11/10/2020

speaker
Operator
Conference Operator

Greetings, and welcome to INovia's third quarter 2020 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 Dribner, Investor Relations. Thank you. You may begin. Thank you.

speaker
Eric Dribner
Host, Investor Relations

Thank you, and good afternoon, and welcome to Inovia's third quarter 2020 earnings call and audio webcast. With me today are Inovia's chief executive officer and chief medical officer, Dr. Sean Ianchulev, Inovia's chief financial officer, John Gandolfo, and Inovia's vice president of commercial, Michael Rowe. Earlier this afternoon, Inovia issued a press release announcing financial results, but the three months ended September 30, 2020. We encourage everyone to read today's press release as well as Inovia's quarterly report from the Form 10-Q for the third quarter of 2020, which will be filed with the SEC. The company's press release and quarterly report will also be available on Inovia's website at inovia.com. In addition, this conference call is being webcast through the company's website and will be archived there for future reference. Please note that on today's call we will be discussing investigational products 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 Act. We caution listeners that during this 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 risk and uncertainties. associated with the company's business. These forward-looking statements are subject to a number of risks, including risks related to fluctuations in our financial results, volatility and uncertainty in the global economy and financial markets in light of the evolving COVID-19 pandemic and uncertainties arising from the U.S. recent U.S. elections. Our estimates regarding the potential market opportunity for our product candidates and potential revenue from licensing transactions, reliance on third parties, the ability of us and our partners to timely develop, implement, and maintain manufacturing, commercialization, and marketing capabilities and strategies for our product candidates. Risks of our clinical trials, including but not limited to the cost, design, and initiation, and enrollment, which could be adversely impacted by COVID-19 and resulting social distancing, timing, progress, and results of such trials, the potential impact of COVID-19 on our supply chain, the timing, and our ability to submit applications for, obtain, and maintain regulatory approvals for our product candidates, the potential advantages of our product candidates, the rate and degree of market acceptance and clinical utility of our product candidates, our ability to raise additional capital, our ability to attract and retain key personnel, intellectual property risks, and others detailed in and qualified by the cautionary statements contained in INOVIA's press release and SEC filings, including the most recent annual report on Form 10-K and subsequent filings. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 10, 2020. 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 all that said, I'd like to turn the call over to Dr. Sean Ein-Shuliff, from Inovia.

speaker
Dr. Sean Ianchulev
Chief Executive Officer & Chief Medical Officer

Thank you, Eric, and welcome everyone to our third quarter 2020 earnings conference call. During the third quarter and more recently, we continue to solidify our business position through both new strategic partnerships and our proprietary clinical programs. We believe that together these activities have positioned us for continued success as we ramp up our manufacturing capabilities and prepare for our first commercial product launch. Starting with strategic partnerships to date, our business development partnerships have provided a total of approximately $14 million of gross non-dilutive capital in 2020, with the potential to increase to approximately $100 million in gross non-dilutive capital once you consider potential non-sales-related milestones as well as clinical cost savings or reimbursements. During the third quarter, we signed an agreement with Arctic Vision for the development and commercialization of Micropin for progressive myopia and MicroLine for presbyopia for Greater China and South Korea. More recently, we signed an agreement with Bausch Health for Micropin in the U.S. and Canada. These agreements build upon our long-standing partnership with Senju Pharmaceuticals, covering Japan and the rest of Asia, and we believe provide further validation as to the value of our robust Phase III pipeline and innovative microdose delivery technology. Our clinical programs, which are directed towards high-value markets with first-in-class treatments, have also made significant positive progress. Our chaperone program for progressive myopia, which is being transitioned to bowel health, addresses a high-risk pediatric market of approximately 3 million children in the U.S. alone, with a potential value exceeding multiple billions of dollars. The market in China may be equally large due to a patient pool that some estimate to be as much as eight times greater than that of the U.S., Our vision program for improvement of near vision targets the approximately 130 million presbyopic adults, translating to a potential market value that we estimate at about $2 billion. And our recently completed MIST program, delivering positive Phase III results as we prepare the new drug application for Microstat or MitCombi, may provide benefits that address a need for touchless, comfortable, effective, and efficient pupil dilation in a world concerned about COVID-19. The common thread among all three programs is our OptiJet microdose array print technology. The OptiJet with its touchless, smart digital health capabilities is designed for safer, gentler, and more precise delivery to give patients the best-in-class therapeutics they deserve. With two strategic partnerships and pending NDA submission, a unique program for presbyopia in late stage development, as well as a platform technology from which we're working to develop new therapeutic indications, we believe INOVA is well positioned to enter 2021 with significant momentum and a line of sight to milestones that could create incremental value for our shareholders. At this point, I'd like to hand the call over to Michael to provide some highlights from our strategic partnerships. Michael?

Disclaimer

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