NASDAQ:EYEN Eyenovia Q1 2024 Earnings Report $1.09 -0.04 (-3.54%) Closing price 04/25/2025 04:00 PM EasternExtended Trading$1.10 +0.01 (+1.38%) As of 04/25/2025 06:27 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Eyenovia EPS ResultsActual EPS-$14.40Consensus EPS -$14.40Beat/MissMet ExpectationsOne Year Ago EPSN/AEyenovia Revenue ResultsActual Revenue$0.01 millionExpected Revenue$1.23 millionBeat/MissMissed by -$1.22 millionYoY Revenue GrowthN/AEyenovia Announcement DetailsQuarterQ1 2024Date5/15/2024TimeN/AConference Call DateWednesday, May 15, 2024Conference Call Time4:30PM ETUpcoming EarningsEyenovia's Q4 2024 earnings is scheduled for Wednesday, May 21, 2025Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Eyenovia Q1 2024 Earnings Call TranscriptProvided by QuartrMay 15, 2024 ShareLink copied to clipboard.There are 8 speakers on the call. Operator00:00:00Good afternoon, ladies and gentlemen, and welcome to the Eyenovia First Quarter 2024 Earnings Conference Call. At this time, all lines are in listen only mode. Following the presentation, we will conduct a question and answer session. This call is being recorded. I would now like to turn the conference over to Mr. Operator00:00:27Eric Ribner of Investor Relations. Please go ahead. Speaker 100:00:33Good afternoon, and welcome to Eyenovia's Q1 2024 earnings conference call and audio webcast. With me today are Eyenovia's Chief Executive Officer, Michael Roe Chief Financial Officer, John Gandolfo and Chief Operating Officer, Brent Kern. This afternoon, we issued a press release announcing financial results for the 3 months ended March 31, 2024. We encourage everyone to read today's press release as well as Eyenovia's quarterly report on Form 10Q for the quarter March 31, 2024, which will be filed with the SEC tomorrow. The company's press release is available on our website at inovia.com. Speaker 100:01:14In addition, this conference call is being webcast to the company's website and will be archived there for future reference. Please note that on today's call, we will be discussing products, product concepts and 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 provision of the Private Securities Litigation Reform Act. We caution listeners that during the call, Eyenovia's management will make 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. Speaker 100:01:50These forward looking statements are subject to a number of risks, which are described in more detail on our annual report on Form 10 ks. The conference call contains time sensitive information that is accurate only as of the date of this live broadcast, May 16, 2020 4. 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 required by the applicable securities law. With that said, I'd like to turn the call over to Michael Rowe, Innovia's Chief Executive Officer. Speaker 200:02:25Michael? Thank you, Eric, and welcome everyone to our Q1 2024 financial results conference call. During the Q1, we took several meaningful steps to strengthen the inherent value of our company, which currently includes our novel OptoJet dispensing technology, 2 FDA approved products, Midcombi and clobetasol and a third, MicroPine in late Phase 3 development. Together these products address a U. S. Speaker 200:02:53Market worth more than $3,300,000,000 annually. By being able to address a broad range of patient needs with a portfolio of novel technologies and products, we believe we are building a solid foundation upon which to drive accelerating sales growth in 2025 and beyond. Our main focus is on the successful commercialization of Bikombe and clobetasol and the expedited development of MicroPine. We are in the process of establishing a solid foundation for our portfolio with a second FDA approved product to be launched by our sales force in the next few months and a potential blockbuster MicroPine Speaker 300:03:30in the Speaker 200:03:31next couple of years. At the same time, our finance and business development teams are diligently executing on an overall strategy to ensure that Eyenovia is well positioned for success beyond the immediate near term and through these challenging times in the capital markets for small cap life sciences companies. Now let's take some time to provide an update on our MicroPine program, which is our Phase 3 candidate for progressive myopia. Pediatric progressive myopia has been called an epidemic in the United States and China, where we have licensed the rights to MicroPine to our partner, Arctic Vision. In the U. Speaker 200:04:08S. Alone, approximately 5,000,000 children are at higher risk of losing functional vision due to this disease, in which the eye elongates and can result in separation of the retinal tissues from the back of the eye. 3rd party sources have estimated the value of this market, which currently has no FDA approved drug treatment options at $1,800,000,000 annually with a similar opportunity in China. The present standard of care involves glasses and contact lenses, which can reduce progression, but does not stop it. And these are often not appropriate or well tolerated by the youngest children who are most at risk. Speaker 200:04:46And this is where MicroPine can make a significant difference addressing this unmet medical need. As a reminder, MicroPine is our investigational 8 microliter ophthalmic spray of atropine delivered by the OptoGen currently being evaluated as a potential treatment for pediatric progressive myopia in the CHAPRONE study. If the results of this study are positive, the FDA has agreed that this single 4 year evaluation could be sufficient for an NDA filing and approval. This is based upon several prior atropine studies in children in Asia, which demonstrated efficacy in slowing myopia progression by as much as 60%. MicroPine may also offer benefits far beyond what would be obtained with an eye drop. Speaker 200:05:30For the OptoGen technology, children in our clinical study as young as 6 years old are dosing themselves every evening without parental involvement. They can do this because the OptoGen doesn't require any head tilting or manipulation of eyedropper bottles and makes aiming easier with a built in mirror so that children can see exactly where they are spraying. The side effects of atropine, which have overwhelmingly been mild and transient in our study, have been consistent with what we have come to expect with our advanced device. In its commercial form, we plan to have MicroPine equipped with our OptiCare system, which can notify patients and their parents when to administer their spray dose as well as communicate important compliance and adherence information for the treating physician. We are continuing to advance the Phase 3 CHAPRONE study and our clinical team is exploring a potential protocol amendment that could greatly expedite the study timelines and registration of MicroPOD. Speaker 200:06:29This protocol amendment would include a plan limited review of the CHAPRONE data by an independent data safety monitoring committee later in Q4 of this year, when approximately 2 thirds of chaperone patients will have reached the study efficacy endpoint. If recommended by the committee, we could potentially be looking at a substantially de risk program, enabling a potential NDA submission as soon as late 2025 or early 2026. As you can imagine, we believe program would then be a very attractive opportunity for commercialization by us or a larger partner. We are eager to reach that milestone as MicroPine if approved would anchor our commercial portfolio and perfectly complement both midcombi and clobetasol, providing significant value to eye doctors, patients and payers by addressing a broad spectrum of unmet needs. Now let's talk about clobetasol for pionate, a ophthalmic suspension of 0.05%, the U. Speaker 200:07:26S. Rights to which we acquired from Taiwan based Formosa Pharmaceuticals last August. Fobenasol was approved by the FDA on March 4th and in rapid succession, the New Drug Application or NDA was transferred to us from Formosa. There have been no new ophthalmic steroids approved in the U. S. Speaker 200:07:44In over 15 years. The last one was Durasol MyAlcon, which for many years was selling well over $100,000,000 annually. Gobenasol addresses many of the unmet needs for an ophthalmic steroid with a highly differentiated clinical and pharmacologic profile, including twice a day dosing and from a safety standpoint, fewer than 1% of patients experiencing sudden eye pressure increases that may be more common with other steroids. Intraocular inflammation and eye pressure spikes are the 2 main safety issues that eye surgeons want to avoid and are paying particular attention to as they can lead to significant clinical consequences, complications and non reimbursable costs to the providers. We believe that clobetasol has the potential to become the leading option in the post surgical space. Speaker 200:08:34Unlike conventional steroid drugs, clobetasol was developed using a breakthrough innovation in ophthalmic formulation and active ingredient development. This unique post ocular surgery steroid is the first product developed using Formosys proprietary APNT nanoparticle formulation platform, which reduces an active pharmaceutical ingredients particle size with high uniformity and purity, thereby allowing penetration to relevant compartments in the eye and ultimately enhancing bioavailability. The nanotechnology is so effective that it essentially makes the suspension act like a solution. In fact, patients don't even have to shake the product prior to use. And this is just one of the unique elements of our approved label. Speaker 200:09:17And while this might not seem like a big deal, it does point to the difference between clobetasol and other ophthalmic steroids. Clobetasol's efficacy and previously discussed safety profile is another point of differentiation. In clinical studies, nearly 9 out of 10 patients achieved complete absence of postsurgical pain and 6 out of 10 achieved complete absence of inflammation within 15 days post ocular surgery and the incidence of all side effects was below 2%. Moreover, twice a day dosing without titration is a benefit all patients can understand, especially versus other treatments, which require dosing up to 4 times a day. This is particularly important as eye surgery patients are often on multiple drugs during recovery. Speaker 200:10:03So any advancement which simplifies the treatment regimen would be welcomed by eye doctors and patients alike. It is estimated that there are more than 7,000,000 ocular surgeries in the U. S. Each year with topical ocular steroids and steroid combinations currently totaling $1,300,000,000 in sales. So this is a very significant market opportunity for us and one that we think we can capture a mid single digit market share over the next 3 to 4 years. Speaker 200:10:31We continue to prepare for robust commercial launch of clobetasol later this summer. And longer term, we see a potential opportunity to develop a formulation of clobetasol for our OptoGen dispenser as a treatment for acute dry eye. To that end, we plan to engage with the FDA in the coming months to discuss a path forward in that indication. Lastly, some of you have asked me about the brand name for clobebasol. That trade name is currently being reviewed by the FDA and we expect the decision from the agency later in June for our launch. Speaker 200:11:04Staying on the topic of dry eye for a moment, in late February, we entered into a collaboration agreement with SGN Nanopharma, an innovation led clinical stage nanopharmaceutical company focusing on creating impactful best in class nanotherapeutics targeting large unmet medical needs. SGN's proprietary platform, the MNP platform allows for the distribution of an active pharmaceutical ingredient into 3 or more phases, thereby improving its bioavailability, biodistribution and pharmacokinetics. For the terms of the agreement, Eyenovia will conduct feasibility and process manufacturing testing with SGN's Phase 3 ready ophthalmic cyclosporin formulation, SGN-one hundred and one, in combination with the Gen 2 OptoGen device as a potential treatment for chronic dry eye. Dry eye is a very significant market opportunity with some external sources valuing it at $3,600,000,000 annually in the U. S. Speaker 200:12:03A combination of a faster working cyclosporin and the OptoJet could be a powerful addition into this large and underserved market. For the SGN collaboration, we may have a Phase 3 ready asset next year in chronic dry eye. As part of our collaboration, SGN will seek independent funding towards advancing the development of this candidate. I'll now provide an update on Midkomib, 1st and only FDA approved fixed combination of 2 popular pupil dilation drugs, tropicamide and phenylephrine, and the 1st approved ophthalmic spray using the OptoGen platform. We are midway through the hiring and training of our 12 person sales and we have satisfied state licensing requirements in states covering over 2 thirds of the U. Speaker 200:12:48S. Population for the distribution strategy to reach offices in those states where we do not yet have a license. The sales force has been out for 5 weeks now since their training and are making inroads into this market. The sales process requires demonstrating and training the office staff on the use of MINCOBI, which is not difficult, but it's important to make sure that these offices have a great initial experience and realize all of the benefits of the technology. To date, they have trained and converted about 50 offices, many of whom you'll see in our social media stream as they talk about their experience with the product. Speaker 200:13:23We have also partnered with these offices in a waiting room promotional campaign showing how they use Midkombe because they care about their patients. And we plan on collecting market research information from these same offices so that they can bolster their own practice satisfaction scores. There are a number of reasons why offices and institutions like the University of California and premier buying groups like Vision Source have turned to Midkombe. With Midkombe, the dilation process is neither since the spray amount is a fraction of what's in an eye drop. It's comfortable with virtually no stinging reported in clinical studies. Speaker 200:14:00It's hygienic with no protruding tips that could accidentally touch one patient and then another when using the same bottle and it works reliably and quickly. To further demonstrate the potential benefits of BENCBI, we recently completed a Phase 4 study to characterize the lowest effective dose to achieve mydriasis. For certain eye care patients, the current standard of care mydriasis eye drops could present safety and tolerability risks, including potential systemic cardiovascular side effects in older patients, particularly those with high blood pressure. In this Phase 4 study, 29 subjects were treated with a half dose of BENCABI or 8 microliters per eye. We won't recap all of the positive results again, but 2 thirds of subjects achieved clinically relevant pupil dilation within 30 minutes post dose and 83% achieved relevant pupil dilation at 60 minutes post dose. Speaker 200:14:52Importantly, the lower dose of BINGCOMBI was safe and well tolerated with only 3 subjects reporting mild instillation site pain and one with mild dry eye upon instillation. And interestingly enough, most patients return to a functional pupil size as soon as 3.5 hours after the drug was used. The duration of pupil dilation is sometimes an issue for patients, especially those that may need to get back to work. So this finding should help eye doctors determine what might be best for an individual patient. Turning now to our overall sales and marketing initiatives. Speaker 200:15:28To complement the efforts of our sales team, we entered into a co promotion agreement with NovaBay Pharmaceuticals to cross promote clobetasol to hundreds of eye care professionals through its telephone based sales force. At the same time, our field sales force will promote their prescription, Avenova Antimicrobial Live and Lash Solution to our doctors who can include this product in their suite of pre and post surgical offerings. In addition to the benefit of the promotion and potential sales for both sides, each party will also get a percentage of the sales that they generate. This is an extremely cost effective way to boost our commercial sales reach and we believe this agreement will be very beneficial to both parties. This agreement with NovaBay complements our recent announcement with VisionSource that VisionSource has added Midkombe as an approved product for its membership of more than 3,000 locally owned optometry offices. Speaker 200:16:22So while our own sales force is targeted, this agreement allows us to significantly expand our commercial reach, particularly in more rural areas where we may not be providing direct sales coverage currently. We are already seeing sales have been coming to VisionSource member offices. Before turning the call over to Bren to provide a manufacturing update, I will conclude with a recap of recent national ophthalmology medical meetings that we participated in. The first was the American Society of Cataract or Refractive Surgery Annual Meeting or ASCRS in Boston. During ASCRS, we featured our entire suite of commercial products, midcombi, clobetasol and abanova. Speaker 200:17:03Both our sales and medical affairs teams were present to demonstrate the products, review data, answer questions and provide attendees with the opportunity to purchase these products on-site. We also attended Vision Source Exchange in Orlando. Vision Source Exchange is the country's largest gathering of private practice optometrists with more than 1,000 of the most successful ODs in the nation. The event featured continuing education, keynote speakers, exchange only pricing for more than 100 vendors and opportunities to network with colleagues. We were on hand to demonstrate and sell MidConvy there as well. Speaker 200:17:36And just recently, we delivered a presentation at the Association For Research in Vision and Ophthalmology 20 24 Annual Meeting or ARVO. The presentation detailed results from a study demonstrating that Formosus APNT technology, on which the development of Clobenzol was based, improves the solubility and bioavailability of topical ophthalmic medications. APNT, much like our OptoGen dispenser, represents an exciting new ophthalmic technology and we are thrilled to feature both in our product portfolio. Our presence at national medical and commercial meetings like these are key to raising awareness of the breadth of our product portfolio and are a critical component of our commercialization strategy. We plan to attend more such meetings later this year. Speaker 200:18:21At this point, I'd like to turn the call over to our Chief Operating Officer, Bren Curran, for our manufacturing update. Bren? Speaker 300:18:30Thank you, Michael. As previously mentioned by Michael, with our sales staff continuing their training, we're experiencing an uptick in midcombi sales orders. Our operations team is working closely with our commercial team to ensure that our growing customer base is being provided with best in class customer service. Enabled by the procurement of state licensing covering 2 thirds of the U. S. Speaker 300:18:51Population, our Redwood City facility serves as our primary distribution center for Mid County. Redwood City is supported by manufacturing, engineering, supply chain, quality and regulatory professionals, all of whom are laser focused on order fulfillment, recognize their integral role in Cutter's customer satisfaction and are fueled by the excitement of providing clinical practices across the country with our groundbreaking technology. Manufacturing operations have been performing to expectations and supply of MidCombi remains sufficient to fulfill current sales demand. In addition to distributing midcombi, Redwood City will also be leveraged as the initial distribution hub for clobetasol. Our operations team is actively optimizing distribution processes in preparation of product receipts. Speaker 300:19:37Formosa Pharmaceuticals has initiated the manufacture of clobetasol and is on schedule for delivery and our subsequent shipment later this summer. These preparatory activities are currently progressing as planned. Our facility in Reno was in part selected to support the future distribution of Eyenovia products as it contains warehousing infrastructure conducive to the proper storage and handling of drug products. The Reno operations team also comprised of manufacturing, engineering, supply chain and quality are actively installing and validating systems similar to those in Redwood City, but at a larger scale. When complete, this increased storage capacity will be complementary to Redwood City and provides us with the flexibility to handle future fulfillment needs. Speaker 300:20:21To this end, we are also establishing internal logistics capabilities, allowing the transportation of materials between the two locations, unbridled by large commercial shipping companies. Eyenovia is also progressing with plans to introduce Gen 2 into the commercial market. Our Redwood City facility, which houses state of the art cleanrooms and aseptic fill and finish operations, is currently preparing for the production of registration batches required for future SMDA submission. These preparations include marked improvements aimed at increasing performance and efficiencies. Our engineering team is also hard at work planning, testing, refining and generating documentation to support the Gen 2 platform. Speaker 300:21:02These activities bear significant similarities to our GEN-one platform and our FDA inspection successes with GEN-one combined with an ever increasing technological knowledge base suggest the successes with GEN-one will be replicated for GEN-two. Further to the expansion of our capacity, the Rita facility has optimized our new ejector manufacturing process, culminating and executing process validation builds. The product generated during this build is being prepared for performance testing and feasibility test results suggest the product should perform as expected. I classify these achievements as impressive. Nacombe has entered into the commercial market and is being well received, demonstrating the Optijet platform is capable and both the technology and our processes are able to fulfill the rigorous standards established by regulatory bodies in scale. Speaker 300:21:52I would now like to turn the call over to our Chief Financial Officer, John Gandolfo to provide a financial update. John? Speaker 400:22:01Thanks, Brent. For the Q1 of 2024, we reported net loss of approximately $10,900,000 or $0.23 per share on approximately 46,600,000 weighted average shares outstanding. This includes a $0.05 loss related to the $2,500,000 of costs for bringing MicroPine back to Eyenovia. 1st quarter 2024 net loss compares to a net loss of $5,700,000 or $0.15 per share and approximately 37,400,000 weighted average shares outstanding for the Q1 of 2023. Research and development expenses totaled approximately $4,400,000 for the Q1 of 2024 and this compares to $2,500,000 for the Q1 of 2023, an increase of 75.7%. Speaker 400:22:55For the Q1 of 2024, G and A expenses were approximately $3,800,000 as compared to $2,900,000 for the Q1 of 2023, an increase of 30.6%. Total operating expenses for the Q1 of 2024 were approximately $10,300,000 including the previously mentioned $2,500,000 in repatriation costs for bringing MicroPine back to Eyenovia. This compares to $5,500,000 for the same period in 2023 and represents an increase of approximately 88%. Our Q1 2024 operating expense figure also included approximately $1,500,000 of non cash expenses. At March 31, 2024, we reported unrestricted cash of approximately $8,000,000 and this does not include the $2,200,000 of additional capital the company raised in April of 2024. Speaker 400:23:58We have reduced our planned spending by approximately $800,000 per quarter compared to the Q1 of 2024 cash based operating expense levels, and we're focusing our resources on validating GEN-two device with the FDA, commercializing Midcombi and clobetasol and the completion of the MicroPine chaperone study. We are also exploring several options and structures to ensure we have sufficient capital to support these programs and continue to execute on that growth strategy. I'll now provide an update on our existing licensing programs with Arctic Vision, which covers all three of our products in China and South Korea, MicroPine, MicroLine and Rapisture and Midcombi, and provides us sales royalties in addition to development milestones. MicroPine in particular has significant opportunity in China for pediatric myopia. If approved, MicroPine could be a potentially meaningful source of non dilutive funding for our company over the long term. Speaker 400:25:01To date, our license agreements have generated approximately $16,000,000 in license fees, and we have the potential to earn additional $25,000,000 in non dilutive net license and development milestones from Arctic Vision over the next 3 to 4 years. If our products are approved upon commercialization, we also are eligible to earn significant sales royalties as well. We are also continuing to assess potential pipeline expansion opportunities similar to our Formosa agreement, And we will continue to leverage the Optijet technology to address unmet needs in additional large ophthalmic indications beginning with dry eye. As Michael indicated earlier, we believe the steps that we have taken to date to create a solid foundation upon which we will drive meaningful sales growth in 2025 and beyond. In conclusion, we are very pleased with our performance in the Q1 of 2024. Speaker 400:25:58And to summarize our key highlights today, we announced FDA approval of clobetasol for the treatment of pain and inflammation following ocular surgery. We reacquired the development and commercial rights to MicroPine for the U. S. And Canada. We entered into a co promotion agreement with NovaBay Pharmaceuticals, whereby NovaBay will market clobetasol through its U. Speaker 400:26:21S. Physician dispense channel. The agreement also gives us access to their prescription Avenova antimicrobial lid and lash solution. We announced that our 2nd manufacturing facility in Redwood City, California has been approved by the FDA as commercial manufacturing facility. We participated in 3 important national ophthalmology medical meetings ASCRS, VisionSource Exchange and ARVO, which provides excellent platforms for us to demonstrate our commercial products and educate doctors on their use. Speaker 400:26:56And finally, our licensing agreement with Arctic Vision is progressing well and remains a promising avenue for significant development and regulatory milestones as well as the potential for sales royalties in the future. That concludes our prepared remarks. We would like to now open the call to questions. Operator? Operator00:27:17Thank We have a question from Matt Kaplan from Ladenburg. Please go ahead. Speaker 500:27:50Hey guys, thanks for taking the question and congrats on the progress during the quarter. Just can you talk a little Speaker 600:27:57bit more Speaker 500:27:57about the transition that you're planning to the Gen 2 device and for your portfolio of products and what you think it will take to get the thumbs up from FDA for that device? Speaker 200:28:12Yes. Hi, Matthew, and thank you for calling in. There's basically 2 things we need to do. The first is we have to demonstrate that the Gen 2 acts like the Gen 1 in terms of performance, how much drug it delivers, how it delivers the drug and so on. And Brendan's team is deep in doing that. Speaker 200:28:32The second thing that we believe the FDA is going to ask for is a very small bridging study that we can essentially do in 3 days, just to give them the additional knowledge that when people actually use this in real life, they get the same result. And like I said, that's literally a 3 day study that could be done while we're manufacturing Gen 2 supply. So at this point, our plan is we've already submitted for the FDA meeting. We will likely have that meeting in mid July. Assuming that goes as we believe it will, we will make the Gen 2 supply shortly thereafter. Speaker 200:29:11While that supply is up for stability, which is 12 months, we will complete small bridging study. And then basically, we take all that information and file an sNDA, which I believe has a 6 month turnaround to it. So that by the end of next year, we may be ready to go into the market with the Gen 2. But the good news is that I believe we've got all the boxes checked and I'm feeling very confident that we're going to be able to do this and it's not going to be anything that's going to be difficult for us. Brent, did I miss anything? Speaker 300:29:48No, Michael, I believe that you see it as a company. Thank you. Speaker 500:29:52Thank you. That's great. And then just a second question on MicroPine. You plan to meet with the FDA soon. When do you think you'll have that squared away in terms of the protocol amendment and be able to do that analysis in the Q4? Speaker 200:30:09Right. Well, my clinical and regulatory team tells me that we can do the protocol amendment without meeting with the FDA because we're putting into place a data monitoring committee. So we at Eyenovia do not actually see the results. And so the DMC would then look at Speaker 600:30:25the data Speaker 200:30:26probably in mid October and basically they come out of that meeting with a thumbs up that everything looks great. Or for example, in the very rare case that nothing's happening, there'll be a thumbs down to tell us that. But basically, they give us the indication of whether or not there's something there. Now from looking at the mask data, my team certainly thinks there's a very, very good signal and that's why we're optimistic about this. And the DMC would then confirm that. Speaker 200:30:54And then once they do confirm that, that's when we meet with the FDA. And we say, look, this is what we have. This is what the DMC said. We have the statistical power at this point. This is why we would like to stop the study and go right into the analysis. Speaker 200:31:08So that would probably happen if the DMC meets in October, it would be 1 or 2 months after that. Speaker 500:31:15Okay. Okay, that makes sense. Great, great. Thanks for taking the questions. Speaker 400:31:21Thank you, Matt. Operator00:31:24Our next question comes from the line of Matthew Coffield from H. C. Wainwright. Please go ahead. Speaker 600:31:33Thank you. Yes. Hi, Michael and team. Thanks for taking our questions and exciting to see the new commercial opportunities here in the near term. So actually for thank you. Speaker 600:31:44So for OptoJet development in presbyopia with Aperture, I believe it's Oresis Pharma that's planning their Pillocarpine launch for first half twenty twenty four. And I was curious what you'd want to see just in the near term kind of what you'd like to see from that from the overall presbyopia market to have Aperture be more of a top strategic priority? Then I just had one follow-up on the Gen 2 device. Speaker 200:32:09Great, Matthew. Thank you. It's a great question. So right now, I believe Unity, which is the only product approved in the market is selling somewhere between $15,000,000 $18,000,000 a year, which obviously was underperforming what everybody had hoped for. So if Aurisys or anybody can go out there and we start seeing a market that starts to grow and gets to $50,000,000 or $100,000,000 that would obviously be very attractive to us. Speaker 200:32:37There's 2 things going on here. One is that people are looking at the efficacy and side effect of these products. But the other thing is also people like the OptoJet. So the eye drops that are going to be out there will likely all the vast majority of potential the vast majority of potential users, they just like the device for all sorts of reasons. It's neat, it doesn't mess up makeup, it's discreet, it's socially acceptable, lots of reasons to use that. Speaker 200:33:12But to go into this market right now and to spend $20,000,000 or $30,000,000 doesn't make sense to me, not in a market of this size. So we are very comfortable with letting other people go in there, spend the resources, build this up to a point where we can say, okay, great, we've done a great job with the eye drops. We can come in with something completely different, completely differentiated that we know people like and you've done the heavy lifting before us. So that's what we'll be looking for. Speaker 600:33:41Very helpful. And I think that definitely makes sense strategically. Speaker 400:33:45So Speaker 600:33:45then just one question on the Gen 2 device. So for the Gen 2 OptoJet, can you remind us if that focuses squarely on the pediatric myopia program? Or is there any chance that the Gen 2 device could be relevant for the current midcombi mydriasis approval? Speaker 200:34:03So Gen 2 ultimately will be our only platform. The reason that we're doing it first, yes, 1st in mid Kabi is because that's our only approved product. So we have to we have to measure it and validate it against an approved product, which is Midkabi. But what it does, Matt, is by doing it against Midkombe, all of the stuff we have to do with performance testing and validation, it's basically identical for all the other programs. So we basically have the recipe that the FDA has accepted so that when we get to the other products, the other one being MicroPine, we just follow the same recipe. Speaker 600:34:40Got you. Understood. Speaker 200:34:42Thank you very much guys and congrats again. Thank you. Operator00:34:49Our next question comes from the line of Kempe D'oliver from Brookline Capital Markets. Please go ahead. Speaker 700:34:59Thanks and good evening. First is, how should we think about the runway situation given the reductions in spending and other adaptations Speaker 200:35:15to your plan? John, do you want to take that? Speaker 400:35:19Sure. So way we're looking at it is that we feel our current cash plus reimbursement from our partners for Gen 2 product development expenses as well as the launch of clobetasol at a 60% gross margin gives us cash resources that are sufficient that we get that data readout on MicroPine, which Michael mentioned is towards the latter part of Q4 of 2024. In addition, as I mentioned in our prepared remarks, we're exploring various options and structures to ensure that we have enough capital and support past that point. So, yes, I think that's probably the best way to look at it. In terms of the reduced cash spending that we put in place, I think that was just down business principle that we felt like we should reduce wherever we could. Speaker 400:36:13One final comment with respect to our cash based expenses is that a large amount of our expenses are project based. So if needed, we could defer some of that spending on some of those longer term projects. Now we don't believe that that's necessary or and we haven't planned for it, but it is important to note that we do have flexibility with our spending going forward too. Speaker 200:36:39Thank you. I would also add to that in my comments about SGN, for example, that we are getting partners now that when they come in, they basically also come in with the funding to do the development rather than us having to come up with that. So that opportunity with that advanced quick acting cyclosporin for dry eye, SGN is doing a great job in raising that money so that we can do our work, which is the sweat work to get it done, but they're going to be able to bring much of that cash in. Speaker 700:37:14Great. Thank you. And with regard to Gen 2, are we still dependent upon Gen 2 to get a cost of goods structure that will help you achieve profitability? Speaker 200:37:30John? Speaker 400:37:30Yes, exactly. So to give Speaker 500:37:33you an Speaker 400:37:33idea, one of the main reasons why we look for FDA approval of MYCOMI with GEN-1 is we wanted to go through the regulatory process and get approval with the product, which had never been done before. And our focus was always going to be to develop a commercial product, which is Gen 2, which you stated, at a much more efficient cost of goods sold. So to give you an example, the cost of goods sold on the Gen 2 delivery system is probably about 20% of the cost of goods sold of the Gen 1 system. So it makes all of our programs generate gross margins between at the low end probably 60% to 70% and at the high end with MicroPine north of 90%. So that is going to be the key driver that gets the company to profitability. Speaker 700:38:35Okay, great. And how is, we're mostly doing with getting the export approval worked out? Speaker 200:38:45It's funny you asked that. So the Taiwanese FDA was in there doing their inspections. They're now waiting for their final report. I've been told by my partners in Taiwan that you can't push them too hard. So we don't do that. Speaker 200:39:00But in the meantime, we have labeling ready. We have all the other preparations ready and we're doing everything we can. So the minute they get that permit, they can drop the pallets off at the airport and send them over to us. Right now, we're counting on that happening somewhere in early to mid July, so that our plan is we want to be on the street by August 1. Operator00:39:35There are no further questions at this time. I would now like to hand the call over to Mr. Michael Rowe. Please go ahead. Speaker 200:39:43Thank you, operator. And thanks to everybody on the call today and through the development of Eyenovia. Our company now has 2 FDA approved products, both very differentiated and well positioned in the eye care space. Our platform technology in the OptoJet is going to be presented to the FDA this summer in its most technologically advanced form and we look forward to rolling it out next year. And MicroPine, a potential blockbuster in the very underserved pediatric progressive myopia market is well positioned to substantially derisked later this year. Speaker 200:40:16I encourage everyone to keep up to date with our progress on Eyenovia.com or through our social media links. This concludes our call and we look forward to talking with you again in August. Thank you. Operator00:40:29Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallEyenovia Q1 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Eyenovia Earnings HeadlinesEyenovia provides development update on Optejet UFDApril 11, 2025 | markets.businessinsider.comEyenovia Provides Development Update on Optejet User Filled Device (UFD)April 10, 2025 | globenewswire.comTrump Treasure April 19Thanks to President Trump… A $900 investment across5 specific cryptos… Could gain 12,000% so quickly that, just 12 months later…April 27, 2025 | Paradigm Press (Ad)Eyenovia enters non-binding LOI to effect reverse merger with BetaliqMarch 21, 2025 | markets.businessinsider.comEyenovia Shares Drop 14% Amid Betaliq Merger TalksMarch 21, 2025 | finance.yahoo.comEyenovia Plans All-Stock Reverse Merger With BetaliqMarch 20, 2025 | marketwatch.comSee More Eyenovia Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Eyenovia? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Eyenovia and other key companies, straight to your email. Email Address About EyenoviaEyenovia (NASDAQ:EYEN), an ophthalmic technology company, engages in the development of therapeutics based on its proprietary microdose array print platform technology. The company's product candidates include MicroPine, which is in Phase III clinical development program with indications for pediatric myopia progression (near-sightedness); MicroLine, which is in Phase III clinical development program with indications for the improvement in near vision in people with presbyopia; and Mydcombi, which is in Phase III clinical development program with indications for pharmaceutical mydriasis. It has a license agreement with Bausch Health Ireland Limited to develop and commercialize MicroPine in the United States and Canada; a license agreement with Arctic Vision (Hong Kong) Limited to develop and commercialize MicroPine, MicroLine, and Mydcombi in China and South Korea; and Senju Pharmaceutical Co., Ltd. to develop and commercialize MicroPine, MicroLine, and Mydcombi. The company was formerly known as PGP Holdings V, Inc. and changed its name to Eyenovia, Inc. in May 2014. Eyenovia, Inc. was incorporated in 2014 and is based in New York, New York.View Eyenovia ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Markets Think Robinhood Earnings Could Send the Stock UpIs the Floor in for Lam Research After Bullish Earnings?Market Anticipation Builds: Joby Stock Climbs Ahead of EarningsIs Intuitive Surgical a Buy After Volatile Reaction to Earnings?Seismic Shift at Intel: Massive Layoffs Precede Crucial EarningsRocket Lab Lands New Contract, Builds Momentum Ahead of EarningsAmazon's Earnings Could Fuel a Rapid Breakout Upcoming Earnings Cadence Design Systems (4/28/2025)Welltower (4/28/2025)Waste Management (4/28/2025)AstraZeneca (4/29/2025)Mondelez International (4/29/2025)PayPal (4/29/2025)Starbucks (4/29/2025)DoorDash (4/29/2025)Honeywell International (4/29/2025)Regeneron Pharmaceuticals (4/29/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 8 speakers on the call. Operator00:00:00Good afternoon, ladies and gentlemen, and welcome to the Eyenovia First Quarter 2024 Earnings Conference Call. At this time, all lines are in listen only mode. Following the presentation, we will conduct a question and answer session. This call is being recorded. I would now like to turn the conference over to Mr. Operator00:00:27Eric Ribner of Investor Relations. Please go ahead. Speaker 100:00:33Good afternoon, and welcome to Eyenovia's Q1 2024 earnings conference call and audio webcast. With me today are Eyenovia's Chief Executive Officer, Michael Roe Chief Financial Officer, John Gandolfo and Chief Operating Officer, Brent Kern. This afternoon, we issued a press release announcing financial results for the 3 months ended March 31, 2024. We encourage everyone to read today's press release as well as Eyenovia's quarterly report on Form 10Q for the quarter March 31, 2024, which will be filed with the SEC tomorrow. The company's press release is available on our website at inovia.com. Speaker 100:01:14In addition, this conference call is being webcast to the company's website and will be archived there for future reference. Please note that on today's call, we will be discussing products, product concepts and 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 provision of the Private Securities Litigation Reform Act. We caution listeners that during the call, Eyenovia's management will make 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. Speaker 100:01:50These forward looking statements are subject to a number of risks, which are described in more detail on our annual report on Form 10 ks. The conference call contains time sensitive information that is accurate only as of the date of this live broadcast, May 16, 2020 4. 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 required by the applicable securities law. With that said, I'd like to turn the call over to Michael Rowe, Innovia's Chief Executive Officer. Speaker 200:02:25Michael? Thank you, Eric, and welcome everyone to our Q1 2024 financial results conference call. During the Q1, we took several meaningful steps to strengthen the inherent value of our company, which currently includes our novel OptoJet dispensing technology, 2 FDA approved products, Midcombi and clobetasol and a third, MicroPine in late Phase 3 development. Together these products address a U. S. Speaker 200:02:53Market worth more than $3,300,000,000 annually. By being able to address a broad range of patient needs with a portfolio of novel technologies and products, we believe we are building a solid foundation upon which to drive accelerating sales growth in 2025 and beyond. Our main focus is on the successful commercialization of Bikombe and clobetasol and the expedited development of MicroPine. We are in the process of establishing a solid foundation for our portfolio with a second FDA approved product to be launched by our sales force in the next few months and a potential blockbuster MicroPine Speaker 300:03:30in the Speaker 200:03:31next couple of years. At the same time, our finance and business development teams are diligently executing on an overall strategy to ensure that Eyenovia is well positioned for success beyond the immediate near term and through these challenging times in the capital markets for small cap life sciences companies. Now let's take some time to provide an update on our MicroPine program, which is our Phase 3 candidate for progressive myopia. Pediatric progressive myopia has been called an epidemic in the United States and China, where we have licensed the rights to MicroPine to our partner, Arctic Vision. In the U. Speaker 200:04:08S. Alone, approximately 5,000,000 children are at higher risk of losing functional vision due to this disease, in which the eye elongates and can result in separation of the retinal tissues from the back of the eye. 3rd party sources have estimated the value of this market, which currently has no FDA approved drug treatment options at $1,800,000,000 annually with a similar opportunity in China. The present standard of care involves glasses and contact lenses, which can reduce progression, but does not stop it. And these are often not appropriate or well tolerated by the youngest children who are most at risk. Speaker 200:04:46And this is where MicroPine can make a significant difference addressing this unmet medical need. As a reminder, MicroPine is our investigational 8 microliter ophthalmic spray of atropine delivered by the OptoGen currently being evaluated as a potential treatment for pediatric progressive myopia in the CHAPRONE study. If the results of this study are positive, the FDA has agreed that this single 4 year evaluation could be sufficient for an NDA filing and approval. This is based upon several prior atropine studies in children in Asia, which demonstrated efficacy in slowing myopia progression by as much as 60%. MicroPine may also offer benefits far beyond what would be obtained with an eye drop. Speaker 200:05:30For the OptoGen technology, children in our clinical study as young as 6 years old are dosing themselves every evening without parental involvement. They can do this because the OptoGen doesn't require any head tilting or manipulation of eyedropper bottles and makes aiming easier with a built in mirror so that children can see exactly where they are spraying. The side effects of atropine, which have overwhelmingly been mild and transient in our study, have been consistent with what we have come to expect with our advanced device. In its commercial form, we plan to have MicroPine equipped with our OptiCare system, which can notify patients and their parents when to administer their spray dose as well as communicate important compliance and adherence information for the treating physician. We are continuing to advance the Phase 3 CHAPRONE study and our clinical team is exploring a potential protocol amendment that could greatly expedite the study timelines and registration of MicroPOD. Speaker 200:06:29This protocol amendment would include a plan limited review of the CHAPRONE data by an independent data safety monitoring committee later in Q4 of this year, when approximately 2 thirds of chaperone patients will have reached the study efficacy endpoint. If recommended by the committee, we could potentially be looking at a substantially de risk program, enabling a potential NDA submission as soon as late 2025 or early 2026. As you can imagine, we believe program would then be a very attractive opportunity for commercialization by us or a larger partner. We are eager to reach that milestone as MicroPine if approved would anchor our commercial portfolio and perfectly complement both midcombi and clobetasol, providing significant value to eye doctors, patients and payers by addressing a broad spectrum of unmet needs. Now let's talk about clobetasol for pionate, a ophthalmic suspension of 0.05%, the U. Speaker 200:07:26S. Rights to which we acquired from Taiwan based Formosa Pharmaceuticals last August. Fobenasol was approved by the FDA on March 4th and in rapid succession, the New Drug Application or NDA was transferred to us from Formosa. There have been no new ophthalmic steroids approved in the U. S. Speaker 200:07:44In over 15 years. The last one was Durasol MyAlcon, which for many years was selling well over $100,000,000 annually. Gobenasol addresses many of the unmet needs for an ophthalmic steroid with a highly differentiated clinical and pharmacologic profile, including twice a day dosing and from a safety standpoint, fewer than 1% of patients experiencing sudden eye pressure increases that may be more common with other steroids. Intraocular inflammation and eye pressure spikes are the 2 main safety issues that eye surgeons want to avoid and are paying particular attention to as they can lead to significant clinical consequences, complications and non reimbursable costs to the providers. We believe that clobetasol has the potential to become the leading option in the post surgical space. Speaker 200:08:34Unlike conventional steroid drugs, clobetasol was developed using a breakthrough innovation in ophthalmic formulation and active ingredient development. This unique post ocular surgery steroid is the first product developed using Formosys proprietary APNT nanoparticle formulation platform, which reduces an active pharmaceutical ingredients particle size with high uniformity and purity, thereby allowing penetration to relevant compartments in the eye and ultimately enhancing bioavailability. The nanotechnology is so effective that it essentially makes the suspension act like a solution. In fact, patients don't even have to shake the product prior to use. And this is just one of the unique elements of our approved label. Speaker 200:09:17And while this might not seem like a big deal, it does point to the difference between clobetasol and other ophthalmic steroids. Clobetasol's efficacy and previously discussed safety profile is another point of differentiation. In clinical studies, nearly 9 out of 10 patients achieved complete absence of postsurgical pain and 6 out of 10 achieved complete absence of inflammation within 15 days post ocular surgery and the incidence of all side effects was below 2%. Moreover, twice a day dosing without titration is a benefit all patients can understand, especially versus other treatments, which require dosing up to 4 times a day. This is particularly important as eye surgery patients are often on multiple drugs during recovery. Speaker 200:10:03So any advancement which simplifies the treatment regimen would be welcomed by eye doctors and patients alike. It is estimated that there are more than 7,000,000 ocular surgeries in the U. S. Each year with topical ocular steroids and steroid combinations currently totaling $1,300,000,000 in sales. So this is a very significant market opportunity for us and one that we think we can capture a mid single digit market share over the next 3 to 4 years. Speaker 200:10:31We continue to prepare for robust commercial launch of clobetasol later this summer. And longer term, we see a potential opportunity to develop a formulation of clobetasol for our OptoGen dispenser as a treatment for acute dry eye. To that end, we plan to engage with the FDA in the coming months to discuss a path forward in that indication. Lastly, some of you have asked me about the brand name for clobebasol. That trade name is currently being reviewed by the FDA and we expect the decision from the agency later in June for our launch. Speaker 200:11:04Staying on the topic of dry eye for a moment, in late February, we entered into a collaboration agreement with SGN Nanopharma, an innovation led clinical stage nanopharmaceutical company focusing on creating impactful best in class nanotherapeutics targeting large unmet medical needs. SGN's proprietary platform, the MNP platform allows for the distribution of an active pharmaceutical ingredient into 3 or more phases, thereby improving its bioavailability, biodistribution and pharmacokinetics. For the terms of the agreement, Eyenovia will conduct feasibility and process manufacturing testing with SGN's Phase 3 ready ophthalmic cyclosporin formulation, SGN-one hundred and one, in combination with the Gen 2 OptoGen device as a potential treatment for chronic dry eye. Dry eye is a very significant market opportunity with some external sources valuing it at $3,600,000,000 annually in the U. S. Speaker 200:12:03A combination of a faster working cyclosporin and the OptoJet could be a powerful addition into this large and underserved market. For the SGN collaboration, we may have a Phase 3 ready asset next year in chronic dry eye. As part of our collaboration, SGN will seek independent funding towards advancing the development of this candidate. I'll now provide an update on Midkomib, 1st and only FDA approved fixed combination of 2 popular pupil dilation drugs, tropicamide and phenylephrine, and the 1st approved ophthalmic spray using the OptoGen platform. We are midway through the hiring and training of our 12 person sales and we have satisfied state licensing requirements in states covering over 2 thirds of the U. Speaker 200:12:48S. Population for the distribution strategy to reach offices in those states where we do not yet have a license. The sales force has been out for 5 weeks now since their training and are making inroads into this market. The sales process requires demonstrating and training the office staff on the use of MINCOBI, which is not difficult, but it's important to make sure that these offices have a great initial experience and realize all of the benefits of the technology. To date, they have trained and converted about 50 offices, many of whom you'll see in our social media stream as they talk about their experience with the product. Speaker 200:13:23We have also partnered with these offices in a waiting room promotional campaign showing how they use Midkombe because they care about their patients. And we plan on collecting market research information from these same offices so that they can bolster their own practice satisfaction scores. There are a number of reasons why offices and institutions like the University of California and premier buying groups like Vision Source have turned to Midkombe. With Midkombe, the dilation process is neither since the spray amount is a fraction of what's in an eye drop. It's comfortable with virtually no stinging reported in clinical studies. Speaker 200:14:00It's hygienic with no protruding tips that could accidentally touch one patient and then another when using the same bottle and it works reliably and quickly. To further demonstrate the potential benefits of BENCBI, we recently completed a Phase 4 study to characterize the lowest effective dose to achieve mydriasis. For certain eye care patients, the current standard of care mydriasis eye drops could present safety and tolerability risks, including potential systemic cardiovascular side effects in older patients, particularly those with high blood pressure. In this Phase 4 study, 29 subjects were treated with a half dose of BENCABI or 8 microliters per eye. We won't recap all of the positive results again, but 2 thirds of subjects achieved clinically relevant pupil dilation within 30 minutes post dose and 83% achieved relevant pupil dilation at 60 minutes post dose. Speaker 200:14:52Importantly, the lower dose of BINGCOMBI was safe and well tolerated with only 3 subjects reporting mild instillation site pain and one with mild dry eye upon instillation. And interestingly enough, most patients return to a functional pupil size as soon as 3.5 hours after the drug was used. The duration of pupil dilation is sometimes an issue for patients, especially those that may need to get back to work. So this finding should help eye doctors determine what might be best for an individual patient. Turning now to our overall sales and marketing initiatives. Speaker 200:15:28To complement the efforts of our sales team, we entered into a co promotion agreement with NovaBay Pharmaceuticals to cross promote clobetasol to hundreds of eye care professionals through its telephone based sales force. At the same time, our field sales force will promote their prescription, Avenova Antimicrobial Live and Lash Solution to our doctors who can include this product in their suite of pre and post surgical offerings. In addition to the benefit of the promotion and potential sales for both sides, each party will also get a percentage of the sales that they generate. This is an extremely cost effective way to boost our commercial sales reach and we believe this agreement will be very beneficial to both parties. This agreement with NovaBay complements our recent announcement with VisionSource that VisionSource has added Midkombe as an approved product for its membership of more than 3,000 locally owned optometry offices. Speaker 200:16:22So while our own sales force is targeted, this agreement allows us to significantly expand our commercial reach, particularly in more rural areas where we may not be providing direct sales coverage currently. We are already seeing sales have been coming to VisionSource member offices. Before turning the call over to Bren to provide a manufacturing update, I will conclude with a recap of recent national ophthalmology medical meetings that we participated in. The first was the American Society of Cataract or Refractive Surgery Annual Meeting or ASCRS in Boston. During ASCRS, we featured our entire suite of commercial products, midcombi, clobetasol and abanova. Speaker 200:17:03Both our sales and medical affairs teams were present to demonstrate the products, review data, answer questions and provide attendees with the opportunity to purchase these products on-site. We also attended Vision Source Exchange in Orlando. Vision Source Exchange is the country's largest gathering of private practice optometrists with more than 1,000 of the most successful ODs in the nation. The event featured continuing education, keynote speakers, exchange only pricing for more than 100 vendors and opportunities to network with colleagues. We were on hand to demonstrate and sell MidConvy there as well. Speaker 200:17:36And just recently, we delivered a presentation at the Association For Research in Vision and Ophthalmology 20 24 Annual Meeting or ARVO. The presentation detailed results from a study demonstrating that Formosus APNT technology, on which the development of Clobenzol was based, improves the solubility and bioavailability of topical ophthalmic medications. APNT, much like our OptoGen dispenser, represents an exciting new ophthalmic technology and we are thrilled to feature both in our product portfolio. Our presence at national medical and commercial meetings like these are key to raising awareness of the breadth of our product portfolio and are a critical component of our commercialization strategy. We plan to attend more such meetings later this year. Speaker 200:18:21At this point, I'd like to turn the call over to our Chief Operating Officer, Bren Curran, for our manufacturing update. Bren? Speaker 300:18:30Thank you, Michael. As previously mentioned by Michael, with our sales staff continuing their training, we're experiencing an uptick in midcombi sales orders. Our operations team is working closely with our commercial team to ensure that our growing customer base is being provided with best in class customer service. Enabled by the procurement of state licensing covering 2 thirds of the U. S. Speaker 300:18:51Population, our Redwood City facility serves as our primary distribution center for Mid County. Redwood City is supported by manufacturing, engineering, supply chain, quality and regulatory professionals, all of whom are laser focused on order fulfillment, recognize their integral role in Cutter's customer satisfaction and are fueled by the excitement of providing clinical practices across the country with our groundbreaking technology. Manufacturing operations have been performing to expectations and supply of MidCombi remains sufficient to fulfill current sales demand. In addition to distributing midcombi, Redwood City will also be leveraged as the initial distribution hub for clobetasol. Our operations team is actively optimizing distribution processes in preparation of product receipts. Speaker 300:19:37Formosa Pharmaceuticals has initiated the manufacture of clobetasol and is on schedule for delivery and our subsequent shipment later this summer. These preparatory activities are currently progressing as planned. Our facility in Reno was in part selected to support the future distribution of Eyenovia products as it contains warehousing infrastructure conducive to the proper storage and handling of drug products. The Reno operations team also comprised of manufacturing, engineering, supply chain and quality are actively installing and validating systems similar to those in Redwood City, but at a larger scale. When complete, this increased storage capacity will be complementary to Redwood City and provides us with the flexibility to handle future fulfillment needs. Speaker 300:20:21To this end, we are also establishing internal logistics capabilities, allowing the transportation of materials between the two locations, unbridled by large commercial shipping companies. Eyenovia is also progressing with plans to introduce Gen 2 into the commercial market. Our Redwood City facility, which houses state of the art cleanrooms and aseptic fill and finish operations, is currently preparing for the production of registration batches required for future SMDA submission. These preparations include marked improvements aimed at increasing performance and efficiencies. Our engineering team is also hard at work planning, testing, refining and generating documentation to support the Gen 2 platform. Speaker 300:21:02These activities bear significant similarities to our GEN-one platform and our FDA inspection successes with GEN-one combined with an ever increasing technological knowledge base suggest the successes with GEN-one will be replicated for GEN-two. Further to the expansion of our capacity, the Rita facility has optimized our new ejector manufacturing process, culminating and executing process validation builds. The product generated during this build is being prepared for performance testing and feasibility test results suggest the product should perform as expected. I classify these achievements as impressive. Nacombe has entered into the commercial market and is being well received, demonstrating the Optijet platform is capable and both the technology and our processes are able to fulfill the rigorous standards established by regulatory bodies in scale. Speaker 300:21:52I would now like to turn the call over to our Chief Financial Officer, John Gandolfo to provide a financial update. John? Speaker 400:22:01Thanks, Brent. For the Q1 of 2024, we reported net loss of approximately $10,900,000 or $0.23 per share on approximately 46,600,000 weighted average shares outstanding. This includes a $0.05 loss related to the $2,500,000 of costs for bringing MicroPine back to Eyenovia. 1st quarter 2024 net loss compares to a net loss of $5,700,000 or $0.15 per share and approximately 37,400,000 weighted average shares outstanding for the Q1 of 2023. Research and development expenses totaled approximately $4,400,000 for the Q1 of 2024 and this compares to $2,500,000 for the Q1 of 2023, an increase of 75.7%. Speaker 400:22:55For the Q1 of 2024, G and A expenses were approximately $3,800,000 as compared to $2,900,000 for the Q1 of 2023, an increase of 30.6%. Total operating expenses for the Q1 of 2024 were approximately $10,300,000 including the previously mentioned $2,500,000 in repatriation costs for bringing MicroPine back to Eyenovia. This compares to $5,500,000 for the same period in 2023 and represents an increase of approximately 88%. Our Q1 2024 operating expense figure also included approximately $1,500,000 of non cash expenses. At March 31, 2024, we reported unrestricted cash of approximately $8,000,000 and this does not include the $2,200,000 of additional capital the company raised in April of 2024. Speaker 400:23:58We have reduced our planned spending by approximately $800,000 per quarter compared to the Q1 of 2024 cash based operating expense levels, and we're focusing our resources on validating GEN-two device with the FDA, commercializing Midcombi and clobetasol and the completion of the MicroPine chaperone study. We are also exploring several options and structures to ensure we have sufficient capital to support these programs and continue to execute on that growth strategy. I'll now provide an update on our existing licensing programs with Arctic Vision, which covers all three of our products in China and South Korea, MicroPine, MicroLine and Rapisture and Midcombi, and provides us sales royalties in addition to development milestones. MicroPine in particular has significant opportunity in China for pediatric myopia. If approved, MicroPine could be a potentially meaningful source of non dilutive funding for our company over the long term. Speaker 400:25:01To date, our license agreements have generated approximately $16,000,000 in license fees, and we have the potential to earn additional $25,000,000 in non dilutive net license and development milestones from Arctic Vision over the next 3 to 4 years. If our products are approved upon commercialization, we also are eligible to earn significant sales royalties as well. We are also continuing to assess potential pipeline expansion opportunities similar to our Formosa agreement, And we will continue to leverage the Optijet technology to address unmet needs in additional large ophthalmic indications beginning with dry eye. As Michael indicated earlier, we believe the steps that we have taken to date to create a solid foundation upon which we will drive meaningful sales growth in 2025 and beyond. In conclusion, we are very pleased with our performance in the Q1 of 2024. Speaker 400:25:58And to summarize our key highlights today, we announced FDA approval of clobetasol for the treatment of pain and inflammation following ocular surgery. We reacquired the development and commercial rights to MicroPine for the U. S. And Canada. We entered into a co promotion agreement with NovaBay Pharmaceuticals, whereby NovaBay will market clobetasol through its U. Speaker 400:26:21S. Physician dispense channel. The agreement also gives us access to their prescription Avenova antimicrobial lid and lash solution. We announced that our 2nd manufacturing facility in Redwood City, California has been approved by the FDA as commercial manufacturing facility. We participated in 3 important national ophthalmology medical meetings ASCRS, VisionSource Exchange and ARVO, which provides excellent platforms for us to demonstrate our commercial products and educate doctors on their use. Speaker 400:26:56And finally, our licensing agreement with Arctic Vision is progressing well and remains a promising avenue for significant development and regulatory milestones as well as the potential for sales royalties in the future. That concludes our prepared remarks. We would like to now open the call to questions. Operator? Operator00:27:17Thank We have a question from Matt Kaplan from Ladenburg. Please go ahead. Speaker 500:27:50Hey guys, thanks for taking the question and congrats on the progress during the quarter. Just can you talk a little Speaker 600:27:57bit more Speaker 500:27:57about the transition that you're planning to the Gen 2 device and for your portfolio of products and what you think it will take to get the thumbs up from FDA for that device? Speaker 200:28:12Yes. Hi, Matthew, and thank you for calling in. There's basically 2 things we need to do. The first is we have to demonstrate that the Gen 2 acts like the Gen 1 in terms of performance, how much drug it delivers, how it delivers the drug and so on. And Brendan's team is deep in doing that. Speaker 200:28:32The second thing that we believe the FDA is going to ask for is a very small bridging study that we can essentially do in 3 days, just to give them the additional knowledge that when people actually use this in real life, they get the same result. And like I said, that's literally a 3 day study that could be done while we're manufacturing Gen 2 supply. So at this point, our plan is we've already submitted for the FDA meeting. We will likely have that meeting in mid July. Assuming that goes as we believe it will, we will make the Gen 2 supply shortly thereafter. Speaker 200:29:11While that supply is up for stability, which is 12 months, we will complete small bridging study. And then basically, we take all that information and file an sNDA, which I believe has a 6 month turnaround to it. So that by the end of next year, we may be ready to go into the market with the Gen 2. But the good news is that I believe we've got all the boxes checked and I'm feeling very confident that we're going to be able to do this and it's not going to be anything that's going to be difficult for us. Brent, did I miss anything? Speaker 300:29:48No, Michael, I believe that you see it as a company. Thank you. Speaker 500:29:52Thank you. That's great. And then just a second question on MicroPine. You plan to meet with the FDA soon. When do you think you'll have that squared away in terms of the protocol amendment and be able to do that analysis in the Q4? Speaker 200:30:09Right. Well, my clinical and regulatory team tells me that we can do the protocol amendment without meeting with the FDA because we're putting into place a data monitoring committee. So we at Eyenovia do not actually see the results. And so the DMC would then look at Speaker 600:30:25the data Speaker 200:30:26probably in mid October and basically they come out of that meeting with a thumbs up that everything looks great. Or for example, in the very rare case that nothing's happening, there'll be a thumbs down to tell us that. But basically, they give us the indication of whether or not there's something there. Now from looking at the mask data, my team certainly thinks there's a very, very good signal and that's why we're optimistic about this. And the DMC would then confirm that. Speaker 200:30:54And then once they do confirm that, that's when we meet with the FDA. And we say, look, this is what we have. This is what the DMC said. We have the statistical power at this point. This is why we would like to stop the study and go right into the analysis. Speaker 200:31:08So that would probably happen if the DMC meets in October, it would be 1 or 2 months after that. Speaker 500:31:15Okay. Okay, that makes sense. Great, great. Thanks for taking the questions. Speaker 400:31:21Thank you, Matt. Operator00:31:24Our next question comes from the line of Matthew Coffield from H. C. Wainwright. Please go ahead. Speaker 600:31:33Thank you. Yes. Hi, Michael and team. Thanks for taking our questions and exciting to see the new commercial opportunities here in the near term. So actually for thank you. Speaker 600:31:44So for OptoJet development in presbyopia with Aperture, I believe it's Oresis Pharma that's planning their Pillocarpine launch for first half twenty twenty four. And I was curious what you'd want to see just in the near term kind of what you'd like to see from that from the overall presbyopia market to have Aperture be more of a top strategic priority? Then I just had one follow-up on the Gen 2 device. Speaker 200:32:09Great, Matthew. Thank you. It's a great question. So right now, I believe Unity, which is the only product approved in the market is selling somewhere between $15,000,000 $18,000,000 a year, which obviously was underperforming what everybody had hoped for. So if Aurisys or anybody can go out there and we start seeing a market that starts to grow and gets to $50,000,000 or $100,000,000 that would obviously be very attractive to us. Speaker 200:32:37There's 2 things going on here. One is that people are looking at the efficacy and side effect of these products. But the other thing is also people like the OptoJet. So the eye drops that are going to be out there will likely all the vast majority of potential the vast majority of potential users, they just like the device for all sorts of reasons. It's neat, it doesn't mess up makeup, it's discreet, it's socially acceptable, lots of reasons to use that. Speaker 200:33:12But to go into this market right now and to spend $20,000,000 or $30,000,000 doesn't make sense to me, not in a market of this size. So we are very comfortable with letting other people go in there, spend the resources, build this up to a point where we can say, okay, great, we've done a great job with the eye drops. We can come in with something completely different, completely differentiated that we know people like and you've done the heavy lifting before us. So that's what we'll be looking for. Speaker 600:33:41Very helpful. And I think that definitely makes sense strategically. Speaker 400:33:45So Speaker 600:33:45then just one question on the Gen 2 device. So for the Gen 2 OptoJet, can you remind us if that focuses squarely on the pediatric myopia program? Or is there any chance that the Gen 2 device could be relevant for the current midcombi mydriasis approval? Speaker 200:34:03So Gen 2 ultimately will be our only platform. The reason that we're doing it first, yes, 1st in mid Kabi is because that's our only approved product. So we have to we have to measure it and validate it against an approved product, which is Midkabi. But what it does, Matt, is by doing it against Midkombe, all of the stuff we have to do with performance testing and validation, it's basically identical for all the other programs. So we basically have the recipe that the FDA has accepted so that when we get to the other products, the other one being MicroPine, we just follow the same recipe. Speaker 600:34:40Got you. Understood. Speaker 200:34:42Thank you very much guys and congrats again. Thank you. Operator00:34:49Our next question comes from the line of Kempe D'oliver from Brookline Capital Markets. Please go ahead. Speaker 700:34:59Thanks and good evening. First is, how should we think about the runway situation given the reductions in spending and other adaptations Speaker 200:35:15to your plan? John, do you want to take that? Speaker 400:35:19Sure. So way we're looking at it is that we feel our current cash plus reimbursement from our partners for Gen 2 product development expenses as well as the launch of clobetasol at a 60% gross margin gives us cash resources that are sufficient that we get that data readout on MicroPine, which Michael mentioned is towards the latter part of Q4 of 2024. In addition, as I mentioned in our prepared remarks, we're exploring various options and structures to ensure that we have enough capital and support past that point. So, yes, I think that's probably the best way to look at it. In terms of the reduced cash spending that we put in place, I think that was just down business principle that we felt like we should reduce wherever we could. Speaker 400:36:13One final comment with respect to our cash based expenses is that a large amount of our expenses are project based. So if needed, we could defer some of that spending on some of those longer term projects. Now we don't believe that that's necessary or and we haven't planned for it, but it is important to note that we do have flexibility with our spending going forward too. Speaker 200:36:39Thank you. I would also add to that in my comments about SGN, for example, that we are getting partners now that when they come in, they basically also come in with the funding to do the development rather than us having to come up with that. So that opportunity with that advanced quick acting cyclosporin for dry eye, SGN is doing a great job in raising that money so that we can do our work, which is the sweat work to get it done, but they're going to be able to bring much of that cash in. Speaker 700:37:14Great. Thank you. And with regard to Gen 2, are we still dependent upon Gen 2 to get a cost of goods structure that will help you achieve profitability? Speaker 200:37:30John? Speaker 400:37:30Yes, exactly. So to give Speaker 500:37:33you an Speaker 400:37:33idea, one of the main reasons why we look for FDA approval of MYCOMI with GEN-1 is we wanted to go through the regulatory process and get approval with the product, which had never been done before. And our focus was always going to be to develop a commercial product, which is Gen 2, which you stated, at a much more efficient cost of goods sold. So to give you an example, the cost of goods sold on the Gen 2 delivery system is probably about 20% of the cost of goods sold of the Gen 1 system. So it makes all of our programs generate gross margins between at the low end probably 60% to 70% and at the high end with MicroPine north of 90%. So that is going to be the key driver that gets the company to profitability. Speaker 700:38:35Okay, great. And how is, we're mostly doing with getting the export approval worked out? Speaker 200:38:45It's funny you asked that. So the Taiwanese FDA was in there doing their inspections. They're now waiting for their final report. I've been told by my partners in Taiwan that you can't push them too hard. So we don't do that. Speaker 200:39:00But in the meantime, we have labeling ready. We have all the other preparations ready and we're doing everything we can. So the minute they get that permit, they can drop the pallets off at the airport and send them over to us. Right now, we're counting on that happening somewhere in early to mid July, so that our plan is we want to be on the street by August 1. Operator00:39:35There are no further questions at this time. I would now like to hand the call over to Mr. Michael Rowe. Please go ahead. Speaker 200:39:43Thank you, operator. And thanks to everybody on the call today and through the development of Eyenovia. Our company now has 2 FDA approved products, both very differentiated and well positioned in the eye care space. Our platform technology in the OptoJet is going to be presented to the FDA this summer in its most technologically advanced form and we look forward to rolling it out next year. And MicroPine, a potential blockbuster in the very underserved pediatric progressive myopia market is well positioned to substantially derisked later this year. Speaker 200:40:16I encourage everyone to keep up to date with our progress on Eyenovia.com or through our social media links. This concludes our call and we look forward to talking with you again in August. Thank you. Operator00:40:29Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.Read morePowered by