Eyenovia to Host Investor Call to Discuss Recent Licensing Agreements Resulting in Total Potential License Payments and Development Cost Reimbursement and Savings of Approximately $100 Million
Company reaffirms near term milestones for the Mydcombi™ (MicroStat) NDA and the MicroLine presbyopia program Phase III results
Call scheduled for today, Tuesday, October 13 at 4:30pm ET
NEW YORK, Oct. 13, 2020 (GLOBE NEWSWIRE) -- Eyenovia, Inc., (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics, today announced that management will host an investor conference call to discuss the company’s recent licensing agreements and provide an update on the company’s short term milestones for its drug programs. The call is scheduled for today, October 13, at 4:30pm ET.
On October 12, 2020, Eyenovia and Bausch Health Companies Inc. (NYSE/TSX: BHC) announced that an affiliate of Bausch Health has acquired an exclusive license in the United States and Canada for the development and commercialization of MicroPine, an investigational microdose formulation of atropine ophthalmic solution, which is being investigated for the reduction of pediatric myopia progression, also known as nearsightedness, in children ages 3-12. This investigational formulation of atropine is delivered with Eyenovia’s proprietary Optejet® dispenser technology.
Under the terms of the licensing agreement with Bausch Health, Eyenovia is eligible to receive up to $45 million in license payments of which $10 million was due upfront and the balance is due upon approval- and launched-based milestones. Upon signing, Bausch Health also assumed oversight and costs related to the ongoing Phase 3 CHAPERONE clinical trial. The upfront license payment and reduced operating expenses are expected to yield cash flow to Eyenovia of approximately $20 to $25 million in total through the end of 2022. In commercialization, Eyenovia is eligible to receive royalties ranging from mid-single digit to mid-teen percentages of gross profit on sales in the United States and Canada. William Blair & Company, L.L.C. served as Eyenovia’s exclusive financial advisor for the transaction.
On August 11, 2020, Eyenovia and Arctic Vision (Hong Kong) Limited announced that Arctic Vision acquired an exclusive license in Greater China and South Korea for the development and commercialization of both MicroPine and MicroLine, an investigational microdose formulation of pilocarpine for the treatment of presbyopia delivered with the Optejet dispenser technology.
Under the terms of the Arctic Vision agreement, Eyenovia may receive up to a total of approximately $45 million in upfront payments as well as additional payments, based on various development and regulatory milestones, including the initiation of clinical research and approvals in Greater China and South Korea, and development costs. In addition, Arctic Vision will purchase its supply of MicroPine and MicroLine from Eyenovia or, for such products not supplied by Eyenovia, pay Eyenovia a mid-single digit percentage royalty on net sales of such products, subject to certain adjustments. Eyenovia will pay a mid-double digit percentage of such payments, royalties, or net proceeds of such supply to its Asian licensee pursuant to the arrangement by whichEyenovia reacquired rights to such products in Greater China and South Korea from the original licensee.
Dr. Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia, stated, “We are very pleased to have reached these agreements with Bausch Health and Arctic Vision. We expect that the non-dilutive upfront license payments and potential cost savings from these recent business development activities could provide us with sufficient capital into the beginning of 2022. Within that timeframe, we plan to advance our other product candidates, including Mydcombi, or MicroStat, for mydriasis, for which we remain on track to submit a New Drug Application by the end of the year, and MicroLine for presbyopia, for which we plan to complete two Phase 3 clinical trials in 2021, subject to any impacts of COVID-19. Together, we estimate that these two indications could represent a market opportunity in excess of approximately $2.2 billion in the United States alone. Additionally, we believe that our licensing agreements validate the use of our Optejet technology as a platform for additional ophthalmic conditions and, over the longer term, could provide us with significant upside, particularly if MicroPine is approved in the United States or China. We look forward to providing more context around our business development activities during this afternoon’s conference call,” Dr. Ianchulev concluded.
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