Eyenovia(EYEN) - 2020 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q1 2020, the company reported a net loss of approximately $5.5 million, or $0.31 per share, compared to a net loss of approximately $5.9 million, or $0.50 per share, for the same period in 2019, indicating a slight improvement in loss per share [20] - Research and development expenses totaled approximately $3.6 million, a decrease of 9.3% from approximately $4 million in Q1 2019 [20] - General and administrative expenses were approximately $1.8 million, down 5.5% from approximately $1.9 million in Q1 2019 [20] - Total operating expenses for Q1 2020 were approximately $5.5 million, a decrease of 8.1% from approximately $6 million in Q1 2019 [20] - As of March 31, 2020, the company's cash balance was approximately $13.7 million, including approximately $5.4 million from a private placement [21] Business Line Data and Key Metrics Changes - The company continues to advance its late-stage therapeutic pipeline, particularly focusing on MicroStat for pharmacologic mydriasis, which is on track for NDA submission by the end of 2020 [9][10] - The MicroLine program for presbyopia is anticipated to initiate once conditions improve, with a focus on a rapid Phase II program [10] - The CHAPERONE study for progressive myopia has been delayed due to COVID-19, but the company is maintaining virtual follow-ups with enrolled patients [14] Market Data and Key Metrics Changes - The company highlights a significant increase in progressive myopia rates, with over 9% of children in the U.S. and more than 80% in Asia affected, potentially impacting future market opportunities [11][12] - The pandemic has led to a decrease in outdoor activities, which is linked to an increased risk of myopia, further emphasizing the need for the company's products [12][47] Company Strategy and Development Direction - The company aims to submit the MicroStat NDA this year and is preparing to initiate Phase III studies for MicroLine and CHAPERONE when safe [23] - The management emphasizes the importance of maintaining health and safety while navigating the challenges posed by COVID-19 [23] - The company is focusing on virtual engagement and partnerships to support the commercialization of its products [16] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the ongoing impact of COVID-19 on operations and clinical trials, but remains optimistic about resuming activities as conditions improve [7][8] - The company is prepared for a potential reduction in cash burn to approximately $3.5 million to $4 million per quarter until full-scale operations resume [39] - Management expresses confidence in the strength of their clinical data and the readiness of their team to resume operations [28] Other Important Information - The company has conducted a national survey indicating that 85% of parents of myopic children had a positive reaction to the CHAPERONE study, which will aid in future commercialization efforts [17] - The management is closely monitoring the situation and adapting strategies to ensure continued progress despite the pandemic [7][8] Q&A Session Summary Question: Timeline for MicroLine Phase III program - Management indicated that once conditions are safe, the study could produce results within three to six months after enrollment begins [25][26] Question: Rate-limiting step for MicroStat NDA filing - The primary rate-limiting step is the completion of stability studies, which are on track for timely NDA submission [27][28] Question: Enrollment status of MicroPine Phase III study - Enrollment has been delayed, but the company is maintaining contact with enrolled patients and ensuring supply continuity [29][30] Question: Clinical sites in affected areas - About one-sixth of clinical sites are in heavily affected areas, but many sites in less affected areas are preparing to resume activities [36] Question: Expected cash burn before resumption of studies - Cash burn is expected to be reduced to approximately $3.5 million to $4 million per quarter until operations ramp back up [39]