Eyenovia Inc (EYEN) 2018 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Eyenovia Second Quarter 2018 Earnings Conference Call.

(Operator Instructions) As a reminder, this call is being recorded.

I would now like to introduce your host for today's conference, Ms. Tram Bui.

Ma'am, you may begin.

Good morning, and welcome to Eyenovia's Second Quarter 2018 Earnings Conference Call and Audio Webcast.

With me today are Dr. Sean Ianchulev, Eyenovia's Chief Executive Officer and Chief Medical Officer; and John Gandolfo, Eyenovia's Chief Financial Officer.

Earlier this morning, Eyenovia issued a press release announcing financial results for the 3 months ended June 30, 2018.

We encourage everyone to read today's press release as well as Eyenovia's quarterly report on Form 10-Q, which will be filed with the SEC later today.

The company's quarterly report and press release will also be available on Eyenovia's website at www.eyenoviabio.com.

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

Please note that certain information discussed in the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act.

We caution listeners that during this call, Eyenovia'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 with the company's business.

These forward-looking statements are subject to a number of risks, including risks related to fluctuations in our financial results, risks to our clinical trials, included but not limited to, the initiation, timing, progress and results of such trials, the timing and our ability to submit applications for, obtain and maintain regulatory approvals for our product candidates.

Our estimates regarding the potential market opportunities of product candidates, our ability to attract and retain key personnel and other details in it are qualified by the cautionary statements contained in Eyenovia's press releases and SEC filings, including its most recent annual report on Form 10-K and subsequent filings.

This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 14, 2018.

Eyenovia 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 that, I'd like to now turn the call over to Sean.

Thank you, Tram, and welcome, everyone, to Eyenovia's Second Quarter 2018 Earnings Conference Call.

In the first half of 2018, we continue to progress with the development of our extensive late-stage pipeline in addition to further validating our novel therapeutic platform for -- with compelling results from our PG21 study, and the notice of grant of additional patents in the U.S.

As we prepare investigation on new drug applications to initiate Phase III development for our programs, we have decided to accelerate our MicroPine program to address the significant medical unmet need and potentially -- and potential market opportunity of progressive myopia.

We look forward to submitting 2 INDs this year and anticipate initiating all 3 Phase III programs throughout late 2018 and 2019.

And with the over-the-counter registration of MicroTears for dry eye on the horizon, we're beginning to develop commercial and marketing strategies with the hire of Michael Rowe as our VP of Marketing.

Michael will play a critical role in advancing our position as an innovator, focusing on the possibilities that microdosing brings to the field of ophthalmology.

For the past 100 years, almost all topical treatments to the eye from glaucoma to dry eye have been delivered using the legacy eyedropper technology.

And with this technology, delivery of medication is highly variable.

In a compelling study highlighted in JAMA ophthalmology, researchers used video recordings to evaluate patient performance of eye drop instillation.

The study found that only 1/3 of patients were able to successfully deliver medication to their eye based on 3 key performance criteria: successful instillation into the eye; instillation of only a single drop; and not touching the bottle to the eye.

Other studies have also identified that patients deliver a mean of 2.6 drops to the eye and touched the bottle tip to their eye in approximately 50% of instillations.

This result runs against patients' perception of their own success.

When asked, more than 60% of patients believe that they never miss their eye drop and 90% report no problem putting in their eye drops.

In reality, though, patients truly don't realize that they aren't getting the prescribed dose or are missing their eye entirely when instilling eye drops, potentially leading to ineffective treatment or overdosing, which may lead to topical and systemic side effects.

Recently, we completed the full analysis of our PG21 study, investigating the medication administration effectiveness in IOP lowering effective microdose latanoprost, 0.005% in 60 eyes of 30 healthy volunteers.

In the study, participants received once-daily microdose treatment over 2 consecutive days and underwent the urinal IOP intraocular pressure assessments 4 times a day.

The primary outcome we examined was success of microdose delivery, with additional outcomes evaluating diurnal intraocular pressure change every day.

In the study, after a brief medication administration training session, investigators successfully administered high-precision piezo-print microdose latanoprost with a single spray 95% of the time.

A separate evaluation of patient's self-administration showed an 88% success rate following limited training.

This is a dramatic leap in efficacy and accuracy of delivery and almost double what is seen with conventional eyedropper technology.

In addition, every single medication administration was within 1 microliter of the prescribed dose and the tear capacity of the eye, while eyedropper administration typically delivers as much as 300% more with high variability of dosing.

Our PG21 study also assessed the topical ocular delivery of highly precise microdose, which matched the physiologic tear film capacity of the eye in single-digit microliter volumes, reducing exposure of toxic preservatives in medications to the eye by more than 75%.

We believe this is extremely important for patients with glaucoma, dry eye and myopia, who might need chronic therapy for ears and suffer the side effects of those therapies.

Needless to say, we're extremely happy that Eyenovia may be on the threshold of introducing a new paradigm of high-precision, high-efficacy topical delivery for front- and back-of-the-eye therapies, where patients and doctors may be assured the prescribed dose is delivered to the eye accurately and consistently.

We believe this will further reduce waste, improve safety and potentially lead to better care in the field of ophthalmology.

Furthermore, as we reported previously, the study also demonstrated that while reducing drug administration volume by 75% by delivering the microdose accurately and directly on the corneal surface, piezo-print micro-formulated latanoprost achieved a very robust reduction in diurnal intraocular pressure of up to 29% from baseline unmedicated intraocular pressure.

This is consistent with the reported reductions of up to 26% achieved with the same concentration of standard latanoprost eye drops.

We find these results very encouraging, as you will recall, we reported similar confirmatory results from our 2 earlier Phase II trials in mydriasis, which have already been published.

In addition to the PG21 study, we also recently noticed -- we received 2 notices of allowance from the United States Patent and Trademark Office, granting us 2 patents which provide us with fundamental coverage on physiologic micro-droplet ejection diameters and velocities, which enable the gentle delivery of ophthalmic therapeutics to the eye at velocities that beat the eye blink's reflex.

These patents are key to delivering our micro-formulations and expand our IP portfolio to a total of 8 in the U.S. Furthermore, we currently have 7 pending patents in the U.S. and 54 pending patents worldwide.

Turning now to our clinical product -- programs, starting with MicroPine for the treatment of progressive myopia, which is becoming an increasingly important part of our pipeline.

Progressive myopia is a back-of-the-eye disease, characterized by increased axial length and progressive elongation of the eye, causing increased refractive error and nearsightedness.

In the U.S. alone, there is an estimated 5 million children with significant myopia, with that number rising sharply to nearly 80% to 90% of young adults in Asia.

Without an FDA-approved therapy to slow progression, we expect to see an increase in the rates of visual impairment by 7 to 13 fold by 2055.

We believe this creates a significant market for a therapy designed to slow progression, with an estimated treatable population greater than that of the total addressable population for open-angle glaucoma and wet macular degeneration combined.

Recently, academic institutions have conducted 2 major collaborative studies examining the therapeutic activity of topical atropine, which is an anticholinergic agent used for dilation.

These studies, which were large 5-year randomly controlled trials, demonstrated an atropine can slow myopia progression by up to 60%.

Despite these studies, though, there remains no FDA-approved treatment for myopia progression to our knowledge.

We think this is because current formulations of atropine have an unacceptable safety profile, with significant side effects, as well as a very short half shelf life.

However, these studies indicated that low-dose atropine offers acceptable efficacy, with a better tolerability and safety profile, laying the groundwork and significantly reducing the risk of using of low-dose atropine.

With that said, we're very excited to accelerate our MicroPine program towards an IND submission, and we'll prioritize the Phase III trial to start in the first half of 2019.

Using our microdose approach, we can deliver precisely 6 to 7 microliters of atropine to the eye in order to potentially obtain the desired therapeutic effect and eliminate 75% of formulation load and exposure.

MicroPine is also a stable formulation with a 2-year shelf life.

Furthermore, as we have previously mentioned, after discussion with the FDA, the agency has indicated that potentially only one Phase III pivotal study will be required for MicroPine, which will reduce the cost and time line we need to invest to reach a potential NDA submission.

Finally, as we prepare for the over-the-counter registration of our dry eye product, MicroTears, in 2019, we have begun developing marketing and commercial strategies, and we're excited to bring onboard Michael Rowe as our VP of Marketing.

Michael is a veteran marketing professional and has more than 20 years of experience commercializing the products in the U.S. and globally.

He has particular expertise in the ophthalmology space, having joined us from Aerie Pharmaceuticals, where he was responsible for the U.S. and international commercialization, planning and execution of Rhopressa.

He also spent 12 years at Allergan, where he supported the strategic planning for the company's worldwide glaucoma franchise.

Michael will help lead the charge as we plan to introduce our revolutionary technology to ophthalmologists, optometrists and patients, starting first with MicroTears into the eye care practitioner's office.

We feel confident that Michael's commercial ophthalmology experience will be an invaluable asset in planning our strategic direction as we near commercialization.

And now I would like to turn the call over to John to discuss our financial results.

Thank you, Sean, and once again, thank you all for joining us this morning.

Second quarter of 2018, we reported net loss of approximately $3.3 million or $0.33 per share compared to a net loss of approximately $1 million or $0.43 per share for the second quarter of 2017.

Research and development expenses totaled approximately $2.4 million for the second quarter of 2018, and this compares to approximately $800,000 for the same period in 2017, an increase of 221%.

The increase is primarily due to an increase in contracted services, supplies and personnel, as we continue to expand our R&D activities for our microdose products.

For the second quarter of 2018, general and administrative expenses were approximately $900,000 compared to approximately $200,000 for the second quarter of 2017, an increase of 304%.

This increase was largely due to increased headcount associated with the growth of our business as well as cost related to being a public company.

Total operating expenses for the second quarter of 2018 were approximately $3.3 million compared to total operating expenses of approximately $1 million for the same period in 2017, an increase of 240%.

As of June 30, 2018, the company's cash balance was approximately $24.6 million, and we believe we have sufficient cash balances to the end of 2019, allowing us to progress our pipeline of programs towards Phase III development and OTC registration.

That concludes our financial remarks.

I would like to hand the call back over to Sean for closing remarks.

Thank you, John, and let me conclude by noting that we're extremely pleased with our accomplishments in the second quarter, including our successful PG21 study, which we believe further validates our novel technology and the notice to grant 2 additional patents in the U.S.

While we prepare to submit 2 IND applications by the end of this year, we are on schedule to initiate our first Phase III clinical study with MicroStat for mydriasis before the end of this year.

As we seek to rapidly develop our marketing and commercialization strategy with the over-the-counter registration of MicroTears, we look forward to working with Michael Rowe as we near potential commercialization.

That concludes our prepared remarks, and we'd like to open now the call to questions.

Operator?

(Operator Instructions) Our first question comes from Scott Henry with Roth Capital.

I was juggling multiple calls so I apologize if you hit on any of these questions during your prepared remarks.

I -- but first of all, on MicroPine.

Clearly, a significant focus for the company.

Could you talk about what the Phase trial -- Phase III trial would look like in terms of endpoint and time line?

Yes, Scott, good to have you on.

This is Sean here.

I want to address your questions.

Yes, MicroPine is becoming a lot more center and front for us as we realize how big of an unmet need that is.

I mean, we're talking dramatic difference in population compared to some of our other programs, and in the field of ophthalmology, in fact, myopia seems to be just as big therapeutically as an opportunity as most of the other back-of-the-eye conditions.

And also, one of the things we realized as we dive into this further is that MicroPine and myopia progression used for this indication -- in fact, myopia progression is a back-of-the-eye disease, as we highlighted earlier, and this may be the first -- one of the very few times we're treating a back-of-the-eye disease and we have a front-of-the-eye approach for that because, as you know, we treat macular degeneration and diabetic macular edema with anti-VEGFs.

But those actually require intravitreal, in-the-eye injections.

And here, what some of the collaborative studies have highlighted and shown us with a lot of data and it is very rare that we get the benefit to design our Phase III programs when most of the, really, the major randomized controlled studies have already been done, and we can benefit from looking at the wealth of that information.

So we're very excited about this.

We're looking at ways to accelerate this dramatically.

And the Phase III program we're looking at is basically a randomized controlled study with 2 concentrations of microdose atropine that we have, which will be our own formulations.

We're doing and pursuing pretty much all of our programs with our own formulations.

And the control arm will be sham/placebo microdose without a therapeutic agent.

And the endpoints for that are really very logical and they're very similar to what was shown in the collaborative studies.

It's basically the change in refractive error over time.

And it will be with a 3-year endpoint because, as we know, this really impacts a lot of patients and it's a chronic condition.

When young adults, in the ages between 5 and 17, are taking that drop, if you're 5 years old, you start out at a refractive error of minus 1 or 2. By the time you're 8, some of those patients go to minus 5, diopters of refractive error, and some of them can reach as much as minus 10, minus 15, which is very unhealthy because it's associated with maculopathy, with retinal detachment, it's a big problem.

And again, that is a therapy that we anticipate people will need for many, many years until the eye reaches about 20 years of age when it stops elongating and stops developing.

So the endpoints reflect that.

They're logical endpoints, about 3-year endpoints.

But in fact, we've seen already 5-year data with low-dose atropine by the collaborative studies, which shows a dramatic effect of almost 60%, and more interestingly, it's replicated in a number of trials.

So again, we are pursuing a very similar endpoint, and we're pursuing a very similar trial design, which is being informed by all these collaborative studies.

But we're pursuing it in a regulated pivotal way for an FDA registration of that program.

Okay.

And if I could just ask one -- or a follow-up question, it would be, how fast do you think this trial would enroll?

And will there be any opportunities for interim data between time 0 and 3 years out?

Yes.

Again, it's a very good question, Scott.

I think that it's not going to be a huge trial.

We anticipate -- again, I wouldn't say we've completely locked down the numbers yet, but we anticipate this would be about a 600-patient study.

And again, as you look, this is not -- compared to other back-of-the-eye diseases, this is not an intravitreal injection.

We're not going to inject the eyes of young adults with a therapy here.

It's just a simple microdose spray.

And we have a tremendously rich population opportunity here, about 5 million in the U.S. addressable population and much more if we go to Asian countries.

I think for this one, we don't even need to worry about going outside the U.S. to source patients.

So I think my -- as a person who has spent a lot of time in ophthalmic development, we headed out the LUCENTIS programs back in the days, the Genentech.

I think, this is a materially different patient population and enrollment strategy.

And with our VP of Clinical Operations, Ginger Clasby, I think, we're pretty confident that we will be able to achieve fast-paced enrollment.

In this case, what I would consider a fast-paced enrollment would be less than 12 months to get the fully -- the program fully enrolled.

In terms of interim analysis, I don't want to commit to anything right now because we're still in the process of completing our statistical analysis plan.

But I would say one thing, Scott, interim analysis sometimes is informative when you have -- when you go in the standard development path from a Phase I to a Phase II to a Phase III, and you have a new molecular entity, for example, that there is very little information.

I think here, we have a situation where we have already preceding and anteceding data, which is -- I mean, which is highly informative of not 3- but 5-year outcomes of low-dose atropine in multiple randomized control studies.

So we're evaluating the need for an interim.

I know, from an investment standpoint, some investors like to see a little peek at the data.

But we also want to make sure that we maintain the most -- the highest level of integrity for the trial and also, we are marching towards the final end here because it's very rare that, in fact, one can have an opportunity to launch a Phase III program in such a big indication with such a dramatically enriched population.

And we already have a fairly good idea from the collaborative studies of what to expect.

Now it can always differ eventually, but it's nice to see that we have not 1, not 2, actually, there are multiple studies out there in myopia progression that have surfaced over the last 2, 3 years.

And that's really informative for our Phase III development.

Okay, great.

If I could just sneak in a very quick question.

I noticed G&A was down a little bit from the first quarter.

The question is, what do you think is more representative of the current G&A rate, what we saw in the first quarter or what we saw in the second quarter?

I think it's probably going to be about where we were in the first quarter.

I know it was down slightly in the second quarter.

But as Sean mentioned, we recently hired Michael and we have some other increased costs that are expected.

So I expect it to be a lot closer to what was in the first quarter going forward.

Our next question comes from Matt Kaplan with Ladenburg.

This is Maria for Matt.

My first question is about the PG21 study.

The primary outcome was a success of microdose delivery.

And this may be a trivial question, but what's defined as success?

Obviously, the delivery of the job, but who determines that, the patient or the physician?

Yes.

Let me address that.

That's a really -- I think it's a basic question and it's a really good one because how do we know when a patient actually gets the correct dose?

And as we demonstrated, and I think part of our script also focused on multiple studies that have shown that patients' perception is very poor when it comes to eye drops.

I mean, most patients think they got it.

It turns out that only half of them or less than half of them actually got the correct dose.

And we have seen multiple studies, have looked at that with videography and video assessment and third-party assessment.

In our study, we have the benefit of both confirmations.

So first that the microdose is very fast and it's a micro-droplet that's delivered to the eye.

But because the eye is very sensitive, the patient can register the delivery of the dose -- of the microdose to the eye.

It's not like they're not aware when the eye gets the micro-droplet because the cornea has -- it's one of the areas in the body where it has the most receptors and nerve endings to detect any exposure.

In our study, we relied on the patient and on a third-party observer confirmation that the microdose was delivered to the eye, and that's why we have very -- [interim instance] or 2, as you see, with the numbers of 95% in the third-party administration and the 88% in the self-administration.

We had a few patients that needed a second try at this.

But again, even at that, we're seeing a real leap in technology here and efficacy of delivery compared to the eyedropper paradigm.

Okay.

So then the study also -- it says that the participants receive once-daily microdose treatment over 2 consecutive days.

Was one eye treated the first day and then the second eye the second day?

No, it was -- basically both eyes were treated at the same time on both days.

So they received 1 dose and then we measured -- which is typical in the glaucoma studies, we measured the intraocular pressure throughout the course of the day because that's how you evaluate, what we call, diurnal intraocular pressure.

And the diurnal intraocular pressure is measured at 3-time points during the day and then averaged, which is the standard paradigm in glaucoma studies.

So they received the 1 dose of micro-formulated latanoprost on day 1 and another one on day 2. And we're preparing now the formal presentation and publication of the results with all the details of the study.

Okay.

So the plan is still to present this data at -- in a coming medical conference and to publish the results?

Right.

Absolutely.

Yes.

We're planning to publish the results just like we did with our first 2 studies that were published in mydriasis.

And again, we were very comfortable with what we learned from mydriasis, which is the pupil dilation study because the pupil dilation study is really -- the endpoint there is dilating of -- dilation of the pupil to pharmacologic exposure, and it's a very sensitive and specific biomarker or pharmacodynamic marker.

And again, for us, showing the same effect of a microdose latanoprost in terms of another pharmacodynamic market, such as intraocular pressure, is really validating across the entire spectrum of front-of-the-eye treatments that you don't need an overdosed or imprecisely dosed or inaccurately dosed eyedropper delivery, but you can achieve a similar efficacy with a high-precision microdose which reduces the total exposure to drug and preservative by more than 75% and has some safety benefits along the way.

Okay.

And then my last question is about MicroPine.

Obviously, a large market opportunity, especially in Asia.

So I think you signed a license and development agreement with Senju in 2015, where they have the rights to develop and commercialize products in Japan and the rest of Asia.

So could you elaborate on that partnership?

And are they working on the same indications, not only the MicroPine, but also the other programs?

And where do they stand in terms of development?

Yes, that's great, and it's a good point to bring out a little bit because when it comes to MicroPine, the opportunity is really big in the U.S. and Europe, and these are the markets that belong to Eyenovia.

But -- and we're seeing here, in general, the population in U.S. and Europe, the rates of myopia are about 40% or so.

In Asia, we're seeing 80% to 90%.

And there's a lot of population studies that have looked at that.

So the opportunity is even dramatically bigger in Asia.

And we're working very closely with our partner Senju.

And Senju is the founding investor in Eyenovia, one of our largest shareholders and also is highly interested to develop the OUS, the Asia opportunity.

In fact, one of the things that we've charged Michael Rowe, who came on board, is really to work very closely with Senju in defining the Asian opportunity [in] distilling our approach there.

As you know that Asia is a big place with a lot of different countries that will have, for sure, different regulatory approaches and development approaches.

So we hope to have a lot more on that.

But for us and in terms of the biggest impact on -- to Eyenovia right now, where we are in charge of our own development and market opportunity, that for us is U.S. and Europe.

And here, it's a huge market because it's a back-of-the-eye disease.

One of the very few back-of-the-eye diseases that we can treat with a topical treatment.

And at the same time, it's a market opportunity, as we mentioned, that's bigger in terms of addressable population, bigger than all of glaucoma and wet macular degeneration combined.

So there is a lot for us to do, and that's why we're motivated to accelerate our development here.

And in parallel, we're also pushing the envelope forward in Asia with Senju.

And hopefully, very soon, in the coming calls, we'll have more to update you in that respect.

(Operator Instructions) Our next question comes from Yi Chen with H.C. Wainwright.

This is Karthik on for Yi.

So I wanted to understand how many more patients will be enrolled in each Phase III trial?

And when exactly will the MicroPine and MicroProst Phase III trial results be reported?

Okay.

So in the Phase III trials, we -- for MicroProst, we're -- as we've said before, we're conducting 2 Phase III programs in MicroProst in chronic angle-closure glaucoma.

Again, an indication where we don't have anything that's currently approved.

And those would be about 250 patients per trial that we've conservatively estimated.

We're going to file the IND.

We're hoping to file the IND, as we've said before, for MicroStat and MicroProst this year and MicroPine next year.

And again, for MicroProst, the trials we hope to enroll, well, the estimates are about 12 months or so.

And then from there on, the primary endpoint is 3 months.

So again, MicroProst is a fairly fast-paced program in terms of endpoints because they're only 3-month endpoints.

And again, 6 months follow-up, total follow-up for the patients.

And from there on, we're going to file the NDAs.

For MicroPine, again, we're hoping to initiate -- and we've said before, we're going to initiate the study in the first half of 2019.

My team is working on prioritizing and potentially accelerating that further.

And if we're planning about a 12-month enrollment, then you tag to that about 3-year follow-up of that -- of those patients.

And you're going to find that we'll be looking afterwards to file the NDA within a few months.

So the MicroPine is a little bit further out.

And that's what we like about our portfolio and pipeline because we have the big crown jewel of a big opportunity, which is a biotech type of economics here without the, kind of, binary new molecular entity risk is MicroPine.

And we're initiating that Phase III.

But in the meantime, while MicroPine is going forward with its longer endpoints, we have the more near-term [problems] coming in with MicroProst and even more near term with MicroStat and MicroTears, which we hope to produce results of the Phase III for MicroStat.

We hope to have those results in Q1 of 2019.

And what's really good about this is that with results in 2019, in the first half of 2019, maybe the first quarter of 2019 for MicroStat, that really validates the whole technology platform in a Phase III program, and there's nothing different about our technology and micro-droplet delivery for MicroProst to any of the other indications.

So from there on, everybody can connect the dots.

But at the same time, MicroStat will do that.

We're then looking at the first half of 2019, having MicroTears, which doesn't require Phase III studies or any clinical studies.

It's an artificial tear over-the-counter.

We hope to have that ready by the middle of 2019.

So we have a lot of work in -- the team is really busy right now because there are near-term opportunities, which are immediate and also groundbreaking because we currently -- we can really transform the way pharmacologic dilation is done in the office and we can really transform how people receive dry eye treatment with artificial tears.

And we know that's about a $2.5 billion market currently that all uses fairly genericized standard conventional artificial tears.

And then follow on to the more -- the later programs with MicroProst and then MicroPine.

So it's a really nice cadence of milestones, a nice cadence of opportunities and unlocking the commercial potential of that technology.

Awesome.

And how much do you estimate that each trial will cost?

I don't think that we've broken it down on a per-trial basis.

When we looked at it, basically, our cash burn in the second quarter was roughly $3 million.

As we start getting involved in these Phase III trials, we expect it to increase on a quarterly basis to roughly $4 million or $4 million plus on average through the end of 2019.

But we haven't broken down the total cost per each trial publicly.

All right, no problem.

And what were the side effects observed in Eyenovia's PG1 study compared to conventional eye drops?

Yes.

So that was an acute study, where we looked at the 2-day effect.

So in the context of that, I mean, nothing surprising.

We actually didn't have any adverse events reported.

The technology was very well tolerated, which is exactly what we saw in our earlier Phase II studies in mydriasis.

I mean, the goal here was more to evaluate the Phase III device going forward before we put it into the Phase III studies, and also to confirm self-administration efficacy and high-precision delivery.

And we're very happy with the delivery efficacy.

I mean, we're a little bit surprised that actually how well it did because as you look at eyedropper, as we mentioned, studies have shown that less than half of the time, patient delivered the dose precisely.

And if you look at some other studies, the efficacy drops off even below 30%.

So to see something in the 80% to 90% plus efficacy, we are very excited about this, and we think that it's really a paradigm shift.

And frankly, it's about time that we have smarter technology to deliver therapeutics to the eyes than what we've been having for the last 100 years.

All right.

And lastly, how much cost of goods savings can microdose products achieve?

And would part of the savings be transferred to patients or end users?

Yes.

Again, we're focusing on -- I mean, as with our programs here, we're focusing on delivering superior therapeutics and we're focusing on improving the health economics equation more than just total dose delivered because, right now, you can deliver -- patients are delivering 2 to 3 drops, and they're running out of their drops halfway through the month period.

And they're not getting the efficacy.

So in fact, there is a lot of waste that's happening and a lot of effectiveness that is missed.

And in fact, we see in our studies, in ophthalmology's efficacy, but we all know that the effectiveness in the real world, when -- where patients are just getting the drops and not getting the same training as in the clinical studies and they're not getting the same monitoring.

The real drop -- the real world effectiveness is very different.

So I think that the way our team is looking at that, and actually with Michael coming onboard, we're going to look at that in even in a more sophisticated way, is not just looking at a volumetric reduction of medication.

We're looking at all of the benefits that come with microdose, and that means unlocking new indications, going into where we haven't been before, such as chronic angle closure, such as myopia, where we can achieve things that we couldn't achieve of what's possible.

Then also, we're looking at reducing the side effects of a drug to the eye, which we know are dramatically important when it comes to compliance.

So that has an economic factor to us and to our society and our patients and physicians.

So there is a lot more to the health economics argument here than a pure volumetric medication dispensation.

At this time, I'm showing no further questions.

Ladies and gentlemen, thank you for your participation in today's conference.

This does conclude the program.

You may now disconnect.

Everyone, have a great day.

Thank you.

Thank you.