Eyenovia Reports Third Quarter 2020 Financial Results
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Eyenovia Reports Third Quarter 2020 Financial Results
“During the third quarter and subsequent period, we continued to execute on our growth strategy to advance our late-stage ophthalmic portfolio while in parallel securing global development and commercialization partnerships to further extend the reach of our proprietary Optejet® microdosing technology,” commented Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer. “We announced important licensing agreements with both Bausch Health and Arctic Vision. We believe these companies can help introduce MicroPine and MicroLine to some of the biggest eyecare markets in the world, while at the same time providing us with non-dilutive capital to advance our corporate initiatives.”
“We remain on track to file an NDA for Mydcombi™, our intended brand name for MicroStat, for pharmacologic mydriasis by the end of this year and plan to initiate our Phase 3 presbyopia program imminently, subject to any impacts of COVID-19. Presbyopia is one of the leading therapeutic opportunities in ophthalmology, estimated to affect more than 100 million people in the
Third Quarter 2020 and Recent Business Highlights
- Licensed our atropine ophthalmic solution, MicroPine, an investigational treatment for the reduction of pediatric myopia progression in children ages 3-12, to Bausch Health for an upfront payment of
$10 million, up to $35 millionin milestone payments, and royalties ranging from mid-single digit to mid-teen percentages of gross profit on sales in the U.S.and Canada.
- Closed a public offering of our common stock for net proceeds of approximately
- Announced an exclusive collaboration and license agreement with Arctic Vision to develop and commercialize MicroPine and MicroLine, our Phase 3-ready treatment for presbyopia in
Greater Chinaand South Korea, with potential licensing and development payments of up to $41.75 million, and additional royalty or supply payments.
- Presented positive clinical study results on our Phase 3 MIST-1 and MIST-2 studies, evaluating a novel microdosed fixed combination of tropicamide and phenylephrine for touchless pharmaceutical mydriasis, at the
American Academy of OptometryAnnual Meeting and remain on track to file an NDA for Mydcombi by the end of this year.
Third Quarter 2020 Financial Review
For the third quarter of 2020, net loss was approximately $5.1 million, or $(0.23) per share, compared to a net loss of approximately $4.6 million, or $(0.29) per share for the third quarter of 2019.
Research and development expenses totaled approximately $3.4 million for the third quarter of 2020, compared to approximately $3.2 million for the same period in 2019, an increase of approximately 5.1%.
For the third quarter of 2020, general and administrative expenses were approximately $1.7 million compared to approximately $1.5 million for the third quarter of 2019, an increase of approximately 16.0%.
Total operating expenses for the third quarter of 2020 were approximately $5.1 million, compared to total operating expenses of approximately $4.7 million for the same period in 2019, an increase of approximately 8.6%.
As of September 30, 2020, the Company’s cash balance was approximately $22.9 million.
Conference Call and Webcast
The conference call is scheduled to begin at 4:30pm ET today,
About MicroLine for Presbyopia
MicroLine is a pharmacologic treatment for presbyopia. Presbyopia is the non-preventable, age related hardening of the lens, which causes a gradual loss of the eye’s ability to focus on nearby objects and is estimated to affect nearly 113 million Americans. Current treatment options are typically device-based, such as reading glasses and contact lenses. Pilocarpine ophthalmic solution is known to constrict the pupil and improve near-distance vision by creating an extended depth of focus through its small aperture effect.
About MicroPine for Progressive Myopia
MicroPine (atropine ophthalmic solution) is Eyenovia’s investigational, potentially first-in-class topical treatment for the reduction of pediatric myopia progression, also known as nearsightedness, in children ages 3-12. It has been developed for comfort and ease-of-use in children, and its microdose administration is designed to potentially result in low systemic and ocular drug exposure.
About Mydcombi for Mydriasis
About Optejet® and MicroRx Ocular Therapeutics
Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including estimated market opportunities for our product candidates and any potential revenue from licensing transactions. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission. In addition, such statements could be affected by risks and uncertainties related to, among other things: fluctuations in our financial results; volatility and uncertainty in the global economy and financial markets in light of the evolving COVID-19 pandemic and uncertainties arising from the recent
Chief Financial Officer
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Condensed Balance Sheets
|Cash and cash equivalents||$||22,864,578||$||14,152,601|
|Deferred license costs||1,600,000||-|
|Prepaid expenses and other current assets||903,090||196,680|
|Total Current Assets||25,367,668||14,349,281|
|Property and equipment, net||360,956||230,538|
|Liabilities and Stockholders' Equity|
|Accrued expenses and other current liabilities||373,609||453,430|
|Deferred rent - current portion||7,809||-|
|Deferred license revenue||4,000,000||-|
|Notes payable - current portion||145,942||-|
|Total Current Liabilities||6,736,677||2,911,661|
|Deferred rent - non-current portion||36,423||45,351|
|Notes payable - non-current portion||424,338||-|
|Commitments and contingencies|
|0 shares issued and outstanding as of
|24,884,251 and 17,100,726 shares issued and outstanding|
|Additional paid-in capital||91,881,790||69,409,949|
|Total Stockholders' Equity||18,650,221||11,740,607|
|Total Liabilities and Stockholders' Equity||$||25,847,659||$||14,697,619|
Condensed Statements of Operations (unaudited)
|For the Three Months Ended||For the Nine Months Ended|
|Research and development||$||3,363,759||$||3,201,196||$||9,913,296||$||10,778,114|
|General and administrative||1,728,366||1,489,739||5,669,311||5,241,608|
|Total Operating Expenses||5,092,125||4,690,935||15,582,607||16,019,722|
|Loss From Operations||(5,092,125||)||(4,690,935||)||(15,582,607||)||(16,019,722||)|
|Small Business Administration Economic|
|Injury Disaster grant||-||-||10,000||-|
|Net Loss Per Share|
|- Basic and Diluted||$||(0.23||)||$||(0.29||)||$||(0.79||)||$||(1.19||)|
|Weighted Average Number of|
|Common Shares Outstanding|
|- Basic and Diluted||22,206,195||16,270,728||19,802,999||13,422,667|
Source: Eyenovia, Inc.