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Eyenovia (EYEN) Down 18% on Disappointing Corporate Update

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Eyenovia, Inc. (EYEN - Free Report) 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 providing any promises for the time being regarding the entry or completion of any transaction.

As of Dec 31, 2023, Eyenovia’s unrestricted cash and cash equivalents were approximately $14.8 million, which barely covers its total outstanding debt (short plus long term) of $14 million.

The company currently has two FDA-approved products, Mydcombi and clobetasol propionate, which are indicated for in-office pupil dilation and post-ocular inflammation and pain, respectively. Currently, only Mydcombi is available commercially and has yet to gain traction in the market.

Mydcombi received FDA approval in May 2023 for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired. The drug was launched in the U.S. market in August 2023. In the same year, Eyenovia recorded $3.8K in revenues from the sale of Mydcombi, which was fully offset by the cost of activities conducted to market the drug.

Clobetasol propionate, on the other hand, was only approved by the FDA last month and is yet to be made commercially available in the U.S. market.

Year to date, shares of Eyenovia have plunged 64.9% compared with the industry’s 5.7% decline.

Zacks Investment Research
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The company intends to focus on its late-stage pipeline candidate, MicroPine, which is under development to treat progressive myopia in pediatric patients and represents a market value of around $1.8 billion. At present, there are no FDA-approved pharmaceutical treatments for this indication, which represents a significant market opportunity.

Eyenovia is currently evaluating MicroPine in a phase III CHAPERONE study for the pediatric progressive myopia indication, expecting to read out data from an interim analysis of the study in fourth-quarter 2024. Subject to positive outcomes from the CHAPERONE study, the company expects to file for regulatory approval of MicroPine in 2025.

Per management, EYEN is simultaneously evaluating strategic opportunities for MicroPine with organizations that have existing capabilities and infrastructure necessary to fully capitalize on the massive opportunity the candidate represents.

Eyenovia plans to engage in corporate savings to reduce operating expenses for extending its cash runway. Furthermore, the company is currently preparing for the U.S. launch of its newest product, clobetasol propionate, for post-surgical management of pain and inflammation by the end of summer 2024.

Zacks Rank and Stocks to Consider

Eyenovia currently carries a Zacks Rank #3 (Hold).  

Some better-ranked stocks from the drug/biotech industry are ADMA Biologics (ADMA - Free Report) , FibroGen (FGEN - Free Report) and Annovis Bio (ANVS - Free Report) . While ADMA sports a Zacks Rank #1 (Strong Buy), FGEN and ANVS carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has remained constant at 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has remained constant at 50 cents. Year to date, shares of ADMA have soared 37.6%.

ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%. 

In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has remained constant at $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share has remained constant at 6 cents. Year to date, shares of FGEN have surged 83.9%.

FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.

In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.49 to $3.35. The estimate for Annovis’ 2025 loss per share is currently pegged at $2.82. Year to date, shares of ANVS have plunged 38.7%.

ANVS’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 15.70%.

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