Eyenovia(US:EYEN)2021-05-13 02:35Financial Data and Key Metrics Changes - For Q1 2021, the company reported a net loss of approximately $5.4 million or $0.21 per share, compared to a net loss of approximately $5.5 million or $0.31 per share for Q1 2020, indicating a slight improvement in loss per share [25] - Research and development expenses totaled approximately $4.2 million for Q1 2021, an increase of approximately 16.9% from approximately $3.6 million in the same period in 2020 [26] - General and administrative expenses were approximately $2.3 million for Q1 2021, up approximately 25.2% from approximately $1.8 million in Q1 2020 [26] - Total operating expenses for Q1 2021 were approximately $6.5 million, representing an increase of 19.7% compared to $5.5 million for the same period in 2020 [26] - As of March 31, 2021, the company's cash balance was approximately $24.9 million, excluding approximately $7.5 million in initial net proceeds from a $25 million credit facility with Silicon Valley Bank [27][28] Business Line Data and Key Metrics Changes - The company completed enrollment in its VISION-1 study of MicroLine, a proprietary pilocarpine formulation for improving near vision in presbyopia patients, with results expected shortly [9][18] - MydCombi, a fixed combination of two mydriatic medications, has a PDUFA date set for October 28, 2021, and is anticipated to transition the company to a commercial stage if approved [7][11] Market Data and Key Metrics Changes - The market opportunity for MydCombi is estimated at approximately $250 million annually in the U.S., with 80 million comprehensive diabetic eye exams and 4 million ophthalmic surgical dilations performed annually [14][15] - The presbyopia market, which affects approximately 113 million people in the U.S., has an estimated market potential of nearly $8 billion [20] Company Strategy and Development Direction - The company has entered into an exclusive agreement with EVERSANA to manage the distribution and order fulfillment of MydCombi, aiming for a streamlined launch process [8][17] - Eyenovia is focusing on out-licensing opportunities and pipeline expansion, leveraging Optejet technology for unmet needs in ophthalmic indications such as anti-infectives and glaucoma [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the upcoming PDUFA date for MydCombi and the potential for significant market opportunities in presbyopia and myopia treatments [30] - The company believes its current cash resources are sufficient to support operations through the third quarter of 2022, enabling the advancement of its clinical programs [28] Other Important Information - The company announced the addition of Dr. Julia Haller to its Board of Directors, which is expected to provide valuable insights as the company advances its programs [10] Q&A Session Summary Question: Comment on Allergan's Phase 3 study and its implications for Eyenovia - Management noted that while Allergan's study has been completed, they have not yet seen the data to make a comparative analysis, and they are optimistic about their own study's broader age range [34][35] Question: Plans for the VISION-2 study design - Management indicated that they plan to analyze VISION-1 results before finalizing the design for VISION-2, potentially making it more efficient based on the data [38][39] Question: Key endpoints to look for in VISION-1 results - Management highlighted that the primary endpoint is a three-line vision gain at near, but they also emphasized the importance of secondary endpoints and the side effect profile, particularly regarding brow ache [42][44]