Q3 2022 Eyenovia Inc Earnings Call
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Please standby we're about to begin.
Good day and welcome to the I know you have third quarter 2022 earnings call. Today's conference is being recorded at this time I'd like to turn the conference over to Eric Bremner lifestyle Advisors. Please go ahead.
Thanks, everyone and good afternoon, welcome to <unk> third quarter 2022 earnings conference call and audio webcast with me today are <unk>.
Chief Executive Officer, and Michael Rowe, and Chief Financial Officer, John Gandolfo.
This afternoon <unk> issued a press release announcing financial results for the three months ended September 32022, we encourage everyone to read today's press release as well as I know your annual report on Form 10-K.
The year ended December 31, 2021, which was filed with the SEC on March 30th 2022, and our most recently filed 10-Q.
<unk> press release and annual report are also available on <unk> website at Www Dot I know via dotcom.
In addition, this conference call is being webcast through the company's website and will be archived for future reference.
Please note that on today's call, we will be discussing investigational product candidates, which have yet to receive the FDA approval. Please also note that certain information discussed on the call today is covered under the Safe Harbor provisions 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 company's business.
These forward looking statements are subject to a number of risks which are described in more detail in our annual report on Form 10-K, and our most recent we filed the 10-Q.
Conference call contains time sensitive information that is accurate only as of the date of this like broadcast November 10 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 maybe required by applicable Securities law.
That said I'd like to turn the call over to Michael Rowe I know he is chief Executive Officer Michael.
Thank you, Eric and welcome everyone to our third quarter 2022 financial results Conference call.
Been about 100 days since I've taken over the CEO role from Doctor I Angela and.
And we have been laser focused on increasing our company's value by advancing our key programs.
We will provide an operational update and then turn the call over to John Gandolfo, Our CFO for a review of the financials.
I would like to begin with mid comedy, which is our proprietary combination microdose formulation of Tropicamide and seen Olaf rent for in office people dilation.
In October of last year, we received a complete response letter or <unk> from the FDA, indicating that bid combi had been reclassified as a drug device combination product.
Which ultimately necessitated additional testing of the off to jet dispensing device.
Additional tests included a microbial challenge study that demonstrated the ability of the off did you have to keep my microbes from entering the device.
Human factor study assessing the ability of users to follow cleaning instructions for that device and electronics safety study and a study on age devices to ensure their long term reliability.
All of these tests have now been successfully completed it is important to note here that these additional tests were non clinical in nature.
No additional clinical data was requested the original NDA was supported by two successful phase III clinical trials mist, one and mist too.
With the additional device testing complete we recently resubmitted our M D E and our mid Con Big NDA for normal procedures. The FDA has 30 days from that submission to review, our NDA for completeness and to notify us of its acceptance once our NDA is accepted.
We would anticipate a six month review process from the date of the Resubmission, which could result in approval around midyear 2023, if all goes as anticipated.
If approved mid Kabi would represent an important validation of the off to jet technology, which has been shown in previous studies to deliver a therapeutic dose of medication with significantly less drug and preservative exposure as compared to standard eye drops. This validation is important not only for our other proprietary program.
Yes.
Our existing partnerships with Bausch and Lomb and Arctic vision, but also for future potential partnerships, where the benefits of the often may be leveraged in other high value ophthalmic indications.
It is also worth noting that the additional device validation testing that we conducted for the mid copy NDA may be referenced bohlen filings for our presbyopia and progressive myopia programs potentially streamlining those regulatory review processes in the future.
Mcafee potentially represents our first commercial product and so we regard the successful resubmission of our NDA as a significant achievement for our company.
Let's move on to micro lines, which list, which is our proprietary topical on demand pilocarpine based therapeutic candidate that we are developing for the temporary improvement in near vision associated with presbyopia.
Presbyopia is the age related hardening of the EIS lens, causing blurred near vision. This is an addressable market representing over 18 million people in the United States alone between the ages of 40, and 55, who otherwise never work glasses and have the resources for a cash pay product in terms of dollars our proprietary market research suggests.
First that this could be a multibillion dollar annual market in the U S alone.
Just a few weeks ago, we announced positive results from vision, two which is our second phase III study of microwave and a modified per protocol analysis of Evaluable patients. Excluding a non study related adverse events impacting pupil size of reactivity, otherwise known as new onset of Addison Korea vision two met its primary endpoint.
With a statistically significant proportion of subjects treated with micro line, showing a 15 letter or more improvement in distance corrected near visual acuity with less than a five weather loss in distance acuity versus placebo in low light conditions at two hours post treatment.
<unk> also achieved all secondary endpoints with statistical significance.
A particular note is the compelling safety and Tolerability profile of the product consistent with prior studies micro line was found to be very well tolerated with fewer than 3% of micro <unk> treated subjects reporting adverse events, all of which were considered mild and transient.
This compares very favorably to other pai-loo based presbyopia treatments were about 15% of study subjects reported some form of headache or ROIC.
Vision two follows the successful outcome of the vision one study that we announced in May of last year. The visual one study evaluated the safety and efficacy of our 1% and 2% pilocarpine microarray print formulations versus placebo all administered by the after jet with vision, one and two we now have completed four studies demonstrating that <unk>.
They have after jets microdose array print technology, and improving the therapeutic index of topical almac drugs.
In terms of next steps, we plan to request a meeting with the FDA to hopefully be held in early 2023 to review the totality of data compiled a micro line to date and to gain alignment on remaining regulatory steps following that meeting we plan to initiate the manufacture of registration batches at our new state of the art facility in Redwood.
City, California.
We believe there is a significant market opportunity for our spray presbyopia treatment and alternative to reading glasses, when wearing glasses is undesirable and we believe the after Jeff will allow us to capture a significant share of this market irrespective of the number of eye drop products that may be on the market when we hopefully launch now.
For the benefit of those of you who may be new to our story. After Jeb is our proprietary dispensing device, which we incorporate across all of our development progress at offer significant advantages as compared to standard eye drops which are difficult to use that can overdose. The guy by as much as 300%. This overdose. He has been shown to cause potentially dane.
Chris ocular and systemic side effects overtime and.
And speaking of ocular side effects recent studies of a human contact table cell line conducted with Tufts University demonstrated that the object and minimize the impact of reserve medications on the ocular surface.
In fact reserve medication delivered to the after jet acted very similar to non reserved eye drops with respect to cell viability cytotoxicity up top ptosis and metabolic activity in the study.
The after Jeff is also stick significantly easier to use than conventional drops since delivers medication horizontally. There is no need to tell once head back and there is no drug overflow. This helps increase compliance, especially among children and there was the form factor that is simply a sophisticated looking device.
Finally, the after Jeff is equipped with smart technology that can be paired with devices for the purpose for both therapeutic monitoring.
Earlier. This year, we served a 100 glaucoma trading ophthalmologists and optometrists to gauge their interest of remote therapeutic monitoring of patients of a type that after jet smart technology can provide.
Of the provider survey, 98% said, they see that the understanding of compliance or adherence behavior with glaucoma medications was important with 93%, saying that was very important notably almost all providers thought that the availability of the new CPT code for remote therapeutic monitoring or RMT would lead to better.
Their patient outcomes.
Delivering the right dose, making administration easier minimizing side effects and improving communication between Doctor and patient are just some of the reasons that we feel the off each other's a paradigm shift in topical ophthalmic medication delivery, we look forward to bringing this technology to not just our own development programs, but through partner interbreeding benefits since the program.
Others.
Before turning the call over to John to review the financials I want to acknowledge the recent retirement of Ken Lee from our board of Directors, Ken has been a valued member of both our board of directors on the I know the family since 2018 and has made many key contributions to our strategy over the years, particularly as it pertains to the Resubmission of our mid Kabi N D. A.
We wish him well in his retirement and we are encouraged that he has agreed to remain available to us for advice and consultation in the future.
I would now like to turn the call over to our Chief Financial Officer, John Gandolfo to provide a financial update Jon. Thank.
Thank you Michael.
For the third quarter of 2022, we reported a net loss of approximately seven $3 million 21 per share on approximately $34 6 million weighted average shares outstanding and this compares to a net loss of approximately $5 6 million or 21 cents per share for the third quarter of 2012.
One on approximately 26 million weighted average shares outstanding.
Research and development expenses totaled approximately $3 9 million for the third quarter of 2022. This compares to approximately $3 $6 million for the same period in 2021, an increase of nine 1%.
For the third quarter of 2020 to general and administrative expenses were approximately $3 $4 million compared with approximately $2.4 million for the third quarter of 2021, an increase of approximately 41, 3%.
Total operating expenses for the third quarter of 2022 were approximately $7 $2 million compared to total operating expenses of $5 $9 million for the same period in 2021. This represents an increase of approximately 22%.
As of September 30th 2022, the Companys unrestricted and restricted cash balance was approximately $25 $3 million, including $7 9 million of restricted cash.
In early November we paid off our outstanding Silicon Valley bank level with that restricted cash funds and which was collateralized alone.
Over the near term, we are focusing our efforts on raising capital through a non dilutive financing transaction as well as closing on additional technology licensing transaction.
Before we open the call to questions I will conclude with a brief update on our licensing programs. We're bashing alone from micro <unk> in the U S and Canada and Arctic vision for all three of our products in China and South Korea.
Micro pain as their proprietary atropine formulation for the reduction of pediatric myopia progression. That's been shown in clinical studies to slow myopia progression by 60% or more there are currently no FDA approved drug therapies for this indication and if left untreated. This can result in retinal.
Tacksman myopic retinopathy, retinopathy and vision loss.
Bifocal, multi multifocal glasses or contact lenses are typically prescribed to myopic children.
Recall that as part of the agreement with fashion loan oversight and costs related to the ongoing phase III chaperone microbial clinical trial were transferred to our partner Chaperone 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 to trial is comparing micro dose atropine point of 1% versus placebo ophthalmic solution.
<unk> is progressing as planned.
Our agreement with Arctic vision covers greater China, South Korea, and while the original agreement that we announced in August 2020 was for micro peanut Micro line. Arctic Vision also subsequently added mid Combi as well so Arctic vision is now licensing all three of our current programs Mike.
Micro paying for pediatric myopia in particular represents a significant opportunity in China. The Ministry of Education estimates that nearly 53% of all Chinese children suffered from myopia in 2020, and 13 million children are estimated to be at the highest risk.
Agreement with Arctic vision provides our sales royalties. In addition to development milestones so away from when approved <unk> could be a significant source of non dilutive funding for our company over the long term.
And finally, we recently announced that Arctic vision has now enrolled the first patient and as Presbyopia study. This marks the first time that a clinical trial has been approved in China to evaluate a pharmacologic treatment for presbyopia.
That program is progressing very nicely.
To date, our license agreement have generated approximately $16 million in license fees and we have the potential to earn an additional $60 million and net likes us and development milestones as well as reimbursable expenses over the next four years.
As noted upon commercialization if approved I know via <unk> significant sales royalties from its products 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 infective anti inflammatories dry eye and glaucoma, each with significant market opportunities pipeline expansion was significant consideration as we were building out our new Redwood City facility.
In conclusion, we continue to be pleased with our performance to date to summarize the key highlights we achieved two key milestones to resubmission of our NDA for med Combi and the positive completion of our vision to Presbyopia study from micro line, we executed on our planned CEO transition.
And that has significant expertise to our board of directors.
Our new state of the art manufacturing facility facility in Redwood City, California is now operational and provides significant additional capacity to complement our existing contract manufacturing relationships.
And our license agreements with Arctic vision, and bashing alone are progressing well and continues to offer the opportunity for remaining 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 the call to questions operator.
Of course, thank you and if you would like to ask a question. Please signal by pressing star one on your telephone keypad, if you're using a speaker phone. Please make sure you mute function is turned off July your signal to reach our equipment.
Again, it is star one if you would like to ask a question and we'll pause just for a moment to allow everyone an opportunity to signal for questions.
Again, it is star one if you would like to ask a question.
Okay.
And we will take our first question from.
<unk> with its stock Davis. Please go ahead.
Oh, hi, thanks for very much.
I had a couple of questions for me and I apologize I was late to the call. So if you went over this.
Please feel free to Paas, but how is it the optometry meeting down in San Diego, a couple of weeks ago, and one of the things I noticed as I spoke to a lot of the optometrists down there is that they seem to be a lot of interest in the <unk>.
Device for its application for making their life easier either with classic patients to younger patients.
And I'm talking about you know.
Bobby and I was just wondering if you could.
So any light on that and then the second thing is <unk>.
He is not off to a really good start.
And some of that might be the way they thought the market would develop with.
Chronic lease rather than PRN use like could you discuss your.
In terms of the improvements you're getting in visual acuity.
Near near vision versus what other companies have had and then on the other side as it relates to brow ache headache.
Our data versus others. Thanks, so very much.
Thank you Landon and thanks for the questions and calling in.
In response to your first one with the optometrists and the use of the <unk> device.
Yes, we have seen that there is a lot of interest, especially among doctors, who treat younger patients in kids.
That they are telling us to put dilation drops or basically any dry eye drops and controlled Ren is an ordeal.
And when they see the after jet and we had it down there the demo for them and they immediately saw.
So they had great interest in using that specifically for those patients right off the bat.
Which was interesting because it wasn't exactly something that we had paid a lot of attention to before but now because we're seeing that kind of interest and acceptance, we're adding that to our targets. When we do eventually commercialize mid kabi hopefully the middle of next year. So that was a learning on all of that very pleasant learning.
For all of US for your second question on the efficacy our efficacy related to view and the view of the launch I'm not going to go into how the beauty launch was done and how Allergan now is coming back and basically doing a relaunched the way probably it should have been done.
But what I will say is that Theyre pilocarpine Weir pilocarpine, the actual efficacy in approving patients getting 15 letters is very very similar between the two drugs. If you compare at the same time point in the study if the same days in the study they're very similar.
Miller, what's not so long as the side effect profile, where our product is fewer than 3% of patients have any kind of adverse events and the adverse events are mild and transient and of that even less than that as brow ache or headache, and we know from our own market research that once you get over 5% brow ache or headache, it really really Dan.
<unk> People's interest in using the product. So that's a key part of what we offer so I think where we benefit is that people really like the after jet device.
Not having to put an eye drops they like the spray a lot more.
Efficacy will be very similar but the side effect profile will be better.
And our value proposition is to provide patients with functional vision, so that they're able to do things like see their telephone.
So they are able to read a menu that could fill in the scorecard playing golf. That's what this is really intended for and not really have to worry that they're going to get some kind of adverse event, that's going to give them a headache. So thanks for the question.
Thank you.
And as another reminder, it is star one if you'd like to ask a question.
And it appears we have no further questions.
Alright, so all of that makes it easier and that concludes today's call. We hope we were successful in conveying the significant progress that we continue to make with the after jet technology and across our key clinical programs. We have one NDA now pending with the FDA in the second late stage program that we will be discussing with the FDA early next year, let's say.
Simply we believe we have potential line of sight to two commercial products. There are also a number of emerging opportunities to license out after jet technology for additional high value ophthalmic indications. We believe we have reached an inflection point and I know this evolution and look forward to positive and potentially value creating developments in the next year and again. Thank you all for.
Joining us and have a good evening.
And with that that does conclude today's call. Thank you for your participation you may now disconnect.
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