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spk04: Greetings and welcome to the Idenovia fourth quarter and full year 2023 earnings call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Eric Ribner of Investor Relations. Thank you. You may begin.
spk05: Good afternoon and welcome to INOVIA's fourth quarter and full year 2023 earnings conference call and audio webcast. With me today are INOVIA's Chief Executive Officer, Michael Rowe, Chief Financial Officer, John Gandolfo, and Chief Operating Officer, Bren Kern. This afternoon, we issued a press release announcing financial results for the three and 12 months ended December 31st, 2023. We encourage everyone to read today's press release, as well as Inovia's quarterly report on Form 10-K for the year ended December 31, 2023, which was filed with the FEC. The company's press release and annual report are also available on our website at www.inovia.com. In 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 provisions of the Private Securities Litigation Reform Act. We caution listeners that during the call, Inovia'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-K. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, March 18, 2024. INOVIA 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. I know he is Chief Executive Officer. Michael, the floor is yours. Thank you, Eric.
spk09: And welcome, everyone, to our fourth quarter and full year 2023 Financial Results Conference Call. Last quarter, I talked about how FOBIA has a great leverage to pull on as we continue our growth into a development and commercial organization. Those levers were revenues, agreements, and sources of capital. Today, I will share with you how we have been executing against these three levers, particularly in terms of our advancing commercial strategy, which continues to accelerate with two approved products and two in phase three. I will also share news about us entering into two significant agreements that will complement our own sales efforts, as well as provide an update on our plans for dry ice. Bren will then take us through the build-out of our manufacturing capabilities, which are now fully integrated, and producing commercial supply of mid-combi. And finally, John will provide an update on the third lever, our financials, and the options we are exploring towards ultimately reaching a break-even point for the company. So let's dive right into it with our two FDA-approved products, Obetazol Propionate Ophthalmic Suspension 0.05%, and Midcombi. As you may recall, the U.S. commercial rights for clobetazole were acquired from Taiwan-based Formosa Pharmaceuticals last August. Just last week, we transferred the NDA for clobetazole from Formosa over to Inovia. Clobetazole was approved just two weeks ago on March 4th. This unique post-ocular surgery steroid is the first product developed using Formosa's proprietary APNT nanoparticle formulation platform. That technology reduces an active pharmaceutical ingredient's particle size with high uniformity and purity, thereby allowing penetration to relevant compartments in the eye and ultimately enhancing bioavailability. Clobetazole is a potent steroid indicated for pain and inflammation following ocular surgery. This is the first time that this molecule is available in ophthalmology. Its efficacy and safety profile is highly desirable. with nearly nine out of 10 patients achieving complete absence of post-surgical pain, and six out of 10 achieving total absence of inflammation within 15 days post-ocular surgery. Clobetazole has an advantageous dosing profile of twice a day without titration versus existing treatments which require dosing up to four times a day. This is particularly important as eye surgery patients are often on multiple drugs during recovery, So any advancement which simplifies the treatment regimen would be welcomed by eye doctors and patients alike. And in terms of safety, side effects were seen in no more than 2% of patients. And our label mentions that some of these side effects could have been the result of the surgical procedure itself. You can find additional information and full prescribing information at cobevazolbid.com. It is estimated there are more than 7 million ocular surgeries in the U.S. each year, most which are treated with topical ocular steroids and steroid combinations, currently totaling 1.3 billion in sales. This is a very significant market opportunity and one that we think we can capture a mid-single-digit market share over the next three to four years. We view clobetazole as a key addition to our commercial product portfolio. which will allow us to further leverage our existing sales force. Together with MidCombi, our Midriasis product, we believe that we can bring significant value to eye care offices and surgical centers, and we are working toward a robust commercial launch of clobetazole as soon as our partner has received their Taiwanese export license later this year. Longer term, we see a potential opportunity to develop a formulation of clobetazole for our OptiJet dispenser as a potential treatment for dry eye, a market estimated to be worth over $3.6 billion. To that end, we plan to engage with the FDA in the coming months to discuss a path forward in that indication. While probetazole is a great product for us, it is only half of our revenue story. MidCombi is the other half. As you know, MidCombi is the first and only FDA-approved fixed combination of two-pupil dilation drugs, tropicamide and phenylephrine, and the first ophthalmic spray using the OptiJet platform. When our sales force talks with customers, they highlight how our products can help bookend the surgery by using Medcombi as their midriatic agent pre-surgery and clobetazole as their steroid post-surgery. We have now hired, trained, and deployed half of our 10-person field sales force with the remainder set to come on board in the coming weeks. Also, we continue to make excellent progress satisfying state commercial licensing requirements where required, with MidCombie now licensed for sale in 16 states, representing more than half of the U.S. targeted population. We have a dozen other license applications in process. In terms of manufacturing, in November, we were very pleased to announce that our contract manufacturer, Coastline International, was approved by the FDA for MidCombie Commercial Manufacturing. We also recently announced FDA approval of our Redwood City facility as a commercial manufacturing facility. With Redwood City, Reno, and Coastline now all online, we have commenced the manufacture of commercial supply of MidCombie, and we now have finished product moving into and out of our warehouse. Bren will provide a more detailed manufacturing update in a moment. Customer feedback on MidCombie has been excellent. And to further illustrate that point, we are very pleased to announce that VisionSource, a leading network of approximately 3,000 locally owned optometry offices, has added Medcambi as an approved product for its membership. We have great expectations for this sales channel as Medcambi has particular benefits for those offices that are patient-focused and choose to incorporate Medcambi to enhance the comprehensive eye exam experience of their patients. As we like to say, These offices and doctors use MidCombie because they care for their patients. The current U.S. market for pupil dilation is valued at approximately $250 million, and we feel we are well poised to take a good portion of that market share over the coming years, especially when we move to our next generation device. Staying on the topic of MidCombie for a moment, we recently completed a study to determine if there was a lower dose that could be effective to achieve pupil dilation for drug-sensitive patients. The study was conducted by Dr. Denise Pencil of the State University of New York School of Optometry. Twenty-nine subjects were treated with a half dose of Micombi, which is eight microliters per eye. In that study, at 30 minutes post-dose, clinically relevant pupil dilation was achieved in approximately two-thirds of patients, and that percentage increased by 60 minutes. Almost all patients returned to a pupil size of less than five millimeters. between three and a half hours and six hours post-installation. This is similar to the time seen in published studies of patients exposed to tripecomide eye drops and a midriasis reversal drug. The dose was well-tolerated with minimal adverse events reported, with three subjects reporting mild installation site pain and one with mild dry eye upon installation. Given that a standard of care midriasis agent, phenylephrine, may present safety risks in a few older patients, the greater dosing flexibility enabled by Midcombe and the OptiJet could address an unmet need among the approximately 100 billion comprehensive and diabetic eye exams and over 4 million cataract surgeries performed in the US each year. We plan to publish the full results in a peer-reviewed journal later this year. As previously mentioned, we will soon have 10 sales representatives and two sales directors in the field to commercialize the combi and clobetazole. Half of this team is already trained and in place, working every day to present the benefits of our products and pull the revenue lever. Additionally, we recently announced a co-promotion agreement with NovaBay, a leading developer of anti-infective eye products. Per the terms of that agreement, NovaBay will promote clobetazole to hundreds of eye care professionals that our salespeople are not calling on, through its telephone-based sales people. They will also conduct outreach to eye doctors in those geographic areas that our sales people are not currently covering. Meanwhile, our field sales force will promote their prescription Avanova antimicrobial lid 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 additional 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. In summary, we are actively promoting McCombie and will be leveraging our new agreement with VisionSource. We are preparing to commercialize Clobetazole and will leverage our new agreement with Novavay. And we are reloading our pipeline by bringing Micropine back, through reacquiring the commercial and development rights this past January for the U.S. and Canada from Bausch and Lomb. Micropine is an investigational 8-microliter ophthalmic spray of atropine delivered by the OptiJet. Micropine is being evaluated as a potential treatment for pediatric progressive myopia or worsening near-sightness, which is characterized by elongation of the sclera and retina. We estimate that more than 25 million children in the U.S. suffer from myopia, and of these, 5 million are believed to be at high risk for progressive myopia. If left untreated, progressive myopia can ultimately lead to significant vision loss and potential blindness. Prior studies have demonstrated that atropine can slow myopia progression by as much as 60%, and there is a significant unmet need for safe and effective FDA-approved pharmaceutical treatment options. In terms of next steps, we are continuing to advance the Phase III chaperone study, and we plan to meet with the FDA to explore options to expedite development and registration of micropine in a capital-efficient manner. One option we are working on is a planned interim look at the chaperone data later this year. If that interim analysis is successful, we could potentially be looking at a substantially de-risked program that could be very attractive either for us alone or for a commercialization partner. Lastly, we're maintaining microline or aperture in our portfolio should the presbyopia market show signs of improvement. Right now, our opinion is that we can make better use of our capital elsewhere in our portfolio, but we can turn very quickly back to this product candidate if the situation should change. So this gives us line of sight to three and possibly four commercial revenue generating products. We continue to explore development of novel therapeutics levering the OptiJet for dry eye, glaucoma, and other large market indications as part of our second lever towards success. These potential partnerships are moving forward, and we anticipate sharing more information when they reach the stage of a full development agreement after all of the device compatibility work has been completed. At this point, I'd like to turn the call over to our Chief Operating Officer, Bren Kern. for our manufacturing update. Fred?
spk07: Thank you, Michael. During the fourth quarter and through early this year, we continue to execute on our strategy to maintain control of our manufacturing processes, ensuring our products meet high levels of reliability and sterility. As a reminder, we use contract manufacturers to supply us with drug substance, which we then use to fill our cartridges at our Redwood City facilities. These cartridges are then married with our electronic base units, which are manufactured at our Reno, Nevada facility. We are now fully capable of supporting our current anticipated mid-combi commercial demand, as well as the needs for ongoing micropine development in 2024. More specifically, last month, we were very pleased to receive FDA approval of our Winwood City facility with no significant concerns raised on the part of the agencies. This approval will provide Redwood City with the ability to perform final assembly, packaging, and labeling activities in support of Midcombi and complements our arena facilities and contract manufacturers. As previously announced, Coastline International also received FDA approval and is now producing Midcombi commercial supply. Redwood City will also be the manufacturing site of our GEM2 device, which has significantly fewer parts than our existing device, making its manufacturing easier and more reliable. We are targeting MIGCOMBI as the first product that will be available in Gen 2, and our Redwood City facility is actually making product to begin engineering stability studies and registration batches before the end of the year. Our strategy for moving from the Gen 1 to the Gen 2 will be the subject of an FDA meeting this summer, and assuming we come to an agreement, Demonstrating comparability between the two devices should provide a path for Inovia to introduce the Gen 2 platform into the commercial market. Our Reno facility is also producing the OptiJet ejector and base in support of MIG-COMBI and continues to expand production capabilities by refining our state-of-the-art equipment. When complete, the capabilities of this new facility will provide significant increase in injector manufacturing capacity enabling fulfillment of both our commercial and clinical product needs. As noted earlier this year, Inovia has reacquired the rights to Micropine. Micropine is an investigational 8-microliter ophthalmic spray of atropine delivered by Inovia's proprietary OptiJet device, being evaluated as a potential treatment for pediatric progressive myopia characterized by elongation of the retina. We are actively uplifting our Micropine clinical management capabilities in this regard, which we expect to be complete in mid-April of this year. With Micropine under our management, Inovia will be speaking with the FDA to discuss opportunities to accelerate the completion of the study. I continue to be excited about our recent successes and the progress we are making. We now have two FDA-approved manufacturing sites that we manage, preparing us to meet the market demands for our products. I'm looking forward to expanding on these significant achievements to be made in this year. I would now like to turn the call over to our Chief Financial Officer, John Gandolfo, to provide a financial update.
spk06: John? Thank you, Brent. For the fourth quarter of 2023, we reported net loss of approximately $8 million, or 18 cents per share, and approximately 45.4 million weighted average shares outstanding. This includes a two-cent loss related to the one-time repatriation cost for bringing micropeme back to Inovia from Bausch. This compares to a net loss of $6.1 million, or 17 cents per share, and approximately 35.9 million weighted average shares outstanding for the fourth quarter of 2022. For the full year of 2023, we reported a net loss of approximately $27.3 million, or 66 cents per share, and approximately 41 million weighted average shares outstanding. This compares to a $28 million, or 83 cents per share, and approximately 33.6 million weighted average shares outstanding for the full year 2022. Research and development expenses totaled approximately $4.1 million for the fourth quarter of 2023, and this compares to $2.2 million for the fourth quarter of 2022, an increase of 84.6%. For the full year 2023, research and development expenses decreased approximately 3% to $13 million, and this compares to $13.4 million for the full year 2022. The full year decrease was driven primarily by lower direct clinical and non-clinical expenses, as well as deferral of costs related to the future delivery of clinical supply to our licensed foreign nurse. For the fourth quarter of 2023, general and administrative expenses were approximately $3.4 million as compared to $3.2 million for the fourth quarter of 2022, an increase of 7.3%. For the full year of 2023, DNA expenses decreased approximately 8.1% to $12.4 million as compared to $13.5 million for the full year of 2022. The full-year decrease was driven by reduction in legal expenses and executive recruitment costs on a year-over-year basis. Total operating expenses for the fourth quarter of 2023 were approximately $7.5 million, as compared to $5.4 million for the same period in 2022. This represents an increase of approximately 39%. Total operating expenses for the full year 2023 decreased approximately 5.6%, $25.4 million, as compared to $26.9 million for the full year 2022. As of December 31st, 2023, companies cashed balance with approximately $14.8 million, as compared to $22.9 million as of December 31st, 2022. We are currently evaluating various structures and alternatives to increase our cash resources in order to fund our corporate strategy going forward. I'll now provide an update on our existing licensing agreement with Arctic Vision for all three of our products in China and South Korea. Regarding our prior partnership with Bausch & Lomb, as Michael mentioned earlier, we reacquired the development and commercial rights to micropene and have taken over continued execution of the ongoing Phase III chaperone trial. Our agreement with Arctic Vision covers micropene, microline, and mid-combi, and provides us sales royalties in addition to development milestones. Micropene, in particular, is a significant opportunity in China for pediatric myopia. If approved, micropene could be a potentially meaningful source of non-dilutive funding for our company over the long term. To date, our license agreements have generated approximately $16 million in license fees, and we have the potential to earn an additional $25 million in net license and development milestones from Arctic Vision over the next three to four years. If our products are approved on commercialization, Inovia is also eligible to earn significant sales royalties as well. We are 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 and additional large ophthalmic indications, beginning with dry eye. In conclusion, we are very pleased with our performance in the fourth quarter of 2023, as well as the subsequent period. To summarize our key highlights today, we reacquired the development and commercialization rights to micropene in the U.S. and Canada from Bausch & Lomb. Micropene is a phase is in phase three of the potential treatment for progressive pediatric myopia, a potential blockbuster opportunity for the company. We announced FDA approval of clobetisol for the treatment of pain and inflammation following ocular surgery. We announced two important agreements to complement our own sales efforts, one with VisionSource for Mitcambi and one with Novavay for clobetisol and Avanova. We finalized the build-out of our manufacturing capabilities to support mid-combe production with coastline manufacturing, and our Redwood City facility is now online, in addition to our facility in Reno. And finally, our licensing agreement with Arctic Vision is progressing well and remains a promising avenue for significant development of regulatory milestones, as well as the potential for sales royalties and commercialization. That concludes our prepared remarks. We would now like to turn the call over for questions. Operator?
spk04: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. And you may press star 2 if you would like to remove your question from the queue. for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star key.
spk01: One moment, please, while we pull for questions. Thank you.
spk04: Our first question comes from the line of Tim Lugo with William Blair. Please proceed with your question.
spk10: Thanks for the question. Now that Micropene has been brought back into the company and you have the rights, can you talk about this accelerating the development of the program? I know you all engaged with the agency about this possibility, but maybe I'd love to hear some initial thoughts around what you could do for this acceleration of the development.
spk09: Yes, Tim, thank you for the question. Our intent is to do a protocol amendment and put in an interim analysis later this year when we believe we would have sufficient power to detect a significant result from one of the arms of this study. And we'll be talking to the FDA about that as well because if we do that and if we are successful as a placebo-controlled study, we may be able to make the argument that it's really not ethical to continue as it is with a placebo arm if we can show that we already have a significant event. And that could shave a number of years off this study and enable us to bring it to an NDA that much faster. So the strategy is to do the interim analysis towards the end of this year. And if that is successful, to talk to the FDA about how we can close that study earlier so that we can move to an NDA.
spk10: That's very helpful. Thank you. And regarding the half-dose study, is that something that OptiJet can adjust to, or do you need to submit an SNDA to get this onto the label?
spk09: Well, to get that onto the label, we would have to submit to the FDA. That study was done to answer a very specific medical question for a specific population. So we are able to adjust to that with the OptiJet because we did want to get that answer. to see if you could go lower for this particular need.
spk10: Okay, fair enough. And for the Nova Bay co-promotion, could you, again, and maybe you had this in the comments and I missed it, but can you just kind of scope out what capabilities they're bringing to the market and Clubhead as well?
spk09: They are bringing an in-house sales force that's very experienced doing telephone sales into cataract surgeons. They do it now for their products. Avanova. So they would take that experience and do the same for Clobetazole in those areas where we do not have salespeople. So essentially they will extend our reach into those offices. And every time they're successful, they will get a percentage of that sale. And likewise, we can hand carry their product Avanova into cataract surgeons where we do have salespeople because it is part of many of their practices. And where we are successful, we get a portion of that. So, basically, it's a way to extend our promotional reach with no additional cost and the opportunity to pick up some money at the same time.
spk10: I understand.
spk02: It makes sense. Thank you. Thank you.
spk04: Our next question comes from the line of Matt Kaplan with Lettenberg Thalmann. Please proceed with your question.
spk03: Hey guys, good evening and thanks for taking the questions and congrats on the progress. Just wanted to first focus on your commercial programs. Can you help us understand the kind of potential launch trajectories for both Clobetazole and MidCombi and what we should expect, I guess, this year and going into next specifically?
spk09: Yeah, hi Matt. It's good to have your call. John, I believe that there have been analysts out there that have spoken to this. I know we haven't given guidance, but maybe you can talk to what our reaction has been to the analysts.
spk06: Yeah, so the analysts do have numbers in their model out there, and we're very comfortable with the analyst estimates that are out there for the balance of 2024. At this point, we're not going to give revenue guidance ourselves. We'll reevaluate that at the end of the year after these products have, you know, been in the market for a while. But overall, I think we're comfortable with the analyst system, et cetera, out there.
spk03: Okay, that's helpful. And maybe just to focus in on a little bit with your new, we signed agreement with VisionSource. You mentioned that there are about 3,000 offices that are associated with that. Should we expect more or additional deals or collaborations such as these kind of going forward as you continue to launch Mitcambi and Colbetazole?
spk09: Yeah, absolutely. So this is the first one that's signed. We do have others that are in the signature phase, and they're a mix. Some of them are like VisionSource. where it's for the retail optometrist. Others are with large institutions where they are looking to replace their disposable use of mid-radiation agents. What they do now is they use a bottle once and they throw it away. And it's costly to them. It's like $15 every time they do this to a patient. So they would replace that with mid-combi. And we are working right now to get some of these agreement signed where we would essentially be on their formulary replacing what they're doing now.
spk03: Great. And then just shifting to your pipeline, your second generation device, can you tell us a little bit more about that and how it differs from the first gen and when we should expect it potentially to be used with McCombie in the marketplace?
spk09: Yeah. Brad, would you like to give a high-level discussion about Gen 2?
spk07: Absolutely. So our Gen 2 product offers simplification from a manufacturing capability, enabling us to produce these more easily with a higher reliability, with MidCombi being the first platform that we're going to take that into production. We're actually actively working on our registration batches to be completed this year. And then we'll be speaking with the FDA on getting the GEN2 platform into MidCombie, hopefully early next year after we get the registration batches put up.
spk03: Okay, great. And then with respect to your dry eye program, can you tell us a little bit more about that and when we, do you expect to move that into the clinic this year?
spk09: Yeah, we actually have three things that we're working on. We have acute dry eye that we're in discussions with Formosa, Proglobetazole. We have chronic dry eye that we're actually actively collaborating with a company where we're working on taking their drug and putting it into the optiJIT and making sure it's entirely compatible. And then we have a third one that also would be in chronic, a different molecule that we're working on. What we want to do is we have collaboration agreements in place, and what's happening in that collaboration agreement is we're working out all of the CMC issues of how do we get your drug over to our facility in a sterile fashion, and how do we make sure it's compatible with our device. All of that takes anywhere between four and six months. When that's done, that leads to an option for a development agreement, and that's when we'll talk about it publicly.
spk02: Okay, great. Well, thanks again for taking our questions. Thanks, Matthew. Thank you.
spk04: Our next question comes from the line of Matthew Caulfield with HC Wainwright. Please proceed with your question.
spk08: Hey, Michael and team. Thanks for taking our question. So, with clobetazole plans for OptiJet development in dry eye, Are there any comparable advantages to ultimately utilizing OptiJet within the approved indication for post-operative pain?
spk09: Thank you, Matthew, for that question. The answer is yes. It would be a lot easier for cataracts and other post-surgical patients to use the OptiJet, in my opinion, than an eyedropper. And we could certainly go back and look at that again. What we would have to do basically is run a pain study, although only one of them, pain and inflammation, because according to the FDA, the OptiJet delivers an ophthalmic spray, which is a different form than an ophthalmic solution. So it requires a phase three study. Why that's a good thing is that it makes it impossible to replace the OptiJet with an eyedrop. So from a generic point of view, you can't simply take a molecule we put into the OptiJet and replace it with something that's in an eyedrop form. So that's a good thing. But on the other hand, it causes us a little bit more time to get something approved. So the strategy was let's get this additional indication for dry eye, which is a much bigger indication for the product, and then we can make the decision to pivot back and redo a pain and inflammation, one study, to add that on to the OptiJet and then ultimately just be on the OptiJet platform.
spk02: Understood. Very helpful.
spk08: And then with the $14.8 million in cash and equivalents through year-end 23, I don't know if I missed this, but did you give any sense of the current cash runway just for the near term?
spk06: John, would you like that? Yeah. Yeah, I'll take that. So as I mentioned in the prepared remarks, we're actually evaluating all different opportunities that we have when they raise cash. in order to fund the company's strategy going forward. The historical burn has been about four and a half to five million per quarter on an operating basis. We don't expect that to change at all. We will see some decrease in R&D expenses, some increase associated with the micropene study. So that's basically where we think the operating burn will come in for the year. We are expecting close to $2 million from Arctic Vision as well for a product development milestone going forward. So that gives you somewhat of a sense of where we see us from a cash standpoint.
spk08: That's great. Very helpful. I appreciate it, guys. And congrats on the transition to a commercialized company.
spk02: Thank you, Matthew. Appreciate it. Thanks, Matt. Thank you.
spk04: Our next question comes from the line of Kent Oliver with Brookline Capital Markets. Please proceed with your question.
spk11: Thanks. I have two questions. First, with regard to aperture, what needs to change for you to start advancing that program again?
spk09: Thank you. It's good to have you on the call and a good question. So right now, that market is pretty stable. And Vuity is selling about $14 or $15 million, maybe not even that high, per year. So to be successful in this market is going to require, in my opinion, a strong promotional effort to basically do a relaunch of this. So if I look at it, you know, if we do it, it's $1 million to do the registration batches. It's $4 million to file the NDA. So that's five, and that's without making the investment try to lift the market. And that's pretty pricey in a market right now that's doing less than $15 million. So there is already one approved product that's waiting on the sidelines, an eye drop to come in. There's another one that's in phase three. I think in the end, there may be multiple eye drop competitors in the market, but we would be the only opt to jet. So if one or two of them come in and they're able to resurrect this market, We are entirely comfortable with letting someone else do that and coming in with what we perceive as the better product, better for patients and better for the doctors as well, and coming in after they do the heavy lifting. So we'll be happy to take our money and use it elsewhere and then wait and know that we can pivot to this at any time.
spk11: Is this something you would partner out possibly?
spk09: We would. And we certainly could be talking with people, but I don't think at the moment there's a tremendous amount of interest in the market. So, again, I think there's a lot of the big players are waiting by the side to see what happens as well.
spk11: Great. Thank you. And the second question is on Clobetasol and with your market share guidance. just to take the other side of the thought process. So you have a product with superior dosing. What's the gating factor with the uptake given that advantage?
spk09: So if you look at the glaucoma market as a surrogate, because it's very similar, you basically have 80% or 85% of the units are actually sold are generics. And then you have a small group of branded products that make up 15% of the units, but they make up about 50% of the value. So it would be very similar in the steroid market. There's one other brand that's in there that I think does about $35 million a year, and it's been out there maybe two years. So we would be coming in to that. So we do have the better product, but we're always going to be up against people who will want to go with the generic option, and this is why we are pricing our product basically at the same as a generic copay so that the economics do not become an issue when using us. And we're going to see what happens over the next two years by doing this strategy of what we call value pricing. And if it takes off the way we suspect after talking with customers, then I would be very happy to come back here a year or two from now and say, you know, that number is much higher than I thought.
spk11: And have you started speaking with payers?
spk09: Do you have any progress to report yet? We're doing the entire thing cash. We're working with an e-pharmacy as well as getting the wholesale licenses because about 85% of ophthalmic surgeons sell the steroid right out of their office. And so the way we're doing this is as a wholesaler, we'll be supplying the physician offices And for individual patients, they'll be using an e-pharmacy, one they're very familiar with, and the entire thing is cash. Again, the same as a branded co-pay. So there's no insurance issues. There's no callbacks. There's none of the things that are both timely and costly for the physicians.
spk02: Great. Thank you. Thank you.
spk04: Thank you. We have reached the end of our question and answer session. And with that, I would like to turn the floor back over to Michael Rowe for closing comments.
spk09: Thank you. And thank all of you for joining us today. And that concludes today's call. We are very pleased with our progress to date. And we are very well positioned to continue our current momentum as our long-term commercial plan and strategy continues to emerge. So thank you again for joining us, and we look forward to talking again with you for our first quarter update in the spring.
spk01: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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