Core Viewpoint - Eyenovia, Inc. reported a quarterly loss of $0.18 per share, slightly worse than the Zacks Consensus Estimate of a loss of $0.17, indicating a negative earnings surprise of -5.88% [1] Financial Performance - The company posted revenues of $0.02 million for the quarter ended June 2024, missing the Zacks Consensus Estimate by 98.33%, compared to zero revenues a year ago [2] - Over the last four quarters, Eyenovia has surpassed consensus EPS estimates only once [2] Stock Performance - Eyenovia shares have declined approximately 58.7% since the beginning of the year, contrasting with the S&P 500's gain of 12% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.18 on revenues of $1.6 million, and for the current fiscal year, it is -$0.76 on revenues of $5.03 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Eyenovia belongs, is currently ranked in the top 30% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Eyenovia's stock performance [5]

Following FDA consultation, announced plans for validation of the Gen-2 Optejet® device and 2025 regulatory submission with Mydcombi™ as lead product Advanced Phase 3 CHAPERONE study of MicroPine as a treatment of pediatric progressive myopia with preparations for analysis in Q4 Commenced sales activities with focus on Mydcombi in 260+ offices and preparations for launch of clobetasol propionate ophthalmic suspension 0.05%, the first new ophthalmic steroid to enter the market in 15 years Announced developme ...

Core Insights - Eyenovia, Inc. has signed a non-binding agreement with Formosa Pharmaceuticals to co-develop a formulation of clobetasol propionate ophthalmic suspension 0.05% for the short-term relief of dry eye disease [1][2] - The collaboration aims to share development costs and profits upon commercialization, expanding an existing partnership that began in February 2023 [2] - Clobetasol propionate was approved by the FDA on March 4, 2024, for reducing inflammation and pain associated with approximately seven million ocular surgeries performed annually in the U.S. [3] Company Overview - Eyenovia, Inc. is a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia [1] - The company is also developing the Optejet device for use with its drug-device therapeutic products [5] - Eyenovia's current product lineup includes Mydcombi™ and clobetasol propionate ophthalmic suspension [5] Market Potential - The U.S. market for topical ocular steroids and steroid combinations is approximately $1.3 billion [3] - The new indication for clobetasol propionate could significantly increase its usage among millions of dry eye patients experiencing flare-ups [3] - Formosa's proprietary APNT® nanoparticle formulation platform enhances the bioavailability of clobetasol propionate, potentially improving treatment outcomes [4]

NEW YORK, Aug. 07, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercialstage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced that it has signed a non-binding agreement with Taiwan-based Formosa Pharmaceuticals (TWO:6838) whereby the companies will co-develop a formulation of clobetasol propionate ophthalmic suspension 0.05% ("clobetasol propionate") in combination with the Optejet device for the shortterm relief of dry ...

Eyenovia, Inc. is an ophthalmic technology company commercializing Mydcombi™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for mydriasis, Clobetasol Propionate Ophthalmic Suspension, 0.05% for postsurgical inflammation and pain, and developing the Optejet® device for use both in connection with its own drug-device therapeutic product for pediatric progressive myopia as well as outlicensing for additional indications. For more information, please visit Eyenovia.com. Except for histor ...

Chardan is acting as the lead-placement agent for the Offering. Brookline Capital Markets, a division of Arcadia Securities, LLC, is also acting as a co-placement agent for the Offering. The gross proceeds to Eyenovia from this Offering are expected to be approximately $5 million, before deducting the placement agents' fees and other offering expenses payable by Eyenovia. Eyenovia intends to use the net proceeds from this Offering to fund commercialization activities for Mydcombi and clobetasol propionate, ...

Core Viewpoint - Eyenovia, Inc. (EYEN) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive shift in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in stock price movements [4]. Company Performance and Outlook - The recent upgrade suggests an improvement in Eyenovia's underlying business, which could lead to higher stock prices as investors respond positively to this trend [5][11]. - For the fiscal year ending December 2024, Eyenovia is expected to earn -$0.70 per share, reflecting a -6.1% change from the previous year, but the Zacks Consensus Estimate has increased by 35.9% over the past three months [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating, indicating superior earnings estimate revisions [9][11]. - Historically, Zacks Rank 1 stocks have generated an average annual return of +25% since 1988, showcasing the effectiveness of the rating system [7].

Financial Data and Key Metrics Changes - For the first quarter of 2024, the company reported a net loss of approximately $10.9 million or $0.23 per share, compared to a net loss of $5.7 million or $0.15 per share in the first quarter of 2023 [64][94] - General and administrative expenses increased by 30.6% to approximately $3.8 million compared to $2.9 million in the first quarter of 2023 [65] - Total operating expenses for the first quarter of 2024 were approximately $10.3 million, an increase of approximately 88% from $5.5 million in the same period in 2023 [65] Business Line Data and Key Metrics Changes - The company is focusing on the successful commercialization of MydCombi and clobetasol, with a potential blockbuster MicroPine in late Phase III development [40][45] - Clobetasol was approved by the FDA on March 4, 2024, and is expected to capture a mid-single-digit market share in a $1.3 billion annual market for topical ocular steroids [31][46] - The sales force has been trained and is making inroads into the market, having converted about 50 offices to date [34][51] Market Data and Key Metrics Changes - The U.S. market for pediatric progressive myopia is estimated at $1.8 billion annually, with a similar opportunity in China [24] - The dry eye market is valued at approximately $3.6 billion annually in the U.S., presenting a significant opportunity for the company [33] - The company has entered into a collaboration agreement with SGN Nanopharma to develop a treatment for chronic dry eye, potentially leading to a Phase III-ready asset next year [32][50] Company Strategy and Development Direction - The company aims to establish a solid foundation for its portfolio with a second FDA-approved product to be launched soon and a focus on the expedited development of MicroPine [40][68] - The strategy includes reducing planned spending by approximately $800,000 per quarter and focusing resources on validating the Gen 2 device with the FDA and commercializing Mydcombi and clobetasol [66][96] - The company is exploring various options to ensure sufficient capital to support its growth strategy [121] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of MicroPine, which could be a significant source of non-dilutive funding if approved [67] - The company is optimistic about the upcoming FDA meeting regarding the Gen 2 device, which is expected to lead to market readiness by the end of next year [70][117] - Management highlighted the importance of the Optejet technology in differentiating their products in the market [74] Other Important Information - The company has generated approximately $16 million in license fees from its agreements and has the potential to earn an additional $25 million in non-dilutive net license and development milestones [67] - The company has participated in several national ophthalmology medical meetings to raise awareness of its product portfolio [69][86] Q&A Session Summary Question: Can you talk about the transition to the Gen 2 device? - The company plans to submit for an FDA meeting in mid-July and expects to make Gen 2 supply shortly thereafter, with a small bridging study to follow [70][101] Question: How does the company view the competition in the eye drop market? - The company believes that the Optejet device offers significant differentiation, as it is preferred by potential users for its convenience and ease of use [74] Question: What is the status of the Gen 2 device and its relevance to current products? - The Gen 2 device will be the only platform moving forward, and its validation against Mydcombi will be crucial for all other programs [107][112] Question: How is the company managing its cash runway? - The company has reduced spending and is exploring various options to ensure sufficient capital to support its growth strategy [121] Question: What are the expectations for the upcoming FDA approval for clobetasol? - The company is preparing for a robust commercial launch of clobetasol later in the summer and sees potential for further development of formulations for acute dry eye [78][98]

Financial Performance - For Q1 2024, Eyenovia reported a net loss of approximately $10.9 million, or $0.23 per share, compared to a net loss of $5.7 million, or $0.15 per share in Q1 2023[7]. - Total operating expenses for Q1 2024 were approximately $10.3 million, an increase of approximately 88.1% from $5.5 million in Q1 2023[9]. - Eyenovia's total assets decreased to $26.2 million as of March 31, 2024, down from $28.8 million at the end of 2023[19]. Research and Development - Research and development expenses increased by approximately 75.7% to $4.4 million in Q1 2024, up from $2.5 million in Q1 2023[8]. - Eyenovia plans to launch clobetasol propionate ophthalmic suspension 0.05% in Q3 2024, the first new ophthalmic steroid in 15 years[5]. - The pediatric progressive myopia market is valued at over $3.0 billion annually in the U.S. and China, with MicroPine in late-stage development[5]. Cash and Expenses Management - As of March 31, 2024, the company's unrestricted cash and cash equivalents were approximately $8.0 million, not including an additional $2.2 million raised in April 2024[10]. - The company reduced anticipated cash-based expenses by approximately $0.8 million per quarter from Q1 2024 actual levels[5]. Sales and Growth Outlook - Eyenovia has executed formulary agreements with Vision Source and the University of California, and trained 50 new Mydcombi-using offices since sales promotion began in April 2024[5]. - The company anticipates meaningful sales growth over the next 18 months, aiming towards profitability[4].

PART I - FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements.) Q1 2024 unaudited condensed financial statements reveal significant financial deterioration and substantial doubt about going concern [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2024, assets decreased, liabilities increased, and stockholders' equity significantly declined to **$1.8 million** Condensed Balance Sheet Summary (Unaudited) | Metric | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $7,976,106 | $14,849,057 | | Total Current Assets | $14,451,085 | $20,706,718 | | Total Assets | $26,177,163 | $28,779,374 | | **Liabilities & Stockholders' Equity** | | | | Total Current Liabilities | $16,459,923 | $9,530,382 | | Total Liabilities | $24,359,391 | $19,780,280 | | Total Stockholders' Equity | $1,817,772 | $8,999,094 | | Total Liabilities and Stockholders' Equity | $26,177,163 | $28,779,374 | [Condensed Statements of Operations](index=6&type=section&id=Condensed%20Statements%20of%20Operations) Q1 2024 net loss widened to **$10.9 million** due to increased operating expenses, including a **$2.0 million** license rights reacquisition charge Condensed Statement of Operations Summary (Unaudited) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Revenue | $4,993 | $0 | | Total Operating Expenses | $10,266,824 | $5,458,836 | | Loss From Operations | $(10,266,824) | $(5,458,836) | | Net Loss | $(10,922,101) | $(5,739,366) | | Net Loss Per Share - Basic and Diluted | $(0.23) | $(0.15) | - Operating expenses included a **$2.0 million** expense for the reacquisition of license rights in Q1 2024, which was not present in the prior year period[12](index=12&type=chunk) [Condensed Statements of Changes in Stockholders' Equity](index=7&type=section&id=Condensed%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Stockholders' equity decreased from **$9.0 million** to **$1.8 million** due to net loss, partially offset by **$3.2 million** from a stock offering - The company raised approximately **$3.2 million** in net proceeds from the issuance of **1,833,323 shares** of common stock in an "At the Market" offering during Q1 2024[15](index=15&type=chunk) [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Q1 2024 net cash used in operations increased to **$9.9 million**, resulting in a **$6.9 million** decrease in cash, ending at **$8.0 million** Cash Flow Summary (Unaudited) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net Cash Used In Operating Activities | $(9,891,747) | $(6,958,708) | | Net Cash Used In Investing Activities | $(114,105) | $(838,052) | | Net Cash Provided By Financing Activities | $3,132,901 | $3,399,562 | | Net Decrease in Cash and Cash Equivalents | $(6,872,951) | $(4,397,198) | | Cash and Cash Equivalents - End of Period | $7,976,106 | $18,466,322 | [Notes to Unaudited Condensed Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) Notes raise substantial doubt about going concern due to recurring losses and negative cash flow, detailing reacquisition, milestone payments, and financing - The company's recurring net losses, negative cash flow from operations, and lack of recurring revenue raise **substantial doubt** about its ability to continue as a going concern for at least one year[29](index=29&type=chunk) - In March 2024, the company accrued **$4.0 million** for development milestones related to the licensed product from Formosa, triggered by FDA approval[42](index=42&type=chunk) - On January 12, 2024, the company reacquired rights to a licensed product from Bausch + Lomb, paying **$2.0 million** in cash upfront and agreeing to issue **$3.0 million** in common stock upon regulatory transfer[51](index=51&type=chunk)[52](index=52&type=chunk) - Subsequent to the quarter end, the company raised approximately **$2.0 million** in a registered direct offering and issued **2,299,397 shares** of common stock valued at **$3.0 million** to Bausch + Lomb[67](index=67&type=chunk)[71](index=71&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management discusses strategic focus and Q1 2024 financial results, highlighting increased net loss and expenses, reiterating going concern doubts and financing needs [Overview](index=23&type=section&id=Overview) Eyenovia focuses on commercializing FDA-approved products and advancing MicroPine, reacquired in January 2024 to regain CHAPERONE study control and plan interim analysis - The company's primary focus is on the late-stage development of **MicroPine** for pediatric progressive myopia and the commercialization of its two FDA-approved products: **Mydcombi** and **clobetasol propionate ophthalmic suspension**[76](index=76&type=chunk) - In January 2024, Eyenovia reacquired the rights to **MicroPine** from Bausch + Lomb to regain control of the **CHAPERONE study**, involving a **$2.0 million** upfront cash payment and a subsequent **$3.0 million** issuance of common stock[82](index=82&type=chunk) - The company plans to conduct an interim analysis of the **CHAPERONE study** data in late 2024, which it believes may substantially increase the asset's value[82](index=82&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Q1 2024 net loss widened to **$10.9 million** due to increased R&D, G&A, and a **$2.0 million** license rights reacquisition expense Comparison of Operating Expenses (Q1 2024 vs Q1 2023) | Expense Category | Q1 2024 | Q1 2023 | Change (%) | | :--- | :--- | :--- | :--- | | Research and Development | $4,431,601 | $2,521,950 | +75.7% | | General and Administrative | $3,835,223 | $2,936,886 | +30.6% | | Reacquisition of license rights | $2,000,000 | $0 | N/A | - The increase in **R&D expenses** was primarily due to higher personnel-related costs, supplies and materials, and direct clinical expenses[101](index=101&type=chunk) - The increase in **G&A expenses** was mainly due to new staff additions and an increase in professional fees for temporary staffing[103](index=103&type=chunk) [Liquidity and Going Concern](index=31&type=section&id=Liquidity%20and%20Going%20Concern) Financial position weakened with cash decreasing to **$8.0 million** and a **$2.0 million** working capital deficit, raising substantial doubt about going concern, dependent on additional capital - Management has concluded that there is **substantial doubt** about the company's ability to continue as a going concern for at least one year from the issuance date of the financial statements[90](index=90&type=chunk)[110](index=110&type=chunk) Liquidity Metrics | Metric | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and Cash Equivalents | $7,976,106 | $14,849,057 | | Working Capital (Deficit) | $(2,008,838) | $11,176,336 | - Net cash used in operating activities increased to **$9.9 million** in Q1 2024 from **$7.0 million** in Q1 2023, reflecting higher cash burn to fund operations[111](index=111&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, Eyenovia is not required to provide market risk disclosures - The company is a **smaller reporting company** and is not required to provide quantitative and qualitative disclosures about market risk[121](index=121&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management deemed disclosure controls effective as of March 31, 2024, with no material changes in internal control over financial reporting - Management concluded that the company's **disclosure controls and procedures were effective** as of March 31, 2024[124](index=124&type=chunk) - No changes in **internal control over financial reporting** occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[125](index=125&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings.) The company reports that it is not currently a party to any material legal proceedings - As of the filing date, the company is not involved in any **material legal proceedings**[127](index=127&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors.) No material changes to the risk factors previously disclosed in the 2023 Form 10-K have occurred - No **material changes** to the risk factors set forth in the 2023 Form 10-K have occurred[128](index=128&type=chunk) [Other Part II Items](index=37&type=section&id=Other%20Part%20II%20Items) This section covers standard disclosures, including no unregistered equity sales, no defaults on senior securities, no mine safety disclosures, and no new Rule 10b5-1 plans - The company reported **no unregistered sales of equity securities** during the three months ended March 31, 2024[129](index=129&type=chunk) - No defaults upon **senior securities** or **mine safety disclosures** were applicable for the reporting period[131](index=131&type=chunk)[132](index=132&type=chunk) - No directors or officers adopted or terminated a **Rule 10b5-1 trading arrangement** during the quarter[133](index=133&type=chunk)