Eyenovia(EYEN)

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Eyenovia(EYEN) - 2019 Q4 - Earnings Call Transcript
2020-03-26 01:16
Financial Data and Key Metrics Changes - For Q4 2019, the company reported a net loss of approximately $5.2 million, or $0.31 per share, compared to a net loss of approximately $6.2 million, or $0.60 per share, for Q4 2018, indicating an improvement in financial performance [44] - For the full year 2019, the net loss was approximately $21.2 million, or $1.47 per share, compared to a net loss of approximately $17.3 million, or $1.82 per share, for 2018, reflecting an increase in losses year-over-year [47] - Research and development expenses for Q4 2019 totaled approximately $3.3 million, a decrease of 19.4% from approximately $4.1 million in Q4 2018 [45] - General and administrative expenses for Q4 2019 were approximately $2 million, down from approximately $2.1 million in Q4 2018, a decrease of 4.5% [46] - Total operating expenses for Q4 2019 were approximately $5.3 million, a decrease of 14.5% from approximately $6.2 million in Q4 2018 [46] - As of December 31, 2019, the company's cash and cash equivalents balance was approximately $14.2 million, excluding the net proceeds from a private placement that closed on March 24, 2020 [50] Business Line Data and Key Metrics Changes - The company successfully completed Phase III studies for MicroStat, validating its technology and approach for pharmacologic mydriasis [10][18] - The initiation of the MicroPine Phase III study for progressive myopia was highlighted as a significant achievement, with hopes to complete patient enrollment by the end of 2020 [11] - The MicroLine program for presbyopia was introduced, with plans to initiate the Phase III VISION trial in the coming months [12] Market Data and Key Metrics Changes - The company believes its reprioritized pipeline represents an approximately $7 billion total market opportunity in the United States [9] - The prevalence of myopia is expected to grow significantly, with nearly half of the population in North America and East Asia projected to be myopic by 2030 [23] Company Strategy and Development Direction - The company is focusing on high-value indications in its pipeline, including MicroStat, MicroPine, and MicroLine, to address significant unmet medical needs [9][12] - The company aims to leverage its patented piezo-print delivery technology to enhance treatment options for ocular diseases [9] - The company is preparing for the potential launch of MicroStat in 2021, aligning its promotional sales and pricing strategy accordingly [34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about 2020, anticipating milestones in Phase III programs and the planned NDA for MicroStat, while closely monitoring the impact of the COVID-19 pandemic [52] - The company has taken proactive measures to ensure supply chain stability and clinical trial continuity amid the pandemic [15][66] Other Important Information - The company successfully closed a private placement, which is expected to fund operations into the first quarter of 2021 [43] - The company is expanding its Scientific Advisory Board to enhance its clinical development efforts [13] Q&A Session Summary Question: Can you help us understand the competitive landscape with respect to new treatments for presbyopia? - Management acknowledged that there are other companies exploring pharmacologic treatments for presbyopia, but emphasized their unique approach and the opportunity for lifestyle modifications [55] Question: Where are you in preparation for the NDA filing for MicroStat? - Management confirmed that they are waiting for physical stability studies and expect to file the NDA by the end of 2020, with no anticipated impact from COVID-19 [58] Question: How do you think MicroStat will be adopted by practices? - Management highlighted the value proposition of MicroStat, including faster patient throughput, improved comfort, and competitive pricing compared to current practices [59] Question: Can you clarify the current enrollment status of the CHAPERONE trial? - Management stated that they aim to fully enroll the study by the end of 2020, despite some disruptions due to the pandemic [73] Question: What are the expected operating expenses for 2020? - Management indicated that cash-based operating expenses are expected to average around $4.5 million to $4.6 million per quarter, with flexibility to reduce expenses if necessary [77]
Eyenovia (EYEN) Presents At H.C. Wainwright 21st Annual Global Investment Conference - Slideshow
2019-09-16 16:53
Company Overview - Eyenovia is a specialty ophthalmic biopharmaceutical company focused on developing late-stage pipeline products for front and back-of-the-eye indications[5] - The company's pipeline includes MicroPine, MicroProst, MicroStat, and MicroTears, targeting markets with significant potential[6] Product Pipeline & Clinical Trials - MicroPine is in Phase III clinical trials for the reduction of pediatric myopia progression, with patient enrollment expected to be completed by the end of 2020[5, 8] - MicroProst, aimed at reducing intraocular pressure in CACG, OAG, and OHT, is scheduled to begin Phase III trials by the end of 2019[5, 8] - MicroStat, for pharmacologic mydriasis, has completed Phase III trials with positive results and is expected to have an NDA filing in 2020[17, 26] - MicroTears, an OTC product for red eye and itch relief/lubrication, is planned for launch concurrently with MicroStat[7, 18] Market Opportunity - The U S market for progressive myopia is estimated to be over $5 billion[6] - The market for glaucoma (CACG+OAG+OHT) is estimated to be over $1.5 billion[6] - The market for mydriasis is estimated to be over $250 million[6] - The OTC eye care market is estimated to be over $850 million[6] Technology & Efficacy - Eyenovia's Optejet technology delivers microdoses of medication, potentially reducing side effects and improving patient compliance[11, 21] - EYN PG21 study showed that 100% of patients achieved IOP reduction ≥ 20%[12] - In technician administration, 95% achieved successful delivery on the first attempt[14] Financial Status - As of September 9, 2019, the share price was $4.17, and the market cap (fully diluted) was $81 million[27] - As of June 30, 2019, the company had $9.2 million in cash, excluding $13.0 million from an underwritten public offering in July 2019[27]