Full Press Release Details
Eyenovia Reports Fourth Quarter and Full Year
2021 Financial Results
Successfully completed Type A meeting with FDA
and anticipates MydCombi(tm) NDA resubmission in Q3 2022
Enrolled first patient in the Phase 3 VISION-2
study evaluating MicroLine as an on-demand treatment for improving near vision (presbyopia)
Entered into a $15 million Securities Purchase
Agreement with Armistice Capital to support the Company's clinical and manufacturing operations
Company to host conference call and webcast today,
March 28, at 4:30pm ET
YORK-March 28, 2022-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 ended December 31, 2021.
Fourth Quarter 2021 and Recent Business Developments
Dr. Sean Ianchulev, Chairman, Chief Executive
Officer and Chief Medical Officer of Eyenovia, commented, "During the fourth quarter and subsequent period, we took meaningful steps
to advance our key programs: MydCombi for pharmacologic mydriasis and MicroLine for presbyopia. Beginning with MydCombi, we completed
a very productive Type A meeting with FDA and, we believe, gained full alignment on the path forward. We are in the process of completing
the additional non-clinical validation of the Optejet dispenser that has been requested by the agency and remain confident that we will
resubmit an NDA during the third quarter of this year. Importantly, the additional testing that we are conducting on the Optejet now can
be referenced in regulatory filings for our other programs - MicroLine and MicroPine - eliminating the need to repeat these
tests on behalf of those programs.
"At the same time, we enrolled the first
patient in VISION-2, which is the second Phase 3 study to evaluate MicroLine as a potential temporary, on-demand treatment for presbyopia,
or blurred near vision. Recall that the results from our first Phase 3 study, VISION-1, were positive. If these results are consistent,
we will be well positioned to file for regulatory approval in this indication as well, giving us potential line of sight to two approved,
commercially available products. We anticipate topline data from VISION-2 mid-year.
"With the additional capital provided through
Armistice Capital, we believe we are sufficiently capitalized to fund our Microline phase 3 Vision 2 study; the resubmission of the Mydcombi
NDA as well as our Redwood City manufacturing expenditures. We look forward to delivering several potentially value creating milestones
in 2022, and potentially our first product approval early next year," Dr. Ianchulev concluded.
Fourth Quarter 2021 Financial Review
For the fourth quarter
of 2021, net income was approximately $3.0 million, or $0.11 per share ($0.10 per share on a diluted basis), compared to a net loss of
approximately $(4.2) million, or $(0.17) per share, fourth quarter of 2020. For the full year ended December 31, 2021, net loss was approximately
$(12.8) million, or $(0.49) per share. This compares to a net loss of approximately $(19.8) million, or $(0.94) per share for the full
Total license revenue
was approximately $10.0 million for the fourth quarter and approximately $14.0 million for the full year 2021 as compared to $2.0 million
for the fourth quarter and full year 2020.
Research and development
expenses totaled approximately $3.2 million for the fourth quarter of 2021 as compared to $3.4 million for the fourth quarter of 2020.
For the full year 2021, research and development expenses were $14.5 million as compared to $13.4 million for the full year 2020.
For the fourth quarter
of 2021, general and administrative expenses were approximately $3.7 million, compared to $2.0 million for the fourth quarter of 2020.
For the full year 2021, general and administrative expenses were $10.8 million versus approximately $7.6 million for the full year of
Total operating expenses
for the fourth quarter of 2021 were approximately $6.9 million compared to $5.4 million for the comparable period in 2020. For the full
year 2021, total operating expenses were $25.3 million compared to $21 million for the full year 2020.
As of December 31, 2021,
the Company's cash and cash equivalents were approximately $27.3 million, including $7.9 million of restricted cash, compared to
$28.4 million as of December 31, 2020.
Conference Call and Webcast
conference call is scheduled to begin at 4:30pm ET today, March 28. Participants should dial 877-407-9039 (domestic) or 201-689-8470
(international) with the conference code 13727374. 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.
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 solution) 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. 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. MicroLine has been licensed to Arctic Vision
(Hong Kong) Limited in Greater China and South Korea.
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. MicroPine has been licensed to Bausch Health Companies, Inc. in the United
States and Canada, and Arctic Vision (Hong Kong) Limited in Greater China and South Korea.
About MyCombi for Mydriasis
MydCombi is Eyenovia's investigational, first-in-class
fixed-dose-combination product (tropicamide 1% and phenylephrine 2.5% ophthalmic solution) 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 Korea.
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 6-8 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, 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% historically seen with conventional eyedroppers. Additionally,
its smart electronics and mobile e-health technology are designed to track and enhance patient compliance.
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic
pharmaceutical 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, visit Eyenovia.com.
The Eyenovia Corporate Information slide deck
may be found at ir.eyenovia.com/events-and-presentations.
Forward-Looking Statements