Q1 2022 Eyenovia Inc Earnings Call
Thank you for standing by and welcome to the I know you have first quarter 2022 earnings call. During the presentation. All participants will be in a listen only mode. Afterwards, we will conduct a question and answer session at that time. If you have a question. Please press star one.
One followed by the four on the telephone if at any time during the conference you need to reach not there. Please press star Zero as a reminder, this conference is being recorded Thursday May 12, 2022, I would now like to turn the conference over to Eric Roegner with lifestyle Advisors. Please go ahead.
Good afternoon, and welcome to <unk> first quarter 2022 earnings conference call and audio webcast.
With me today are <unk>.
Chairman, Chief Executive and Chief Medical Officer, Dr. Shaun <unk> Chief.
Chief Operating officer, Michael Rowe, and Chief Financial Officer, John Gandolfo.
This afternoon <unk> issued a press release announcing financial results for three months ended March 31 2022.
We encourage everyone to read today's release as well as <unk> annual report on Form 10-K for the year ended December 31, 2021, which was filed with the SEC on March 32022.
The company's press release and annual report are also available on <unk> website at <unk> Dot com.
In addition, this conference call is being webcast through the company's website and will be archived for future reference.
Please note on today's call, we will be discussing investigational product candidates, which have yet to receive FDA approval.
Please also note that certain information discussed on the call today is covered under the safe Harbor provision of the private Securities Litigation Reform Act, we caution listeners that during this call <unk> 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 Companys business.
Forward looking statements. These forward looking statements are subject to a number of risks which are described in more detail in our annual report and Form 10-K, and most recent filed 10-Q.
This conference call contains time sensitive information that is accurate only as of the date of this live broadcast May 12, 2022, <unk> 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.
That said I'd like to turn the call over to Dr. Sean <unk>.
Yes.
Thank you. Thank you Eric and welcome everyone to our first quarter 2022 financial results Conference call. We're excited to report on a quarter during which we continued to make notable progress with our presbyopia clinical program as well as the preparation for the Refiling of our mydriasis drug the mid Columbia with the FDA we can.
To track towards the third quarter Resubmission of the mid Columbia, NDA with <unk>, our investigational program for Pharmacologic Mydriasis. We have now successfully completed three of the four device validation test of the <unk> device.
That had been requested by the FDA following our reclassification as a drug device combination product.
The last test should be completed by late summer none of these evaluations involve clinical work. So we remain on track to resubmit, our mid Combi NDA in the third quarter of this year consistent with our prior guidance.
We're assuming a six month review period and are making plans for a targeted commercial launch if approved for the first half of next year.
As we have stated previously much of the device validation work just described for mid Combi may be referenced in regulatory filings for our other programs that are also that also used the <unk> device, including micro line and micro <unk> potentially streamlining the FDA review.
<unk> for those product candidates.
The other data requirements are also fulfilled.
In parallel we continue to enroll patients in our vision two phase III study for our micro line Presbyopia program and anticipate top line data in the middle of this year.
If positive we plan to begin manufacturing our registration lots to support stability and commercial expiration dating is a requirement for the NDA for Micron line.
Many of you have likely seen the advertisement for olive gardens viewing.
Pilocarpine based presbyopia Eyedrop that was approved by the FDA in October of last year for the temporary improvement of near and intermediate vision. We believe that <unk> is helping to create this new multibillion dollar market for pharmacologic presbyopia treatment.
One did not previously exist.
We believe our micra line product.
If and when approved will be poised to capture a significant share of this market due to the many unique benefits of the <unk> dispenser, not the least of which is at superior Tolerability profiles that we demonstrated in vision one.
And we are looking to replicate also envision too.
Michael will expand on that and the other benefits shortly.
These are exciting times for a navi is we believe we have a clear line of sight to two commercially approved products, both leveraging our proprietary <unk> dispensing technology.
At this point I'll turn the call over to Michael for an update on our operations Michael.
Thank you, Sean I would like to begin where Sean left off with a more detailed update on our investigational <unk> candidate <unk>.
As Sean indicated we have now completed all but one of the device validation tests that were required by the FCA subsea.
Subsequent to our original NDA submission when mid Combi was reclassified to a drug device combination.
Specific tests all of which were completed successfully include the microbial challenge study.
Human factor study assessing the ability of users to follow cleaning instructions for the device and electronics safety study. The fourth test drug stability is ongoing we expect results in late summer shortly after which we intend to resubmit the <unk> NDA.
We are assuming a six month review period and are making plans for a targeted commercial launch if approved for the first half of next year.
We are pleased to have completed this extra device validation work on the <unk> now as we expect to reference it in future regulatory filings potentially streamlining FCA review, our future programs, most notably micro lines, which I will now discuss.
Micro line, our proprietary Microdose array print pilocarpine therapy for the temporary improvement in near vision associated with Presbyopia.
Represents a market of over 8 million people in the United States between the ages of 40, and 55, who otherwise never wear glasses and the bigger one trial, we demonstrated positive efficacy.
Very low rate of headache, which is a common side effect as compared to pilocarpine Carpi eye drop formulations.
We hope to replicate these same positive results envision too which is ongoing.
<unk> two is a phase III registrational double masked placebo controlled superiority trial.
Value added, 2% multi array print pillow carpeting versus placebo.
We aim to enroll about 140 subjects into the study and anticipate top line data around mid year. This year.
Just a moment ago, Shawn mentioned allergens pilocarpine based presbyopia treatment deal with it the first eyedrop approved by the FDA to treat presbyopia and they are supporting us with a very robust and broad based direct to consumer advertising campaign.
This is a brand new market that we estimate could be worth multiple billions of dollars annually in the U S alone. So while we are eager to successfully complete vision two and submit an NDA for micro line. We remain nonetheless confident that we will be able to capture a significant share of the market irrespective of the number of therapeutic options that may ultimately exit.
Due to the many unique advantages conferred to the user by the <unk> dispenser NDA.
And there may be multiple eye drop options, but they will only be one after jet product.
One of those potential advantages is tolerability and with pilocarpine, specifically reduced incidence of headache.
Conventional pilocarpine eye drops can cause headache, and about 15% of patients.
So the options that we saw this rate reduced to less than 3% and our vision one trial and we hope to replicate that as very favorable results in <unk> two.
In addition, microlite delivered through the oxygen dispenser is easier and neater to administer and it was designed to use on demand.
Also the Microdose array print technology embedded in our proprietary offerings at the sponsor has been found to deliver far less preservative than traditional eye drops.
As you May know the vast majority of topical ophthalmic medications containing preservatives to help ensure the sterility of the products and to increase in shelf life.
Over time, this can lead to adverse events and ocular stress due to the toxicity from overexposure to these preservatives.
Our recent work with Tufts demonstrated that preserve drugs delivered with the after jet act more like unpreserved drugs, reducing ocular stress and potentially avoiding these long term adverse events.
In the past year, we have compiled a significant body of market research, indicating strong consumer and prescriber preference for the <unk> smart delivery system over traditional eyedropper.
The ease of use of precision dosing of the off the jet along with the potential for fewer side effects.
Some of the main reasons for this preference.
There is also the cool factor of people just like the form factor of the device. So while we are pleased that allergan is creating a market for our pilocarpine based presbyopia treatment.
Ultimately believe that micro line, if approved will better address with patients and prescribers actually want.
Product for this indication.
Last quarter, we recap the study that we recently completed in collaboration with Dr. Pedro Hamrock and.
I'm, the chairman of Ophthalmology at Tufts Medical Center.
The purpose of the study was to compare the impact on contract viable cells are the most commonly prescribed reserved glaucoma medications.
<unk> by the after jet versus the same medication deliver than the traditional eye drops.
We also compare the half suggests a numbers of medication delivered by our drop I'm not going to go through the whole results again here, but overall the study demonstrated that humans conjunctiva epithelium cells tolerated preserve drug treatment administered goods the opposite Jeff Sprague definitely better than the same drug administered by eyedrops and similar to non.
Reserve drugs treated cells and control with respect to cell viability cytotoxicity apoptosis and metabolic activity.
This is important because they preserve medications delivered by the options that appears to provide the same benefit as non preserved eye drops, but then the dispenser that makes administration of the drug easier and more comfortable bringing us back to the emergency emerging presbyopia market.
Relatively unconcerned with a number of competitors that may one day exists to differentiate themselves on being preserved or non preserved providing dosed once or twice a day because I know there will be the only one with the after Jeff expensive.
So the optics that we believe will provide a significant significant differentiator and competitive advantage for us no matter how crowded the market may be.
It is also worth mentioning that the findings from this study could potentially have significant positive implications for our company as we look to expand our development pipeline into indications such as glaucoma and dry eye, where exposure to preservative. Some chronic use is a very serious consideration.
The major benefit of our technology that we have previously discussed is the potential of the after jet to enable providers to follow patient compliance through remote therapeutic monitoring.
Recently surveyed 100, glaucoma treating ophthalmologist and optometrists to measure their interest in remote therapeutic monitoring.
The provider survey, 98% said that understanding compliance or adherence behavior with the glaucoma medications was important and 93% said it wasn't very important.
Notably all the providers thought that the availability of the new CPT code for remote therapeutic monitoring would lead to better patient outcomes.
When presented with the option get smart therapeutic monitoring concept, 98% of those surveyed were interested with 81% being moderately or very much interested and providers felt that a smart platform with monitoring capabilities with improved the care patients receive.
Further 80 per cent of providers surveyed said that they would change their treatment regiment.
One that used off if that change would cost their patients $20, a month or less out of pocket.
That's $20 of additional or less out of pocket with the remaining 20%, believing the patient will not move off of the least expensive option.
The results from the survey validate the wide ranging benefits of our <unk> platform that doctors can already envision applying in their practices, especially related to smart technology that will improve patient compliance and outcomes.
I would now like to turn the call over to our Chief Financial Officer, John Gandolfo to provide the financial update John .
Thank you Michael.
For the first quarter of 2022, we reported a net loss of approximately $7 3 million or 24 per share on approximately $30 million weighted average shares outstanding and this compares to a net loss of approximately $5 4 million or 21 per share for the first quarter of 2021 on.
<unk> <unk> $25 3 million weighted average shares outstanding.
Research and development expenses totaled approximately $3 7 million for the first quarter of 2022. This compares to approximately $4 3 million for the same period in 2021, a decrease of approximately 14, 1%.
For the first quarter of 2022, G&A expenses were approximately $3 5 million compared.
Compared with approximately $2 2 million for the first quarter of 2021, an increase of approximately 54, 9%.
Total operating expenses for the first quarter of 2022 were approximately $7 2 million compared.
Compared to total operating expenses of $6 6 million for the same period in 2021 and this represents an increase of approximately nine 5%.
As of March 31, 2022, the company's unrestricted and restricted cash balance was approximately $34 6 million, which includes the recent $15 million of our offering through Armistice capital, which was completed in March.
Before we open the call to questions I will conclude with a brief update on our licensing programs with Bausch health from micro <unk> in the U S and Canada and Arctic vision for all three of our drugs in China and South Korea.
Micro opinion as you may recall is to proprietary atropine formulation for the reduction of pediatrics myopia progression that's.
Yes, it's been shown in clinical studies to slow myopia progression by 60% or more and there are currently no FDA approved drug therapies for this indication and if left untreated. This can result in retinal detachment myopic.
Retinopathy and vision loss.
Bifocal multifocal glasses or contact lenses are typically prescribed to myopic children.
Recall that as part of the agreement with <unk>.
<unk> III to assume oversight and costs related to the ongoing phase III chaperone clinical trial. This is a 48 month U S. Based multicenter randomized double masked trial that is enrolling more than 400 children between three and 12 years of age. The trial is comparing micro dose atropine one person.
<unk> <unk>, 1% versus placebo ophthalmic solution enrollment is progressing as planned.
Our agreement with Arctic fishing covers greater China, and South Korea, and while the original agreement was for micro <unk> and micro lines. They also recently added mid combi as well so Arctic vision now licenses all three of our current programs and we are pleased to announced that Arctic vision recently enrolled the first patient in his press <unk>.
So that program is also progressing nicely.
To date, our license agreements have generated approximately $616 million.
License fees and we.
<unk> has the potential to earn an additional $60 million.
License and development milestones and Reimbursable expenses over the next four years.
In addition, with the transfer of the chaperone preclinical study and related costs.
Clinical trial expenses will be reduced by $3 million to $4 million per year from originally anticipated levels. Since we are no longer responsible for those expenses.
Commercialization if approved I know via can earn significant sales royalties as well.
We are also continuing to assess potential pipeline expansion opportunities as we believe we can leverage the <unk> technology to address unmet needs in additional large ophthalmic indications. Some examples include anti infectives anti inflammatories dry eye and glaucoma each with significant mark.
Operator.
In conclusion, we continue to be pleased with our performance to date and to summarize our key highlights today, we are continuing to rapidly advance our phase III micro line Presbyopia program and we are enrolling patients in our phase III trial vision, two and expect top line data in mid 2012.
<unk> two <unk>.
So we are actively.
Preparing for the re submission of our <unk> NDA in the third quarter of this year, which if approved would give us our first commercial product and validates our up to jet dispensing technology.
In parallel we are continuing to expand the body of research on average.
By the remarkable findings in our collaboration study with tests that highlighted the significant potential of the optics, yet to bypass common adverse effects associated with chronic ophthalmic therapy use.
And our licensing agreements with articulation of our shelves are progressing well and continuing to offer the opportunity for meaningful development and regulatory milestones as well as line of sight to potential sales royalties, possibly within the next two years.
That concludes our prepared remarks, we would now like to open up the call to questions operator.
Thank you.
I'd like to waste a question. Please press the one four on your telephone Youll hear US can you tell me pumps just to answer your question. If your question has been answered and you would like to withdraw your decision. Please press star one.
Thank you for your first question.
Our first question comes from the line of Chang with Northland Capital. Please proceed with your question.
Hi, Thanks.
Shawn and Michael could you just talk a little bit about.
Just some of the details on the mission to study, how many patients who enrolled.
Primary and secondary endpoints.
Again.
Right.
Go ahead, Michael Yeah, Michael you want to know now Sean Sean do you want I can give the update on that.
Enrolment is that we are looking forward to have our last patient last visit.
And about the next.
It's probably in the next month and a half and then shortly after that to have some top line data.
If you wanted to talk about the specific endpoints are very similar to vision, one Sean would you like to talk about that.
Yes, I mean, they are very much the same as youll recall vision, one we used two doses and we did a crossover design.
At that time, we were using pilocarpine, 1% pilocarpine, 2% and then placebo crossover.
The design of vision, two is pretty much spot on the same.
We have the 140 patients.
It really looks at the same endpoint, which is the three line gain in distance corrected near visual acuity.
And.
And again, we have a very much the same crossover design, which is very efficient and it really is in line with our.
Overall.
Lan for the program, which is really for the temporary on demand.
Improvement of near visual acuity, which Michael has been talking about.
In terms of how this product will be used.
We hope to have those results.
Pretty imminently over the next couple of months.
With that we will combine them with division one data package and.
I will share that with you but.
It's really a confirmation of confirmatory trial by design of divisional one study.
Okay, good and I just had one.
Follow up to that.
The age difference in the patients who enrolled envision to its slightly different than what you could you just talk a little bit about why you did that.
Yeah. So I think we learn in general from our clinical experience as you know vision. One was our first trial that we did in fact it was we.
We didn't we didn't have a benefit of a phase one or phase II.
You do that.
April to really look at the spectrum of response.
We had a very.
Unselected population envisioned one.
And we learned that most of the.
Really the target population for that product and as well as well as the sweet spot of response is the younger Presby ops, which is kind of where everybody else is as well mostly with.
The patients below 55 years of age.
Most of the Presbyopia hits around 40 late forties and this is where you capture most of the people who start to experience those problems.
If you talk to the market research that we've done that.
Users are not the people who have been wearing glasses for 20 years, it's really the new Presby ops. So we refocused our study really towards the.
The beachfront of where the target population is the best therapeutic response and effect is and really the entire overall program.
Michael if you want to add some some additional insights here feel free.
No I think Tim what Sean said is exactly right and in fact, it's also matches what most other people are doing in matches with Allergan did in their studies.
Okay, great those are great details.
Best of luck.
Thank you Tim.
Yep.
Yes. Thank you.
As a reminder to register for a question press the one four on the telephone keypad.
Our next question is from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed.
Oh hi.
Is raymond in for Matt Thanks for taking our questions and for all the updates just a few on our end I'm just following up on the.
The vision question I was wondering did you have any updated plans to perhaps in the data from the vision trial in totality in a medical conference or publication.
Yes.
Yes so.
The way we we proceed with this is we think the most important activity right now is to integrate and get all of the data and prepare that for the FDA.
Our review on submission.
And once we have that of course.
We will synchronize our publication and presentation plans.
So probably once we have the totality of the data for analysis and.
Probably within a few months of submitting that to the EBITDA.
Then we will turn our attention to presenting it.
And for.
For us it's most important to make sure that we do all the necessary work for the FDA registration of the product.
Okay. That's helpful. Okay, and I guess.
Michael One program I was wondering if you had any direct learnings or surprises from the beauty launch that you think might be instructive for the microwave.
Well that's a good question I think personally again, it's hard to know because we don't have that many data points from the Vod launch, meaning that we at least.
Don't have numbers to see how the launch is really proceeding.
Being a clinician.
And.
Knowing the patient interest in this.
I think it's really the right time for our launch and there is a lot of demand that my colleagues and I see in the clinics.
The advertising and the consumer outreach.
Has been quite good.
Has resonated.
With patients.
And ultimately we hope by the end of the year, we will be able to get some hard metrics around that like any new market and having being of the new metric market of anti VEGF from the time of my experience with Lucentis Genentech.
Really hard to know how this would go and what the acceleration will be so the next 12 months will probably give us a lot of information that we currently don't have.
But for sure.
What is very evident is that patients now are starting to hear about options.
And they are coming to the clinic. They are asking for that they think it's exciting it's a new paradigm they want to get out of glasses. It really things that we never paid attention to before and now are coming to the forefront among the physicians in and also the patients. So I hope that translates and good numbers.
The launch.
And and I Hope this also translates in <unk>.
<unk> market for a best in class product as is the micro line up T J.
Yes. Thanks for that could also I would add to that that one of the actually benefits of what's happening with beauty.
It's encouraging a lot of people, who have not gone to C&I doctor before.
Into the office to get a real eye exam. Many of these people would have just gone to the drugstore and purchased a pair of readers.
But now because they are interested in finding a different way.
To treat the presbyopia theyre going in and for many of them, they're getting their first eye exam ever.
So it's actually doing a good service for a lot of these people.
Thanks for the color, yes, I have seen no debt I. Just last question just a clarification I was wondering is there a milestone payment associated with the completion of enrollment for the chaperone trial.
No.
The milestones are associated with.
The FDA approval and the commercialization and Novartis agreement.
Okay. Thanks, so much that's awesome. Thanks sure.
Okay.
And our next question.
Private Investor Lemme assay is proceed with your question.
Thank you very much had a couple of questions for you.
I'm thinking that given the consumer advertising that.
Abbvie Allergan are doing for beauty.
Debt.
That will drive as you say the patients to the dock and unlike other more therapeutic.
Pharmacological agents, where this one is more of a pseudo cosmetic.
That would be sufficient.
To get the interest and the dock would be able to tell the patient about after January .
If the Doc thinks that Thats.
A better alternative and the patient will not for much resistance on like when you get another drug categories, a lot of advertising and the patient is sit on the AD in one specific drug. So I was wondering if you think that that's the case or if you think you'll have to do.
It's likely to be extensive.
Consumer advertising television advertising and if you do in order to save money, we use Michael as the model on the TV spot.
I wish, but I, aged out of the out of the product.
But when you bring an interesting question and then let me bring this back to mid Tommy.
Because remember mid Combi, hopefully will be on the market for.
A bit of time before micro line, we're looking hopefully to win approval early next year and if that's the case you can imagine that somebody would go into the office have their standard eye exam and have their eyes dilated with mid Tommy and then the conversation comes to would you like to have micro line by the way it's in the same.
Device that I use to dilate your eyes, very futuristic and comfortable and easy to use thing that my technician came in here and took all of 10 seconds.
To use audio so.
Mid Combi serves that strategic purpose for us to get it into the doctor's offices into their hands. So the patient will actually see.
Very much what micro line is all about.
Okay, and then yes, and I think.
Another found by the way I think about it is when you when you validate something and you drive patients there, it's kind of you've sold them on the.
More or less on the flip phone.
And at that time, we come out with better more elegant.
<unk> differentiated technology smartphone so to speak with better profile I think in ophthalmology, particularly optometry and ophthalmology.
We are very biased towards the best technology, because we know patients like the best when it comes to their Pi site and the most precise and the most elegant and the most.
The safest type of approach so.
I think this probably will play in the more patients that driven through the offices.
The more patients are already alerted to this technology in the market is primed for many product and hopefully for the best in class.
Thank you and then a second question is.
Micro pine, which we Havent discussed further out obviously, but I think it's potentially the largest market.
Of the three that Youre addressing.
Any updates on that in terms of the time of clinical trials, when we might get some data because that's the potential there seems to be incredibly significant.
Yes, yes, well I think that's true Mike <unk> and Michael can give more details, but you are right <unk>.
<unk> was.
Gene therapy, or a back of di product with.
With the same economics.
Probably it will be a multibillion dollar company. So it's true it's a huge opportunity that somehow.
Because maybe of the timelines into longer horizon.
As currently ignored from valuation perspective, but again I think that.
We are excited Bausch is really committed to this in a major way.
There.
Executing well with transferred now the program to them so they own the program.
And I think the.
The communication so far that we're looking at.
Complete enrollment by the end of this year of course, the details and the more granular details would come from them.
And then we know we have a three year end point.
And an additional fourth year, which is not part of the primary but he has to follow up so really the pacing.
The pacing timeline is the three year endpoint and.
Again, this will be a 2025 horizon program, but have enormous impact and huge unmet need that is really in the core of <unk>.
Preserving site for our children and our next generation. So Michael maybe you can add a few.
Additional comments here.
I would add Sean that we shouldn't also discounts Arctic vision, they will be starting their version of the chaperone study.
This year I believe the study does not have to be as long as the U S. One in the market.
Opportunity in China, even when you adjust for prices and things like that because there are so many more children at risk for progressive myopia.
There is about the same size as the U S opportunity so.
We are very much looking forward to our partner they're starting their trial later this year.
Great. Thanks, so much guys.
Thank you Lynn.
There are no further questions registered at this time, Jon I will now turn the call back to you.
Yes. Thank you I felt again, thank you for everybody for joining us today and learning about our programs and update as you can see the next 12 months.
We have a lot of inflicting milestones into team is.
Completely committed to we are a small company with a small team that's doing a lot of heavy lifting on three programs with major indications and we look forward to sharing additional details.
Over the coming months.
And again, thank you all for joining today.
Thank you.
Thank you that does conclude the conference call for today, we thank you for your participation and ask you. Please disconnect your line.
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