Full Press Release Details
Eyenovia Reports Fourth Quarter and Full Year
2020 Financial Results
Announces MydCombi expected PDUFA date of October
Completes patient enrollment in Phase 3 VISION-1
study evaluating MicroLine for the treatment of presbyopia; topline data on track for Q2
Company to host conference call and webcast
today, March 25, at 4:30 pm ET
NEW YORK- March 25, 2021-Eyenovia,
Inc. (NASDAQ: EYEN), a clinical stage ophthalmic company developing a pipeline of advanced therapeutics based on its proprietary microdose
array print (MAP ) platform technology, today announced its financial results for the fourth quarter and full year ended December
Fourth Quarter 2020 and Recent Business Highlights
Chief Executive Officer and Chief Medical Officer of Eyenovia, commented, "We have made significant progress during 2020 advancing
our proprietary clinical programs. Most recently, we announced that the FDA has accepted our NDA for MydCombi, our proprietary fixed combination
mydriatic, or pupil dilation agent, for potential use in the over 80 million comprehensive eye exams currently conducted each year in
the United States. If approved, not only would MydCombi be the first microdosed ocular therapeutic applied with our proprietary high precision
smart delivery system, the Optejet , but it would transition us into a commercial stage company. We look forward to our PDUFA date
announced that the first patient had been dosed in our VISION-1 Phase 3 clinical study evaluating our proprietary pilocarpine formulation,
MicroLine, which is also delivered via the Optejet, for the improvement of near vision in patients with presbyopia, an estimated multi-billion-dollar
indication. Today, we are pleased to report that we recently completed enrollment in VISION-1 and, as this is a relatively short study,
we continue to anticipate topline data in the second quarter of this year. With our second Phase 3 program now initiated, an NDA accepted,
and several robust development partnerships with ophthalmologic leaders established, we believe we have significant momentum. We look
forward to building on this progress towards multiple potentially value creating milestones ahead," concluded Dr. Ianchulev.
Fourth Quarter and Full Year 2020 Financial
For the fourth quarter
of 2020, net loss was approximately $(4.2) million, or $(0.17) per share, compared to a net loss of approximately $(5.2)
million, or $(0.31) per share for the fourth quarter of 2019. For the full year ended December 31, 2020, net loss was approximately $(19.8)
million, or $(0.94) per share. This compares to a net loss of approximately $(21.2) million, or $(1.47) per share,
for the full year of 2019.
Total revenue was approximately $2.0
million for the fourth quarter and full year 2020. The revenue represented a milestone payment from the Company's previously
announced exclusive collaboration and licensing agreement with Arctic Vision. The Company did not generate revenue in 2019.
Research and development
expenses totaled approximately $3.4 million for the fourth quarter of 2020, compared to approximately $3.3 million for
the same period in 2019. For the full year 2020, research and development expenses decreased approximately 6% to approximately $13.3
million compared to approximately $14.1 million in the prior year.
For the fourth quarter
of 2020, general and administrative expenses were approximately $2.1 million compared to approximately $2.0 million for
the fourth quarter of 2019, an increase of 5%. For the full year 2020, general and administrative expenses increased 7% to approximately $7.7
million versus approximately $7.2 million for the full year of 2019.
Total operating expenses
for the fourth quarter of 2020 were approximately $5.4 million, compared to total operating expenses of approximately $5.3 million for
the same period in 2019, an increase of 2%. For the full year 2020, total operating expenses decreased 1% to approximately $21 million compared
to $21.3 million for the full year of 2019.
2020, the Company's cash and cash equivalents were approximately $28.4 million, compared to $14.2 million as of December 31,
is scheduled to begin at 4:30 pm ET on Thursday, March 25, 2021. Participants should dial 1-877-407-9039 (United States)
or 1-201-689-8470 (International) with the conference code 13716228. A live webcast of the conference call will also be available on
the Investor Relations page of the Company's corporate website at www.eyenovia.com.
The webcast will be archived
on Eyenovia's website for one year.
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ: EYEN) is a clinical
stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP) therapeutics. Eyenovia is currently focused
on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis. For more Information, visit www.eyenovia.com.
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. Eyenovia believes that its administration of pilocarpine
using the Company's high precision microdosing technology could provide a meaningful improvement in near vision while enhancing
tolerability and usability.
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 MicroStat (MyCombiTM)
Mydcombi is Eyenovia's first-in-class
fixed-combination micro-formulation product (tropicamide 1% - phenylephrine 2.5%) candidate for pharmacologic mydriasis (eye dilation),
which is targeted to improve the efficiency of the estimated 80 million office-based comprehensive eye exams performed every year in the
United States, as well as the estimated 4 million pharmacologic mydriasis applications for cataract surgery. Developed for use without
anesthetic, Eyenovia is developing MicroStat to help improve the efficacy and tolerability of pharmacologic mydriasis.
About Optejet and Microdose Array Print
(MAPTM) Therapeutics
Eyenovia's Optejet microdose formulation
and delivery platform for ocular therapeutics uses high-precision piezo-print technology to deliver 6-8 L of drug, consistent with
the capacity of the tear film of the eye. We believe the volume of ophthalmic solution administered with the Optejet is less than 75%
of that delivered using conventional eyedroppers, thus reducing overdosing and exposure to drug and preservatives. Eyenovia's patented
microfluidic ejection technology is designed for fast and gentle ocular surface delivery, where solution is dispensed to the ocular surface
in approximately 80 milliseconds, beating the ocular blink reflex. Successful use of the Optejet has been demonstrated more than 85% of
the time after basic training in a variety of clinical settings compared to 40 - 50% with conventional eyedroppers. Additionally,
its smart electronics and mobile e-health technology are designed to track and enhance patient compliance.
Forward-Looking Statements
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 regulatory review timing,
and market opportunities for our product candidates and platform technology. 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; our ability to raise additional money to fund our operations
for at least the next 12 months as a going concern; our estimates regarding the potential market opportunity for our product candidates
and potential revenue from licensing transactions; reliance on third parties; risks of our and our licensees' clinical trials, including,
but not limited to, the costs, design, initiation and enrollment (which could still be adversely impacted by COVID-19 and resulting social
distancing), timing, progress and results of such trials; the potential impacts of COVID-19 on our supply chain; the timing and our and
our licensees' ability to submit applications for, obtain and maintain regulatory approvals for our product candidates; changes
in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to