Q4 2021 Eyenovia Inc Earnings Call
[music].
Greetings and welcome to the <unk> fourth quarter and full year 2021 earnings call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation.
Anyone should require operator assistance during the conference. Please press star zero on your telephone keypad. Please note. This conference is being recorded.
I'll now turn the conference over to your host Eric Ridner you may begin.
Good afternoon, and welcome to <unk> fourth quarter, and full year 2021 earnings conference call and audio webcast.
With me today are <unk>, Chairman and Chief Executive Officer, and Chief Medical Officer, Dr. Shaun <unk>, Chief operating Officer, Michael Rowe, and Chief Financial Officer, John Gandolfo.
This afternoon, I know via issued a press release announcing the financial results for the three and 12 months ended December 31, 2021, we encourage everyone to read today's press release as well as <unk> annual report on Form 10-K for the year ended December 31, 2021, which was filed at the SEC 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 for future reference.
Please note that on today's call, we will be discussing investigational product candidates, which have yet to receive FDA approval.
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, including risks related to fluctuations in our financial result volatility and uncertainty in the global economy and financial markets.
Light of the evolving COVID-19 pandemic.
And the Russian Division of Ukraine, 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 market opportunity for our product candidates the potential revenue from licensing transaction reliance on third parties the ability of Boston, our partners to timely develop implement and maintain manufacturing commercialization and <unk>.
And capabilities and strategies for our product candidate.
Risks of our and our licensees clinical trials, including but not limited to the cost design initiation and enrollment which could be adversely impacted by COVID-19, and resulting social distancing.
Timing progress and the results of such trials the potential impact of COVID-19 in the Russian invasion of grain related economic disruptions on our supply chain, including the availability of sufficient component materials used in our product candidate <unk>.
Timing of our licenses ability to submit applications for obtain and maintain regulatory approvals for our product candidates changes in the legal regulatory and legislative environment and markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our product candidate.
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.
And others detailed and qualified by the cautionary statements contained in <unk> press release and SEC filings.
This conference call contains time sensitive information that is accurate only as of the date of this live broadcast.
Yeah.
I know via undertakes no obligation to robots.
Forward looking statements to reflect events or circumstances. After the date of this conference call, except as maybe required by applicable law with all that said I'd like to turn the call over to Dr. Shawn I am too.
Thank you. Thank you, Eric and welcome everyone to our fourth quarter and full year 2021 financial results.
Conference call, we're excited to recap a very productive quarter and a year during which we made significant progress across both of our clinical programs regarding mid Combi. We are working to complete the <unk> device validation work that had been previously requested by the FDA and remain on track to resubmit the NDA in the <unk>.
Third quarter of this year.
We're assuming a six month review cycle and are making plans for a targeted launch if approved for the first half of next year.
At the same time, we're continuing to enroll our second phase III study vision two <unk>.
For our microwave Presbyopia program and anticipate data next quarter, if positive we plan to begin manufacturing our registration lots to support stability and commercial expiration dating is a requirement for an M D and NDA of micro line.
Importantly, the device validation work that we're now completing from its combi may be referenced in regulatory filings for our other programs that also used the op to jet, including Mike who might potentially streamlining the FDA review process for those product candidates have to other data.
<unk> are also fulfills.
These are exciting times at <unk>.
As we believe we have a clear line of sight to commercially approved products, both leveraging our proprietary opt to jet dispensing technology.
As Michael will discuss in a moment, we also demonstrated empirically for the first time in vitro that delivery of ophthalmic medications with our microarray print delivery system can provide similar benefits to the Congress Tiber.
Our other non preserved medications the importance of this finding cannot be overstated, the optical technology as a key differentiator for us we leverage it for all of our pipeline programs as well as microbial which as you may recall has been out licensed to Bausch health and Arctic vision addictive.
I will turn the call to Michael for an update on our operations Michael Thank you Sean.
As you mentioned and the <unk> teams have been very busy working on demonstrating the value of our technology and preparing for future commercial scale manufacturing across the product line one of those value drivers as potentially improving ocular surface safety and comfort due to our microdose array print technology.
As you May know the vast majority of topical ophthalmic medications contain preservatives to help ensure the sterility of the product and to increase its shelf life.
However, many patients on chronic treatments such as for glaucoma or dry eye often experience adverse effects in ocular stressed in the long term due to the toxicity from overexposure to these preservatives.
With the opted yet we have demonstrated something match of our knowledge no. Other delivery technology has achieved namely to limit the negative impact of ocular preservatives and to transform a preserve formulation enjoying non preserve therapeutic profile without any re formulation.
Evidence of this comes from a study was recently conducted in collaboration with Dr. Pedro Hamra at Tufts Medical Center. The purpose of this study was to compare the impact of the most commonly prescribed preserve glaucoma medication delivered by the after jet versus the same medication deliver than their traditional eyedrop, we also compare themselves versus.
Non preserved medications delivered by eye drop we looked at the impact of these medications on human contact type of cells to assess toxicity and metabolic impact.
The results of this study demonstrated that human contact hivol epithelium cells tolerated preserve drug treatment administered by after just spray the other than the same drug administered by stands with eye drop and similar to a non preserve drug treated cell line as a control with respect to cell viability.
Sicily, apoptotic Sis and metabolic activity.
Why is this important because all else being equal non preserved topical ophthalmic medications is the preference as it is better for the long term health of the eye. However, today's non preserved medications are often provided either an inconvenient and difficult to use unit dose vials when clumsy bubble like devices that filter out the preservative.
The ability of the of the opt the jet to provide the same benefit as these non preserved options, but then the dispenser that makes administration of the drug easier more comfortable and without inducing the ocular stress is a big win and opens the door the products with superior profiles for use in chronic disease states such as glaucoma.
Another study we conducted to further demonstrate the value of our technology was called speed and we will be presenting data from this study at the American Society of cataract and refractive surgery conference in Washington D. C. Next month in short speed demonstrated that the efficacy seen with a single <unk> mist, which not significantly different.
When you added the second spray, establishing yet again and even though our doses just one fifth out of an eye drop that all you need to achieve similar clinical effect is one spray.
Moving onto micro line as you May recall Micra line is our proprietary microdose array print pilocarpine therapy for the temporary improvement in near vision associated with presbyopia or other watch for the treatment of presbyopia, a market representing over 18 million people in the United States between the ages of 40 and 55 well.
Otherwise never wore glasses micro line is unique and that is designed to be used on demand. The way most people would like to use this type of treatment.
Recall that vision, one demonstrated positive efficacy with a very low rate of brow ache or headache, as compared to pilocarpine eye drop formulations, we hope to replicate the same positive results envision too which is ongoing vision two is a phase III registrational double masked placebo controlled superiority trial of 2% multi ray.
Clinton Pilocarpine versus placebo, we aim to enroll about 140 patients into the study and anticipate top line data around mid year enrollment is tracking according to plan.
We believe micro line if approved will be a great step forward in the treatment of presbyopia. It will be highly differentiated from other miotic presbyopia formulations for one horizontal on demand delivery is a game changer for patients or they're struggling with legacy Eyedropper technology. In addition, micro dosing is able to do something not readily achieved with the <unk>.
Standard eyedrop, delivering a therapeutic profile with potential tolerability benefits conventional pilocarpine eyedrops, such as the one recently approved can cause headache, and 15% to 20% of patients with the after jet we saw this rate reduced to less than 3% and our vision. One trial also as mentioned earlier the study of ocular surface.
Toxicity with preserved Microdose formulation shows equivalents to preserve the free MACRA does this potentially means a healthier ocular surface with long term use.
Presbyopia with its multibillion dollar market opportunity has one of the largest addressable markets of any ophthalmic condition. Allergan recently launched the product viewing which uses the same active ingredient as micro line and has a broad direct to consumer advertising campaign to raise awareness of the product and the fact that there was a pharmacologic treatments for presbyopia.
P available.
Over the last two years, we have compiled a significant significant body of market research, indicating strong consumer and prescribed prescriber preference for the after jet dispenser.
While we are pleased that allergan is creating a market for pilocarpine based presbyopia treatment. We ultimately believe that micro line, if approved will better address what patients and prescribers actually want in a product for this indication.
We remain very bullish on micro line and believe it has the potential to be a significant long term value driver for Nokia as well as our Chinese and Korean licensing licensee Arctic vision combined with the positive clinical data generated to date, our upcoming results revision too and the significant benefits of after jet we believe.
Micro line could be transformational ophthalmic therapy upon its approval.
We have previously discussed changes that were being contemplated at the centers for Medicare and Medicaid services regarding potential reimbursement for remote therapeutic monitoring or our T. M.
Archie M gained widespread acceptance during the peak of the Covid pandemic and as a result, nuvaring reimbursement codes were approved for RPM beginning in January of 2022.
One of which we believe is applicable for ophthalmology.
Such remote monitoring allows treating physicians to gather compliance and adherence data in real time, ultimately leading to better patient care between office visits and or avoiding unnecessary office visits.
We're off to chip dispensers purpose built for such remote monitoring and therefore has the potential to become a go to option for the remote therapeutic monitoring associated with topical almac drug adherence and compliance.
And with the potential benefits to the ocular surface that we just discussed from the tough study the reduce systemic impact of drug as seen in our published studies and the ease of use versus standard eye Droppers. We believe we have the potential to partner with companies, who want to leapfrog ahead, and chronic disease management for most therapeutic monitoring can open a new pathway for smart.
More personalized eyecare with real world benefits for patients with chronic diseases, such as glaucoma, while also potentially enabling doctors to get compensated for their patient management, we look forward to providing further updates on their progress on future calls.
Turning now to manufacturing and preparation for the commercialization of and Kabi and micro line. If approved we are finishing validation of our fill and finish drug facility in Redwood City, California and are preparing to install equipment that will allow us to have better control over the logistics and costs for device production in Reno, Nevada. The same equipment will also help us efficient.
We supply our partners Arctic vision in China, and Korea, and Dou Shen the U S and Canada as they continue their clinical programs.
I'd now like to turn the call over to our Chief Financial Officer, John Gandolfo to provide the financial update John Thank you Michael subs.
Subsequent to the end of the fourth quarter, we further strengthened our balance sheet through a $15 million equity investment from Armistice capital Master Fund.
Together with our cash position as of December 31, 2021.
Our pro forma unrestricted and restricted cash position as of today is approximately $35 $7 million. We believe this is sufficient to bring them a combi mydriasis product candidate through the NDA process and commercial launch complete our presbyopia clinical program for micro line and complete the preparation.
Our pilot manufacturing facility in Redwood City, California.
Now I would like to review the financial results for the three and 12 months ended December 31 2021.
For the fourth quarter of 2021, we reported net income of approximately $3 million or <unk> 11 per share on approximately 27.9 million weighted average shares outstanding and 10 cents per share on approximately 30 million diluted basis shares outstanding. This compares to a net loss of approximately.
<unk> $4 2 million or <unk> 17 cents per share for the fourth quarter of 2020 on approximately $24 9 million weighted average shares outstanding.
For the full year 2021, net loss was approximately $12 $8 million or a loss of 49 cents per share and this compares to a net loss of approximately $19 $8 million or a loss of 94 cents per share for the full year 2020.
Research and development expenses totaled approximately $3 $2 million for the fourth quarter of 2021.
This compares to approximately $3 $4 million in the same period in 2020.
Decrease of approximately six 5%.
Full year 2021, R&D expenses increased eight 6% to approximately $14 $5 million and this compares to $13 4 million for the full year 2020.
For the fourth quarter of 2021 general and administrative expenses were approximately $3 $7 million compared with approximately $2 million for the fourth quarter of 2020.
An increase of approximately 84, 7%.
For the full year 2021, G&A expenses increased 41, 5% to approximately $10 $8 million and this compares to $7 5 million.
For the full year 2020.
Total operating expenses for the fourth quarter of 2021 were approximately $6 $9 million compared to total operating expenses of $5 $4 million for the same period. In 2020. This represents an increase of approximately 27, 4%.
For the full year of 2021 operating expenses increased 26% to approximately $25 $3 million compared to $21 million for the full year 2022.
2021 operating expenses included approximately $2 $9 million.
Noncash stock compensation expense.
As of December 31, 2021, the company's unrestricted and restricted cash balance was approximately $27 $3 million, which excludes the recent $15 million offering through armistice capital, which was completed in March.
Before we open up the call to quest questions. Our conduct a brief update on our licensing programs with Bausch health for micro <unk> in the U S and Canada and Arctic fascia for all three of our drugs in China and South Korea.
Micro pain as you may recall is a proprietary atropine formulation was a reduction of pediatric myopia progression. It has 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 detachment myopic retinopathy ambition loss bifocal multifocal glasses or contact lenses are typically prescribed to myopic children.
Recall that as part of this agreement with Bausch Health Bausch agreed to assume oversight and costs related to the ongoing phase III chaperone clinical trial. This was a 48 month U S. Based multi center randomized double masked trial that is enrolling more than 400 children between three and 12 years of age.
The trial is comparing Microdose atropine point out 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 peanut micro line. They also recently added met Combi as well so Arctic pitching now licenses all three of our current programs.
We're pleased that Arctic vision recently had this micro P&I and D clearance in China is completing a PK study and is preparing to start a phase III study. So that program is also progressing nicely.
To date, our license agreements have generated $16 million in license fees and we have the potential to earn an additional $60 million in net license and development milestones and Reimbursable expenses over the next four years.
In addition, with the transfer of the Chaperone clinical study and related cost to Bash, our 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 these expenses.
Upon 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 optic jet technology to address unmet needs in additional large ophthalmic indications. Some examples include anti infectives anti inflammatories dry eye and glaucoma each.
With significant market opportunities.
Conclusion, we continue to be pleased with our performance to date.
To summarize our key highlights today, we are continuing to rapidly advance our phase III micro line Presbyopia program and we are rolling patients into FERC in the first patient in our phase III trial vision, two and expect top line data this year.
We're actively preparing for the Resubmission never met Combi M B, a and the third quarter of this year, which if approved would give us our first commercial product and validate our royalty check dispensing technology.
In parallel we are continuing to expand the body of research on novelty jet as shown by the remarkable findings in our collaboration study with tops that highlighted the significant potential of optics, yet to bypass common adverse events associated with chronic <unk>.
Ophthalmic therapy use.
And our license agreement with Arctic vision, Ambev share progressing well and continue to offer the opportunity for meaningful development and regulatory milestones as well as line of sight to potential sales royalty, possibly within three to four years.
That concludes our prepared remarks, we would now like to open the call to questions to the operator.
Thank you and at this time, we'll be conducting a question and answer session.
To ask a question. Please press star one on your telephone keypad.
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One moment, please while we poll for questions.
Okay.
Our first question comes from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.
Hey, Hey, guys. Thanks for taking my questions.
That's on the progress.
Just wanted to.
With that I guess relative near term resubmission of the Combi NDA.
An approval in the first half of next year, how should we think about potential launch of that product.
Heading into next year.
Hey, Matt its Michael good to hear from you.
The launch is going to be a very targeted this is a brand new technology and we want to make sure that our potential customers have a great experience as we roll it out so the way I would think about it is that we're going to start and keep the expenses low and we're going to pay for it as we go along so for example, what you won't see US 100 salespeople being hired by the company.
You'll see us starting out at the highest population centers and once that is successful then then going out from there. So I would say that our expectation would be a targeted controlled launch, but one where the expenses are very controlled so that we're not going to get ahead of our skis.
And then the upside down with us.
Okay. That's really helpful. Thank you and then I guess with the <unk>.
To Ah study you know now ongoing results expected soon.
Can you talk a little bit about the differentiation of micro line versus other products principally up either in development or I guess, how allergan is as well.
Yeah, Matt This is Sean and I think we've with.
But because of that that we're very.
Passionate about the differential approach that Mike.
Micro line.
Represents.
It really incorporates.
<unk> paid the distilled value prop of our entire technology.
Technology here. We all are for example, we have a drug like pilocarpine that's used.
By Allergan today in other companies.
Companies.
But we need to deliberate on the Microdose technology would be after jet it really inflect the therapeutic index of.
That compound.
What does that really mean again, probably the most.
The first pass.
Differentiation is obviously you can deliver something that you can get into the eye and a very easy way in the convenience should not be underestimated, particularly for a population like the 40 50 year olds, who who you haven't been trained they are not like the glaucoma patients who are being trained and they are trying to get accustomed.
To use the legacy Eyedropper technology that half of the time, they cannot even get into their eyes. So obviously the convenience the streamline delivery. The fact that we're using modern day technology in the smart delivery technologies huge.
But I think another part is really important is topical and systemic safety in our trial for vision. One we saw that the rate of headache, which is a very well established and even in even before the presbyopia studies, we know from the glaucoma literature, it's at about 15% to 20% of <unk>.
Patients.
Have a headache and that becomes very key when you're using something of a more kosmos vertical type of nature. So headaches in the Alexander trials I think were reported at about 15% or so which is very consistent with the literature with micro dosing. We're seeing the same thing we're seeing with some other compounds.
As we've demonstrated before for Hyperemia for example, with rocker inhibitors, where we are able to reduce that dramatically here, we're able we're seeing rates of about two and a half below 3%.
And again, we think that's key and it's come up Michael has done a number of marketing surveys.
He was a surveys and patient surveys that show that headache is something people don't want to get when they're trying to address their near vision.
So again hyperemia and other things that are really important I think we are really demonstrated something that I've always wanted to do even in the early stages of the technology. We finally were able to get to do the study for the ocular surface Tolerability to show that a preserved microdose behaves and offers the same.
Therapeutic.
Profile as a non preserved the way people have to carry those unit dose containers with them everywhere. They go they carry too many things as it is so having a multi dose preserved that behaves as a preservative free with a huge differentiator as well.
Again all of these are not just for Mike Lyon, they carry through the entire platform for anything else, we want to do or are doing such as micro penis well.
Okay. Yeah, that's really helpful. Shawn Thanks for that detail and then I guess last question.
And you did you did well.
Last year with milestone payments.
<unk> totaling $14 million.
What what's what are you expecting this year for for potential milestones.
Some partners.
So we are we are not expecting any license fee milestones. This year, we will continue to receive a reimbursable expenses associated with some of our product development work as well as clinical study.
And to the extent that we are supplying our partners with.
Clinical study units, our clinical study supply opted jets will continue to receive reimbursement there but.
Nothing on the license fee side for this year.
Okay, Okay fair enough.
Thanks again guys.
Thank you Matt.
Our next question comes from the line of Tim Chiang with Northland Securities. Please proceed with your question.
Hi, Thanks.
Assuming that the vision two studies positive.
When could we expect.
You have to file.
Hum.
Micro line.
What would that be a second half of the year filing with or do you think youll need to do it in an additional study on top of what you've done with vision, one and vision two <unk>.
Yeah. That's a good question I think again this would be.
We hope to see a positive.
<unk>.
<unk> vision to phase III.
And again, we are planning to launch ultimately the.
Division too in the micro line.
The Gen two streamlined and improved our delivery platform, we're going to do that because the gen. Two offers some very key advantages when it comes to the consumer side, it's much more elegant and and it's something that we've planned all along before I commit to you and tell you exactly what we're going to.
Do I think we want to check in at the end of the vision to with the FDA just to make sure we make some confirmations.
And as you know we're also will be towards the second half of this year, we will be also marching towards the filing and the resubmission for the NDA. So.
As much as I would like to answer specifically your questions. Most importantly, we want to sync up with the FDA makes them confirmations, because we know that certain timelines changed after they made some.
Changes to their classification.
And we are now a drug device combination and the transition from the Gen. One to the Gen. Two certain things we want to confirm before we give any guidance on that.
But again, we hope that the revision to its positive and it really confirms division one and if there are any bridging things too that needs to be done we will have to confirm those hopefully not.
And after we do that meeting with the MTF. The division two results, we're going to revisit and give you guys more detailed information about that I think we can also add Sean that.
What we said in the comments earlier was that one of our next steps as we are making registration batches.
For micro lines so Tim.
We're going to start those as soon as we have a positive.
See some positive results.
So that will be the beginning of making those batches. So that will help you with kind of estimating what that timeline would be.
Okay, and maybe just just to clarify I know you guys showed some.
Data on.
Your spray formulation being comparable to.
Drop formulations that a preservative free are you guys working on your own preservative free.
Formulations as well or not.
Well. Good question did we made this decision a long time ago when we.
We have to really think through what the true benefits of micro dosing arc.
And right now we are seeing and we've proven now even further with these data that we're seeing what we saw with some of the patients that they see very little discomfort.
From micro dose preserved formulations, and we saw that Didnt missed one we sold that didn't miss to NPG 'twenty one.
And this really confirms not only the data that we're seeing from the patient is just confirms the on physiologic level.
Cellular level, so I would say, we're seeing very little motivation to pursue preservative free.
Formulations given that.
The preserved ones behave the same way on top of that there are some data that are very well known in the ophthalmic literature that when you go to a preservative free formulation in a nine drop or for example, you may take that would be the tradeoff of efficacy and we've seen that with some of the glaucoma formulations why because.
Cause the preservative.
<unk> be important a little bit of preservative may be important to open up the epithelium cells and increased penetration through the cornea.
So I think at this point to sum up I think we're very happy that we were really proving out that micro dosing of preserve formulation.
Is the way to go not only for direct targeted delivery not only for the liability now we're seeing it at a cellular level as well.
And I don't think we see any.
Major drivers here to switch to preservative free that being said I think that we don't say that our technology is not able to work with preservative pre formulations in the future should we want to do that.
I see and Sean I promise. This is the last question you know when you guys show your vision take your time.
Oh, thanks, Thanks, Sean.
When you show your vision two results will you provide.
More of the details on for instance.
Some of the comparable efficacy parameters.
So we can sort of compare it to beauty, because obviously I think I think the markets going to want to see that right I mean.
Will you be able to show.
Some sort of apples to apples.
David data on efficacy.
Right.
So we obviously have made.
Mentioned, what our endpoints are and actually we've given some data at the encouragement of the of the interested parties and stakeholders from vision one.
I think that are we.
Once we see the data we're going to share. It we will have to presented also at the peer review venues.
We haven't committed one way or another whether we're going to change the way we present the data from vision. One I think we gave a lot of guidance. There. Most importantly, we want to meet the endpoints and we also want to keep the key.
Safety factors for which we've given very detailed information.
And again, we want to make sure that whatever we do is consistent with our best in class regulatory approach, we don't want anything to necessarily jeopardize the the NDA.
Submission and ultimately where.
Again, coming second or third on the market with that.
We will be able to internally compare it and control to some degree how much we're going to inform that the competition on that.
It's a long winded answer of saying, we haven't really decided if we're going to change the exact paradigm, although I do feel that vision. One we did provide increasingly more data and visibility to our endpoint.
Okay. Okay. Thanks, Thanks, Sean.
Thank you Tim.
Yes.
And again as a reminder, if anyone has any questions you May press star one on your telephone keypad to join Q&A queue.
Our next question comes from the line of Glenn you actually with stock Doc Partners. Please proceed with your question Alright. Thank you very much I had two questions for you guys. The first is I was really.
Interested in hearing because it's something I always thought there was tremendous value in about the possibility of expanding the applications of the I forget delivery system and you mentioned poor conditions.
I believe three of which are in extremely large but theyre competitive.
And in a lock on the case there are several generics I was just wondering are these indications and maybe it's a mixture that you intend to develop yourself from existing medications that are out there available generically either as monotherapy or combo therapy or is that the technology that you plan on.
Licensing to those companies.
It may be a patented products and one of these areas.
My second question is you talked about.
Maybe having to do some sort of a bridging study if I heard right. After vision two as it relates to getting approval and I was just wondering for Michael line and I was just wondering I believe back in January .
That you expect.
The product to be on the market in the second half of 'twenty three.
With this altra, if anything has to be done easily justify the second generation device or anything else that the FDA may want could this alter that timeline for when you might get on the market. Thanks, so much.
Right Glenn. Thank you very very good question, so I'll start with the first one.
I think that.
It's really we're very encouraged to see that we can have a purchase on many many formulations and applications within the topical space for ophthalmic pharmaceuticals and.
We really can.
Provide a number of huge value props in.
From glaucoma too as we have now with micro lining.
<unk> and progressive myopia in microbial.
Again being a small company at the valuation where we are right now unless that changes materially our preferred approach will be to really partner new to new indications and new applications.
And at the same time, we are exploring things we cannot to the pipeline with the same meaningful approaches we did with presbyopia and progressive myopia I think the reason we chose those were not just because they were available entities that we can put on our system, but really they opened up.
Huge indications big unmet needs, where we can pivot into this technology and we can really inflect the therapeutic index of dose formulations. So.
Our preferred approach would be to really hum.
Use the approval of a one day hopefully with the Gen. One and the mid Combi to really catalyze our business development and partnerships and I think that would be fair statement to how we feel the.
The immediate horizon is for us.
On the vision to we would love if there are no changes and if we just Ah.
Approach this in a very linear and the most direct vector.
We would love to do beyond that timeline for for the mid 2023.
But again as we consider to consider.
Consider all the as.
Facets of this development in the drug and device.
I think it will be premature to commit to that before we see.
The results of the vision to data and we go to the FDA for confirmation as well as as we see how the registration batches also pan out because those.
We know we've waited for registration batches before we have not activated too many things at risk given that were small and were very budget conscious. So we definitely will in this case to use the sequential approach we want to see the vision to data and then activate some of the registration batches, which is really connected with.
Significant expense for a small company like we are Michael.
Michael do you want to add anything else no I think that's.
Exactly okay. Thanks, Thank you.
Thank you Juan.
Yes.
Yeah.
And we have reached the end of the question and answer session I'll now turn the call over to Dr. Sean <unk>.
Julia for closing remarks.
Thank you well great.
It was a pretty substantive call and I think we've provided a lot of update particularly on the finances.
And on the operations.
Again, we hope to that you'd take away from today's call that last year, we made significant progress on all fronts.
And I believe this is the year that it all comes together.
We have set ourselves to achieve a number of clinical and regulatory milestones in the near term and we're working diligently to advance the two main programs in mid Colombian microlite towards NDA submission and potential commercial approvals for the U S market.
That concludes today's call and we look forward to our first quarter update in May and thank you all for joining and have a good afternoon. Thank you.
Yes.
And this concludes today's conference you may disconnect. Your line at this time. Thank you for your participation.
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