Full Press Release Details
Eyenovia Reports Fourth Quarter 2022 Financial
Results and Provides Business Update
Announced FDA acceptance of Mydcombi New Drug
Application (NDA) and PDUFA action date of May 8, 2023
Announced positive results from Microline Phase
3 program as a potential treatment for presbyopia and received feedback from the FDA outlining a clear path forward for the program
Entered into co-development agreement with Formosa
Company to host conference call and webcast
today, March 30th, at 4:30 pm ET
YORK-March 30, 2023-Eyenovia, Inc. (Nasdaq: EYEN), a pre-commercial ophthalmic technology company developing the Optejet
delivery system for use both in combination with its own drug-device therapeutic programs for mydriasis, presbyopia and pediatric progressive
myopia as well as out-licensing for additional indications, today announced its financial and operating results for the fourth quarter
and full-year ended December 31, 2022.
Fourth Quarter 2022 and Recent Business Developments
Michael Rowe, Chief Executive
Officer, commented, "We continue to make significant progress with our two lead programs, Mydcombi and Microline. Specifically,
we are preparing for our May 8th PDUFA date for Mydcombi which, if approved, would validate the Optejet dispensing technology
that is core to all of our proprietary and partnered programs, and would transition us to a commercial stage company. We are in the middle
of a FDA inspection of our manufacturing facility as part of that review process."
"Regarding Microline,
having completed our VISION 2 study, we recently received feedback from the FDA which outlines a clear path forward for the program. Importantly,
the feedback is in line with our expectations, and our development timeline for the program remains unchanged. Presbyopia represents a
very significant market opportunity for our company, and the agency's feedback is very encouraging."
"Finally, our co-development
agreement with Formosa represents an opportunity to significantly expand our pipeline and will serve as a model for any future partnerships.
We are in advanced discussions with additional potential partners to leverage the Optejet in high-value indications, and we are optimistic
that we will sign one or more partnership agreements this year."
Fourth Quarter and Full Year 2022 Financial
For the fourth quarter
of 2022, net loss was approximately $[6.1] million, or $[0.17] per share compared to a net income of approximately $3.0 million, or $0.11
per share, for the fourth quarter of 2021. For the full-year 2022, net loss was approximately $[28.0] million, or $[0.83] per share on
approximately 33.6 million weighted average shares outstanding, and this compares to a net loss of approximately $[12.8] million, or $[0.49]
per share, for the full year 2021 on approximately 26.3 million weighted average shares outstanding.
and development expenses totaled approximately $2.2 million for the fourth quarter of 2022 as compared to $3.3 million for the fourth
quarter of 2021, a decrease of approximately 33%. For the full-year 2022, research and development expenses decreased approximately
10% to $13.4 million, versus $14.9 million for the full-year 2021. The decrease was driven primarily by lower direct clinical and non-clinical
expenses, as well as deferral of costs related to future delivery of clinical supply to our partners.
the fourth quarter of 2022, general and administrative expenses were approximately $3.2 million, compared to $3.7 million for the fourth
quarter of 2021, a decrease of approximately 13.3%. For the full-year 2022, general and administrative expenses were $13.5 million,
an increase of 28% as compared to $10.6 million for the full-year 2021. The full year increase was driven by staff additions, higher professional
fees, and an increase in stock-based compensation.
operating expenses for the fourth quarter of 2022 were approximately $5.4 million compared to $6.9 million for the fourth quarter of 2021.
This represents a decrease of approximately 22.7%. Total operating expenses for the full-year 2022 were $26.9 million, representing
an increase of 6% versus $25.4 million for the full-year 2021.
As of December 31, 2022,
the Company's unrestricted cash and cash equivalents were approximately $22.9 million, as compared to $27.3 million in unrestricted
and restricted cash as of December 31, 2021.
Conference Call and Webcast
conference call is scheduled to begin at 4:30 pm ET today, March 30th. Participants should dial 1-877-407-9039 or 1-201-689-8470.
A live webcast of the conference call will also be available here and on the investor relations page of the Company's
corporate website at www.eyenovia.com.
After the live webcast,
the event will be archived on Eyenovia's website for one year.
About the VISION Trials
The VISION trials are
Phase 3, double-masked, placebo-controlled, cross-over superiority trials that enroll participants with presbyopia. The primary endpoint
is improvement in high-contrast binocular distance corrected near visual acuity in low light conditions. Microline is intended for the
"on demand" improvement of near vision in people with presbyopia.
About Microline for Presbyopia
Microline (pilocarpine
ophthalmic spray) is Eyenovia's investigational pharmacologic treatment for presbyopia. Presbyopia, or farsightedness, 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. 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. Microline has been licensed to Arctic Vision (Hong Kong) Limited in Greater China and South Korea.
About MicroPine for Progressive Myopia
MicroPine (atropine ophthalmic
spray) 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. MicroPine has been licensed to Bausch+Lomb,
Inc. in the United States and Canada, and Arctic Vision (Hong Kong) Limited in Greater China and South Korea.
About Mydcombi for Mydriasis
Mydcombi is Eyenovia's
investigational, first-in-class fixed-dose-combination product (tropicamide 1% and phenylephrine 2.5% ophthalmic spray) for pharmacologic
mydriasis (eye dilation), which is targeted to improve the efficiency of the estimated 100 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 as a micro-formulation for use without anesthetic, Eyenovia believes Mydcombi will help improve the efficacy, tolerability,
and efficiency of pharmacologic mydriasis. Mydcombi has been licensed to Arctic Vision (Hong Kong) Limited in Greater China and South
About Optejet and Microdose Array Print
Eyenovia's Optejet microdose formulation
and delivery platform for ocular therapeutics uses high-precision piezo-print technology to deliver ~8 L of drug, consistent with
the capacity of the tear film of the eye. We estimate the volume of ophthalmic solution administered with the Optejet is less than 20%
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. 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% historically seen with conventional
eyedroppers. Additionally, future versions with smart electronics and mobile e-health technology are being designed to track and enhance
About Eyenovia, Inc.
Eyenovia, Inc. (Nasdaq:
EYEN) is an pre-commercial ophthalmic technology company developing a pipeline of microdose array print (MAP) therapeutics. Eyenovia is
currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia and myopia progression. For more information,
The Eyenovia Corporate
Information slide deck may be found at ir.eyenovia.com/events-and-presentations.
Forward-Looking Statements
Except for historical
information, all the statements, expectations and assumptions contained in this presentation 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 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