Financial Performance and Funding - The company has incurred net losses of approximately $57.7 million since inception, with net losses of $21.2 million and $17.3 million for the years ended December 31, 2019 and 2018, respectively [237]. - As of December 31, 2019, the company had federal net operating loss carry-forwards of approximately $45.0 million, with about $10.8 million expiring between 2034 and 2037 [243]. - The company requires substantial additional funding to continue research and development activities and advance commercialization efforts, which may not be available on acceptable terms [231]. - A recent private placement raised approximately $6 million, but additional capital may cause dilution to existing stockholders [234]. - The company has not generated any product sales revenue and expects to continue incurring substantial losses while preparing product candidates for the market [236]. - The company has substantial doubt about its ability to continue as a going concern without additional funding [229]. - The company may need to significantly scale back or reprioritize research and development activities if additional capital is not available [231]. Research and Development Challenges - The company may face significant delays in clinical trials due to various factors, including patient enrollment challenges and regulatory approvals [249]. - The company’s approach to developing therapeutic product candidates is new and may never lead to marketable products, increasing investment risks [256]. - The company’s research and development activities may be impeded by scientific or technological difficulties, potentially delaying commercialization [258]. - The company is preparing for Phase III clinical trials for its lead product candidates, MicroLine and MicroPine, which are critical for obtaining regulatory approval and launching commercial sales [260]. - The success of the company's business strategy relies on developing several pipeline product candidates over the next 3-4 years, requiring substantial investment and regulatory approvals [263]. - The company faces significant competition in the specialty pharma market, which is characterized by rapid technological change and the potential for competitors to achieve regulatory approval before the company [271]. Market and Commercialization Risks - The commercial success of the product candidates will depend on market acceptance among ophthalmologists, optometrists, and third-party payors, as well as the safety and efficacy of the products [269]. - The company must establish effective distribution processes and maintain adequate sales and marketing capabilities to achieve commercial success [276]. - Regulatory approvals are essential for commercialization, and any delays or failures in obtaining these approvals could materially impair the company's ability to generate revenue [283]. - The company is exposed to risks related to product liability claims, which could divert resources and limit commercialization of its products [279]. - The company must comply with extensive regulatory requirements, including post-marketing studies and safety monitoring, which can be costly and time-consuming [291]. - The company may face penalties for non-compliance with regulatory requirements, which could include fines, product recalls, or withdrawal of marketing approvals [293]. Legal and Regulatory Environment - The company is subject to various federal and state healthcare fraud and abuse laws, which could lead to substantial penalties if compliance is not achieved [296]. - The U.S. federal anti-kickback statute prohibits remuneration for referrals related to services covered by federal healthcare programs, impacting business arrangements [296]. - Legislative changes, including the Medicare Modernization Act, have altered reimbursement methodologies, potentially reducing coverage and prices for approved products [304]. - The Affordable Care Act (ACA) includes provisions that impose fees on manufacturers and increase rebate requirements, affecting profitability [305]. - The Budget Control Act of 2011 mandates up to 2% reductions in Medicare payments to providers, impacting revenue streams [308]. Operational and Management Considerations - The company relies on a small workforce of 27 full-time employees as of March 25, 2020, and may face challenges in managing growth and infrastructure [323]. - Future performance is contingent on the ability to attract and retain qualified personnel amidst intense competition in the pharmaceutical industry [321]. - Compliance with anti-corruption laws, such as the FCPA and the Bribery Act, is critical and may incur significant costs and legal risks [312]. - The company may face delays in product launches due to pricing regulations in foreign markets, affecting revenue generation [311]. - The potential for legislative measures aimed at reducing drug costs could adversely impact anticipated revenue from product candidates [310]. Intellectual Property Risks - The company’s success depends on its ability to protect intellectual property, with potential challenges from competitors that could harm its competitive advantage [344]. - The patent application process is expensive and time-consuming, and there is no guarantee that patents will be issued to protect the company's technology [344][354]. - The company may face challenges in enforcing patent rights, which could limit its ability to prevent competitors from commercializing similar technologies [350]. - The company cannot be certain it was the first to file for patent protection, which could lead to disputes over patent rights with third parties [353]. - The patent application process is subject to numerous risks and uncertainties, which may result in partial or complete loss of patent rights in relevant jurisdictions [355]. - Competitors may seek or have already obtained patents that could limit the company's ability to make, use, and sell its potential product candidates [357]. - The company cannot assure that any of its patent applications will be found patentable or will issue as patents, which could materially harm its business [361]. - The lifespan of patents is generally 20 years after filing, and the company may not obtain adequate protection for its products if patents expire before commercialization [369]. - The company may face challenges in enforcing its intellectual property rights globally, particularly in jurisdictions with less favorable patent laws [376]. - Legal proceedings to enforce patent rights could result in substantial costs and divert resources from other business aspects [379]. - The company’s commercial success depends on its ability to develop and market product candidates without infringing third-party intellectual property rights [383]. - The company may face substantial intellectual property litigation risks, including potential infringement claims from third parties [384]. - If found to infringe on third-party intellectual property rights, the company could be forced to cease development or obtain licenses that may not be commercially reasonable [385]. - The company relies on licenses for certain patent rights and proprietary technology, which may not provide exclusive rights, potentially allowing competitors to develop similar products [396]. - The company may be unable to control patent prosecution or maintenance under licensing agreements, risking the validity and enforceability of necessary patents [397]. Stockholder and Market Considerations - The company’s management and Board of Directors beneficially owned approximately 23% of the capital stock as of March 25, 2020, allowing them to influence stockholder decisions significantly [407]. - A significant portion of the company's outstanding shares may be sold into the market in the near future, potentially causing a significant drop in stock price [408]. - As of March 25, 2020, the company had 19,776,019 shares of common stock outstanding, including 2,675,293 shares issued in a recent private placement [409]. - The per share trading price of the company's common stock has fluctuated between $1.77 and $10.74 from the IPO in January 2018 to March 25, 2020 [412]. - The company is required to file a resale registration statement with the SEC within the next 30 days for shares issued in the private placement and warrants [409]. - The company has broad discretion in the use of cash from financings, which could impact operational results if not applied effectively [414]. - The company is subject to increased legal, accounting, and financial compliance costs due to regulations such as the Sarbanes-Oxley Act [417]. - The company identified material weaknesses in internal controls in 2017, which have since been remedied, but future weaknesses may arise [421]. - The company is classified as an "emerging growth company," allowing it to delay adopting new accounting standards [424]. - The company will remain an emerging growth company until certain financial thresholds are met, including a market value exceeding $700 million or total annual gross revenue of $1.07 billion [426]. - The stock market has experienced extreme price fluctuations, which could affect the company's stock price and trading activity [412]. - The company may face challenges in maintaining effective internal controls, which could adversely affect financial reporting and investor confidence [422].

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]

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]