Eyenovia Q1 2023 Earnings Call Transcript

Quartr
Provided by Quartr
May 11, 2023

There are 10 speakers on the call.

Operator

Greetings. Welcome to Eyenovia First Quarter 2023 Earnings Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. Please note this conference is being recorded.

Operator

I will now turn the conference over to John Gandolfo, Chief Financial Officer. Thank you. You may begin.

Speaker 1

Thank you. Good afternoon, and welcome to Eyenovia's Q1 2023 Earnings Conference Call and Audio Webcast. With me today are Eyenovia's CEO, Michael Rowe and COO, Brent Kern. This afternoon, we issued a press release announcing financial results for the 3 months ended March 31, 2023. We encourage everyone to read today's press release as well as Eyenovia's quarterly report on Form 10 Q for the quarter ended March 31, 2023, which will be filed with the SEC tomorrow, May 12, 2023, as well as our most recently filed 10 ks.

Speaker 1

The company's press release and annual report are also available on our website at In addition, this conference call is being webcast to the company's website and will be archived there for Please note that on today's call, we will be discussing investigational product candidates, some of 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 the call, Eyenovia's management will be making forward looking statements. Actual results could differ materially from those stated or implied by these forward looking statements due to risks and uncertainties associated with the company's business. These forward looking statements are subject to a number of risks, which are described in more detail in our annual report on Form 10 ks.

Speaker 1

This conference call contains time sensitive information that is accurate only as of the date of this live broadcast, May 11, 2023. Eyenovia undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances after the date of this conference call, except as may be required by applicable securities law. With that said, I'd like to turn the Call over to Michael Rowe, Eyenovia's Chief Executive Officer. Michael?

Speaker 2

Thank you, John, and welcome everyone to our Q1 2023 Financial Results Conference Call. I will start with an update of our recent FDA approval of Midcombi, How that approval fits within our overall strategy and then provide a status update for Microline. Bren Kern, our Chief Operating Sir, will follow with an update on our manufacturing and commercial readiness progress. We will then turn things over to John Gandolfo, our CFO, We will review the financials as well as our partnerships with Bausch and Lomb and Arctic Vision. We will then open the call for your questions.

Speaker 2

During the Q1 of this year and more recently, we have made significant progress on all of our stated goals, punctuated by FDA approval of our first product, MidCombi. We also received very encouraging feedback from the FDA and believe that we have a clear path forward for our MicroLine presbyopia program. In terms of manufacturing, we are ramping up our activities and we'll have our Reno So, we'll be online next quarter with OptoGen Gen 2 clinical batches being produced later this year. Finally, our partnership with Formosa as well as others that we expect to come will pave the way for additional ophthalmic activities that leverage our OptoGen technology. I'll begin the call by highlighting our most recent achievement.

Speaker 2

Just a few days ago, we received FDA approval of Midcombi, our proprietary combination of a microdose formulation of tropicamide and phenylephrine for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. This is the first approved fixed dose combination of tropicamide and phenylephrine in the U. S. And importantly, it is also the first approved product using our OptoGen dispensing device. I cannot overstate the importance to our company of this approval.

Speaker 2

The OpRegen is foundational to our development pipeline as well as our partnered programs. And this FDA approval sets a precedent for the future development of additional ophthalmic therapies delivered by the OptoGen and other high value indications. The FDA's approval of MYKOBBI provides crucial external validation of our technology and is just the first of many ophthalmic indications that can utilize the OptoGen. The approval also marks the formal transition of Eyenovia from a development company to a commercial organization. The management team is extremely grateful to all of our Eyenovia colleagues for their dedication in advancing this program through this important milestone.

Speaker 2

Since Monday, we have received numerous inbound calls and emails from ophthalmology and optometry offices asking when they can get Midcombi. The reasons for wanting the product include the horizontal delivery, the lower drug volume exposure, ease of use for both the doctors and technicians. One doctor said that she planned to modify her office flow so that she could dilate patients right in the waiting room, since she didn't have to have them tilt their heads back. We of course see this as very encouraging. We plan to introduce midcombi later this summer to several key ophthalmology and optometry offices as part of our targeted launch process.

Speaker 2

As much as we would like to be out there tomorrow, we need some time to bring our internal manufacturing capabilities, which are more cost efficient online. By early 2024, we expect to have our facilities in Redwood City and Reno at full production capacity. For now, customers and all of you can find out more about Mycami and soon track our launch progress and ultimately hear what I'll now turn to MicroLine, our proprietary topical on demand piloparkine based therapeutic candidate that we are developing for the temporary improvement in near vision associated with presbyopia. As you'll recall, presbyopia is the age related hardening of the eye's lens, Causing blurred near vision. This is an addressable market representing over 18,000,000 people in the United States alone between the ages of 4055 will otherwise never wear glasses and have the resources for a cash pay product.

Speaker 2

Our proprietary market research suggests This could be a multibillion dollar annual market in the U. S. Alone. We recently received feedback from the FDA believing AAVIA clear path forward to this program Towards a New Drug Application or NDA. MicroLine is being designed for use with our smaller and more advanced Gen 2 OptoJet device, which has been optimized for in home use.

Speaker 2

The machinery to build and fill the Gen 2 Cartridge is being installed and validated in our Redwood City facility, We anticipate running NDA registration batches in the first half of twenty twenty four after satisfying the contracted clinical needs of our partners. The FDA requires 12 months of real time stability data on the final packaged product before filing the NDA. So we intend to file approximately 10 months after we run those batches. During those 12 months, however, we will not be sitting and waiting. We will be conducting other critical pre NDA activities, including supportive human factors and clinical work to demonstrate the usability of the Gen 2 device in the target population, as well as measuring patient preference for the OptoJet system.

Speaker 2

This work will be used to support both the MicroLine NDA and upcoming commercialization of the product. As an ophthalmic spray in the OptoJet device, we believe that MicroLine has a number of unique features That may set us apart from presbyopia eye drop options. The features of our technology may make using the product easier while lowering drug and preservative exposure and potentially improving tolerability. The attractiveness of the device itself has been pointed to as a highly desired feature in market research we have conducted. And MicroLine may also fit better with the business model of many optometrists.

Speaker 2

Many Have a retail portion of their practice where they sell eyeglasses, contact lenses and other products for presbyopia patients. Microline could fit well into their paradigm as they may be able to include supporting items such as unique device skins, starter kits and so on as part of those offerings. We recently conducted market research with 100 Optometrists Microline was compared with the 5 existing or potential presbyopia eye drops that may be on the market in 2025. What we found was that MicroLine was rated number 1 by the doctors surveyed in terms of meeting the optometrists and their patients' overall needs. These doctors estimated that Microline could capture as much as 1 third of the presbyopia pharmaceutical market with the other 5 eye drops competing for the remaining 2 thirds of the market.

Speaker 2

Should MicroLine be approved, we believe that the OptoJet With its design, ease of use and lower drug volume, distinguishes the product and ultimately patients, other doctors will be choosing from a number of different eye drops or MicroLine, the one and only spray. Turning to our partnering activities, We were very excited to announce in February a development collaboration agreement with Taiwan based Formosa Pharmaceuticals. This agreement seeks to combine our OptoGen with Formosa's unique APNT nanoparticle formulation platform for the potential developments of new topical ophthalmic therapeutics that employ the OptoGen device. Formosys' proprietary innovative TNT platform improves bioavailability and solubility of active pharmaceutical ingredients, allowing more homogenous formulations that may expand our universe with existing and future drugs that could benefit from delivery using the OptoGen. We believe this agreement with Formosa will open up new and large market indications for potential expansion of our pipeline and may serve as a model for future partnerships.

Speaker 2

We're continuing to advance discussions with potential partners that may benefit from OptoGen within their own development programs, such as glaucoma and dry eye. Co development partnerships such as this addressing large ophthalmic indications with unmet needs are a key part of our mid and long term growth strategy. We are continuing to build a large body of data demonstrating the benefits of Optogen over conventional eye drops. In January, we announced positive results from a research study conducted in collaboration with Doctor. Pedram Hamra, Interim Chairman of Ophthalmology at Tufts Medical Center.

Speaker 2

This study evaluated the gene and protein expression of cytokines and chemokines after treatment with latanoprost, A glaucoma medication preserved with BAK administered via OptoGen versus administered via standard eye drops. In these early findings, the OptoGen technology appears superior to standard eye drops in reducing the inflammatory process. The OpReget was found to achieve a therapeutic dose of lataloprost with significantly less exposure to those excess drugs and harmful preservatives that can be achieved using conventional drops. These results were also presented at the Association For Research in Vision and Ophthalmology Annual Meeting At this point, I'd like to turn the call over to our Chief Operating Officer, Bren Kern, for our manufacturing update. Bren?

Speaker 3

Thank you, Michael. With FDA approval of MYCOMI in hands, we've been working with our suppliers to finalize preparations for our upcoming MYCOMI commercial launch. Material order plans are being finalized and we are optimizing processes to align with requests made by the FDA during the review period. Our Redwood City facility, along with our contract manufacturers, continue to support our clinical partners, Bausch and Lomb and OrcaVision, with clinical supplies being delivered regularly. Additionally, the Redwood City facility has made significant progress in qualifying our fill and finish line to support the Gen 2 Dispenser platform.

Speaker 3

This progress has instilled confidence to initiate the design of a high capacity Automated fill and finish line, which would support our anticipated demand streams for the Gen 2 device. This state of the art system should be installed in the 2nd half of twenty twenty four with additional qualifications occurring thereafter. Additionally, Arena facility continues to make significant progress in establishing base in ejector manufacturing. Recall on our last earnings call, we noted the facility construction was ongoing. These activities have now been completed and our Reno office staff has taken occupancy.

Speaker 3

Production equipment is arriving and installation and qualification activities followed thereafter. Last quarter, we announced the addition of Enrico Brambilla as Innovia's Vice President of Product Research. Enrico joins us in April, and we are already leveraging his expertise in rapidly increasing our engineering capabilities through the identification of new hires, Engineering tools and increased efficiencies, which will be leveraged across our dispenser and an array of drug products. I am genuinely excited about the significant amount of progress we have made over the last few months. Our operations capabilities are increasing on a daily basis And the approval of MYCOMBI has successfully demonstrated our dispenser platform is a viable technology solution to topical ophthalmic drug application.

Speaker 3

I'd now like to turn the call over to our Chief Financial Officer, John Gilpinho, to provide a financial update. John?

Speaker 1

Thanks, Brent. For the Q1 of 2023, net loss was approximately $5,700,000 or $0.15 per share compared to a net loss of approximately $7,300,000 or $0.24 per share for the Q1 of 2022. Research and development expenses totaled approximately $2,500,000 for the Q1 of 2023. This compares to approximately $3,700,000 for the same period in 2022, a decrease of approximately 32%. For the Q1 of 2023, general and administrative expenses were approximately $2,900,000 compared with approximately $3,500,000 for the Q1 of 2022, a decrease of approximately 15.5%.

Speaker 1

Total operating expenses for the Q1 of 2023 were approximately $5,500,000 compared to total operating expenses of $7,200,000 for the same period in 2022. This represents a decrease of approximately 24%. As of March 31, 2023, company's cash balance was approximately $18,500,000 compared to $22,900,000 as of December 31, 2022. In addition, the company has the ability to draw down Additional $5,000,000 on its Avenue Capital Credit Facility through July 31, 2023, based upon the recent approval of MidCombi. Licensing programs are an important source of current and potential future revenues for the company, and a major part of our strategy is to complete additional agreements as a source of non dilutive capital.

Speaker 1

In addition to the cash balance I noted above, We have a receivable from our license partners of approximately $975,000 as of March 31, 2023, and expect a reimbursement payment of approximately $2,000,000 from Arctic Vision for product development expenses in the second half of twenty twenty three. Before we open the call to questions, I will conclude with a brief update on our existing licensing programs with Bausch Health for MicroPine in the U. S. And Canada and Arctic Vision for all three of our products in China and South Korea. MicroPine is a proprietary atropine formulation for the reduction of pediatric myopia progression.

Speaker 1

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. 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 this agreement with Fashion Loan, costs related to the ongoing Phase 3 CHAPARONE clinical trial were transferred to our partner and enrollment is progressing as planned.

Speaker 1

Our agreement with Arctic Vision covers Greater China and South Korea and covers MicroPine, MicroLine as well as Midcombi. So Arctic Vision is now licensing all three of our current programs in those territories. MicroPine 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. Our agreement with ThorOptik Vision provides us sales royalties in addition to development milestones.

Speaker 1

So if and when approved, MicroPine could be a significant source of non dilutive funding for our company over the long term. To date, our license agreements have generated approximately $16,000,000 in license fees, and we have the potential to earn an additional $60,000,000 and net license and development milestones as well as reimbursable expenses over the next 4 years. Upon commercialization, if our products are approved, Eyenovia can earn significant sales royalties as well. We are also continuing to assess potential pipeline expansion opportunities such as our Formosa agreement as we believe we could Continue to leverage the OptoJet technology to address unmet needs and additional large ophthalmic indications. Pipeline expansion was a significant consideration as we were building our new manufacturing facilities.

Speaker 1

In conclusion, we continue to be pleased with our performance to date. To summarize our key highlights today, We received FDA approval of Midcombi, a fixed dose combination of tropicamide and phenylephrine for mydriasis and the 1st FDA approved product to utilize the OptoJet. We received feedback from FDA on our Phase 3 MicroLine Presbyopia candidate that provides a clear and efficient path forward for the program that can potentially address a multi $1,000,000,000 annual market in the U. S. Alone.

Speaker 1

We announced a co development agreement with Formosa Pharmaceuticals. Our manufacturing facility in Redwood City, California is operational and our second facility in Reno, Nevada is on track to be operational in the Q3. We have continued to expand the body of research On Optijet, as shown by the results from our collaboration study with Tufts that highlighted the significant potential of Optijet to bypass common adverse effects associated with chronic ophthalmic therapy use. Our licensing agreements with Arctic Vision and Bastian Lomb are progressing well and continue to offer the opportunity for meaningful development and regulatory milestones as well as line of sight to potential sales royalties possibly within 2 years. That concludes our prepared remarks.

Speaker 1

We would now like to open up the call to questions. Operator?

Operator

A confirmation tone will indicate your line is in the question And for participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. Our first question is from Matt Kaplan with Ladenburg Thalmann. Please proceed.

Speaker 4

Guys, good afternoon and Congratulations on the approval of Midkomi. That was terrific news earlier this week.

Speaker 1

Thanks, Matt.

Speaker 4

Can you talk a little bit about the commercial rollout? And you mentioned some of that In your prepared remarks, but how we should be thinking about that as we move to later this year and to next year?

Speaker 2

Yes, I'll take that. Thank you, Matt, very much. We're going to be rolling out later this Summer, it's going to be a staged or targeted rollout. The reason for that is that I'm actually here in Reno, in our Reno facility right now, Watching them installing lasers and ovens and other equipment, and it is much more cost efficient for us To be producing much of this on our own rather than using contract manufacturing. So we're going to have a targeted rollout to get the product out to some key offices Later this summer, but the real push from Mid Compu will come towards the end of this year, going into next year when we have our production facility here fully validated and running.

Speaker 2

So I would look at it as for this year, it's more to get it into the hands of some very key doctors and get the immense building for it, collecting names on the commie.com, for example, and then we'll be able to turn everything on next year.

Speaker 4

And can you talk a little bit about pricing and how that's going to work out?

Speaker 2

Yes. So Price is $5.99 for 5 cartridges. So let's say roughly $1.20 a cartridge. Each cartridge will support about 75 patients. So on a per patient basis, it's about 1.60 Right now, if you look what doctors are spending on the 3 eye drops, they're spending about $1.20 So it's a $0.40 Increase, but the customers have told us that when they compare that against the time savings, the convenience and the overall better situation for their patients, they don't see that as being any hurdle for them to adopt it.

Speaker 2

Okay,

Speaker 4

great. And then just shifting gears a little bit, you mentioned that you received some positive feedback from the FDA On your Microline program, can you give us some more details on that feedback and the path forward to the NDA registration? Right.

Speaker 2

So our VISION 1 and VISION 2 studies were conducted in the same dispenser that MidConvi was approved at. And it's a great dispenser. It's perfect for the clinic. We want, however, for MicroLine to be more consumer friendly. And therefore, we want to transition it to our Gen 2, which is more slender and more portable, which fits better with that product.

Speaker 2

So our question to the FDA was basically how do you get from GEN-1 to GEN-two, given that they have very similar Characteristics and how they deliver the medication, the FDA gave us that information. It involves validating the device the Same way we did for mid combi. And the wonderful thing by having the mid combi approval is we know exactly how to do that. And in fact, we're doing that right now. And the other thing they were looking for when I mentioned human factors is they just want us to demonstrate that people can actually use the device, Which we're also very confident about because they have been using it.

Speaker 2

So there's a little formal study you have to do with that. So none of that is going to delay us. Really the big hole in the tent is making the registration batches and the only reason we can't make those sooner It's because we have to make atropine batches for MicroPine for our partners at Bausch and Lomb and at Arctic Vision because they have ongoing clinical studies

Speaker 4

And can you just detail the timeline for those registration batches?

Speaker 2

Yes. So we plan to have those registration batches very early next year and then 12 months of real time stability. As soon as we get the STABILITY results, we drop it into the NDA and off it goes.

Speaker 5

Great. Okay.

Speaker 4

Thanks. Thanks for that. And then final question questions. Can you give us kind of an update in terms of the progress that Dausch and Lomb and OctoXVision have been making on their programs, specifically The MicroPine program and the chaperone Phase 3.

Speaker 2

So, Bausch and has said publicly that they are intending to finish enrollment by the end of this year. When they do, it's 3 years to that The efficacy endpoint. Arctic Vision is going to be starting Their study with the Generation 2 device, as soon as we get that to them, which is later this year, I don't believe their study is 3 years. I think it's shorter than Bausch's. So both of these are probably going to finish up at roughly the same time.

Speaker 4

Okay,

Speaker 6

great.

Speaker 4

Well, congrats again on the approval.

Speaker 2

Thank you, Matt.

Operator

Our next question is from Matthew Clawfield with H. C. Wainwright. Please proceed.

Speaker 7

Great. Can you guys hear me okay?

Speaker 8

Yes, Matthew.

Speaker 2

Yes, Matthew. Awesome.

Speaker 7

On the seemingly negative sentiment from the stock following the approval. What do you think investors could have been missing or mis about the prospects for Midkombe or the OptoJet opportunity overall. And then just separately, I was curious If you could further if sorry, if further financing could prospectively be necessary tied to the internal MidCombi launch. Thanks again.

Speaker 2

John, do you want to start with that one as it is a bit of a head scratcher?

Speaker 1

So from an overall financing it's a good question. So from an overall financing standpoint, we have multiple financing alternatives, including as I mentioned the Avenue Capital Credit Facility where we could draw down $5,000,000 immediately. The reimbursement for clinical supplies from Bausch and Arctic Vision as well as Partnership milestones or partnership or licensing opportunities, and we're pretty much working on all of these as of now. We also have traditional financing mechanisms in place. In terms of the financing for the MidCombi launch, We will not be building up a sales force.

Speaker 1

So there really is we don't expect our operating cash burn for the MidCombi launch Really to be much different than it was last quarter, where we had an operating cash burn of Roughly about $5,500,000 So we factored that into all of our Cash projections and we are constantly evaluating what alternatives we have in terms of financing going forward. But with our current cash resources as well as the funds that we know we could draw down, We're pretty confident that we have sufficient cash through the Q2 into the Q3 of next year. So I hope that answers your question.

Speaker 2

Yes, very helpful. Matthew, I'd like to add because Something else is, I think there might be some people looking, if you look at other companies or the history of companies that they get approval and They put together a 100 person sales force and they start spending like crazy basically. And I've observed that at other companies And I've seen that not work. And our philosophy here is we're not going to over commit ourselves. We can get to our goals being extremely efficient.

Speaker 2

And as the product grows, we can add resources And ad spend to go along with that to keep it almost like feeding the fire. So people may be concerned that with the approval That there's going to be this huge increase in commercial spend, that's not going to be the case. Understood. Very helpful, guys. Thank you.

Speaker 2

Thank you, Matthew.

Operator

Our next question is from Jason McDonald, Private Investor. Please proceed.

Speaker 9

Yes. Thanks for taking my questions, guys. Just had a quick one, kind of to your last point there, Michael. When you talk about a hybrid organization having some products in house and some being outsourced, of course, Does the team really view the outsourcing of the technology as the bigger revenue generated an opportunity long term? I mean, obviously, you have to wait and see.

Speaker 9

But I'm just curious where your heads are at, if you think that's really the long term opportunity.

Speaker 2

Thank you, Jason, and thank you for being a shareholder and partner with us. Let me give an example. If we talk about the opportunity in glaucoma, there are many different segments in the glaucoma market. You could be a prostaglandin, you could be a beta blocker, you could be a ROCK inhibitor and so on. So one way to look at this is that By partnering with different companies that have different drugs in those segments, you can actually multiply The number of opportunities that we would have ourselves if we wanted to go into the glaucoma market with a product.

Speaker 2

So we are looking at some of these areas as ways that we can magnify the impact that we can have And get the OptoJet out there. I mean, it's good for patients, it's good for doctors, and it's good for you as a shareholder if we can get this used in more situations. Does that answer your question?

Speaker 9

Yes, makes total sense. Appreciate it.

Speaker 1

Yes, if I could add one thing also. As we think about the structure, I think that we think about it more As a partnership type of opportunity, where we could retain a really large portion of the economics as opposed to A straight out license type agreement where you're giving up pretty much all of the upside. So I think structurally, that's an

Speaker 9

Absolutely. And just to follow-up on to that point, When it comes to the expenses, long term, are you guys looking to keep this fairly small, like you're saying, Michael, to go in, Not guns blazing, be careful with how you're kind of proceeding with these products to kind of see what the uptake is and maybe one works better than the other. Is that kind of the To stay agile in that sense?

Speaker 2

That is exactly it. So we will look and see, Maybe 2 years from now, we might have 24 salespeople as we get ready to launch MicroLine. And when MicroLine takes off, we can add more, but we don't have to incur that expense today.

Speaker 9

Fantastic. Thanks for taking my questions. Thank you. Thank

Operator

Our next question is from Robert Mucci with RN and Associates.

Speaker 5

My question goes back to the financing that was brought up and asked by the previous caller. Is it safe to say I know we all disdain Financing that is of a dilutive nature. Is it safe to say you're not contemplating any dilutive financing secondary offering Anything in the near future, possibly not to only be 2024?

Speaker 1

Well, I think it's safe to say that what we're doing is we're Evaluating all of the opportunities that are out there. We certainly I will tell you that Whenever we think about financing the company, our main focus is to do it in the least dilutive fashion possible. So as I mentioned, we do have cash available over the short term from Avenue Capital Facility Well, some other receivables that will be coming in, but we do a full in-depth analysis. So I don't want to say yes, I don't want to say no, but I will tell you that we do have a lot of optionality when it comes to our financing.

Speaker 5

Okay. But as of right now, you've made no decision to pursue Any secondary dilutive offerings, is that correct?

Speaker 1

Well, as of right now, we're evaluating all of Financing opportunities that we have with our partners and everything, but there's been no absolute firm decision on a capital raise.

Speaker 5

Okay. And do you have I don't mean to beat us to a dead horse, but if you do decide on that, How far off into the future would you think that would be?

Speaker 1

I haven't really thought about that at this point in time. I will tell you that we evaluate our alternatives constantly. So I don't want to commit to anything like that at this point in time.

Speaker 5

All right. It's just a concern a lot of investors have. I think I see that as the only hurdle for stopping someone to invest in your company is It's a factor. It is a factor. They don't want to invest in your company knowing that there's a secondary waiting to come To the market within a few weeks or a couple of months.

Speaker 5

It's an overhang. And if there was some assurance there was no overhang, I'm sure everybody here would be a lot more bullish. I appreciate your answer. And do you have anything to add to that or no?

Speaker 1

No. I think that's it that we're constantly evaluating all of our alternatives.

Speaker 5

Okay. But this would be probably the last one you'd want to use, I gather from what's been said so far.

Speaker 2

Let me, John, if I can and correct me if I'm wrong. Our strategy, Among other things is to develop partnerships as John had mentioned. And those partnerships obviously would bring in some money associated with them. So things like that that are not dilutive are absolutely our preference. So if you're looking, Robert, for what our preference is, It would be to close a partnership or 2, and we're working very hard on those, and then do the non dilutive and save diluted for the last option.

Speaker 2

John, would that be correct?

Speaker 1

Yes. Look, I think that I think you're trying to corner us into an answer. And what I'm telling you is that we look to, at all times, do things in the least dilutive fashion possible.

Speaker 5

Yes, I understand. And I am glad that you've got capital to last you, you said until the first or

Speaker 2

Thank you. Thanks.

Speaker 5

All right. You're welcome.

Operator

Our next question is from Len Yaffe with StockDock Partners, please proceed.

Speaker 6

Thank you very much and congrats on the Development with MidConvi and all the other success, Michael, that you've enjoyed since you took over as CEO. It's clear Financing to build out the company for all the potential applications that you have and that shouldn't be a Surprise and it should be welcome. My question is, given that you've got a study, I believe through Tufts that showed the superiority OctoJet versus drops in glaucoma, which are widely prescribed medications. Midcombi clearly seems to have benefit both in terms Heather, instead of having to be those separately and the ease of use and convenience, Could you discuss perhaps the size of the major ophthalmological markets Such as glaucoma, where there might be partnership opportunities, because I think not only would people be interested, But I would expect that the dollar size that would accrue to Eyenovia could be significant to over

Speaker 2

Thank you, Len. So if we use glaucoma as an example, There are somewhere between 3,000,000 4,000,000 glaucoma patients are actually treated with topical medications In the United States, if you look at first line therapy, it makes up about half of that, which I believe is about a 1,500,000,000 Last time I checked, any good first line branded medication in glaucoma should expect to make between $150,000,000 $300,000,000 and that's without really going crazy. Historically, they made more than that Before many of them were genericized. So there are a number of partners out there who are looking at this opportunity and saying, this is meaningful for us, Especially if we can convey all of these benefits to patients and we didn't even mention the potential benefits Of the Gen 2 to the doctors where you could track compliance of the adherence because of the electronics that are embedded in the OptoGen Gen 2. So that's what we're looking at and that's why we're interested in it.

Speaker 2

I think a good glaucoma medication And the OpRegen can bring basically the whole package that people have looked for in this market. Thanks.

Operator

Yes. Our next question is from Alex Matthews with he's a private investor. Please proceed.

Speaker 8

Yes. Thank you for taking my question and congratulations on the great achievement. I just want to find out about marketing of the product. I know I talked to my ophthalmologist and he hadn't heard about the Optigent, so how do you plan to get the word out to all the optometrists and ophthalmologists around the country?

Speaker 2

Well, thank you, Alex, and I'm glad your doctor didn't hear about it because it would mean my marketing person was Promotion ahead of what it should have been. But now that we are approved, the next step is we have to get materials approved through the FDA That takes a few weeks and then we will be reaching out to various meetings through email, through social media, go on to things like LinkedIn or Instagram, we have a presence there. We will be able to get the news out. I think also when we start placing the product Some of these very highly visible offices, they all talk to each other, all of the doctors, they will all begin To see it. So, the fact that your doctor doesn't know now, that's good.

Speaker 2

I would suspect that he or she will know 6 months from now about the product.

Speaker 8

Yes. That's wonderful. Thank you.

Speaker 2

Thank you.

Operator

We have reached the end of our question and answer session. I would like to turn the conference back over to Michael for closing comments.

Speaker 2

Thank you very much, operator, and thank all of you for joining us today. And that concludes today's call. We hope we have conveyed our excitement on our significant progress and outlook for the coming year. We have our first FDA approval in hand. And with the approval of MYCOMBI, our Microline presbyopia program is progressing and we look forward to updating you on the manufacturing progress as well as discussions with So thank you again for joining us and we look forward to our second quarter update later this year.

Speaker 2

Bye bye.

Operator

Thank you. This does conclude today's conference. You may disconnect your lines at this time and thank you for your participation.

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Earnings Conference Call
Eyenovia Q1 2023
00:00 / 00:00