well with events that must be completed to initiate upcoming clinical studies.

Neither of our programs involves patient populations, where it's most at risk for the virus and we're taking steps to help ensure the health of our clinical partners involved in the study by eliminating unnecessary travel and alike, but it is possible this patient maybe less equine.

For unable to participate in our studies, if they're mobility is limited by sheltering place orders or the clinical sites with temporarily scaled down investigational activities.

Additionally, on the vendor side that we depend on U.S. base that realization that her all steel partners for all products.

And any shut down for backlogs on their end.

Good to have an adverse impact in our business and anticipated milestones.

Turning now to our product candidate.

My first thought is our first pipeline program to complete phase three studies in early 2019, which was very exciting for us if it further validated our technology and approach.

As a reminder, micro studies, our novel fixed combination formulation of phenylephrine entropic them I'd for pharmacologic dryness.

Two product that are often used together during the approximately 18 million diagnostic eye exams, and 4 million cataract surgeries performed each year in the United States.

During the first quarter of 29 can we were very pleased to report positive results from the missed one and Mr. trial demonstrating.

That Microsoft with saving affected for pharmacologic midrise, it by achieving clinically and statistically superior Neil I mean people dilation to both the individual components and lets people.

Both studies achieved their primary endpoint would slightly more than 93% of treated eyes, achieving pupils relation of at least six millimeter F 35 minutes post installation just shy of two thirds patient reached this same endpoint within 20 minutes.

Equally importantly, this efficacy was achieved with only one patient reported opinion amounted to 131 patients tested.

The current I dropped formulations to these drugs often called significant thing.

Enough sold that many doctors will pretreated with them on the study I drop.

With these phase three trial result in hand, that's why was ongoing stability testing of registration like we're preparing to file the M.D.A., we'd be F.D.A. late 20 Twond.

If approved this would be our first commercial product and it will begin introducing ophthalmologists and optometrists and patients to the opposite jet technology.

We believe that this will help prepare the eye care market for our additional products in presbyopia and myopia.

One thing I would like to highlight is the design feature of our off digit Spencer.

We purposely designed the dispenser without any protruding part to minimize the child's cross contamination.

The product by preventing direct contact with <unk>.

A recent studies, 40% of Eyedrop users.

Fountain accidentally touched <unk> with the bottle to wanting stealing drops avoiding these potential contamination source may turn out to be a great. Much greater importance. Then we felt in the past, particularly since practices used the same eyedropper bottles of multiple patients.

Before the current situation the word epidemic.

I had been used to describe what is happening with our children and their ice side.

Around the World. These is estimated at hundreds of millions of children are becoming progressively more myopic.

For the last couple of years I know there has been working to address this crisis, our phase three program, Michael hoping for the treatment of Progressive myopia in children is currently enrolling patients in our chaperone trial.

My grouping represents our largest potential market opportunity the prevalence of myopia has grown at an unprecedented rate over the last few decades and according to a recent article in the Ale Journal Ophthalmology by 2030, nearly half of the population in North American East Asia is expected to be myopic.

With our micro pain program, we aim to tackle this epidemic Kuwait starts in children and we believe that we could have one of the first potential pharmacologic treatment options.

Progressive myopia.

In 29 thing we initiated our phase three shopper all city, which is a randomized double masked trial that we enrolled more than 400 children between three and 12 years of age. The study is examining the safety and efficacy of our proprietary utrophin topical micro formulation delivered in the Optidriver dispenser sell through.

Reduction of Progressive myopia.

Subject I being randomized to receive treatment, we either have to micro pin concentrations or placebo and the primary efficacy endpoint is the change in refractive are up from baseline to 36 months.

As we continue to enroll patients in our city, we've been able to gather some preliminary data with regards to patients being able to properly administered then medication with teacher.

After enrolling into chaperone study parents and their child received the short training session and recent instructions on how to use the off the jet. After this session. We found that in every case either the Peregrino trial was able to successfully use the defense or at home to reliably deliver a micro those to the <unk> and in most cases.

The children somebody's youngest six we're able to use the dispenser by themselves.

This data is really encouraging.

And further supports our platform technologies potential to vastly improved the way, we treat off to a disease for people across all age groups.

Before we move on from our Myopia program I wanted to highlight one regulatory pathway.

Oh for micro being.

As many people might wonder why are we only conducting a single phase three study as compared to the typical too.

Our phase three chaperone trial is not the only study that we will be including in our potential and be a from our discussions with the FDA <unk> agency 'cause agreed.

They will accept data from the previously completed collaborative academic studies that were published over the last few years.

And this is not just for our chaperone study, but for all companies and studies looking at Progressive myopia. So this is a very consistent towns by the agency. This supplemental studies include Adam.

Welcome to and lump, which were all well controlled randomized long term cities that we have discussed in the past each of these studies show that atrophy income flow the progression of myopia by between 60 and 70%.

We plan to leverage this study's alongside our chaperone study in a potential and be a filing and we believe that the result of this study significantly de risk the chaperone study.

Now, let's take a look at our newest broker micro mindful presbyopia, which has garnered significant interest from the optometric community since we reprioritized our pipeline last year.

You may remember presbyopia use the non preventable age related hardening of the opt to Atlanta, which causes the gradual loss of the eyes ability to focus on nearby object.

Currently the space is dominated primarily by devices such as the reading glasses and there are no pharmacologic drugs for this indication.

In the United States Presbyopia affects an estimated I'm going to 13 million people of that population, we estimate that 43 million people between the ages, the 40, and 65, who have otherwise normal vision and available disposable income.

Could benefit from a pharmacologic treatment option like my Cooley.

Micro mine is our proprietary micrels array print formulation of pilot Carping, which has the potential to improve near vision.

Mike line works by Constricting, the pupil, increasing the depth of field and focused and making it easier to see up close.

Mike line is designed is it complements to reading glasses for when patients do not wish to use glasses and together with our often said the sponsor is designed to provide good tolerability and make installation easy and simple versus traditional eyedrops, we believe that we'd the combination of our proprietary formulation.

Our micro dose platform, we have the opportunity to enhance the lifestyle of millions of people with a cash they prescription drugs will be improvement of near vision in the model of other aesthetic focused products.

Looking ahead, we're currently preparing our phase three vision, along and vision two studies and expects to initiate both trials. This year, although the impacts of the Corona virus epidemic could result delay.

Subject will be randomized to receive treatment with either have to micro and concentrations or a placebo.

And our primary endpoint of the studies will be buying off to a distance corrected near visual acuity.

So no I would like to turn the call over to our VP of commercial Michael role to discuss commercialization.

<unk>.

Thank you Sean.

Later this year, we're planning on filing the NDA for Microsoft that our novel fixed combination like traffic for the approximately 80 million comprehensive eye exams performed in the United States each year.

This means that we need to prepare for potential product launch next year and align our promotional sales and pricing strategy ahead of that.

We recently conducted quantitative market research on my first that with 100, ophthalmologists and optometrists, who conduct a significant number of pupil dilated eye exams weekly.

This research was designed to test our unique selling proposition.

He product attributes measure interested in using micro set in place of current products and test or pricing assumptions. The results were compelling for the post approval launch of Mike was that I would like to share of the major findings with you know.

First we establish what practitioners are currently using other offices, where pupil dilation and found that most of those we study were in fact using for pick them either people efron together in two separate bottles at a cost of about $1 per patient not including any additional cost will be topical anesthetic that was often use.

Typically the offices were using larger bottles across multiple patients although in the current environment that might be changing on the cost to the office might be increasing.

In summary, we were pleased to see from this study that the products being used how they were being used and the cost of them matched the prior assumptions.

In terms of product concept, a micro dose PK, so print fixed combination that reduced the efficacy and tolerability seen in our phase three program.

About two thirds of these practitioners reported high moderate to high interest in the Microsoft product concept.

The key comments included this is a great idea, it's no I can't wait to use it while the few concerns were almost exclusively around cost, which we plan on addressing with our pricing strategy.

Among the key product attributes it was great interest and the fact that dispenser had no protruding cards that dilation was quick and that the product could be given to patients without a doubt static.

Currently conventional dilation, it's often preceded by now that said the drop to reduce any discomfort and pain from the dilating eyedrops, which as you know can take three to four times more acidic formulation and preservative than what would be in the micro dose problem.

On the micro line product that would presbyopia. We also conducted market research with 100, presbyopic adults, who use glasses for reading of the household income over $50000 and who were between the ages 40 and 60.

And this survey we saw that there was very high interest from these patients more than two thirds indicated they would be very interested in using the product as described we found the strongest interest among men between 45 in 16 and women between 50, and 60 and for those who had a household income over $100000, which we believe comprises about.

30% of the Presbyopic population in these age groups.

Among these people virtually all of them more highly interested in Michael.

Overall, the survey helped to further validate our commercial assumptions and that there is a very high interest from patients within the target subgroup that we had previously identified representing approximately 43 million people in the United States.

In summary, the results of the surveys hope belding their assumptions and show that there was significant interest to their products with the micro Joe's delivery platform.

With that said I would like now to turn the call over to John to discuss our financial results.

Thank you Michael I'm once again, thank you all for joining us this afternoon.

Before I review, our financial results from three months in full year 2019, I would like to know how pleased we are that I know via was able to close as private placement yesterday.

We do believe that the net proceeds from the transaction will help fund our operations likely into the first quarter of 2021 to support our micro line and Mike repeating clinical studies as well as complete and submit our new drug application for Microsoft that.

And now let me review our financials for the three months ended December 31st 2019.

For the fourth quarter 2019, we reported a net loss of approximately $5.2 million with 31 cents per share. This compares to a net loss of approximately $6.2 million, where 60 cents per share from the fourth quarter 2018.

Research and development expenses totaled approximately $3.3 million for the fourth quarter 2019, and this compares to approximately $4.1 million. The same period 2018, a decrease of 19.4%.

The fourth quarter, 2019, general and administrative expenses for approximately $2 million compared with approximately 2.1 million in the fourth quarter of 2018, a decrease of 4.5%.

Total operating expenses for the fourth quarter 2019 were approximately $5.3 million compared to total operating expenses of approximately $6.2 million for the same period in 2018.

Decreased 14.5%.

Operating expenses include approximately $600000 of noncash stock compensation expenses.

Now I'll review as a result for the full year ended December 31st 2019.

For the full year ended December 31st we reported a net loss of approximately $21.2 million per dollar 47 for sure and this compares to a net loss of approximately $17.3 million, where dollar maybe two per share for 2018.

Research and development expenses increased 26.8% to approximately $14.1 million in 2019 compared to approximately $11.1 million and the prior year.

This was primarily the result of increased direct clinical and non clinical expenses personnel related expenses and noncash stock based compensation expense.

For the full year 2019, GE in a expenses increased 17.4% to approximately $7.2 million versus approximately $6.1 million for the full year 2018.

The increase was primarily attributable to an increase in payroll related expenses cost related to being a public company noncash stock based compensation expense rent expense and advertising marketing expenses related to marketing analysis upon the potential commercialization of our products.

Total operating expenses increased 23.5% to approximately $21.3 million for 2019 compared to $17.3 million for the full year 2018.

2019 operating expenses include approximately $2.5 million of noncash stock compensation expense.

As of December 31st 2019, the company's cash and cash equivalents balance was approximately $14.2 million and this obviously excludes the approximately $6 million in gross proceeds and $5.3 million for net proceeds from our private placement, which closed on March 24th.

That concludes our for natural for you now I'd like to end the call back over to Sean for his closing remarks.

Thank you John.

Before we open the call to questions I would like to say that we're working diligently to make 2020, a strong here for a novia.

As John just mentioned, we were very pleased to have bolstered our balance sheet, we anticipate milestones in our phase three programs for presbyopia and myopia. That's why was the planned Microsoft Pang da these here, although although we have very closely monitoring the evolving situation of the public 19 pandemic and its potential impact on that.

Our business.

We have a resilient team and as we embark on 2020, we look forward to leveraging their experience as well as that of our expanded scientific advisory board, including Professor Mark Blinn more in April Jasper to make this year they success.

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

Certainly ladies and gentlemen, if you have a question at this time. Please press Star then one and your Touchtone telephone. If your question has been answered and you'd like to move yourself from the Q. Please press the pound key our first question comes from the line of Matt Kaplan from Ladenburg Thalman. Your question. Please.

This gap when you might have your phone.

You are now we can you.

I can hear me.

Yes, Hi, Matt.

Hi, Sean Thanks, Thanks for taking the questions.

Question for you I guess can you help us understand the competitive landscape with respect to against new treatments in development for presbyopia understanding like you know obviously the current standard of care as is our reading glasses, but what do you see.

On the Horizon Oh.

In terms of other drugs or other therapies that are involved.

Yeah, Mike, let me take that or Michael do you want to take that perfect. Oh, you had started Sean.

Alright, well I would just I'll pass it on quickly to Michael I think it can really educators, but oh I wanted to start out by saying that we're obviously not the only company that has clued into the opportunity here.

I think today much more than ever before and there's enough them. All at just I can say, how we always used to discount.

People's Affliction with near vision problems and send them a immediately to reading glasses and I can say this paradigm and patients awareness and need for a lifestyle modification and not to be shackled to a hardware approach has really changed and more so than before so again. This is.

Great opportunity for pharmacologic treatment of Presbyopia and we're at the forefront of this obviously other companies are following suit or in that space. It's well currently nothing approved but I'll pass on to Michael to give a little more granularity on the competitive landscape Michael Yeah. Thank thank you Sean.

Matt the way I look at this is that there is basically three different groups of things, there's new devices, there's a using existing drugs.

For what I would call the on demand treatment. The presbyopia and then there longer term, there's new drugs for the more permanent.

Correction of presbyopia on the front the drugs for perhaps a more permanent correction that for example is being done I believe by Novartis. There in phase two that's still many years away and we don't know what that has a high probability of success, but there are approaches to do something that actually softens the lens.

To to affect the disease in that way.

In terms of big devices, you have a new contact lenses for example for presbyopia, a that people might want to try that will be coming out and then on the drugs from the existing ones. All the ones that are being booked out there's about four companies. Currently active in this area are either pilot harping like ours or some combination with pilot card.

And I think where we potentially when there is because of the Mike with those platform. We can affect the same kind of physiological effect on the pupil that the others would do but what we're looking for is to have something that's much better tolerated as with less of the nuisance side effects no wonder.

I will carping, primarily the one being a headache HM does that answer the question.

That's very helpful. Thank you in terms of the the stages of development that those four companies are in Oh are you argue ahead of them behind them were where they ended up.

We are the ahead of everyone, except possibly Allergan, who has as far as we know finished their phase three studies, but have not filed anything yet.

Everyone else, we are I haven't.

Great. Thank you and then just focusing on micro stat for for for a moment, Yeah. Just wanted to get a sense in terms of where you are in preparation for the NDA filing later this year and and could the coded 19 or pandemic haven't have an issue.

I'm not filing or is that is that well that timeline lumpy wont be.

Perfect.

Yeah, Matt I'll I'll take that also because we lost Sean for a moment, but I can tell you where we are is exactly where we said before we were just actually waiting for the physical a stability studies are we just have to take another dip into their next couple of months other than that everything is ready to go and as soon as we have.

Those stability results I will be able to file that India Oh by the end of this year, there's nothing that we can see at the moment.

That would impact us in terms of coal good because this is really just getting the stability results and then just writing it off.

Okay. That's helpful. Thank you and then Michael last question for <unk> for you. How do you. How do you think that Mike was that will be adopted by by practices and I guess, what you know specifically what do you see it the value proposition that for that you're going to make to practices.

That's a great question the value proposition there was actually helps in that a number of different ways first of all it is faster for them and what they want to deal with increased throughputs instead of waiting 2035 minutes or longer for patients and I like to be able to know reliably what's going to happen they could schedule better and get the patients in the now it's.

More comfortable for the patients as Sean said only one the other 131 of the patients and their study how the complained about singing a which is unusual for these drugs because when you take them with the regular eyedropper bottles, often they have to use and anesthetic because of this thing.

It's safer potentially because you can't touch the guy and I've spoken to a number of doctors, where they do have a concern about using these larger bibles, but they do for economic reasons and having the tip touching and eyelash, we're touching something it shouldn't touch and then go onto the next patient nice taking the current environment. This is.

Going to become even more important and then lastly, our strategy is to make it available to them at a cost, but it's not going to be very different than what they're currently doing so we know that they're currently spending about a dollar a patient if not more with those big bottles. Our intent is to price Microsoft that roughly about $85.

As a unit, which will get you about 75 patients uses out of there so that the the idea of cost as a barrier gets completely removed.

Okay. Thanks, Thanks like I'm.

Well thank you.

Thank you Mike.

Thank you. Our next question comes in the line of Jonathan Aschoff from Roth Capital. Your question. Please.

That's right.

Might have your phone on mute not hearing you at the moment.

Hello.

Now we can hear you.

Okay great.

Thanks, So the one question that I have pertains to micro line and although it's a similar to Matt Yeah, I think it's a little more direct some I'm going ask anyway.

As beneficial as it as it can be to be stuff into market, you know with a competitive advantage such such as method of administration.

Hey, after allegations pressed to so and you know large salesforce and then paving the way in a marketplace against you know relatively inexpensive reading glasses.

Most of my question is how do you plan to teach Mike line against say Novartis is caught up potentially being disease modifying no persons both personnel again.

Okay, I guess I'll take that one also this is Michael.

You know the var. This product we we are keeping an eye on but this is not the first time somebody has tried to come up in something that softens. The lens I've been doing this for almost 30 years and I remember they used to be drugs that people were looking out to soften the lens to prevent cataract.

And they've not been successful so we'll keep an eye on it.

But you know I don't know what the probability of success of that product will be as far as allergens products I would think.

That will have a better profile, we know from testing in our recent quantitative research.

Our assume profile versus there were some profile and if we perform in the clinical trial the way that I suspect that we will the idea of being able to offer a patient something that is easier to take neither to take and also doesn't give them as much about headache.

In itself can be a winning proposition.

Sean do you want to add anything for that.

No I think I think that's covered that I know everybody wants to us Chrysler probabilities.

Two products and development Ah Ah developments in the pipeline, obviously, the probability of a new molecular entities, which will be in a first in class indication without going to establish mechanism of action is very different in face to face Threed, then and establish molecular entity that's been around for six years.

Still a pretty profile, we know extremely well and again I think that Ah. Obviously, there is a huge need for on demand and we don't even know what the side effects will be for a disease modifying them city a lot of things that on certain when you talk about skittering perfect, particularly through the telescope.

Oh.

Looking at and it's something we don't completely understand it has never been on the market. So I think that right now micro line than what we see Union our research and Michaels research has been extremely compelling I mean, it's really been off the charts in terms of what people skills. The need a that can immediately address pharmacologically.

That presbyopia and only the future will tell what other therapeutic modalities are on the landscape.

Okay guys. Thank you very much.

Huh.

Thank you aren't next question comes from the line of Esther Acevedo from Oppenheimer. Your question. Please.

Hi, Thank you for taking my question and I have a couple one that you touched on the supply chain. Initially can you help us understand.

How much how much product you have in Oh, you know for your clinical trial right now that you have access to and I'm also they devices.

And then I have a quick follow up as well.

[noise] [noise], yeah, that's there let me answer that again.

As a public health person in addition to being a doctor one of the thing I don't really understand today is what are we facing oh, we facing a pandemic in a situation that.

Last four weeks of Ah of current measured a this is left 14 weeks or does it lost 44 week.

Well, we as a team have made contingency measures and we've also assume proactively measures to create leach time cushion in our supply chain. So we currently thing under the current circumstances.

We have enough supply chain 12 months to meet our clinical trial needs.

Oh, the in Raleigh, known called clinical trials and also for a clinical trials like micro aligned with the vision water Chu.

Again, it will be interesting to see what happens in were monitoring it very cold between 44 weeks a weird the same situation, obviously the impact will be different.

But currently we we've taken measures to ensure patients enrolling our trials continue to be supported and and we want to be backing the santo as quickly as possible. When this crisis is down so that we can regain time and hopefully the cushion that we've built the old.

Be helpful for us in that respect.

[laughter].

Understood and had intended to make the line.

While initiation it I have that down for the second quarter, if it yeah with the potential topline by yearend 2020 is that timeline bill intact.

So the guidance that we've given a that <unk> an hour really most meaningful outcomes here.

I have been to produce phase three data in the result by the end of the year.

And then our current evaluations support that.

Of course, we really don't and all the uncertainty were facing again is that a for 14, a 44 week or locked down.

And where we're gonna be so I would like not to give.

Answers to questions that nobody in this country really has any answers that maybe we can revisit that are in the quarter.

Right, but the F.D.A. has decided to have played out guidance. That's basically have even stop clinical trial enrollment for oncology child. So I'm just curious to understand us. If this second quarter because essentially you know in a couple in up in a week or so.

That kind of fall within that one month time period that you're talking about rates. If there is like yes. If there is a delay of instead of starting in the second quarter. If you end up starting in the third quarter. It does that affect the timeline for that read out.

Yeah. So after I think we're tracking with our milestones and most meaningful milestone for us is producing faith. The results by the end of the year and we build the enough cushion and some of our operations to do that.

I would not like to be has granular about things that we cannot predict right now and where are reassessing. The situation as we go forward to we have four readiness.

And of course, a whole lot of it is impacted more immediately by where we are always the coffee on danek, but it's a pandemic that really nobody knows how long it will last we currently.

Continually dollar guidance that edecrin moment, unless that becomes much longer than anticipated.

We will be able to get back into satellite to produce phase three results by the end of the or from the Mike line product.

And then my last question and it didn't device that you're using for for Michael line as well as for micro team is that that you had initially it kinda talk about that that second can device that well have that well have sort of compliance monitors and and and then Bluetooth capability.

Is that the device that you're using for the trial.

Yeah, our divide the we're using into clinical trials and the one word on a go forward. The trouble will have they both have.

All of the compliance and electronics necessary.

All that and again this is part of the its inherent to the all conjecture.

Yes.

Thank you.

Well, thank you weren't.

Next question comes in the line of each in from H.C. Wainwright. Your question. Please.

Thank you for taking my questions. My first question is could you tell us the current im hoping Roman status up to chaperone trial.

For example, what percentage of completion Roman talking <unk> has been reached.

Yeah. So everything we've said before where I think this was a question that came out the last quarter.

We are abstain from giving a day to day enrollments out us to access for the board on our clinical trials. What we have provided guidance is that we would like to end. The goal is to fully enrolled the study.

By the end of the a 2020 I.

I think we're looking at that is the most meaningful one.

Because obviously from that time once we have lots of patients into the trial LPI into the study by the end up here from there on where you really start tracking the clock for the three year endpoint.

So for us. So so the key objective is to get the Las station to our study and fully enrolled the trial by the end up here.

So so far you have observed any disruption in that realm and speed due to the open dynamic right.

I doubt it wouldn't be absolutely correct, because it will be remiss to say that we have certain sites that especially the New York area I know, where we are where were facing a real situation here with a lot of cases and there has been an impact on certain sites to continue to enroll.

Then really leaves us hopeful Dol that vary at the point when this is resolved and people are black.

To normalize we can catch up on that and we are in the process. Then as the you know, we're bringing up a very strong steel side.

A validated insights with a lot of experience in soft enrollment. This is not a population where patients are hard to find.

So we really called the that by the end of the year.

We will be able to compensate and it's not we're going to let you know a lots we are really understand where we're heading and I think that understanding.

At least from my chair stop and for our company will probably be in a month or two.

Okay second question just to clarify be micro line [laughter].

Phase three study presbyopia is still going to start Inc. second quarter produce results by the end up yes, you're correct.

So is that as I mentioned before two after I think she asked the same question.

We're committed to providing face to be a result for the completed a program for micro line and trial.

By the end of year exactly when we're gonna initiated right now it's something that were evaluating whether we initiated late in the second quarter or the beginning of the third quarter, but back to us has been much less.

The question is much it can we completed the study by the end of year. The vision, one division to city, which is walk really determine the clock for the end da submission.

Oh that funnel quite as much fun, okay. If I might have to what can I just had one one thing for that.

I guess, a feeling that some people might be comparing our vision study to the studies done by our again and I think we should just make the point that our design.

Is substantially more efficient and quicker than what Allergan did so you know why are we can't see exactly when that study will start precisely the ability to finish it up by the end of year is something that we're still comfortable with.

Got it final question could you talk about the expected yeah.

You expected operating expenses for 2020, and a weather the permanent shares outstanding It was 19.8 million shares.

The current shares outstanding or 19.8 million shares.

Correct statement post a post transaction.

In terms of the operating expenses. So if you look at the fourth quarter. We showed total operating expenses of $5.3 million.

Included in that amount was about roughly 700000, a non cash.

Stock compensation and depreciation expense so.

On a quarterly basis, if you look at it we were about 4.5 4.6 million per quarter of cash based operating expenses are.

We think that's probably a solid numbers, we look out over the next three quarters or so.

It might be a little smaller as we look second quarter and third quarter and increase.

You know as we get into the micro line phase three study, but do you know that's a good average if you look at about 4.5 to 4.6 million corridor.

Got it. Thank you know that being said, let me just had two comments that I think a pretty important.

Okay.

A lot of our expansion is probably a majority of them or project oriented expenses. So we do have the flexibility that if we needed to reduce expenses from the level. I. Just gave you. We do have the ability to reduce if needed. If you know not just to give you some idea with the current I'm certain.

And what's happening in the country, we do actually flexibility on that number but that's certainly oh, the operating plan that we're looking at.

Okay. Thanks.

Thank you.

Thank you. Our next question comes in the line up Maria.

From National Securities. Your question. Please.

Yeah.

Well, the a kitten I keep mentioning 2019.

So.

Yeah. My two line initiation and you already said that you hope to starting to second quarter 2020, but depending on do circumstances, but I was wondering if you can answer the question of has the I.M.D. Vincent need it.

No. The high end be has not been submitted as of now although it it's a prepared and Oh, we have not submitted it.

At this very point in time, but again, we will submitted prior to the initiation of the study, which we hope to complete before the end of this year. So we can provide you with phase three data on the problem.

Okay, Great and then for my Chris that I believe you said the it didn't Moody's study when we finish and the next couple of months.

Thank you will see median today, but I do we Michael said aim to 2020 or so is there a reason why you wouldn't be able to estimate the meat 2020.

Yeah. So we have basically mentioned before that into second half of the 2020, we're going to submit the NDA.

Again, the module was beam compiled the we have all the clinical data, we're very fortunate that our phase three clinical studies.

Were completed we've been very strong data, both the efficacy and safety.

And that's been already completed and thing included in the module. When we have the final stability 12 months stability data that would be compiled into the module.

And from what we understand now I think at the FDA still operating and repaying submissions and able to handle submission. So we hope that sometime in the second half of 2020 and again, we need to see how everything unfolds in the next month or so but the goal is to submit it.

Early as we have the data from the stability studies and and move forward it would be an NDA submission.

Okay, great. Thank you for taking the questions.

Sure Maria.

Thank you and this does conclude the question and answer session of today's program I'd like to hand, the product program back to Dr. into live for any further remark.

[noise]. Thank you again, I I would like to thank everybody for joining us today and I really hope that this 2020 year, which is symbolic for ophthalmology 2020 vision a in our vision, one and vision two trials in micro line that we hope to.

Initiate fan and ER and complete the fear I really want to thank you for participating today and I wish everybody to stay safe alert and that prepared and Oh farewell through this difficult times and hopefully we'll be able to provide you more granular updates or the next conference call. Thank you.

Thank you, ladies and gentlemen for your participation in today's conference. This does include the program you may now disconnect good day.

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