Eyenovia, Inc.

Good day ladies and gentlemen and welcome to IMovia's third quarter of 2023 earnings conference call. At this time all participants are in listen only mode. A question and answer session will follow the formal presentation. As a reminder this conference is being recorded. I will now turn the call over to Glenn Garment. Please go ahead sir.

Thank you, Judith. Good afternoon and welcome everybody to Inovia's third quarter 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 months ended September 30th, 2023. We encourage everybody to read today's press release, as well as Inovia's quarterly report on Form 10-Q for the quarter ended September 30th, 2023, which will be filed with the SEC tomorrow, November 14th, and our most recently filed Form 10-K. 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 product, 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, 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 10k this conference call contains time sensitive information that is accurate only as of the date of this live broadcast november 13 2023. 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. And with that said, I'd like to turn the call over to Mike Rowe, Inovia's chief executive officer. Michael.

Thank you, Glenn, and welcome everyone to our third quarter 2023 financial results conference call. Inovia had a highly productive third quarter, both in terms of tangible results, as well as setting the stage for our future success. I'm excited to share our progress and plans this afternoon. as we prepare for our targeted launch of Midcombi, the potential approval and launch of AP13007, and future partnerships in glaucoma and dry eye to leverage and monetize the OptiJet technology beyond our own development programs. Let's start with our commercial preparations for the Midcombi launch. For those of you who might not be familiar with Midcombi, it's the first and only FDA-approved fixed combination of two popular pupil dilation drugs, and the first electromechanical spray platform using the OptiJet. Earlier this month, we were thrilled to announce that our contract manufacturer, Coastline International, was approved by the FDA for Midcombi commercial manufacturing. Production has already begun at Coastline, and we expect to receive finished product into our warehouse in January 2024. In addition to manufacturing Midcombi, We are also continuing to prepare the market and raise awareness about the product and the OptiJet technology. Last week, we sponsored a course during the International Joint Commission on Allied Health Personnel and Ophthalmology's 51st Annual Continuing Education Program. The course was offered to ophthalmic technicians and provided hands-on experience with our OptiJet dispensing technology and the use of MidCombi. We also had a significant exhibition booth at the American Academy of Ophthalmology and collected many leads and product requests from doctors who believe that technology addresses a significant unmet need in their practice. Last month, we presented data at the American Academy of Optometry annual meeting, demonstrating the optogen's ability to maintain sterility even when exposed to a high microbial load. This presentation was particularly timely given all the recent news about contaminated over-the-counter eye drops being pulled off the shelves of major drugstore chains and retailers due to the risk of serious eye infection and even blindness. In conditions that far exceed the microbial load that the OptiJet would be exposed to in actual daily use, the device demonstrated its ability to maintain product sterility. We are now in the process of validating the OptiJet's ability to deliver topical medication without preservatives for an extended period of time. Our activities at these professional meetings have been a great avenue to continue socializing MidCombie to ophthalmologists, optometrists, and technicians, and positions us well for a broader commercial launch of MidCombie early next year. The current US market for pupil dilation is valued at approximately $250 million, and we feel we are poised to take a good portion of that market share over the coming years especially when we move to our next-generation device. More information, including ordering instructions and customer reaction to this unique product, will appear shortly on midcombi.com. In 2024, we not only anticipate Midcombi generating revenue for us, but we are looking forward to the potential FDA approval of APP 13007 in early March 2024. We recently announced an agreement with Formosa Pharmaceuticals to acquire the exclusive U.S. rights to distribute and sell APP13007 or clobetazole-prypionate ophthalmic solution. APP13007 is a potent steroid with a highly desirable safety and efficacy profile. It is currently under FDA review for post-ocular surgery inflammation and pain. Unlike almost all alternatives, this product is intended to be dosed twice daily without titration, which is significantly more convenient than the four times a day dosing regimens with titration for existing treatments. There are approximately 7 million ocular surgeries annually, and almost all of these procedures utilize topical steroids during the recovery process. This is potentially a significant market for us, and we expect to leverage our planned 10-person sales force for both MidCombie and APP13007 and add significant value to optometry and ophthalmology offices and surgical centers. In addition to providing near-term revenue, APP13007 has the potential for additional indications in the OptiJet, including DryEye, a multi-billion dollar market opportunity. Following the potential approval for the post-surgical indication on March 4th of next year, we look forward to working with Formosa and the FDA to determine the most efficient path forward for this new product. We continue to explore additional partnering opportunities that we believe will benefit our company and our shareholders, specifically in glaucoma and dry eye, and we will provide you with updates on these developments when appropriate. I'll provide a brief regulatory update now. We have always believed that the OptiJet, due to its ergonomic design that eliminates the need for head tilting and handling small eyedropper bottles, would be easier to use in many populations than currently available topical options. In our own market research that we shared with you in the past, consumers and patients reported using eye drops was among the most difficult ways to use medication that they experienced. With that in mind, we recently held a successful meeting with the FDA to ask how we might demonstrate this benefit. We confirmed with the agency that there was a path forward to include language in our labeling that covers patients who have difficulty or cannot reliably use eye drops as long as we provide evidence of a clinical benefit, either in efficacy or safety, of the OptiJet product compared to the eye drop product. We believe such labeling would not only help prescribers select our future products in classes such as glaucoma or dry eye, but this difference could lead to better formulary coverage for OptiJet products as they would be the only products to provide an option for patients who have a challenging time with eye drops. Now turning to Apersure, our proprietary topical on-demand pilocarpine-based therapeutic candidate that we are developing for the temporary improvement in near vision associated with presbyopia. Apersure is being designed with our more advanced Gen 2 OptiJet device, which has been optimized for in-home use. These will be manufactured in our Redwood City facility, which is currently prioritizing manufacturing the Gen 2 device to supply our partners Bausch & Lomb and Arctic Vision with product for use in their pediatric myopia studies at the beginning of 2024. As a reminder, we are paid by our partners for reducing the supply, and that income helps cover a portion of our overhead for that facility. Because of this, we have moved the manufacture of registration batches for aperture into the first quarter of 2024. We do not believe this change will materially impact the eventual timing of the Appisher launch as the market for topical presbyopia treatments continues to evolve and mature as evidenced by the performance to date of the only presbyopia eye drop currently on the market. Finally, for a corporate update, we are pleased to announce the appointment of Mr. Michael Geltziler to our board of directors as an independent director and chair of our audit committee. Mike comes to us with more than 35 years of senior financial leadership experience, including as former Chief Financial Officer of ADT Corporation, New York Stock Exchange Euronext, Reader's Digest Association, and AC Nielsen. Mike previously served on the boards of Cypress Creek Renewables and the Euronext Supervisory Board, and is currently a board member for Madison Square Boys and Girls Club and the University of Delaware. We are excited to have Mike on board and look forward to his guidance and insights. At this point, I'd like to turn the call over to our Chief Operating Officer, Bren Kern, for our manufacturing update. Bren?