Eyenovia, Inc.

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.

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.

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?