Q1 2021 Eyenovia Inc Earnings Call
Greetings and welcome to the I know V. S first quarter 2021 earnings call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad.
Note. This call is being recorded I will now turn the conference over to your host Eric refer. Please go ahead.
Good afternoon, everyone and welcome to <unk> first quarter 2021 earnings conference call and audio webcast with me today are I know he is chief Executive Officer, and Chief Medical Officer, Dr. Sean I answer that I know he is chief financial Officer, John Gandolfo, and I know he is chief operating officer.
Well we're out.
Earlier this afternoon <unk> issued a press release announcing financial results for the three months ended March 31st 2021, we encourage everyone to read today's press release as well as I know via its quarterly report on form 10-Q for the quarter ended March 31st 2021, which will be filed with the SEC the company's press release and quarterly rig.
<unk> will also be available on <unk> 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 that on today's call, we will be discussing investigational products, which have yet to receive 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 I know he is management will be making forward looking statements actual results.
Else could differ materially from those stated or implied by those by these forward looking statements due to the risks and uncertainties associated with the company's business day.
These forward looking statements are subject to a number of risks, including risks related to fluctuations in our financial results volatility and uncertainty in the global economy and financial markets and in light of the evolving COVID-19 pandemic, our ability to raise additional money to fund our operations for at least the next 12 months as a going concern our estimates regarding the potential.
A market opportunity for our product candidates and potential revenue from licensing transactions.
Clients on third parties, the ability of us and our partners to timely develop implement and maintain manufacturing commercialization and marketing capabilities and strategies for our product candidates risks of our our licensee clinical trial, our licenses clinical trials, including but not limited to the cost design initiation and enrollment which.
Could be adversely impacted by COVID-19, 19, and resulting social distancing timing progress and results of such trials the potential impact of COVID-19 on our supply chain the timing and our.
And our licensees ability to submit applications for obtain and maintain regulatory regulatory approvals for our product candidates changes in legal regulatory and legislature, let legislative environment.
On the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products the potential advantages of our product candidates the rate and degree of market acceptance and clinical utility of our product candidates, our ability to attract and retain key personnel intellectual property risks and others detailed in and qualified by the <unk>.
Cautionary statements contained in line Ob as press release, 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 May 12, 2021, I know via 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.
Both Securities law with all that said I'd like to turn the call to over to Dawn you Angela.
Doctor on July.
Thank you Eric.
And welcome everyone to our first quarter 2021 earnings conference call. Our key highlights since our last quarterly update is that the FDA has confirmed.
October 28th as the Paducah date to review, our mid Combi N D. A.
Recall that mid Combi is our unique fixed combination of two leading mydriatic medications for pupil dilation.
If approved this would be the first microdose ocular therapeutics applied with a high precision smart delivery system the omni channel.
It would also transition us to a commercial stage company.
So we are rapidly approaching a very significant milestone for our company. If approved we would anticipate launching with combi commercially soon after the FDA approval.
In anticipation of potential approval later this year in March we announced an exclusive agreement with ever Sona, a leading commercial service provider to the life sciences industry to manage the physical distribution of mid Combi and to oversee the order fulfillment process.
Michael will elaborate on this shortly.
Also during the first quarter, we completed enrollment in our vision one study of micro line, our proprietary pilocarpine formulation for the improvement in near vision in patients with presbyopia.
Presbyopia.
Is the age related hardening of the lengths of the eye.
Causing blurred near vision that affects approximately 130 million people in the U S alone.
The most common remedies glasses of readers contact lenses or surgery.
The line is intended to be a companion product to glasses to be used situationally on demand.
And not necessarily as a full replacement of glasses altogether.
We're expecting to see vision, one top line results shortly pending data export on analogies by our data management partners.
We anticipate sharing the results in the coming weeks.
Those results will help inform how vision two will be conducted helping us to quickly and efficiently complete this program and they've approved unlock a market opportunity that we estimate at nearly 8 billion in the U S alone.
Before turning the call to Michael I want to comment on the significant addition debt we've made to our board of directors last month, we announced that renowned ophthalmologists and scientific leader Dr. Julia Haller has joined our board. Dr. Halle is one of the world's leading retinal surgeons and physician educators. She currently serves as.
As an ophthalmologist and cheap at Wills Eye Hospital in Philadelphia, where she holds the William Hoffman and Dow Chair She's also professor and chair of the Department of Ophthalmology at Sydney came on medical College at Thomas Jefferson University, and hospitals Needless to say, we're very pleased that Dr. Hollar has decided to join us.
And we believe our insights and guidance will be invaluable as we advance our current programs.
Now in parallel working on our pipeline.
At this point I'll turn the call over to our Chief operating Officer, Michael Roth.
On a more detailed update on our clinical program Michael.
Thank you, Sean let's lead off today with an update on mid comedy hour unique fixed combination of two leading mydriatic medications or pupil dilation agents because.
As we announced a few weeks ago, the U S food and drug administration accepted our new drug application and has now informed or confirmed that <unk> date of October 28 2021.
The NDA was supported by two phase III studies mist, one and mist, two which demonstrated that mid Combi provides quick effective a reliable pupil dilation with fewer than 1% of subjects reported blurred vision reduced visual acuity photophobia or installation site pain.
Mid combi as a diagnostic agent with meaningful potential benefits to both the practitioner on the patient.
For the practitioner there has the potential to increase patient throughput without increasing costs with med combi doctors and staff can spend less time, putting different eye drops into patients, including those have helped minimize the state of the current formulations.
On a daily basis, we believe that over an hour of exam room time can be reclaimed just by switching to this faster more comfortable option.
And for patients since there are no patrolling parts with the opt to jet and the recess nozzle mid combi is far less likely to touch the surface of the eye as compared to a conventional eyedropper.
This results in a potential decrease in cross contamination and improve patient safety something that resonates loudly and the COVID-19 era also as mentioned the product was reported to be very comfortable and use in our clinical studies.
All of these benefits, we hope will translate to more people being willing to undergo a comprehensive eye exam.
Market research suggests that millions of people fail to get the comprehensive eye exam every year due to the discomfort and other side effects of traditional mydriatic drops, but combi may be able to address these issues and doctor Mays doctors may be able to further encourage people to take better care of themselves by having a comprehensive exam.
The market opportunity from it copy of substantial there on estimated 80 million office based comprehensive and diabetic eye exams, and 4 million of Falmouth surgical dilation performed annually in the U S alone we.
We estimate this market to be approximately $250 million annually in value.
Last quarter, we went into some detail on our commercialization plan for mid Combi.
Just recapping the key points upon FDA approval, our planned approach will not resemble a traditional drug launch with the related expenses around the large sales force and corporate infrastructure.
Instead, we plan to target high volume practices, and the 10 largest metropolitan areas with just 11 sales professionals to.
To help maximize this efficiency and create quick payback our sales force will initially address the top 20% of eye care practices in terms of total patient volume and expand from there.
Another key differentiator is that mid combi as a diagnostic pharmaceutical agent is something purchased directly by the Doctor's practice. This means no managed care contracting no waiting for formulary placement no need to purchase prescription drug data to track sales and so on the savings and infrastructure direct.
Cost and time are substantial and along with our distribution agreement with ever Sona means that we do not have to ramp up other areas of the company for launch.
If the economy is ultimately approved we're currently aiming to launch within about six weeks of approval.
Turning now to our micro line program for Presbyopia, which is the non preventable age related hardening of the highest less.
Presbyopia causes blurred vision that normal reading distances and can lead to ice strain and headaches. We recently announced that we have completed enrollment of our placebo controlled vision, one study, which is assessing our proprietary pilocarpine solution for the treatment of blurred near vision in patients with presbyopia.
Pilocarpine is a compound whose efficacy in improving their vision has been well validated and the administration via the after Jeff. That's one of the factors that sets us apart from future competition.
With the opted yet the eye is not overdosed with drug as often happens with conventional droppers a century old technology that can lead to unwanted side effects.
The primary endpoint in our studies, the buying ocular distance corrected near visual acuity.
One has been a relatively quick study and we anticipate reporting topline data in a few weeks and as Sean mentioned the results of vision, one will help inform how we conduct vision too as part of our overall plan to develop micro line quickly and efficiently.
I'd like to take a minute to address the potential mark to market opportunity from micro line nearly a third of the U S population or 113 million people suffer from presbyopia and the most common remedy is reading glasses within these 113 million people or about 18 million younger people for whom having to rely on reading glasses has a significant impact.
On their quality of life.
We believe there would be a significant uptake for an on demand option that contemporary low temporarily replace classes in this population.
Presbyopia market Research report from December 2020 estimated the market potential to be nearly 8 billion in the U S alone.
We are very pleased with how these two programs are progressing and now I'd like to turn the call back to Sean. Thank you.
Yeah.
Thank you Michael.
For those of you who have been following I know you know that where we out licensed our third program microbial for the treatment of progressive myopia to Bausch health in the U S and Canada, and Arctic vision in greater China, and South Korea.
Mike <unk> is a proprietary atropine formulation that has been shown in clinical studies to slow myopia progression by 60% or more debt currently no FDA approved therapies and if left untreated. This can result in retinal detachment myopic retinopathy and vision loss.
These partnerships are having the intended benefit of extending our extending our commercial reach.
While at the same time, providing non dilutive capital.
Good day to we have received 16 million in upfront and milestone payments with the potential for significantly more when milestone based payments reimbursed development cost and potential sales royalties are factored in.
We expect partnerships such as these will continue to be an important part.
Of our long term growth strategy and to that end, we continue to evaluate additional out licensing opportunities in other parts of the world.
We're also assessing pipeline expansion opportunities.
As we believe we can leverage the <unk> technology to address unmet needs in additional large ophthalmic indication.
Some examples include anti infective anti inflammatory dry eye and glaucoma, each with significant market opportunities.
We have nothing definitive to share today.
We do look forward to keep you apprised of our progress in that front.
Of course, the beauty here is that these development activities would be at least partly funded by outsourcing opportunities such as those just described.
I'd now like to turn the call over to John to review the financials.
Thank you Sean now I would like to review the financial results from the three months ended March 31, 2021.
So in the first quarter of 2021, where we reported a net loss of approximately $5 $4 million or 21 cents per share and this compares to a net loss of approximately $5 $5 million or <unk> 31 per share for the first quarter of 2020.
Well the first quarter of 2021, the company reported license fee revenue from Arctic Vision license agreement Thats $2 million on a corresponding cost of revenue representing attainment send you of $800000.
Research and development expenses total approximately $4 $2 million for the first quarter of 2021, and this compares to approximately $3 $6 million from the same period in 2020, an increase of approximately 16, 9%.
So the first quarter of 2021, G&A expenses were approximately $2 $3 million compared with approximately $1.8 million for the first quarter of 2020, an increase of approximately 25, 2%.
Total operating expenses for the first quarter of 2021 were approximately $6 $5 million compared to total operating expenses of $5 $5 million from the same period on 2021.
Represents an increase of 19, 7%.
Operating expenses in the first quarter of 2021 included approximately $657000 of noncash stock compensation expense.
As of March 31, 2021 company's cash balance was approximately $24 $9 million on this figure excludes approximately $7.5 million. The initial net proceeds from the recently announced $25 million credit facility with Silicon Valley Bank.
We believe our current cash resources on the initial SBB loan proceeds provides the company with sufficient cash into the third quarter of 2022.
Our current cash resources inclusive of D S.
B B proceeds.
Fishing to bring out MIPCOM big mydriasis product through the NDA process on commercial launch complete our presbyopia clinical programs from micro line and prepare our pilot manufacturing capabilities.
Our advanced suspension technology.
This concludes our prepared financial statements on that I'll now turn it over to Sean.
Thank you John.
In closing, we're very pleased with our performance during the first quarter and subsequent period.
To summarize our key highlights today, we look forward to on October 28, <unk> date pertaining to our Combi N D. A.
We are rapidly advancing our phase III Presbyopia program, you know an estimated multibillion dollar indication and anticipate data from vision one in the very near term.
In our licensing agreements with Arctic vision and Bausch health.
Are progressing well and continue to offer the potential for meaningful development and regulatory milestones non diluted dilutive funding if realized we can use to expand on advanced our pipeline.
We believe we're well positioned to achieve multiple commercial regulatory and development catalysts. This.
It is here for the benefit of patients and shareholders.
That concludes our prepared remarks, we would now like to open the call to questions operator.
Thank you we will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone Keypad, Inc.
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You May press star two if he would like to remove your question from the queue.
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Okay.
Our first question comes from Yafei Woodstock Doc partners. Please go ahead.
Thank you very much I was wondering if you could comment on the Allergan on phase three study that's been completed from bigger it could be equity.
Approval I'm pretty sure they looked at a patient cohort age age.
40 to 55 and in your vision. One you were looking at age 40 to 60.
And given that presbyopia tends to.
Decline.
Quite significantly I think between ages 55, and 60 and then it stabilizes.
Because al again, not focusing on that age group potentially confer an advantage to you or does it make it more difficult. If you included patients 55 to 16 year cohort.
To show benefit in that group and can you tell us.
And the vision one study roughly what the breakdown was.
By five year increments in the phase III clinical study. Thank you very much.
Well land. Thank you.
[laughter] you know I think I'll be better able to answer more detailed these question once we have the data.
Which will be shortly and we look forward to analyzing it first I want to step back and just mentioned that.
We have not.
In our field seen.
Too many well conducted.
Registration level studies and in Presbyopia, it's a fairly new field and even though we are approaching it and all of us and many other company store going into that field with established agents, such as pilocarpine, which seem to be very active again.
We're yet to see.
High quality, well rigorously conducted data.
In the field.
Mentioned correctly that all or again is one of the first ones and they have conducted phase III studies.
And completed and I believe announced.
Our debt pilocarpine in their formulation in an eye drop perform he is has met the primary endpoint of their studies.
That being said, we really haven't seen to date at least I haven't seen the actual data presented so that I can really answer your question in a more informed way.
We haven't seen even the point estimates or the exact results nor have we seen subgroup analyses.
We and other companies too are approaching D.
D L P a slightly bigger range of population.
With another five fifth five year.
The population between 55 and 60 that wasn't included in in Allergan on study.
Again this is not a population that is price biopic on one can argue that that population is more praise myopic because obviously.
Between 50 and above 50, the population is more severely affected in and they lose their accommodative potential almost completely.
We're hoping to see a balanced population in our study per.
Robley bias or maybe more on the earlier side.
Given that those are the patients. The 40 to 50 that are not quite settled into eyeglasses and they're the ones that experienced presbyopia firsthand and for the first time and are looking for solutions.
That being said, we are yet to see the the exact breakdown.
There is also a little bit of a factor of how COVID-19 really impacted the enrollment.
Whether it was it led to more preferential enrolment with established older patients or younger.
So in order to answer your question I think will give us a few more weeks months, we come out with the data, we'll be able to talk a little bit more about that but we really haven't seen too. Many results from other companies, neither allergan or others that will give us that and hopefully we'll see all of that and be able to do comparative analysis, Michael do you want to comment anything more.
No I think I think you handled that quite well. Thank you.
Thank you very much.
Our next question comes from Tim Chiang with Northland. Please go ahead.
Alright. Thanks.
Sean I know I know I know you haven't seen the results from vision one.
I noticed in the press release, you guys talk a little bit about.
Planning for the second Phase three study division two study.
Have you guys already.
Thought about how that study is going to be designed the study was going to be very similar division, one, but I'm sort of wondering if theres going to be any slight tweaks to the second pivotal study.
Yeah.
Yes.
It's a good question first maybe I I would I would also ask another question why did we not do them all at the same time.
Why not just run them in parallel both of them and I think we thought about that.
Given the dearth of data and and real rigorous clinical.
<unk> results all around a lot of it is anecdotal or phase twos, we definitely wanted to see.
Results from one trial before we plunge with the second one.
Just to be prudent and do vary more conservative development.
Also we found that.
If we look at the data from vision, one who we may be able to.
Inform vision two in a way that will make it more efficient.
Maybe we modified the population on a little bit on maybe.
We who.
We.
Eliminate one of the doses because if you look at the design vision one day.
Actually it's a bit of a dose ranging study I would call it almost.
Phase two slashed III.
Because it's definitely one that can be qualified for registration.
Positive.
But it really doesn't have a full dose selection and we may be able to find adult debt, we like and full vision to we could keep a very similar design, but the Gulf with one dose and make it more efficient and faster.
So I tend to in clinical development you never know.
It's always good to look at empiric data, so I tend to obtain exactly how we're gonna modified but I can tell you my team and our advisers.
We'll be able to get through the data quickly and it.
We will be able to find the best path forward.
With vision too.
Okay No that's helpful.
Sean.
Yes.
Once again, if you would like to ask a question. Please press star one on your telephone keypad.
Our next question comes from Matt Kaplan with Ladenburg Thalmann. Please go ahead.
Hi, Good afternoon, guys. Thanks for taking my question.
I just wanted to follow up a little bit a little bit on lens question in terms of the vision. The vision one what should really be we'd be looking for in terms of the the primary end point of top line results that are that should be.
Exciting in terms of leaching and achieving that endpoint.
Yeah.
Good question, Matt and I think that I would look not only at the primary end point I would also look at some of the secondary endpoints too.
The primary endpoint is three line vision gain at near and it's a very standard point that we use in ophthalmology across multiple indications.
Such as macular degeneration DMA its a bit of a non specific and I don't think it's necessarily the most realistic for actually what matters to patients I think patients want to be able to see their smartphone or tablet on their computer they don't.
Certainly have gained three lines that are 40 centimeters, but that is what is required for registration and.
It's actually a pretty pretty standardized way for ophthalmology.
So the other parts that are also important is that we have.
We'll be looking at to line gainers.
We'll be looking at also inter media division.
And again these are things that really will inform the overall therapeutic benefit for patients now.
You know Michael has done a lot on I'll, let him answer more specifically because we've done a ton of market research of what matters to patients, but since this will be on on demand as needed.
<unk> therapy.
Therapy.
You would want to see a fairly quick action.
That effect comes in quickly.
And our endpoint is at two hours, which is great. We expect maybe it will go even to three or four.
But again this will be on demand episodic treatment and we wanted to be.
Close to on and off type of treatment as possible. So.
Michael do you want to comment anything more to debt yes.
Yeah, Sean Thank you and hi, Matt I think the other thing I would pay attention to is the side effect profile one of the major theses behind micro dosing is that you can get efficacy and minimize some of the side effects and we know that pilocarpine in probably all miotic have an issue with <unk>.
Brow ache from the local circulation that comes out of the eye and gets into the brow and contracts. The muscle we know from market research that if we're seeing or if anybody has seen a brow ache of 20% that could really put a damper on acceptance of this product.
So I would be looking for a a side effect profile with a very low level of ROIC, which would then differentiate us from.
From the eye drops as well.
Thank you.
That's helpful.
Thank you for taking the questions on that in detail.
Thank you Matt.
I will now like to turn the floor over to show on this for closing remarks.
Well. Thank you all I think we look forward to.
Ah communicating with you.
On our upcoming milestones and with that.
I want to thank you again for joining us and hope everybody has a good afternoon.
This concludes today's teleconference. You may disconnect your lines at this time and thank you for your participation.
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Okay.
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