Michael Rowe
Analyst · Ladenburg Thalmann
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 MydCombi, how that approval fits within our overall strategy and then provide established update for MicroLine. Bren 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, and who will review the financials as well as our partnerships with Bausch + 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 stated goals, punctuated by FDA approval of our first product, MydCombi. 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 ramping up our activities and we'll have our Reno facility online next quarter with Optejet Gen2 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 that leverage our Optejet technology. I'll begin the call by highlighting our most recent achievement. Just a few days ago, we received FDA approval of MydCombi, 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 in the U.S. and, importantly, is also the first approved product using our Optejet dispensing device. I cannot overstate the importance to our company of this approval. The Optejet is foundational to our development pipeline as well as our partnered programs. And this FDA approval sets the precedent for the future development of additional thalamic therapies delivered by the Optejet in other high-value indications. The FDA's approval of MydCombi provides crucial external validation of our technology and is just the first of many ophthalmic indications that can utilize the Optejet. The approval also marks the formal transition of Eyenovia from a development company to a commercial organization. The management team is extremely grateful to all of our Eyenovia colleagues for their dedication in advancing this program through this important milestone. Since Monday, we have received numerous inbound calls and e-mails from ophthalmology and optometry offices asking when they can get MydCombi. 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 plans 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 MydCombi 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 MydCombi and soon track our launch progress and ultimately hear what doctors and patients are saying about the product by going to the website mydcombi.com. I'll now turn to MicroLine, our proprietary topical on-demand pilot parking 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 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, will otherwise never wear glasses and have the resources for a cash pay product. Our proprietary market research suggests, this could be a multibillion-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 Optejet 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 anticipate 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 support of 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 Optejet system. This work will be used to support both, the MicroLine NDA and upcoming commercialization of the product. As an ophthalmic spray in the Optejet device, we believe that MicroLine has a number of unique features that may set it apart from presbyopia eye-drop 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 5 existing or potential presbyopia eye drops that may be on the market in 2025. What we found was that MicroLine was rated #1 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 1/3 of the presbyopia pharmaceutical market, with the other 5 eye drops competing for the remaining 2/3 of the market. Should MicroLine be approved, we believe that the Optejet, with its design, ease-of-use and lower drug volume, distinguishes the product, and ultimately, patients other 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 Optejet with Formosa's unique APMT nanoparticle formulation platform for the potential development of new topical ophthalmic therapeutics that employ the Optejet device. Formosa's proprietary innovative APMT 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 Optejet. 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 Optejet within their own development programs such as glaucoma and dry eye. 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 Optejet over conventional eye drops. In January, we announced positive results from a research study conducted in collaboration with Dr. Pedram Hamrah, Interim Chairman of Ophthalmology at Tufts Medical Center. This study evaluated the gene and protein expression of cytokines and chemokines after treatment with latanoprost, a glaucoma medication preserved with BAK administered via Optejet versus administered by standard eyedrops. In these early findings, the Optejet technology appears superior to standard eyedrops and reducing the inflammatory process. The Optejet was found to achieve a therapeutic dose of latanoprost 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 in 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. Bren?