Eyenovia(EYEN)

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Eyenovia Announces Pricing of $5M Registered Direct Offering
GlobeNewswire News Room· 2024-06-28 12:00
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, ...
All You Need to Know About Eyenovia (EYEN) Rating Upgrade to Buy
zacks.com· 2024-05-20 17:01
Eyenovia, Inc. (EYEN) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices. The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate. Since a changing earnings ...
Eyenovia(EYEN) - 2024 Q1 - Earnings Call Transcript
2024-05-18 01:12
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]
Eyenovia(EYEN) - 2024 Q1 - Quarterly Results
2024-05-15 20:19
Exhibit 99.1 Eyenovia Reports First Quarter 2024 Financial Results and Provides Updates on its Myopia Phase III Program and its Two FDA Approved Commercial Products, Mydcombi and Clobetasol Remains on track towards accelerating development of its late-stage product candidate in the multi-billion-dollar pediatric progressive myopia market, MicroPine Preparing for a 3Q 2024 launch of the first new ophthalmic steroid in 15 years, clobetasol propionate ophthalmic suspension 0.05%, for the treatment of inflammat ...
Eyenovia(EYEN) - 2024 Q1 - Quarterly Report
2024-05-15 20:19
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)
Eyenovia Reports First Quarter 2024 Financial Results and Provides Updates on its Myopia Phase III Program and its Two FDA Approved Commercial Products, Mydcombi and Clobetasol
Newsfilter· 2024-05-15 20:01
Remains on track towards accelerating development of its late-stage product candidate in the multi-billion- dollar pediatric progressive myopia market, MicroPine Preparing for a 3Q 2024 launch of the first new ophthalmic steroid in 15 years, clobetasol propionate ophthalmic suspension 0.05%, for the treatment of inflammation and pain following ocular surgery Company to host conference call and webcast today, May 15th, at 4:30 pm ET NEW YORK, May 15, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a c ...
Eyenovia to Report First Quarter 2024 Results on Wednesday, May 15th
Newsfilter· 2024-05-14 11:00
NEW YORK, May 14, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced that the Company will release financial results for the first quarter ended March 31, 2024 on Wednesday, May 15th, 2024, after the markets close. Following the release, Eyenovia management will host a conference call and webcast at 4:30 p.m. ET to review the financial and operating results. Participants should di ...
Eyenovia Provides Clinical and Scientific Update on FDA-Approved Products Mydcombi™ and Clobetasol Propionate Ophthalmic Suspension
Newsfilter· 2024-04-25 11:00
Company announces results from a Phase IV study of Mydcombi designed to characterize the efficacy and duration of the lowest deliverable dose (one 8µL spray per eye) Also announces upcoming ARVO presentation on the unique technology behind clobetasol that allows for future ophthalmic suspensions to be dispensed with the Optejet® NEW YORK, April 25, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a commercial-stage ophthalmic company, today provided an update on its two FDA-approved products. Phase IV ...
Eyenovia (EYEN) Down 18% on Disappointing Corporate Update
Zacks Investment Research· 2024-04-09 14:31
Eyenovia, Inc. (EYEN) stock lost 18% in the last trading session after it announced plans to consider a wide range of options, including a potential sale of the company or its assets, a merger or other strategic actions, amid a severe cash crunch and poor performance of marketed drugs.Per EYEN, such a decision has been taken to maximize value for shareholders. The company is currently gearing up to engage in discussions with investment banks to assist with the evaluation. However, it has refrained from prov ...
Eyenovia Announces Updated Strategy and Corporate Priorities to Focus on Shareholder Value Generation and Immediate Commercial Opportunities
Newsfilter· 2024-04-08 11:00
Company focusing on multi-billion dollar opportunity in pediatric progressive myopia represented by MicroPine, with interim analysis planned for 4Q 2024 and a potential NDA to the FDA in 2025Continuing to advance commercialization of Mydcombi for mydriasis and preparing to launch clobetasol propionate ophthalmic suspension 0.05% for post-surgical management of pain and inflammation; both represent large multi-million-dollar opportunitiesCompany exploring wide range of strategic alternatives NEW YORK, April ...