PART I [CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS](index=4&type=section&id=CAUTIONARY%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) The report contains forward-looking statements involving risks and uncertainties that may cause actual results to differ - Forward-looking statements in the report involve risks and uncertainties that could cause actual results to differ materially from projections[13](index=13&type=chunk) - Statements cover estimates for expenses, future revenue, capital requirements, product development, and economic conditions[13](index=13&type=chunk) - The company undertakes no obligation to update any forward-looking statements to reflect subsequent events or circumstances[13](index=13&type=chunk) [Summary Risk Factors](index=5&type=section&id=Summary%20Risk%20Factors) The company faces material risks related to its financial position, product development, and regulatory compliance - The company faces risks related to its financial position, including the ability to continue as a **going concern** and the need for additional capital, which may cause dilution or restrict operations[17](index=17&type=chunk)[18](index=18&type=chunk) - Development and commercialization risks include potential **delays or failures in clinical trials**, difficulties in patient enrollment, inability to develop marketable products, and intense competition[19](index=19&type=chunk)[20](index=20&type=chunk) - Regulatory and legal compliance risks involve potential failure to obtain marketing approval, penalties for non-compliance, and the impact of new legislation[21](index=21&type=chunk)[22](index=22&type=chunk)[23](index=23&type=chunk) [RISKS RELATED TO OUR FINANCIAL POSITION AND NEED FOR ADDITIONAL CAPITAL](index=5&type=section&id=RISKS%20RELATED%20TO%20OUR%20FINANCIAL%20POSITION%20AND%20NEED%20FOR%20ADDITIONAL%20CAPITAL) - The company may not be able to continue as a **going concern**, potentially leading to significant loss for stockholders[17](index=17&type=chunk) - **Additional capital is required** for product development, manufacturing, and commercialization, and failure to secure it could force delays or termination of efforts[18](index=18&type=chunk) - Raising capital may **dilute existing stockholders**, restrict operations, or require relinquishing rights to technologies[18](index=18&type=chunk) - The company has incurred **operating losses since inception** and expects to continue doing so, with no guarantee of future profitability[18](index=18&type=chunk) [RISKS RELATED TO DEVELOPMENT AND COMMERCIALIZATION OF OUR PRODUCT CANDIDATES](index=5&type=section&id=RISKS%20RELATED%20TO%20DEVELOPMENT%20AND%20COMMERCIALIZATION%20OF%20OUR%20PRODUCT%20CANDIDATES) - Substantial **delays or failures in clinical trials** by the company or its licensees are possible[19](index=19&type=chunk) - Difficulty in enrolling or maintaining patient participation in clinical trials could occur[20](index=20&type=chunk) - The company may not be able to develop marketable products using its technology or successfully implement alternative development strategies[20](index=20&type=chunk) - The **marketing approval process is expensive, time-consuming, and uncertain**, potentially preventing commercialization[20](index=20&type=chunk) - Product candidates may cause undesirable side effects, and market opportunities might be smaller than anticipated[20](index=20&type=chunk) - Commercial success depends on market acceptance, and licensing partners may not exert commercially reasonable efforts[20](index=20&type=chunk) - The company faces **intense competition** and risks from rapid technological change[20](index=20&type=chunk) - Failure to establish and maintain effective manufacturing and distribution processes, and exposure to product liability claims, are significant risks[20](index=20&type=chunk) [RISKS RELATED TO REGULATORY APPROVAL AND LEGAL COMPLIANCE MATTERS](index=5&type=section&id=RISKS%20RELATED%20TO%20REGULATORY%20APPROVAL%20AND%20LEGAL%20COMPLIANCE%20MATTERS) - Inability or delays in obtaining required **regulatory approvals** could prevent commercialization of product candidates[21](index=21&type=chunk) - Failure to obtain marketing approval in foreign jurisdictions would prevent product marketing there[22](index=22&type=chunk) - Term restrictions for products in the U.S. and other licensed jurisdictions may limit manufacturing and marketing[22](index=22&type=chunk) - Substantial penalties may be incurred for **non-compliance with regulatory requirements** or unanticipated product problems[22](index=22&type=chunk) - Recently enacted and future legislation may affect the ability to commercialize products and their prices[22](index=22&type=chunk) - Failure to comply with laws governing operations could lead to penalties, remedial measures, or restrictions on product development and sales[22](index=22&type=chunk)[23](index=23&type=chunk) [RISKS RELATED TO OUR BUSINESS OPERATIONS AND MANAGING GROWTH](index=7&type=section&id=RISKS%20RELATED%20TO%20OUR%20BUSINESS%20OPERATIONS%20AND%20MANAGING%20GROWTH) - High dependence on **senior management team** services[25](index=25&type=chunk) - Limited corporate infrastructure and potential difficulties in managing growth[25](index=25&type=chunk) - Reliance on information technology, with risks of failure, inadequacy, interruption, or **cybersecurity incidents**[25](index=25&type=chunk) [RISKS RELATED TO OUR DEPENDENCE ON THIRD PARTIES](index=7&type=section&id=RISKS%20RELATED%20TO%20OUR%20DEPENDENCE%20ON%20THIRD%20PARTIES) - Limited clinical trial experience and **reliance on third parties** for conducting and managing clinical trials[26](index=26&type=chunk) - Potential need to contract with additional third parties for manufacturing product candidates, especially for commercialization[26](index=26&type=chunk) [RISKS RELATED TO OUR INTELLECTUAL PROPERTY AND POTENTIAL LITIGATION](index=7&type=section&id=RISKS%20RELATED%20TO%20OUR%20INTELLECTUAL%20PROPERTY%20AND%20POTENTIAL%20LITIGATION) - Success depends on the ability to **protect intellectual property**, proprietary technology, and trade secrets[27](index=27&type=chunk) - Patents covering proprietary technology may be challenged, narrowed, circumvented, or invalidated by third parties[28](index=28&type=chunk) - Uncertainty regarding being the first to invent or file for patent protection[28](index=28&type=chunk) - The patent application process is risky, with no assurance of successful patent obtainment[28](index=28&type=chunk) - Changes to patent law could diminish patent value, impairing product protection[28](index=28&type=chunk) - Risk of expensive, time-consuming, and unsuccessful lawsuits to protect or enforce intellectual property[28](index=28&type=chunk) - Failure to comply with intellectual property license obligations could lead to loss of important license rights[28](index=28&type=chunk) - Inadequate protection of trademarks and trade names could adversely affect business and name recognition[28](index=28&type=chunk) [RISKS RELATED TO OWNERSHIP OF OUR COMMON STOCK](index=7&type=section&id=RISKS%20RELATED%20TO%20OWNERSHIP%20OF%20OUR%20COMMON%20STOCK) - Management and Board of Directors can substantially influence all matters submitted to stockholders for approval[29](index=29&type=chunk) - Potential for a significant portion of outstanding shares to be sold, causing a drop in common stock market price[29](index=29&type=chunk) - The price of common stock may be **volatile** and fluctuate substantially[29](index=29&type=chunk) - Broad discretion in the use of cash[29](index=29&type=chunk) - Business is subject to changing regulations regarding corporate governance and disclosure controls, increasing costs and noncompliance risk[29](index=29&type=chunk) - Failure to develop and maintain adequate financial controls could lead to material weaknesses[29](index=29&type=chunk) - Provisions in corporate charter documents and Delaware law could make an acquisition more difficult[29](index=29&type=chunk) - Certificate of incorporation designates the Delaware Court of Chancery as the sole forum for most disputes[29](index=29&type=chunk) [Item 1. Business](index=8&type=section&id=Item%201.%20Business) The company develops ophthalmic therapeutics using its proprietary Optejet® microdose delivery platform - Eyenovia is a clinical-stage ophthalmic company developing advanced therapeutics based on its proprietary microdose array print (MAP™) platform technology, Optejet®[32](index=32&type=chunk) - The Optejet® system aims to improve safety and delivery success by achieving high-precision microdosing with up to a **75% reduction in ocular drug exposure**[32](index=32&type=chunk)[52](index=52&type=chunk)[56](index=56&type=chunk) - The company's pipeline focuses on late-stage development for progressive myopia (MicroPine), presbyopia (MicroLine), and mydriasis (MydCombi™)[33](index=33&type=chunk) [Corporate Information](index=8&type=section&id=Corporate%20Information) - Eyenovia, Inc. was organized in Florida on March 12, 2014, and reincorporated in Delaware on October 6, 2014[31](index=31&type=chunk) - Principal executive office is located at 295 Madison Avenue, Suite 2400, New York, NY 10017[31](index=31&type=chunk) [Overview](index=8&type=section&id=Overview) - Eyenovia is a clinical-stage ophthalmic company developing advanced therapeutics using its proprietary microdose array print (MAP™) platform technology, Optejet®[32](index=32&type=chunk) - The Optejet® system aims to improve safety and patient compliance by delivering micro-volume doses with up to a **75% reduction in ocular drug and preservative topical dosing**[32](index=32&type=chunk) - The company's pipeline includes MicroPine for progressive myopia (Phase III), MicroLine for presbyopia (Phase III initiated), and MydCombi™ for mydriasis (NDA accepted by FDA)[33](index=33&type=chunk)[34](index=34&type=chunk)[37](index=37&type=chunk)[39](index=39&type=chunk)[40](index=40&type=chunk) - License agreements were signed for MicroPine with Bausch Health (**$10.0M upfront**) and for MicroPine and MicroLine with Arctic Vision (**$4.0M upfront**)[35](index=35&type=chunk)[38](index=38&type=chunk) [Our Strategy](index=9&type=section&id=Our%20Strategy) - Establish a portfolio of first-in-class micro-therapeutic products for multiple eye treatments through the **505(b)(2) pathway** with the FDA[41](index=41&type=chunk) - Improve clinical outcomes and patient experiences by providing an improved tolerability profile with microdose therapeutics[43](index=43&type=chunk) - Leverage electronic, smartphone-enabled 'e-health' technology (Optejet) for patient-specific compliance monitoring[44](index=44&type=chunk) - Develop next-generation targeted microdose treatments for other ophthalmic diseases independently or in collaboration with third parties[45](index=45&type=chunk)[46](index=46&type=chunk) [Limitations of Conventional Eye Therapies](index=10&type=section&id=Limitations%20of%20Conventional%20Eye%20Therapies) - Conventional eye drops suffer from issues like **overdosing, poor compliance, and imprecise dosing**, with low correct administration rates (22%-30%)[47](index=47&type=chunk) - Traditional eye drops (30-50 µL) severely overdose the eye, leading to ocular and potential systemic side effects[48](index=48&type=chunk) - MydCombi microdosing demonstrated **few ocular adverse events and no systemic adverse events** in Phase III studies, suggesting improved tolerability[50](index=50&type=chunk) [Our Solution: The Optejet](index=11&type=section&id=Our%20Solution%3A%20The%20Optejet) - The Optejet dispenser delivers precise 6-8 µL doses, reducing drug and toxic preservative exposure by **over 75%**[52](index=52&type=chunk)[56](index=56&type=chunk) - The technology is based on high-precision inkjet printing (MAP™) and includes smart electronics with Bluetooth connectivity to track patient medication administration[54](index=54&type=chunk)[60](index=60&type=chunk) - The FDA classifies Eyenovia's products as **drugs, not medical devices**, meaning the Optejet dispenser does not require separate FDA approval[32](index=32&type=chunk)[55](index=55&type=chunk) - Key advantages include precise volumetric control, targeted delivery, fast delivery (less than 100 milliseconds), and smart electronics for compliance tracking[56](index=56&type=chunk)[57](index=57&type=chunk)[58](index=58&type=chunk)[60](index=60&type=chunk) [Clinical Trial Results](index=13&type=section&id=Clinical%20Trial%20Results) - Preclinical and clinical studies suggest that an **8 µL microdose provides comparable clinical efficacy** to traditional eye drops with fewer side effects[61](index=61&type=chunk) - A canine glaucoma model showed **>40% IOP lowering** with an 8-9 µL latanoprost microdose, and a study demonstrated a 3 µL timolol microdose reduced systemic plasma levels by a factor of 17[62](index=62&type=chunk) - Phase II EYN-1601 trial for mydriasis showed microdosed phenylephrine 10% achieved similar dilation to drops with **35-40% lower plasma levels** and fewer ocular adverse events[65](index=65&type=chunk)[68](index=68&type=chunk)[70](index=70&type=chunk) Ocular Adverse Events by Treatment (EYN-1601) | Adverse Event Description | PE 10% (Eyedrops) | EYN (PE 10% microdose) | |:---|:---|:---| | Ocular blurriness | 1 | 0 | | Ocular burning/stinging/irritation | 4 | 1 | | Ocular dryness | 2 | 0 | | **Subtotal by Treatment Group** | **7** | **1** | - The EYE-103 study showed equivalent pupil dilation to eye drops, with **91% of participants preferring Optejet** administration and nearly two times better ocular comfort scores[71](index=71&type=chunk) - EYN-POC-PG-21 trial (latanoprost 0.005% microdose) demonstrated **mean diurnal IOP reduction similar to traditional eye drops** (35.5% on Day 3 vs. 35.0% for drops)[73](index=73&type=chunk)[74](index=74&type=chunk)[76](index=76&type=chunk) - Optejet administration success rate was **96% on the first attempt**, and almost 90% of subjects demonstrated accurate self-administration after training[77](index=77&type=chunk)[79](index=79&type=chunk) [Our Product Candidates](index=17&type=section&id=Our%20Product%20Candidates) - Eyenovia's current focus is on three programs: MicroLine (presbyopia), MicroPine (progressive myopia), and MydCombi (mydriasis)[82](index=82&type=chunk) [MicroLine](index=17&type=section&id=MicroLine) MicroLine is a proprietary microdosed pilocarpine formulation for presbyopia, an age-related near vision impairment - MicroLine is a proprietary microdosed version of pilocarpine, designed to induce miosis and improve near visual acuity in individuals with presbyopia[83](index=83&type=chunk)[84](index=84&type=chunk) - Presbyopia affects approximately **113 million people in the United States**, representing a significant unmet medical need as there are no known FDA-approved drugs for this indication[37](index=37&type=chunk)[85](index=85&type=chunk)[86](index=86&type=chunk) - The company has initiated two **Phase III VISION trials** to evaluate the safety, tolerability, and efficacy of Optejet-administered pilocarpine microdosing[37](index=37&type=chunk)[87](index=87&type=chunk) [MicroPine](index=18&type=section&id=MicroPine) MicroPine is a first-in-class topical micro-formulation of low-dose atropine for progressive myopia - MicroPine is a first-in-class topical micro-formulation of low-dose atropine for progressive myopia, a disease affecting an estimated **25 million children in the U.S.**[34](index=34&type=chunk)[89](index=89&type=chunk)[90](index=90&type=chunk)[95](index=95&type=chunk) - The FDA accepted an IND for the **Phase III CHAPERONE study** in February 2019, with enrollment resuming after initial COVID-19 related delays[34](index=34&type=chunk)[96](index=96&type=chunk) - Low-dose atropine has **Level 1 evidence of efficacy** in reducing myopia progression, but conventional 1% atropine has undesirable side effects that MicroPine aims to mitigate[93](index=93&type=chunk)[95](index=95&type=chunk) - The CHAPERONE study is a U.S.-based, multi-center, randomized, double-masked trial enrolling over 400 children[96](index=96&type=chunk) [MydCombi](index=19&type=section&id=MydCombi) MydCombi is a fixed-combination micro-formulation of phenylephrine-tropicamide for mydriasis - MydCombi (MicroStat) is a fixed-combination micro-formulation for mydriasis, designed for over **100 million annual office-based eye exams** in the U.S., with an estimated market exceeding **$250 million**[39](index=39&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk) - The company completed two **Phase III trials (MIST-1 and MIST-2)** in November 2019, demonstrating positive results for pupil dilation[39](index=39&type=chunk)[103](index=103&type=chunk) - In MIST-1, MicroStat showed statistically significant pupil dilation, achieving ≥6.0 mm pupil diameter in **95.2% of right eyes** and **93.5% of left eyes** at 35 minutes[109](index=109&type=chunk)[112](index=112&type=chunk)[113](index=113&type=chunk) - In MIST-2, MydCombi achieved highly statistically significant pupil dilation, with ≥6.0 mm pupil diameter in **92.8% of right eyes** and **94.2% of left eyes** at 35 minutes[118](index=118&type=chunk)[121](index=121&type=chunk)[123](index=123&type=chunk) Efficacy of MydCombi in MIST-1 and MIST-2 Studies (PP Populations) | | MIST-1 | MIST-2 | |:---|:---|:---| | Mean change in pupil diameter from baseline at 35 minutes | 4.6 mm right eyes, 4.7 mm left eyes | 4.7 mm right eyes, 4.8 mm left eyes | | Proportion of eyes with pupil diameter ≥ 6.0 mm at 35 minutes | 95.2% of right eyes, 93.5% of left eyes | 92.8% of right eyes, 94.2% of left eyes | | Median time to maximum post-baseline pupil diameter with ≥ 1.0 mm increase from baseline | 73.0 minutes | 71.0 minutes | - The FDA accepted the NDA for MydCombi in March 2021, with an expected Prescription Drug User Fee Act (PDUFA) date of **October 28, 2021**[39](index=39&type=chunk)[126](index=126&type=chunk) [Our Technology](index=23&type=section&id=Our%20Technology) - The Optejet system consists of a reusable base and a disposable cartridge with a piezo-driven ejector nozzle[127](index=127&type=chunk) - Patients self-administer by aligning with an illuminated circle and pressing a button to emit a micro-jet of micro-droplets in **less than 100 milliseconds**[128](index=128&type=chunk) - The system minimizes drug waste and preservative delivery to the eye, and the rechargeable base provides consistent dose delivery[128](index=128&type=chunk) - The technology is based on piezo-driven printer technology, adapted for therapeutic delivery to the eye[130](index=130&type=chunk) [Sales and Marketing](index=25&type=section&id=Sales%20and%20Marketing) - Eyenovia employs a staged commercialization approach, retaining rights for MydCombi and partnering for products requiring larger sales forces[131](index=131&type=chunk) - MydCombi, as a **cash-pay pharmaceutical** for in-office use, is expected to have significantly lower sales and marketing costs[132](index=132&type=chunk)[140](index=140&type=chunk) - MicroLine is also expected to be a cash-pay product, with plans to expand the U.S. sales force to 50 people[133](index=133&type=chunk)[142](index=142&type=chunk) - MicroPine is a standard therapeutic, likely reimbursed by payers, and its commercialization is handled by licensees (Arctic Vision, Bausch Health)[134](index=134&type=chunk)[143](index=143&type=chunk) [Manufacturing](index=25&type=section&id=Manufacturing) - For clinical supply, the company relies on a combination of limited internal manufacturing capacity and **third-party manufacturers**[135](index=135&type=chunk) - The company does not have long-term agreements with current manufacturers and plans to use multiple **contract manufacturing organizations (CMOs)** for commercialization[135](index=135&type=chunk)[137](index=137&type=chunk) - Potential replacements for existing third-party suppliers exist, but delays in sourcing materials or services could occur[135](index=135&type=chunk) [Competition](index=26&type=section&id=Competition) - The biotechnology and pharmaceutical industries are **highly competitive**, characterized by rapid technological advancements[138](index=138&type=chunk) - Competitors include large pharmaceutical/biotechnology companies and specialty/generic drug companies, many with significantly greater resources[139](index=139&type=chunk) - For MydCombi, there are **no known FDA-approved micro-therapeutics or fixed-combination products**, but competitive macrodose drops exist[140](index=140&type=chunk) - For MicroLine, there are **no FDA-approved drugs for presbyopia**, though other companies are developing therapies without microdosing technology[141](index=141&type=chunk) - For MicroPine, there are **no FDA-approved drugs to slow myopia progression**, but other traditional eye drop atropine versions are under development[143](index=143&type=chunk) [Intellectual Property](index=26&type=section&id=Intellectual%20Property) - The company's success depends on its ability to obtain, maintain, and enforce proprietary rights related to its products and technologies[144](index=144&type=chunk) [Patents](index=26&type=section&id=Patents) As of December 31, 2020, Eyenovia owned nine U.S. issued utility patents and 53 issued foreign patents - As of December 31, 2020, Eyenovia owned **nine U.S. issued utility patents**, one issued design patent, 53 issued foreign patents, and multiple pending applications[145](index=145&type=chunk) - Patent coverage includes piezoelectric devices for micro-droplet ejection, methods of delivering medicament, and devices with specially shaped openings for laminar flow[147](index=147&type=chunk)[148](index=148&type=chunk)[149](index=149&type=chunk)[150](index=150&type=chunk)[151](index=151&type=chunk) - U.S. patents are expected to expire between **2031 and 2033**, with potential for patent term extension under the Hatch-Waxman Act[147](index=147&type=chunk)[149](index=149&type=chunk)[150](index=150&type=chunk)[151](index=151&type=chunk)[153](index=153&type=chunk)[154](index=154&type=chunk) - In Asia, patents have been granted in China, South Korea, and Japan for piezoelectric devices and methods of use[157](index=157&type=chunk) [Trademarks](index=28&type=section&id=Trademarks) Eyenovia markets its products under trademarks and service marks, including EYENOVIA® and OPTEJET™ - Trademarks in the company's portfolio include **EYENOVIA®, OPTEJET™, EYELATOVA™, and EYETANO™**, which are registered or applied for in the United States[158](index=158&type=chunk) - The company plans to file additional trademark applications to protect its market positions globally[159](index=159&type=chunk) [Proprietary Technology](index=28&type=section&id=Proprietary%20Technology) Beyond patents, Eyenovia relies on trade secrets and proprietary know-how to protect its technology - The company relies on **trade secrets and proprietary know-how** to protect its technology, including methods of manufacture and systems[160](index=160&type=chunk) - Protection measures include non-disclosure and confidentiality agreements with employees, consultants, and third parties[160](index=160&type=chunk) - Invention assignment agreements are required with employees, consultants, and contractors[160](index=160&type=chunk) [Government Regulation and Product Approvals](index=28&type=section&id=Government%20Regulation%20and%20Product%20Approvals) - Pharmaceutical products are extensively regulated by government authorities in the United States (FDA) and other countries[161](index=161&type=chunk) - Obtaining regulatory approvals and ensuring compliance requires substantial time and financial resources[161](index=161&type=chunk)[162](index=162&type=chunk) [Review and Approval of Drugs in the United States](index=28&type=section&id=Review%20and%20Approval%20of%20Drugs%20in%20the%20United%20States) The FDA regulates drug products under the FDCA, requiring a multi-stage approval process - The FDA regulates drug products under the Food, Drug, and Cosmetic Act (FDCA), requiring extensive and costly processes for approval and compliance[162](index=162&type=chunk) - The typical approval process involves preclinical studies, IND submission, human clinical trials, NDA submission, and post-approval requirements[163](index=163&type=chunk)[164](index=164&type=chunk) - The **505(b)(2) NDA pathway** allows applicants to rely on the FDA's previous findings of safety and efficacy for a similar product, potentially expediting approval[195](index=195&type=chunk) - Generic drugs are approved via Abbreviated New Drug Applications (ANDAs) by demonstrating bioequivalence to a reference-listed drug (RLD)[196](index=196&type=chunk)[197](index=197&type=chunk) - Exclusivity periods (e.g., 5 years for New Chemical Entities, 3 years for new clinical investigations) impact market entry[200](index=200&type=chunk)[201](index=201&type=chunk)[202](index=202&type=chunk)[203](index=203&type=chunk)[204](index=204&type=chunk)[205](index=205&type=chunk)[206](index=206&type=chunk)[210](index=210&type=chunk) - The **21st Century Cures Act** (2016) aims to modernize healthcare, spur innovation, and streamline drug development[213](index=213&type=chunk)[214](index=214&type=chunk) [Review and Approval of Drug Products in the European Union](index=37&type=section&id=Review%20and%20Approval%20of%20Drug%20Products%20in%20the%20European%20Union) Marketing products outside the U.S. requires compliance with lengthy and varied foreign regulatory requirements - Marketing products outside the U.S. requires compliance with numerous and varying foreign regulatory requirements[215](index=215&type=chunk) - In the European Union, clinical trials require approval from competent national authorities and favorable ethics committee opinions[216](index=216&type=chunk)[224](index=224&type=chunk) - Marketing authorization applications (MAAs) can be submitted via **centralized (single EU-wide approval)** or decentralized procedures[217](index=217&type=chunk)[218](index=218&type=chunk)[220](index=220&type=chunk) - New chemical entities in the EU receive **8 years of data exclusivity** and an additional **2 years of market exclusivity**[229](index=229&type=chunk) - Post-marketing, products are subject to comprehensive regulatory oversight, including pharmacovigilance and cGMP compliance[230](index=230&type=chunk)[231](index=231&type=chunk) [Pharmaceutical Coverage, Pricing and Reimbursement](index=40&type=section&id=Pharmaceutical%20Coverage%2C%20Pricing%20and%20Reimbursement) - MydCombi and MicroLine are intended as **'cash pay' products**, likely exempt from complex coverage and reimbursement issues[233](index=233&type=chunk) - MicroPine's sales will depend on **third-party payor coverage** and adequate reimbursement levels[233](index=233&type=chunk)[234](index=234&type=chunk) - Obtaining coverage and reimbursement may require expensive pharmacoeconomic studies[234](index=234&type=chunk) - Governments globally are implementing cost-containment programs, which could limit revenue from approved products[235](index=235&type=chunk)[236](index=236&type=chunk)[237](index=237&type=chunk) [Healthcare Law and Regulation](index=41&type=section&id=Healthcare%20Law%20and%20Regulation) - The company's arrangements with healthcare providers are subject to various federal and state healthcare laws, including **anti-kickback statutes and HIPAA**[239](index=239&type=chunk) - Non-compliance with these laws could result in substantial penalties, fines, or exclusion from government programs[239](index=239&type=chunk)[240](index=240&type=chunk) - State and foreign laws also govern health information privacy and security, often differing from HIPAA[240](index=240&type=chunk) [Changes in the Healthcare Marketplace](index=41&type=section&id=Changes%20in%20the%20Healthcare%20Marketplace) - The U.S. healthcare industry is driven by cost containment, with legislative changes impacting pharmaceutical pricing[241](index=241&type=chunk) - The **Affordable Care Act (ACA)** included provisions expanding Medicaid rebates and imposing fees on branded manufacturers[243](index=243&type=chunk) - Future reform efforts are expected to continue prioritizing reductions in Medicare and other healthcare spending[244](index=244&type=chunk)[245](index=245&type=chunk)[330](index=330&type=chunk) [Employees](index=43&type=section&id=Employees) - As of March 29, 2021, the company had **31 full-time and 3 part-time employees**, and also engages various consultants and contractors[246](index=246&type=chunk) [Available Information](index=43&type=section&id=Available%20Information) - Annual, Quarterly, and Current Reports are available free of charge on the company's website and the SEC's website[247](index=247&type=chunk) [Item 1A. Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) The company faces comprehensive risks related to its financial stability, product development, and regulatory hurdles - Investing in Eyenovia's common stock involves a **high degree of risk**[249](index=249&type=chunk) - There is **substantial doubt about the company's ability to continue as a going concern** without additional funding[251](index=251&type=chunk) - The company has incurred approximately **$77.4 million in net losses since inception** and expects to continue incurring substantial losses[258](index=258&type=chunk)[488](index=488&type=chunk) - Key risks include the need for substantial additional capital, potential dilution, delays or failures in clinical trials, and intense competition[252](index=252&type=chunk)[255](index=255&type=chunk)[267](index=267&type=chunk)[290](index=290&type=chunk)[291](index=291&type=chunk)[292](index=292&type=chunk)[293](index=293&type=chunk)[294](index=294&type=chunk)[303](index=303&type=chunk)[304](index=304&type=chunk)[305](index=305&type=chunk)[306](index=306&type=chunk)[361](index=361&type=chunk)[362](index=362&type=chunk) [Item 1B. Unresolved Staff Comments](index=73&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) As a smaller reporting company, Eyenovia is not required to provide this information - Smaller reporting companies are not required to provide information for this item[454](index=454&type=chunk) [Item 2. Properties](index=73&type=section&id=Item%202.%20Properties) The company maintains offices and facilities in New York, Nevada, and California - Principal executive offices: approximately **3,800 sq ft** in New York City, NY[455](index=455&type=chunk) - Research and development activities: approximately **1,000 sq ft** in Reno, Nevada[455](index=455&type=chunk) - Planned commercial manufacturing facility: approximately **4,500 sq ft** in Redwood City, California[455](index=455&type=chunk) - Clinical and marketing team offices: **120 sq ft** in Newport Beach, California[455](index=455&type=chunk) - The company believes existing facilities are adequate and suitable additional spaces will be available on commercially reasonable terms[456](index=456&type=chunk) [Item 3. Legal Proceedings](index=74&type=section&id=Item%203.%20Legal%20Proceedings) Eyenovia reported no legal proceedings as of the filing date - The company has no legal proceedings to report[459](index=459&type=chunk) [Item 4. Mine Safety Disclosures](index=74&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Eyenovia - This item is not applicable to the company[461](index=461&type=chunk) PART II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=76&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq, and no cash dividends have been declared or are planned - Eyenovia's common stock trades on the Nasdaq Capital Market under the symbol **"EYEN"**[471](index=471&type=chunk) - As of March 29, 2021, there were approximately **130 holders of record** of the company's common stock[471](index=471&type=chunk) - The company has **never declared cash dividends** and does not plan to in the foreseeable future, intending to retain future earnings for business growth[472](index=472&type=chunk)[451](index=451&type=chunk) - No recent sales of unregistered securities or issuer purchases of equity securities were reported[474](index=474&type=chunk)[475](index=475&type=chunk) [Item 6. Selected Financial Data](index=76&type=section&id=Item%206.%20Selected%20Financial%20Data) As a smaller reporting company, Eyenovia is not required to provide selected financial data - Smaller reporting companies are not required to provide information for this item[477](index=477&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operation](index=76&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operation) Management discusses financial results, highlighting revenue from licensing, R&D expenses, and going concern uncertainty - Eyenovia is a clinical-stage ophthalmic company developing advanced therapeutics based on its proprietary microdose array print (MAP™) platform technology, Optejet®[480](index=480&type=chunk) - The company's pipeline includes MicroPine for progressive myopia, MicroLine for presbyopia, and MydCombi™ for mydriasis, all utilizing the Optejet® system[480](index=480&type=chunk) - Historically, operations have been financed through equity offerings and, more recently, licensing arrangements[487](index=487&type=chunk) - There is **substantial doubt about the company's ability to continue as a going concern** for at least the next twelve months due to recurring net losses[487](index=487&type=chunk)[502](index=502&type=chunk) [Overview](index=77&type=section&id=Overview_77) - Eyenovia is a clinical-stage ophthalmic company developing microdose therapeutics via its Optejet® platform, which has demonstrated **~90% delivery success**[480](index=480&type=chunk) - The pipeline includes MicroPine (Phase III), MicroLine (Phase III initiated), and MydCombi™ (NDA accepted with PDUFA date of October 28, 2021)[481](index=481&type=chunk)[482](index=482&type=chunk)[483](index=483&type=chunk)[484](index=484&type=chunk)[485](index=485&type=chunk) - The company has incurred net losses of **$19.8 million (2020)** and **$21.2 million (2019)**, with an accumulated deficit of **$77.4 million** as of December 31, 2020[488](index=488&type=chunk) [Financial Overview](index=78&type=section&id=Financial%20Overview) - Revenue is generated from upfront licensing fees, development/regulatory milestones, and royalties on sales of licensed products[489](index=489&type=chunk) - Research and development expenses are expensed as incurred and are expected to increase with ongoing initiatives[490](index=490&type=chunk)[491](index=491&type=chunk)[492](index=492&type=chunk) - General and administrative expenses are anticipated to increase due to headcount growth and public company compliance costs[493](index=493&type=chunk) [Results of Operations](index=79&type=section&id=Results%20of%20Operations) [Year Ended December 31, 2020 Compared with Year Ended December 31, 2019](index=79&type=section&id=Year%20Ended%20December%2031%2C%202020%20Compared%20with%20Year%20Ended%20December%2031%2C%202019) [Revenue and Cost of Revenue](index=79&type=section&id=Revenue%20and%20Cost%20of%20Revenue_79) In 2020, Eyenovia recognized $2.0 million in revenue from a milestone under the Arctic Vision License Agreement - In August 2020, received **$4.0 million upfront payment** from Arctic Vision License Agreement, recorded as deferred license fee[495](index=495&type=chunk) - In October 2020, received **$10.0 million upfront payment** from Bausch Health License Agreement, recorded as deferred license fee[495](index=495&type=chunk) - In December 2020, recognized **$2.0 million in revenue** from an Arctic Vision milestone, with an accrued **$0.8 million cost of revenue** to Senju[495](index=495&type=chunk) [Research and Development Expenses](index=79&type=section&id=Research%20and%20Development%20Expenses_79) Research and development expenses decreased by $0.8 million (6%) to $13.3 million in 2020 Research and Development Expenses | | For the Year Ended December 31, 2020 | For the Year Ended December 31, 2019 | |:---|:---|:---| | Direct clinical and non-clinical expenses | $6,717,452 | $7,830,488 | | Personnel-related expenses | 3,688,948 | 3,136,860 | | Supplies and materials | 1,438,928 | 1,666,284 | | Non-cash stock-based compensation expenses | 1,350,894 | 1,459,055 | | Other | 67,595 | 9,762 | | **Total research and development expenses** | **$13,263,817** | **$14,102,449** | - Overall R&D expenses **decreased by $0.8 million (6%)** from $14.1 million in 2019 to $13.3 million in 2020[496](index=496&type=chunk) - The decrease was primarily driven by cost reimbursements from Arctic Vision and Bausch Health and reduced activity due to COVID-19[496](index=496&type=chunk) - Offsetting factors included an increase in personnel-related expenses due to new hires and increased depreciation[496](index=496&type=chunk) [General and Administrative Expenses](index=79&type=section&id=General%20and%20Administrative%20Expenses_79) General and administrative expenses increased by $0.5 million (7%) to $7.7 million in 2020 - General and administrative expenses **increased by $0.5 million (7%)** from $7.2 million in 2019 to $7.7 million in 2020[497](index=497&type=chunk) - Key drivers of the increase were **$0.2 million in payroll-related expenses**, **$0.4 million in patent expense**, and **$0.8 million in legal costs**[497](index=497&type=chunk) - These increases were partially offset by decreases in travel and meeting expenses due to COVID-19[497](index=497&type=chunk) [Liquidity and Going Concern](index=79&type=section&id=Liquidity%20and%20Going%20Concern) Recurring losses and negative cash flows raise substantial doubt about the company's ability to continue as a going concern Key Financial Position Data (as of December 31, 2020) | Metric | Amount (USD) | |:---|:---| | Cash and cash equivalents | $28.4 million | | Working capital | $15.2 million | | Stockholders' equity | $15.3 million | | Accumulated deficit | $77.4 million | - The company incurred a **net loss of $19.8 million** and used **$6.4 million in operating activities** for the year ended December 31, 2020[488](index=488&type=chunk)[503](index=503&type=chunk) - These conditions raise **substantial doubt about the company's ability to continue as a going concern**, requiring additional capital[502](index=502&type=chunk) Cash Flow Summary (Years Ended December 31) | Cash Flow Activity | 2020 (USD) | 2019 (USD) | |:---|:---|:---| | Net Cash Used In Operating Activities | $(6,384,276) | $(18,919,308) | | Net Cash Used In Investing Activities | $(261,257) | $(166,643) | | Net Cash Provided By Financing Activities | $20,864,760 | $13,510,352 | | Net Increase (Decrease) in Cash and Cash Equivalents | $14,219,227 | $(5,575,599) | | Cash and cash equivalents - End of Year | $28,371,828 | $14,152,601 | [Risks and Uncertainties](index=80&type=section&id=Risks%20and%20Uncertainties_80) - The COVID-19 pandemic caused initial delays in trial enrollment and initiation for the MicroPine CHAPERONE study[506](index=506&type=chunk) - Enrollment in the CHAPERONE study has since resumed[506](index=506&type=chunk) [Off-Balance Sheet Arrangements](index=80&type=section&id=Off-Balance%20Sheet%20Arrangements) Eyenovia has no material off-balance sheet arrangements - The company has no off-balance sheet arrangements that have a material effect on its financial conditions or results of operations[507](index=507&type=chunk) [Critical Accounting Policies](index=80&type=section&id=Critical%20Accounting%20Policies) Eyenovia's critical accounting policies are detailed in Note 2 of its financial statements - Critical accounting policies are included in Note 2 – Summary of Significant Accounting Policies of the financial statements[508](index=508&type=chunk) [Recently Issued Accounting Standards](index=81&type=section&id=Recently%20Issued%20Accounting%20Standards) Information on recently issued accounting standards is provided in Note 2 of the financial statements - Recently issued accounting standards are included in Note 2 – Summary of Significant Accounting Policies of the financial statements[510](index=510&type=chunk) [Item 7A. Quantitative and Qualitative Disclosures About Market Risk](index=81&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Eyenovia is not required to provide this information - Smaller reporting companies are not required to provide information for this item[511](index=511&type=chunk) [Item 8. Financial Statements and Supplementary Data](index=81&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The financial statements and supplementary data are included at the end of the report - Financial statements and supplementary data are included at the end of this report, beginning on page F-1[513](index=513&type=chunk) [Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosures](index=81&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosures) Eyenovia reported no changes in or disagreements with accountants - Not applicable, indicating no changes in or disagreements with accountants on accounting and financial disclosures[515](index=515&type=chunk) [Item 9A. Controls and Procedures](index=81&type=section&id=Item%209A.%20Controls%20and%20Procedures) [Evaluation of Disclosure Controls and Procedures](index=81&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management concluded that its disclosure controls and procedures were effective as of December 31, 2020 - As of December 31, 2020, management concluded that **disclosure controls and procedures were effective**[519](index=519&type=chunk) - Disclosure controls are designed to provide reasonable assurance that required information for SEC reports is recorded, processed, summarized, and reported timely[519](index=519&type=chunk) [Management's Report on Internal Control over Financial Reporting](index=81&type=section&id=Management%27s%20Report%20on%20Internal%20Control%20over%20Financial%20Reporting) Management concluded that the company's internal control over financial reporting was effective as of December 31, 2020 - Management is responsible for establishing and maintaining adequate internal control over financial reporting[520](index=520&type=chunk) - Based on an evaluation using the COSO 2013 Framework, management concluded that **internal control over financial reporting was effective** as of December 31, 2020[522](index=522&type=chunk) [Changes in Internal Control over Financial Reporting](index=82&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) There were no material changes in internal control over financial reporting during the fourth quarter of 2020 - **No material changes** in internal control over financial reporting occurred during the fourth quarter of 2020[523](index=523&type=chunk) [Attestation Report of Registered Public Accounting Firm](index=82&type=section&id=Attestation%20Report%20of%20Registered%20Public%20Accounting%20Firm) This report does not include an attestation report due to an exemption for emerging growth companies - An attestation report from the independent registered public accounting firm is not included due to the **JOBS Act exemption** for emerging growth companies[524](index=524&type=chunk) [Item 9B. Other Information](index=82&type=section&id=Item%209B.%20Other%20Information) Eyenovia reported no other information for this item - No other information is reported for this item[526](index=526&type=chunk) PART III [Item 10. Directors, Executive Officers, and Corporate Governance](index=83&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%2C%20and%20Corporate%20Governance) Information regarding directors and corporate governance is incorporated by reference from the proxy statement - Information on directors, executive officers, and corporate governance is **incorporated by reference** from the 2021 Annual Meeting of Stockholders proxy statement[530](index=530&type=chunk)[532](index=532&type=chunk) - Information concerning the Audit Committee is incorporated by reference from the proxy statement[531](index=531&type=chunk) - The company has adopted a code of business conduct and ethics for all employees, executive officers, and directors, available on its website[531](index=531&type=chunk) [Item 11. Executive Compensation](index=83&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive and director compensation is incorporated by reference from the proxy statement - Information on executive and director compensation is **incorporated by reference** from the proxy statement[532](index=532&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=83&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) This section provides information on security ownership, with details incorporated by reference from the proxy statement - Information on security ownership of certain beneficial owners and management is **incorporated by reference** from the proxy statement[534](index=534&type=chunk) Equity Compensation Plan Information (as of December 31, 2020) | Plan Category | Number of securities to be issued upon exercise of outstanding options, warrants and rights | Weighted-average exercise price of outstanding options, warrants and rights | Number of securities remaining available for future issuance under equity compensation plans | |:---|:---|:---|:---| | Equity compensation plans approved by security holders: 2014 Equity Incentive Plan, as amended | 1,140,630 | $2.88 | 15,333 | | Amended and Restated 2018 Omnibus Stock Incentive Plan | 2,423,993 | $3.57 | 502,853 | | Equity compensation plans not approved by security holders | - | - | - | | **Total** | **3,564,623** | **$3.34** | **518,186** | [Item 13. Certain Relationships and Related Transactions, and Director Independence](index=83&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information regarding related-party transactions and director independence is incorporated by reference from the proxy statement - Information on certain relationships, related-party transactions, and director independence is **incorporated by reference** from the proxy statement[535](index=535&type=chunk) [Item 14. Principal Accounting Fees and Services](index=84&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information regarding principal accounting fees and services is incorporated by reference from the proxy statement - Information on principal accounting fees and services is **incorporated by reference** from the proxy statement[537](index=537&type=chunk) PART IV [Item 15. Exhibits, Financial Statement Schedules](index=85&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists the documents filed as part of the report, including financial statements and an exhibit index - The report includes financial statements and related reports of the independent registered public accounting firm[540](index=540&type=chunk) - No financial statement schedules are filed[541](index=541&type=chunk) - An exhibit index lists various documents, including corporate charter documents, license agreements, and certifications[542](index=542&type=chunk)[543](index=543&type=chunk)[544](index=544&type=chunk)[545](index=545&type=chunk)[546](index=546&type=chunk)[547](index=547&type=chunk)[548](index=548&type=chunk)[549](index=549&type=chunk)[550](index=550&type=chunk) [Item 16. Form 10-K Summary](index=87&type=section&id=Item%2016.%20Form%2010-K%20Summary) Eyenovia did not provide a Form 10-K Summary - No Form 10-K Summary is provided[551](index=551&type=chunk) [SIGNATURES](index=88&type=section&id=SIGNATURES) The report is signed on behalf of Eyenovia, Inc. by its CEO and CFO as of March 30, 2021 - The report is signed by Tsontcho Ianchulev (CEO, CMO, Director) and John Gandolfo (CFO, Secretary) on behalf of Eyenovia, Inc.[556](index=556&type=chunk)[558](index=558&type=chunk) - Signatures are dated **March 30, 2021**[557](index=557&type=chunk)[558](index=558&type=chunk) INDEX TO FINANCIAL STATEMENTS [Report of Independent Registered Public Accounting Firm](index=90&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The auditor issued an unqualified opinion but highlighted substantial doubt about the company's ability to continue as a going concern - Marcum LLP issued an **unqualified opinion** on Eyenovia's financial statements for 2020 and 2019[562](index=562&type=chunk) - An explanatory paragraph was included, citing **substantial doubt about the company's ability to continue as a going concern**[563](index=563&type=chunk) - The financial statements do not include adjustments that might result from the outcome of this going concern uncertainty[563](index=563&type=chunk) [Balance Sheets](index=91&type=section&id=Balance%20Sheets) The balance sheets present the company's financial position as of December 31, 2020 and 2019 Balance Sheet Summary (as of December 31) | Item | 2020 (USD) | 2019 (USD) | |:---|:---|:---| | **Assets** | | | | Cash and cash equivalents | $28,371,828 | $14,152,601 | | Deferred license costs | $1,600,000 | - | | License receivable | $2,966,039 | - | | Total Current Assets | $33,391,345 | $14,349,281 | | Property and equipment, net | $396,380 | $230,538 | | Total Assets | $33,906,760 | $14,697,619 | | **Liabilities** | | | | Accounts payable | $1,461,665 | $1,541,358 | | Accrued compensation | $1,150,672 | $916,873 | | Accrued expenses and other current liabilities | $1,480,692 | $453,430 | | Deferred license fee | $14,000,000 | - | | Notes payable - current portion | $97,539 | - | | Total Current Liabilities | $18,198,377 | $2,911,661 | | Total Liabilities | $18,602,875 | $2,957,012 | | **Stockholders' Equity** | | | | Common stock | $2,498 | $1,710 | | Additional paid-in capital | $92,742,306 | $69,409,949 | | Accumulated deficit | $(77,440,919) | $(57,671,052) | | Total Stockholders' Equity | $15,303,885 | $11,740,607 | | Total Liabilities and Stockholders' Equity | $33,906,760 | $14,697,619 | - Cash and cash equivalents increased significantly from **$14.15 million** in 2019 to **$28.37 million** in 2020[569](index=569&type=chunk) - Deferred license fees of **$14.0 million** were recorded in 2020, contributing to a substantial increase in total liabilities[569](index=569&type=chunk) - The accumulated deficit grew from **$57.67 million** in 2019 to **$77.44 million** in 2020, reflecting ongoing operating losses[569](index=569&type=chunk) [Statements of Operations](index=92&type=section&id=Statements%20of%20Operations) The company recognized $2.0 million in revenue in 2020, leading to a net loss of $19.8 million Statements of Operations Summary (Years Ended December 31) | Item | 2020 (USD) | 2019 (USD) | |:---|:---|:---| | Revenue | $2,000,000 | $- | | Cost of revenue | $(800,000) | $- | | Gross Profit | $1,200,000 | $- | | Research and development expenses | $13,263,817 | $14,102,449 | | General and administrative expenses | $7,725,408 | $7,206,095 | | Total Operating Expenses | $20,989,225 | $21,308,544 | | Loss From Operations | $(19,789,225) | $(21,308,544) | | Net Loss | $(19,769,867) | $(21,156,758) | | Net Loss Per Share - Basic and Diluted | $(0.94) | $(1.47) | | Weighted Average Number of Common Shares Outstanding - Basic and Diluted | 21,054,706 | 14,349,738 | - The company recognized **$2.0 million in revenue** in 2020, with a gross profit of **$1.2 million**, compared to no revenue in 2019[571](index=571&type=chunk) - **Net loss improved** from $21.2 million in 2019 to **$19.8 million** in 2020[571](index=571&type=chunk) - **Net loss per share decreased** from $(1.47) in 2019 to **$(0.94)** in 2020, partly due to an increase in weighted average common shares outstanding[571](index=571&type=chunk) [Statements of Changes in Stockholders' Equity](index=93&type=section&id=Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Stockholders' equity increased to $15.3 million in 2020, driven by proceeds from public offerings and private placements Statements of Changes in Stockholders' Equity Summary (Years Ended December 31) | Item | Common Shares (2020) | Common Stock Amount (2020) | Additional Paid-In Capital (2020) | Accumulated Deficit (2020) | Total Stockholders' Equity (2020) | |:---|:---|:---|:---|:---|:---| | Balance - January 1, 2019 | 11,468,996 | $1,147 | $53,388,216 | $(36,514,294) | $16,875,069 | | Issuance of common stock in public offering [1] | 5,046,763 | $505 | $12,958,070 | - | $12,958,575 | | Exercise of stock options on cashless basis | 236,466 | $24 | $(24) | - | - | | Exercise of stock options | 348,501 | $34 | $551,743 | - | $551,777 | | Stock-based compensation | - | - | $2,511,944 | - | $2,511,944 | | Net loss | - | - | - | $(21,156,758) | $(21,156,758) | | **Balance - December 31, 2019** | **17,100,726** | **$1,710** | **$69,409,949** | **$(57,671,052)** | **$11,740,607** | | Issuance of common stock and warrants in private placement [2] | 2,675,293 | $267 | $5,451,475 | - | $5,451,742 | | Issuance of common stock in public offering [3] | 3,833,334 | $383 | $12,495,325 | - | $12,495,708 | | Exercise of stock warrants | 1,332,841 | $134 | $2,820,228 | - | $2,820,362 | | Exercise of stock options | 36,391 | $4 | $82,157 | - | $82,161 | | Stock-based compensation | - | - | $2,483,172 | - | $2,483,172 | | Net loss | - | - | - | $(19,769,867) | $(19,769,867) | | **Balance - December 31, 2020** | **24,978,585** | **$2,498** | **$92,742,306** | **$(77,440,919)** | **$15,303,885** | - Total stockholders' equity increased from **$11.74 million** in 2019 to **$15.30 million** in 2020[573](index=573&type=chunk) - This increase was primarily driven by net proceeds from public offerings (**$12.5 million**) and private placements (**$5.57 million**) of common stock and warrants[573](index=573&type=chunk) - The accumulated deficit increased by **$19.77 million** in 2020 due to the net loss[573](index=573&type=chunk) [Statements of Cash Flows](index=94&type=section&id=Statements%20of%20Cash%20Flows) Cash and cash equivalents increased to $28.37 million in 2020, driven by financing activities Statements of Cash Flows Summary (Years Ended December 31) | Cash Flow Activity | 2020 (USD) | 2019 (USD) | |:---|:---|:---| | Net Cash Used In Operating Activities | $(6,384,276) | $(18,919,308) | | Net Cash Used In Investing Activities | $(261,257) | $(166,643) | | Net Cash Provided By Financing Activities | $20,864,760 | $13,510,352 | | Net Increase (Decrease) in Cash and Cash Equivalents | $14,219,227 | $(5,575,599) | | Cash and cash equivalents - End of Year | $28,371,828 | $14,152,601 | - Net cash used in operating activities **decreased from $18.9 million in 2019 to $6.4 million in 2020**[503](index=503&type=chunk)[580](index=580&type=chunk) - Net cash provided by financing activities **increased from $13.5 million in 2019 to $20.9 million in 2020**, driven by proceeds from public offerings and warrant exercises[505](index=505&type=chunk)[580](index=580&type=chunk) - The company's cash and cash equivalents increased by **$14.2 million** in 2020, ending the year at **$28.4 million**[580](index=580&type=chunk) [Notes to Financial Statements](index=96&type=section&id=Notes%20to%20Financial%20Statements) [Note 1 – Business Organization and Nature of Operations](index=96&type=section&id=Note%201%20%E2%80%93%20Business%20Organization%20and%20Nature%20of%20Operations) Eyenovia is a clinical-stage ophthalmic company developing microdose therapeutics using its proprietary Optejet® delivery system - Eyenovia, Inc. was organized in Florida on March 12, 2014, and reincorporated in Delaware on October 6, 2014[584](index=584&type=chunk) - The company is a clinical-stage ophthalmic company developing advanced therapeutics based on its proprietary microdose array print (MAP) platform technology[585](index=585&type=chunk) - Eyenovia's products are classified by the FDA as **drugs, not medical devices**[585](index=585&type=chunk) - The COVID-19 pandemic caused initial delays in the MicroPine CHAPERONE study, but enrollment has since resumed[586](index=586&type=chunk) [Note 2 – Summary of Significant Accounting Policies](index=96&type=section&id=Note%202%20%E2%80%93%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines Eyenovia's significant accounting policies, including liquidity and going concern - The company's accounting policies cover liquidity and going concern, use of estimates, revenue recognition, and stock-based compensation[592](index=592&type=chunk)[594](index=594&type=chunk)[596](index=596&type=chunk)[597](index=597&type=chunk)[600](index=600&type=chunk)[601](index=601&type=chunk)[604](index=604&type=chunk)[609](index=609&type=chunk)[617](index=617&type=chunk)[618](index=618&type=chunk)[619](index=619&type=chunk)[620](index=620&type=chunk)[621](index=621&type=chunk) - As of December 31, 2020, the company had **$28.4 million in cash** and an accumulated deficit of **$77.4 million**, raising substantial doubt about its ability to continue as a going concern[587](index=587&type=chunk)[588](index=588&type=chunk) - Revenue from licensing agreements is recognized upon satisfaction of performance obligations, with upfront payments recorded as deferred license fees[609](index=609&type=chunk)[614](index=614&type=chunk)[617](index=617&type=chunk) - Recently adopted and issued accounting standards had no material impact or are being evaluated for future impact[625](index=625&type=chunk)[626](index=626&type=chunk)[627](index=627&type=chunk)[630](index=630&type=chunk)[631](index=631&type=chunk) [Note 3 – Prepaid Expenses and Other Current Assets](index=102&type=section&id=Note%203%20%E2%80%93%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) Prepaid expenses and other current assets increased to $453,478 in 2020 Prepaid Expenses and Other Current Assets (as of December 31) | Item | 2020 (USD) | 2019 (USD) | |:---|:---|:---| | Payroll tax receivable | $151,942 | $95,233 | | Prepaid insurance expenses | $110,094 | $33,923 | | Prepaid research and development expenses | - | $17,978 | | Prepaid licenses and subscriptions | $57,051 | - | | Prepaid patent expenses | - | $12,404 | | Prepaid conference expenses | $29,403 | $10,600 | | Prepaid board of directors expenses | $68,250 | - | | Prepaid rent and security deposit | $25,004 | $2,463 | | Other | $11,734 | $24,079 | | **Total prepaid expenses and other current assets** | **$453,478** | **$196,680** | - Total prepaid expenses and other current assets **increased by $256,798** from 2019 to 2020[632](index=632&type=chunk) - Significant increases were observed in payroll tax receivable, prepaid insurance expenses, and prepaid board of directors expenses[632](index=632&type=chunk) [Note 4 – Property and Equipment, Net](index=103&type=section&id=Note%204%20%E2%80%93%20Property%20and%20Equipment%2C%20Net) Net property and equipment increased to $396,380 in 2020 due to additions in equipment and leasehold improvements Property and Equipment, Net (as of December 31) | Item | 2020 (USD) | 2019 (USD) | |:---|:---|:---| | Equipment | $435,521 | $229,529 | | Leasehold improvements | $137,765 | $82,500 | | Less: accumulated depreciation and amortization | $(176,906) | $(81,491) | | **Property and equipment, net** | **$396,380** | **$230,538** | - Net property and equipment **increased by $165,842** from 2019 to 2020[634](index=634&type=chunk) - Depreciation and amortization expense was **$95,415 in 2020**, with $67,595 allocated to R&D and $27,820 to G&A[634](index=634&type=chunk) [Note 5 – Accrued Expenses and Other Current Liabilities](index=103&type=section&id=Note%205%20%E2%80%93%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) Accrued expenses and other current liabilities increased significantly to $1,480,692 in 2020 Accrued Expenses and Other Current Liabilities (as of December 31) | Item | 2020 (USD) | 2019 (USD) | |:---|:---|:---| | Accrued research and development expenses | $348,254 | $208,175 | | Accrued consulting and professional services | $235,355 | $97,396 | | Credit card payable | $50,002 | $56,979 | | Leasehold improvements | - | $42,500 | | Accrued franchise tax | $32,480 | $40,995 | | Accrued travel and entertainment expenses | - | $7,385 | | Accrued licensing fees | $804,447 | - | | Accrued interest | $3,068 | - | | Accrued expense reimbursements | $5,459 | - | | Other | $1,627 | - | | **Total accrued expenses and other current liabilities** | **$1,480,692** | **$453,430** | - Total accrued expenses and other current liabilities **increased by over $1 million** from 2019 to 2020[635](index=635&type=chunk) - Key increases include accrued R&D expenses, accrued consulting services, and new **accrued licensing fees ($804,447)**[635](index=635&type=chunk) [Note 6 – Accrued Compensation](index=103&type=section&id=Note%206%20%E2%80%93%20Accrued%20Compensation) Accrued compensation increased to $1,150,672 in 2020, driven by higher accrued payroll expenses Accrued Compensation (as of December 31) | Item | 2020 (USD) | 2019 (USD) | |:---|:---|:---| | Accrued bonus expenses | $938,873 | $897,839 | | Accrued payroll expenses | $211,799 | $19,034 | | **Total accrued compensation** | **$1,150,672** | **$916,873** | - Total accrued compensation **increased by $233,799** from 2019 to 2020[636](index=636&type=chunk) - The increase was mainly driven by a significant rise in **accrued payroll expenses ($192,765)**[636](index=636&type=chunk) [Note 7 – Notes Payable](index=104&type=section&id=Note%207%20%E2%80%93%20Notes%20Payable) As of December 31, 2020, Eyenovia had $463,353 in notes payable from a Paycheck Protection Program loan Notes Payable (as of December 31) | Item | 2020 Current Portion (USD) | 2020 Non-Current Portion (USD) | 2020 Total (USD) | 2019 Current Portion (USD) | 2019 Non-Current Portion (USD) | 2019 Total (USD) | |:---|:---|:---|:---|:---|:---|:---| | Paycheck Protection Program loan | $97,539 | $365,814 | $463,353 | - | - | - | | **Total** | **$97,539** | **$365,814** | **$463,353** | **-** | **-** | **-** | - As of December 31, 2020, total notes payable were **$463,353**, entirely from a PPP Loan received on May 8, 2020[639](index=639&type=chunk)[640](index=640&type=chunk) - The PPP Loan has a fixed interest rate of **1.00% per annum**, with a maturity date of May 3, 2022[640](index=640&type=chunk) - The company intends to apply for **loan forgiveness** on the PPP Loan[641](index=641&type=chunk) - A separate note payable for a D&O insurance policy was fully repaid during 2020[639](index=639&type=chunk) [Note 8 – Income Taxes](index=104&type=section&id=Note%208%20%E2%80%93%20Income%20Taxes) The company reported no provision for income taxes due to a full valuation allowance against its deferred tax assets Provision for Income Taxes (Years Ended December 31) | Item | 2020 (USD) | 2019 (USD) | |:---|:---|:---| | Deferred tax provision (benefit): Federal | $(3,797,052) | $(4,999,920) | | Deferred tax provision (benefit): State and local | $(434,082) | $68,762 | | Change in valuation allowance | $4,231,134 | $4,931,158 | | **Provision for income taxes** | **$-** | **$-** | Deferred Tax Assets (as of December 31) | Item | 2020 (USD) | 2019 (USD) | |:---|:---|:---| | Net operating loss carryforwards | $12,972,865 | $9,479,512 | | Stock-based compensation | $1,385,554 | $943,370 | | Intangible assets | $409,705 | $328,773 | | Research and development tax credits | $1,861,938 | $1,584,75

Financial Data and Key Metrics Changes - For Q4 2020, the company reported a net loss of approximately $4.2 million or $0.17 per share, compared to a net loss of approximately $5.2 million or $0.31 per share in Q4 2019 [29] - For the full year 2020, the net loss was approximately $19.8 million or a loss of $0.94 per share, compared to a net loss of approximately $21.2 million or $1.47 per share for 2019 [29] - Revenue for Q4 and the full year 2020 was $2 million, representing a milestone payment related to a collaboration with Arctic Vision, with no revenue recognized in the same periods of 2019 [29] Business Line Data and Key Metrics Changes - Research and development expenses for Q4 2020 totaled approximately $3.4 million, roughly flat compared to $3.3 million in Q4 2019 [30] - For the full year 2020, R&D expenses decreased by 6% to approximately $13.3 million from $14.1 million in 2019 [30] - General and administrative expenses for Q4 2020 were approximately $2.1 million, an increase of 5% from $2 million in Q4 2019 [30] Market Data and Key Metrics Changes - The company anticipates a PDUFA date of October 28, 2021, for MydCombi, which, if approved, would be its first commercially available product [20][34] - The market potential for MicroLine, aimed at treating presbyopia, is estimated to exceed $7 billion in the U.S. alone [26] Company Strategy and Development Direction - The company aims to efficiently market MydCombi with a small, targeted salesforce and a specialty pharmacy network, rather than a large conventional sales force [9][18] - The strategy includes leveraging partnerships with organizations that have significant reach to augment sales efforts [19] - The company is focused on advancing its proprietary microdosing technology, Optejet, to improve drug delivery and patient experience [23][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made in 2020 and the momentum entering 2021, with multiple potential value-creating milestones on the horizon [13][34] - The company is aware of the risks associated with the evolving COVID-19 pandemic and its impact on operations and clinical trials [6] Other Important Information - The company has outlicensed MicroPine and MicroLine to Arctic Vision in Greater China and South Korea, generating approximately $16 million in upfront and milestone-based fees [12] - The cash balance as of December 31, 2020, was approximately $28.4 million, expected to last into the middle of Q1 2022 [32] Q&A Session Summary Question: Are there any secondary outcome measures in the VISION-1 study? - Yes, the study is collecting secondary and exploratory endpoints, and a wealth of data is anticipated [36][37] Question: When will specialized salespeople be brought in for MydCombi? - Specialized salespeople are not expected to be onboarded before August, in preparation for the October approval [41] Question: How does the agreement with EVERSANA fit into the marketing plans for MydCombi? - EVERSANA will handle invoicing, billing, and customer service, allowing the company to maintain a leaner infrastructure [43][44] Question: What are the plans for the VISION-2 study? - The company plans to initiate VISION-2 by the end of the year, learning from VISION-1 results [47][48] Question: What is the initial pricing for MydCombi? - The anticipated price is about $100 per cartridge, which should treat at least 75 patients, aligning closely with current spending by doctors [54]

Financial Data and Key Metrics Changes - For Q2 2020, the company reported a net loss of approximately $5 million or $0.25 per share, compared to a net loss of approximately $5.3 million or $0.44 per share for Q2 2019, indicating an improvement in loss per share [31] - Research and development expenses totaled approximately $2.9 million for Q2 2020, a decrease of 18.3% from approximately $3.6 million in the same period of 2019 [32] - General and administrative expenses were approximately $2.1 million for Q2 2020, an increase of 16.3% compared to approximately $1.8 million in Q2 2019 [32] - Total operating expenses for Q2 2020 were approximately $5 million, a decrease of 6.7% from approximately $5.4 million in Q2 2019 [33] Business Line Data and Key Metrics Changes - The company successfully resumed recruitment for its Phase III CHAPERONE study for progressive myopia, which is set to enroll over 400 children [24] - The MicroStat Phase III trials were completed, and the company anticipates initiating the presbyopia Phase III programs in the coming months [9][12] Market Data and Key Metrics Changes - The exclusive license agreement with Arctic Vision for the development and commercialization of MicroPine and MicroLine in Greater China and South Korea is expected to provide payments of up to $45.75 million, enhancing the company's market potential in Asia [11][13] Company Strategy and Development Direction - The company is focused on building its U.S. operations and expanding its late-stage clinical pipeline in the ophthalmic space [9] - The Arctic Vision agreement is part of the company's international distribution strategy, aimed at addressing significant markets for progressive myopia and presbyopia [15] - The company plans to submit a new drug application for MicroStat by the end of 2020 and initiate Phase III VISION studies for MicroLine [12][36] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing clinical initiatives despite the COVID-19 pandemic, highlighting the importance of patient safety during recruitment [8] - The company anticipates that the COVID-19 pandemic may increase the incidence of progressive myopia due to children spending more time indoors [65] - Management emphasized the need to expedite the development of their products to address the growing unmet needs in the market [64] Other Important Information - The company had a cash balance of approximately $10.2 million as of June 30, 2020, which is expected to be sufficient through at least the end of Q1 2021 [34] - The Opteject dispenser has been highlighted as a potential solution to reduce contamination risks associated with traditional eyedropper bottles, especially in the context of COVID-19 [20][22] Q&A Session Summary Question: Update on the MicroStat NDA process and its timing - Management confirmed that stability studies for MicroStat have not been materially impacted by COVID-19, and they are on track to submit the NDA by the end of the year [37] Question: Thoughts on commercializing MicroStat - Management noted significant interest from clinicians in the Opteject dispenser, which is expected to facilitate commercialization efforts [38] Question: Impact of the Arctic Vision deal on cash runway - The upfront payment from the Arctic Vision deal is expected to help extend the company's cash runway, but additional capital will still be required for long-term strategy execution [41] Question: Speed of enrollment for the CHAPERONE trial - Management indicated that nearly all clinical sites are operational and enrollment is progressing well, with expectations to complete enrollment in the next nine months [45] Question: Competitive position regarding other companies working on atropine for progressive myopia - Management acknowledged competition but emphasized the unique advantages of their delivery system, which minimizes systemic absorption and improves patient compliance [62][64]

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]

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]