Eyenovia(US:EYEN)2021-03-26 02:50Financial Data and Key Metrics Changes - For Q4 2020, the company reported a net loss of approximately $4.2 million or $0.17 per share, compared to a net loss of approximately $5.2 million or $0.31 per share in Q4 2019 [29] - For the full year 2020, the net loss was approximately $19.8 million or a loss of $0.94 per share, compared to a net loss of approximately $21.2 million or $1.47 per share for 2019 [29] - Revenue for Q4 and the full year 2020 was $2 million, representing a milestone payment related to a collaboration with Arctic Vision, with no revenue recognized in the same periods of 2019 [29] Business Line Data and Key Metrics Changes - Research and development expenses for Q4 2020 totaled approximately $3.4 million, roughly flat compared to $3.3 million in Q4 2019 [30] - For the full year 2020, R&D expenses decreased by 6% to approximately $13.3 million from $14.1 million in 2019 [30] - General and administrative expenses for Q4 2020 were approximately $2.1 million, an increase of 5% from $2 million in Q4 2019 [30] Market Data and Key Metrics Changes - The company anticipates a PDUFA date of October 28, 2021, for MydCombi, which, if approved, would be its first commercially available product [20][34] - The market potential for MicroLine, aimed at treating presbyopia, is estimated to exceed $7 billion in the U.S. alone [26] Company Strategy and Development Direction - The company aims to efficiently market MydCombi with a small, targeted salesforce and a specialty pharmacy network, rather than a large conventional sales force [9][18] - The strategy includes leveraging partnerships with organizations that have significant reach to augment sales efforts [19] - The company is focused on advancing its proprietary microdosing technology, Optejet, to improve drug delivery and patient experience [23][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made in 2020 and the momentum entering 2021, with multiple potential value-creating milestones on the horizon [13][34] - The company is aware of the risks associated with the evolving COVID-19 pandemic and its impact on operations and clinical trials [6] Other Important Information - The company has outlicensed MicroPine and MicroLine to Arctic Vision in Greater China and South Korea, generating approximately $16 million in upfront and milestone-based fees [12] - The cash balance as of December 31, 2020, was approximately $28.4 million, expected to last into the middle of Q1 2022 [32] Q&A Session Summary Question: Are there any secondary outcome measures in the VISION-1 study? - Yes, the study is collecting secondary and exploratory endpoints, and a wealth of data is anticipated [36][37] Question: When will specialized salespeople be brought in for MydCombi? - Specialized salespeople are not expected to be onboarded before August, in preparation for the October approval [41] Question: How does the agreement with EVERSANA fit into the marketing plans for MydCombi? - EVERSANA will handle invoicing, billing, and customer service, allowing the company to maintain a leaner infrastructure [43][44] Question: What are the plans for the VISION-2 study? - The company plans to initiate VISION-2 by the end of the year, learning from VISION-1 results [47][48] Question: What is the initial pricing for MydCombi? - The anticipated price is about $100 per cartridge, which should treat at least 75 patients, aligning closely with current spending by doctors [54]