Q3 2019 Earnings Call

Good number of patients about 30 patients each so we're tracking with nine and and we hope to have the the trial wrapped up in 2020, and then it's going to be the follow up for 36 months sure sure and then the new program that you emphasize recently in terms of the refocusing on on the Mike right.

You expect to start those studies income.

Guess both in in in 2020.

I can't give us a sense in terms of when when in 2020, you could have read out of top line results as it really kind of late next year or or is this something that yeah. Much faster. It's just it's easier to to do you know, Matt I liked to speak in in in <unk>.

Versus quarters. So I think we're we're planning to initiate it in the first half of beer and you have results by the second half a in the second half of the are probably toward the end of the second huh.

Okay.

And then and then and just with for for Michael in terms of help us understand the from Michaeline. The <unk> kind of that current competitive landscape, there and and then in terms of competitive <unk> programs in in in in development right now right.

Right well the current competitive landscape is devices basically reading glasses.

You know that's the the current option what we do know or is that there's about four companies who are working on presby over your drops drops of some kind most of them are related to pile carping or or parlor or they are pilot carpeting.

Probably the one that's furthers to head might be <unk> and the rest of them are unfazed to basically so the landscape looks like a will be up there probably before many of them among the first and in the end you know you're talking about a population of 43 million people, there's plenty of opportunity for everybody, but we believe that.

Hour solution, well matched the needs of this market better because of the way that the product is delivered how the product works and also with fits well with the opt to metric model in that the dispenser is is something that optometrist like to use like to provide.

I'd like to talk to patients about rather than just simply writing in our x.

You know very good and and just last question in terms of.

Micro line Michaeline, how do you how do you how do you envision patients using it I guess in other words, perhaps some patients will be frequent users and and and others less so in help us <unk> send a sure mask you've done there.

Yeah, So Matt it's a it's a companion product I drove to eye glasses is not meant to replace your eye glasses. It's meant to be used on demand. So it's more and episodic type of thing that you would use when you don't want aware of your glasses, you're going to dinner, you're going to a game you're doing something wear glasses, just would not be your first option and this will give you.

You know significant folk functional vision for a period of time. So we we are envisioning that you would use them on demand on the way we do our forecast. For example is we assume that there is a proportion of the population that we'll use this kind of therapy and have that population. There's a some population that when you use it maybe.

Daily there's a bigger population that would use it perhaps twice or three times a week and there's you know population that would use it on an episodic basis in terms of the duration abuse that we're targeting we're looking for something that will work about three and a half four hours in duration. So again that would fit very nicely with.

Oh, you can easily plan to use it for some kind of a van some kind of thing that you're doing and then and then it doesn't work any more you could take it again I suppose but you know that would be the ends without episode, Yeah, and and Matt [noise] I think that I have a lot of patients do who you know him. The age of 40 45 and for them. It's also not only near vis.

But it's also intermediate vision, yeah. He had a computer and it's all gonna be good for that basically Michael here doesn't have to read he can just it's just like that [laughter] wish I could see what was going on here because I was taking my glasses on and off [laughter]. During this whole thing and they were saying I wish I had the damn thing now yeah.

Right. Thanks, Thanks for that color guys.

Thank you ma'am.

Thank you aren't next question <unk>, Russia.

Oppenheimer proceeded your question.

I think even taking my question I just had a couple of like one.

Michaeline I'm product with Florida competitors potentially starting tasty child for the same time are are you know.

<unk>.

And you seem to have a fairly aggressive recording time nine now how do you think that kind of planes into the basement of treatment.

Yeah, I think that <unk>, we've looked at that and in fact, we already have the the sites identified and we've done a lot of work.

As you know ginger and her team they initiated a and completed the microphone that studies in a blink and I think that we feel this kind of program has the same acute nature of enrollment and and delivery have results.

So also the patient population is not something that you really have to go looking for.

And and frankly, the third part is when people look at our delivery system and this wouldn't be the only one that we know up Ah that's out there in any stage of for relevance that will not be on an eyedropper. It will be on a horizontal delivery micro <unk> with Alex Ronnie delivery so dramatic.

Different so I think we feel that this is gonna be absolutely.

No issue in terms of identifying patients enrolling the studies.

Gotcha.

And in Texas.

What kind of a.

Can you said our expectations.

Product is going to trends.

Standpoint, an adoption standpoint.

Yeah. So.

So the the nice thing about this because it's not a typical prescription drug and it's more like a diagnostic supply is once you get it into a large practice it takes over for that large practice. It replaces what they're currently using for pupil dilation. So our goal is to go into those very very.

Practices first.

And help them with the switch over so that we can expect a relatively fast uptake initially it's not going to be the kind of thing with traditional pharmaceuticals, you'll have to wait for a patient to show up and then you have to do a sample and then you have to switch and you have other people counter detailing you it's not like that at all in this case, you're going you have to show that.

Doctor the value of the technology, which from our meetings and advisory board so they all by into.

And then once they do you set up the technician on the office staff to make the weather and they make the transition and then that's it there's no reimbursement there's no insurance company. So we look at the uptake is not one of these where it will be five to seven years will be much faster than.

Okay, great. Thank you very much.

Welcome.

Thank you aren't next question comes from you Chen with each human Wainwright you may proceeded your question.

Hi, This is blue Marlin dialing in for each one and thanks for taking my question Oh actually got a couple of them about micro line for the first one what are your thoughts on the pricing of micro line for <unk>, yeah, given to the glasses are available as cheap and if they are effective.

And our model. We are you know we're price of this and again because this is episodic it doesn't go on a month basis. The way. We're looking at it is what would we price it on a cartridge basis I work hard trudge withhold sufficient medication for 75.

Killer application, so 75 episodes of use and our model has a price of $85 for that so if you assume somebody uses this maybe four or five times a week that would last about nine months I'm, sorry, three months and that would cost them you know roughly 20 $530 a month.

The other thing to also considers that many people have a flexible spending account or health care spend the account. This is still a prescription medication. So even though it's cash paying not covered by insurance they can still get reimbursed for it.

Alright, great. So the next one while my Caroline improves neither distance vision could it possibly interfere with the long distance vision.

[noise], yeah, so [noise] micro <unk> again, the major the major impact in the major mechanism actually through which my client axes through a pinhole pupil.

Not as much through accommodation and of course, we we will have to ultimately answer your question through our faith preclinical program. When we have the results. So I would I would differ full full comment on that until we have our faith three trials, but due to a little bit <unk>.

Highlight the mechanism that we think is that clay, we'd Mike <unk> Carping is mainly through pinhole effect or small aperture effects, which creates an extended depth to focus.

And extended depth focus effect is something that doesn't interfere with your distance vision.

The only time it would it if it really act through some sort of been accommodative effect, which could potentially have some involvement here, but we believe the major effect is the extended that the focus through the pinhole and that should give people the enjoyment of both the distance intermediate and.

Near visual acuity, which is not the case with reading glasses, because the mom when you put reading glasses.

Now shifted to your vision to near and no distance.

[noise] alright, that's it from me thinking so much.

Sure.

Thank you are next question comes from Scott Henry with Ross Capitol You May proceeded your question.

Thank you and good afternoon, just a couple of follow ups on Mike Reliner.

Hi, Lokar pain, I guess first.

<unk>.

Could you speak a little bit about of the magnitude of effect.

Typically has.

Similar to eye glasses, just just trying to get qualitatively an idea <unk>.

Impact.

Yeah, and and again, it's called this is this is something that is supported by a lot of literature. In fact extended up the focus through pinhole has been something that has been also part of developments in technologies into intraocular lenses, where they've done it being hall affect.

As well isn't even in some other procedures. So painful effect is really beneficial and is able to create a about a day opt her in a half to two day opt or near point and and it's really from that perspective is really great because it also.

Leaves you the benefit of intermediate and also distance vision. So yeah, it's something that there's plenty of data it's something that one can even look at surrogates through the intraocular lenses were extended up the focus.

Was done in as well as even corneal in life have also investigated I pinho effect for presbyopia. So <unk> those those data and all studies indicate about a day off trying a half to two and I think that covers most patients from where they are today in terms of their.

Intermediate in your vision needs.

Okay, great thanks for that color.

Final question, you know when it comes to a micro line as a cash pay large market product yeah. How would you expect to market that product teams kind of like in a an awareness campaign, a D.T.C. campaign would all lend well into that but those can.

Be somewhat cost prohibitive. So is this something you would do yourself or would you bring in a partner it just seems like it <unk> it would appeal to to amass audience. Thank you.

Sure Scott I mean, certainly if there were partners interested we're not we're going to talk with whoever that might be but regardless of that this is the kind of product that we would see being offered to patients while they're getting their eyes exam. So they go to their optometrist, they're getting their annual I examination there.

Getting the new reading glasses.

Optometrist will offer this to them as a companion product and the reason that he or she might do that over something else is because the to jet dispenser lends itself to some extra things that with <unk> can monetize when he <unk> when he writes a prescription for this <unk>.

Example, he or she can sell a travel kid or he had she console customization to the dispenser it fits within their economic model.

So yeah, we we see them going to this very very quickly and making this part of their practice.

And also I think given that that we have <unk>. How many companies. We mention that are going into that space I think that we're going to see some sort of pharmacologic treatment out there with all of that and I think all they're gone is the one leading as Michael mansion with the phase three nah that they're very experienced in developing.

Aesthetic market very well and I think that there will be some pharmacologic treatment because we're now realize that our patients today are very different than patients 2030 years ago in terms of their lifestyle and and independence. So we we we think that that fits very well we've.

The retail modeling off them, all energy and optometry and and also with the lifestyle needs and what will be ultimately developed by many companies into space.

Okay, great. Thank you for the additional color.

Sure.

[noise]. Thank your next question comes from.

Maria Barbara with National Security proceeded commercial.

Thank you for taking the question is my first question is for John .

It seems that mm mm.

Hmm.

<unk> first quarter 18, so I was wondering that's something that we should expect that so far.

Mmm.

Yeah, so because a lot of our expenses, specifically r. and D. expenses, our project related they are going to go up and down and they will not be linear.

But I would say overall I wouldn't expect that trend to continue because as we ramp up the Mike relying phase three study and continue with the increase in Rome, and micro pain as well as to Microsoft N.D.A. filing I do anticipate the R. and D. expenses to go back probably at the level of <unk> They were right.

I you know maybe first quarter of this year.

G.N.A. one you know, it's slightly up and down I don't think well see large increases in G.N.A. by any stretch the imagination, but more.

Cost of living type a adjustments that you will see what you're a gene expenses.

Okay. Okay times, and then I have a couple of questions about my typing.

The first one.

I'm unemployed at 36 Mountains and I was wondering why did you stay in rational for then.

<unk> children for it again and then following up down for 12 months.

Yeah. So it's it's it's the primary endpoint as you said is a at 36 months and doesn't really defines the recent benefits for for the study and that's where we're going to be filing the extended follow up is partially because I think the F.D.A. would like to see.

What happens when patients stopped taking the drug as we know for example in glaucoma when you take an L.P. lowering dragging your I.P. goes down if you stop taking it your eye opening goes back up into Oklahoma progress is we have seen that from some of the collaborative studies.

That when when the drug is discontinued AD for pain. You. You you can have a regression affect myopia. If you discontinued before the age of 18 to 20. When you were development stops. So I think that the last year. This additional here.

Tibet to characterize what happens in to see whether it's real easy in line, we well we happened to collaborative study groups, which really reinforces the fact of compliance and reinforces. The fact of how important is to take that drive until a young kids come out of the development stages of the I., which happens about.

18 to 20 years of age and also reinforces the importance of our compliance monitoring system why is it so important to have an electronic delivery and compliance monitoring because you wanted to have a compliance and you want to have consistent dozing through <unk> you know the teenage both.

Teenage years, after which really be myopia doesn't seem to progress even if you stop the treatment.

<unk> 12 months sorted out there that the following day.

We will be filing the N.D.A., we'd the D. 36 month data in the primary and point, we certainly during the review Psycho as we have the data come through we can roll that in from the 48 months, but the filing will be with the primary and point of race benefit that 36 months.

Okay.

I have a question about a day.

You mean, they study so how long does that do it then is the idea to make sure that the children or parents know how do you.

They started to trial.

The period is only two weeks.

Two weeks.

Yes.

Okay. Thank you, but they're going to questions.

Sure I can't get Maria.

Thank you I'm not showing any further questions at this time.

Gentleman. This concludes today's conference call. Thank you for participating you may not disconnect.