Eyenovia, Inc.

Greetings. Welcome to Inovia first quarter 2023 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to John Gandolfo, Chief Financial Officer. Thank you. You may begin.

Thank you. Good afternoon, and welcome to Inovia's first quarter 2023 earnings conference call and audio webcast. With me today are Inovia's CEO, Michael Rowe, and COO, Brent Kern. This afternoon, we issued a press release announcing financial results for the three months ended March 31st, 2023. We encourage everyone to read today's press release as well as Inovia's quarterly report on Form 10-Q for the quarter ended March 31st, 2023. which will be filed with the SEC tomorrow, May 12th, 2023, as well as our most recently filed 10-K. Companies 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 investigational product candidates, some of which have yet to receive FDA approval. Please also note that certain information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during the call, 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 certainties 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, May 11, 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. With that said, I'd like to turn the call over to Michael Rowe, INOVA's Chief Executive Officer. Michael?

Thank you, John, and welcome, everyone, to our first quarter 2023 Financial Results Conference Call. I will start with an update of our recent FDA approval of MidCombi, how that approval fits within our overall strategy, and then provide a status update from MicroLine. Brent Kern, our Chief Operating Officer, will follow with an update on our manufacturing and commercial readiness progress. We will then turn things over to John Gandolfo, our CFO, who will review the financials as well as our partnerships with Bausch and Lomb and Arctic Vision. We will then open the call for your questions. During the first quarter of this year and more recently, we have made significant progress on all of our goals. punctuated by FDA approval of our first product, MidCombi. We also received very encouraging feedback from the FDA and believe that we have a clear path forward for our microline presbyopia program. In terms of manufacturing, we are wrapping up our activities and we'll have our Reno facility online next quarter with OptiJet Gen 2 clinical batches being produced later this year. Finally, our partnership with Formosa, as well as others that we expect to come, will pave the way for additional ophthalmic opportunities that leverage our OptiJet technology. I'll begin the call by highlighting our most recent achievement. Just a few days ago, we received FDA approval of Midcombi, our proprietary combination of a microdose formulation of tropicamide and phenylephrine for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired. This is the first approved fixed-dose combination of tropicamide and phenylephrine in the U.S. And importantly, it is also the first approved product using our OptiJet dispensing device. I cannot overstate the importance to our company of this approval. The OptiJet is foundational to our development pipeline as well as our partnered programs. And this FDA approval sets a precedent for the future development of additional ophthalmic therapies delivered by the OptiJet in other high-value indications. The FDA's approval of Mitcambi provides crucial external validation of our technology and is just the first of many ophthalmic indications that can utilize the OptiJet. The approval also marks the formal transition of Inovia from a development company to a commercial organization. The management team is extremely grateful to all of our Inovia colleagues for their dedication in advancing this program through this important milestone. Since Monday, we have received numerous inbound calls and emails from ophthalmology and optometry offices asking when they can get MedCombi. The reasons for wanting the product include the horizontal delivery, the lower drug volume exposure, ease of use for both the doctors and technicians, One doctor said that she planned to modify her office flow so that she could dilate patients right in the waiting room, and she didn't have to have them tilt their heads back. We, of course, see this as very encouraging. We plan to introduce McCombie later this summer to several key ophthalmology and optometry offices as part of our targeted launch process. As much as we would like to be out there tomorrow, we need some time to bring our internal manufacturing capabilities, which are more cost efficient, online. By early 2024, we expect to have our facilities in Redwood City and Reno at full production capacity. For now, customers and all of you can find out more about MidCombi and soon track our launch progress and ultimately hear what doctors and patients are saying about the product by going to the website midcombi.com. I'll now turn to MicroLine, our proprietary topical on-demand tylocarbine-based therapeutic candidate, that we are developing for the temporary improvement in near vision associated with presbyopia. As you'll recall, presbyopia is the age-related hardening of the eye's lens, causing blurred near vision. This is an addressable market representing over 18 million people in the United States alone between the ages of 40 and 55 who otherwise never wear glasses and have the resources for a cash-paid product. Our proprietary market research suggests This could be a multi-billion dollar annual market in the U.S. alone. We recently received feedback from the FDA delineating a clear path forward for this program towards a new drug application, or NDA. Microline is being designed for use with our smaller and more advanced Gen2 OptiJet device, which has been optimized for in-home use. The machinery to build and fill the Gen2 cartridge is being installed and validated in our Redwood City facility and we anticipated running NDA registration batches in the first half of 2024 after satisfying the contracted clinical needs of our partners. The FDA requires 12 months of real-time stability data on the final packaged product before filing the NDA, so we intend to file approximately 10 months after we run those batches. During those 12 months, however, we will not be sitting and waiting. We will be conducting other critical pre-NDA activities including supportive human factors and clinical work to demonstrate the usability of the Gen2 device in the target population, as well as measuring patient preference for the OptiJet system. This work will be used to support both the MicroLine NDA and upcoming commercialization of the product. As an ophthalmic spray in the OptiJet device, we believe that MicroLine has a number of unique features that may set it apart from presbyopia eyedrop options. The features of our technology may make using the product easier while lowering drug and preservative exposure and potentially improving tolerability. The attractiveness of the device itself has been pointed to as a highly desired feature in market research we have conducted. And MicroLine may also fit better with the business model of many optometrists. Many doctors have a retail portion of their practice where they sell eyeglasses, contact lenses, and other products for presbyopic patients. Microline could fit well into their paradigm, as they may be able to include supporting items such as unique device skins, starter kits, and so on as part of those offerings. We recently conducted market research with 100 optometrists where Microline was compared with the five existing or potential presbyopia eye drops that may be on the market in 2025. What we found was that Microline was rated number one by the doctors surveyed in terms of meeting the optometrists and their patients' overall needs. These doctors estimated that Microline could capture as much as one-third of the presbyopia pharmaceutical market, with the other five eye drops competing for the remaining two-thirds of the market. Should Microline be approved, we believe that the OptiJet, with its design, ease of use, and lower drug volume, distinguishes the product, and ultimately patients and their doctors will be choosing from a number of different eye drops or Microline, the one and only spray. Turning to our partnering activities, we were very excited to announce in February a development collaboration agreement with Taiwan-based Formosa Pharmaceuticals. This agreement seeks to combine our OptiJet with Formosa's unique APNT nanoparticle formulation platform for the potential development of new topical ophthalmic therapeutics that employ the OptiJet device. Formosa's proprietary, innovative APNT platform improves bioavailability and solubility of active pharmaceutical ingredients, allowing more homogenous formulations that may expand our universe with existing and future drugs that could benefit from delivery using the OptiJet. We believe this agreement with Formosa will open up new and large market indications for potential expansion of our pipeline and may serve as a model for future partnerships. We're continuing to advance discussions with potential partners that may benefit from OptiJet within their own development programs, such as Glaucoma and DryEye. Co-development partnerships such as this, addressing large ophthalmic indications with unmet needs, are a key part of our mid- and long-term growth strategy. We are continuing to build a large body of data demonstrating the benefits of OptiJet over conventional eye drops. In January, we announced positive results from a research study conducted in collaboration with Dr. Pedram Hamra, Interim Chairman of Ophthalmology at Tufts Medical Center. This study evaluated the gene and protein expression of cytokines and chemokines after treatment with latanabras, a glaucoma medication preserved with BAK, administered via OptiJet versus administered via standard eye drops. In these early findings, the OptiJet technology appears superior to standard eye drops in reducing the inflammatory process. The OptiJet was found to achieve a therapeutic dose of litanoprost with significantly less exposure to those excess drugs and harmful preservatives that can be achieved using conventional drops. These results were also presented at the Association for Research and Vision and Ophthalmology Annual Meeting last month. At this point, I'd like to turn the call over to our Chief Operating Officer, Bren Kern, for our manufacturing update.