Eyenovia(EYEN) - 2019 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q2 2019, the company reported a net loss of approximately $5.3 million or $0.44 per share, compared to a net loss of approximately $3.3 million or $0.33 per share in Q2 2018, indicating a worsening financial position year-over-year [19] - Research and development expenses increased by 48% to approximately $3.6 million in Q2 2019 from approximately $2.4 million in the same period in 2018, primarily due to advancements in the clinical drug pipeline [20] - General and administrative expenses rose by 99% to approximately $1.8 million in Q2 2019 from approximately $900,000 in Q2 2018, largely due to increased personnel costs, professional fees, and rent [21] - Total operating expenses for Q2 2019 were approximately $5.4 million, up 62% from approximately $3.3 million in Q2 2018 [22] - As of June 30, 2019, the company's cash and cash equivalents were approximately $9.2 million, not including the $13 million from a public offering completed in July 2019, which is expected to meet operating capital requirements into Q4 2020 [23] Business Line Data and Key Metrics Changes - The company initiated the MicroPine Phase III CHAPERONE study for progressive myopia in children, representing an estimated $5 billion U.S. market opportunity [8] - The MicroProst program is preparing for a trial aimed at lowering intraocular pressure in an expanded glaucoma population, expected to start by the end of 2019 [9][14] - The MicroStat program is focused on preparing for a new drug application (NDA) submission in 2020, targeting the clinic-based and surgical markets for pupil dilation [15][34] Market Data and Key Metrics Changes - The MicroPine program targets a significant market opportunity in treating myopic progression, with no FDA-approved therapies currently available [10] - The potential market for MicroProst includes approximately 4 million patients in the U.S. with elevated intraocular pressure [14] Company Strategy and Development Direction - The company aims to develop first-in-class therapeutics to address unmet medical needs in ophthalmology, with a focus on advancing clinical milestones for MicroPine and MicroProst [26] - The company is also exploring partnership opportunities for its presbyopia program, which is seen as a significant market opportunity [51][52] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of clinical trials and the financial position following a successful public offering, which provides sufficient capital to achieve upcoming goals [18][27] - The company is committed to maintaining the integrity of its clinical trials and aims to provide updates on enrollment without planned interim safety updates [48] Other Important Information - The company raised approximately $14 million in gross proceeds from a public offering in July 2019, which is expected to support ongoing clinical studies and operational needs [17] Q&A Session Summary Question: How is enrollment going for the MicroPine Phase III CHAPERONE study? - Enrollment is proceeding as forecasted, with plans to have around 20 sites operational by Q1 of next year [28][29] Question: What is the status of the MicroStat NDA submission? - The company is on track to complete the stability and manufacturing requirements for the NDA submission in 2020 [30] Question: What are the commercial opportunities for MicroStat? - The addressable market includes 80 million clinic-based dilations and 4 million cataract surgeries annually, with a focus on differentiating the product from legacy eyedropper technology [34][36] Question: What is the timeline for the MicroTears OTC registration? - The OTC registration is synchronized with the MicroStat program, with plans to launch both in 2021 [40][42] Question: What are the expected operating expenses moving forward? - The average cash burn is projected to be about $4.5 million per quarter through Q3 2020, with variability depending on clinical and manufacturing activities [43]