Eyenovia, Inc.

Greetings. Welcome to the Inovia second quarter 2023 earnings call. At this time, all participants are in a listen-only mode. The question and answer session will follow the formal presentation. If anyone should require operator assistance during the call, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. At this time, I would like to hand the call over to your moderator, Eric Ribner of Investor Relations. Thank you. You may begin.

Good afternoon, everyone, and welcome to INOVIA's second quarter 2023 earnings call, 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, Brian Kern. This afternoon, we issued a press release announcing financial results for the three and six month period ending June 30th, 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 June 30th, 2023, which will be filed with the SEC tomorrow, August 11th, and our most recent filed 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 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 provision of the Private Security 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 those 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, Informed 10-K, and other SEC filings. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 10, 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, Inovia's Chief Executive Officer. Michael?

Thank you, Eric, and welcome everyone to our second quarter 2023 financial results conference call. We have an extremely productive second quarter, and I am excited to share with you our progress this afternoon. During our last conference call, we spoke of our efforts to begin our targeted launch of MidCombi and our goal of partnering with other companies to leverage and monetize the OptiJet technology beyond our own development programs. Today, we will provide an update for both of these topics, starting with MidCombi and our recent first commercial sale. As you'll recall, in May, we received FDA approval of MidCombi, the first and only fixed combination of tropicamide and phenylephrine, and the only ophthalmic spray for inducing mitriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired. We are proud to have delivered the first FDA-approved product that leverages our OptiJet dispensing device. This important advancement was featured at the annual Octane Ophthalmology Tech Forum in June, where we highlighted the innovative nature of Mitgabi and the future of the OptiJet technology to the ophthalmic community, including potential industry partners, thought leaders, and investors. We're thrilled to have initiated sales of BINCOMBI to a targeted group of professional offices. Ophthalmologists, optometrists, technicians, and patients are now experiencing the benefits of BINCOMBI themselves, and together we are learning how the product can streamline practices and help with patient management. As we announced last week, upon receipt of our New York pharmacy license, we achieved our first commercial sale of BINCOMBI the world-renowned board-certified ophthalmologist, Dr. Nathan Radcliffe, who becomes first to incorporate Metcalfe into his daily practice. Last week, we conducted training at OC Retina in Orange, California, and as soon as our California pharmacy license is received, we anticipate initiating sales in this state. We're already receiving positive feedback from doctors, technicians, and patients, and we anticipate this will only increase with additional sales and marketing wrap-up. To that end, we are in the process of formally adding additional commercial manufacturing sites to support MidCombie, including our Redwood City facility, as well as Coastline Manufacturing as a secondary site. Bren will provide additional details during his manufacturing overview. These additional sites will provide us with increased capacity to meet and anticipate demand not only at MidCombie, but potential future ophthalmic therapies utilizing the OptiJet. If you would like to find out more about Midcombi, track our launch progress, and hear what doctors and patients are saying about the product, you can go to the website at midcombi.com. Now, I'd like to talk a bit more about our efforts to leverage and monetize the OptiJet technology through partnerships with other companies. We have engaged in active discussions in this area with no fewer than four companies across a variety of topical ophthalmic markets. Some of these discussions take longer than would be assumed because we need to first determine if the products under discussion are compatible with the OptiJet. This is something that is true for any container closure system, and usually those tests include both spray performance as well as material compatibility. We anticipate being able to announce the first of these arrangements very shortly. Our goal with all of these discussions is to marry our leading delivery technology with a new or unique drug asset to bring the best of both worlds to patients and prescribers while providing near-term revenue and or capital opportunities for the company. I'll now provide an update on Apresure, our intended brand name for the MicroLine project. Apresure is our proprietary topical on-demand pilocarpine-based therapeutic candidate that we are developing for the temporary improvement in near vision associated with Ethiopia. As you may know, presbyopia is the age-related hardening of the eye's lens causing blurred near vision. This addressable market represents over 18 million people in the United States alone between the ages of 40 and 55 who otherwise never wore glasses and have the resources for a cash-paid product. Our proprietary market research suggests this could be nearly a billion-dollar annual market in the U.S. alone. As we discussed last quarter, we received feedback from the FDA outlining a clear path forward for this program towards a new drug application, or NDA, and we continue to make progress on this front. APRASURE is being designed for use 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, and we anticipate that manufacturing of registration batches will commence in the fourth quarter of this year. Based on the FDA requirement of 12 months of real-time stability data on the final package product before filing an NDA, we plan to file the NDA approximately 12 months after we run those batches, the late 2024. ApiSure differs from the current topical drug treatment option for presbyopia on the market and those in development in that it is a drug-device combination. As such, many optometrists would be able to include ApiSure as an offering to patients along with eyeglasses. Aperture has been described by some in market research as a second pair of invisible glasses or the way to gain vision for those times when wearing glasses is not desirable. We tested this concept with 100 optometrists who found that aperture would meet the needs of both themselves and their patients better than any other pharmaceutical option that they have or believe will have available. These doctors estimated that aperture ophthalmic spray could capture as much as one-third of the presbyopia pharmaceutical market, with the other five products, all eye drops, competing for the remaining two-thirds of that market. If approved, we believe that aperture administered using the OptiJet will stand out as the one and only spray, distinguished by its ergonomic design, ease of use, and potentially advantageous side effect profile. At this point, I'd like to turn the call over to our Chief Operating Officer, Brent Kern, for our manufacturing update. Brent?