Company reaffirms near term milestones for the Mydcombi™ (MicroStat) NDA and the MicroLine presbyopia program Phase III results
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 which Eyenovia 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.
Conference call and webcast details:
Tuesday, October 13, 2020 at 4:30pm ET / 1:30pm PT
Domestic dial-in: 1-877-407-0789
International dial-in: 1-201-689-8562
Webcast link: http://public.viavid.com/index.php?id=141978
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics. Eyenovia’s pipeline is currently focused on late-stage development programs for presbyopia, myopia progression and mydriasis. For more information, please visit www.eyenovia.com.
Forward-Looking Statements
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including estimated market opportunities for our product candidates and any potential revenue from licensing transactions. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the SEC. In addition, such statements could be affected by risks and uncertainties related to, among other things, our estimates regarding the potential market opportunity for our product candidates and potential revenue from licensing transactions; reliance on third parties to develop and commercialize our product candidates; impacts of and uncertainty related to COVID-19; 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 costs, design, initiation and enrollment (which could still be adversely impacted by COVID-19 and resulting social distancing), timing, progress and results of such trials; the timing and our ability to submit applications for, obtain and maintain regulatory approvals for our product candidates; the potential impacts of COVID-19 on our supply chain; the potential advantages of our product candidates; the rate and degree of market acceptance and clinical utility of our product candidates; fluctuations in our financial results, particularly given market conditions and the potential economic impact of COVID-19; our need to raise additional capital; intellectual property risks; our ability to attract and retain key personnel; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; and our competitive position. Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not undertake any obligation to update any forward-looking statements.
Eyenovia Investor Contacts:
John Gandolfo
jgandolfo@eyenovia.com
(917) 289-1117
Eric Ribner
LifeSci Advisors, LLC
eric@lifesciadvisors.com
(646) 751-4363
Eyenovia Media Contact:
Diana Soltesz
Pazanga Health Communications
dsoltesz@pazangahealth.com
(818) 618-5634
