Full Press Release Details
Eyenovia Reports Fourth Quarter and Full
Year 2019 Financial Results
New York, NY - March 25, 2020
-Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose
therapeutics utilizing its patented piezo-print delivery technology, today announced its financial results for the fourth quarter
and full year ended December 31, 2019.
Fourth Quarter 2019 and Recent Business
"2019 was a very successful year
for Eyenovia, as we made significant advancements in our late stage ophthalmology pipeline that continued to validate our high
precision microdosing platform," commented Dr. Sean Ianchulev, Eyenovia's Chief Executive Officer and Chief Medical
Officer. "We completed our MicroStat Phase III MIST-1 and MIST-2 studies for pharmacologic mydriasis, which support our novel
approach to treating front and back of the eye conditions. These results also paved the way for the initiation of our MicroPine
Phase III CHAPERONE study for progressive myopia, which is currently enrolling subjects. In 2019, we also reprioritized our pipeline
to focus on our highest value opportunities and introduced our Phase III ready MicroLine program for presbyopia. We believe that
we could transform the primarily device-based treatment paradigm for an estimated 43 million people in the United States with a
cash-pay prescription therapy with our proprietary microdose formulation of pilocarpine. With a bolstered balance sheet, we have
anticipated milestones in our Phase III programs for presbyopia and myopia, as well as the planned MicroStat NDA this year, although
we are closely monitoring the evolving situation of the COVID-19 pandemic and its potential impact on our business."
Fourth Quarter and Full Year 2019 Financial
For the fourth quarter of 2019, net loss
was approximately $5.2 million, or $(0.31) per share, compared to a net loss of approximately $6.2 million, or $(0.60) per share
for the fourth quarter of 2018. For the full year ended December 31, 2019, net loss was approximately $21.2 million, or $(1.47)
per share. This compares to a net loss of approximately $17.3 million, or $(1.82) per share for the full year of 2018.
Research and development expenses totaled
approximately $3.3 million for the fourth quarter of 2019, compared to approximately $4.1 million for the same period in 2018,
a decrease of 19.4%. For the full year 2019, research and development expenses increased 26.8% to approximately $14.1 million compared
to approximately $11.1 million in the prior year.
For the fourth quarter of 2019, general
and administrative expenses were approximately $2.0 million compared to approximately $2.1 million for the fourth quarter of 2018,
a decrease of 4.5%. For the full year 2019, general and administrative expenses increased 17.4% to approximately $7.2 million versus
approximately $6.1 million for the full year of 2018 due largely to an increase in non-cash stock compensation expense of approximately
Total operating expenses for the fourth
quarter of 2019 were approximately $5.3 million, compared to total operating expenses of approximately $6.2 million for the same
period in 2018, a decrease of 14.5%. Operating expenses for the fourth quarter of 2019 include approximately $0.6 million of non-cash
stock compensation expense. For the full year 2019, total operating expenses increased 23.5% to approximately $21.3 million compared
to $17.3 million for the full year of 2018. 2019 operating expenses include approximately $2.5 million of non-cash stock compensation
As of December 31, 2019, the Company's
cash and cash equivalents was approximately $14.2 million. This excludes approximately $5.3 million of net proceeds from Eyenovia's
private placement which closed on March 24, 2020.
Conference Call and Webcast
The conference call is scheduled to begin
at 4:30 pm ET on Wednesday, March 25, 2020. Participants should dial 1-866-916-2921 (United States) or 1-210-874-7771 (International)
with the conference code 7487792. 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. In addition, a telephonic replay of the call will be available until April
1, 2020. The replay can be accessed by dialing 1-855-859-2056 (United States) or 1-404-537-3406 (International) with confirmation
Eyenovia, Inc. (NASDAQ: EYEN) is a clinical
stage ophthalmic biopharmaceutical company developing a pipeline of microdose therapeutics utilizing its patented piezo-print
delivery technology. Eyenovia's pipeline is currently focused on the late-stage development of microdosed medications for
presbyopia, myopia progression and mydriasis. For more Information please visit www.eyenovia.com.
About MicroLine for Presbyopia
MicroLine is Eyenovia's 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.
Anticipated Milestone: Initiate and Complete
Phase III VISION Trials in 2020
About MicroPine for Progressive Myopia
MicroPine (atropine ophthalmic solution)
is Eyenovia's first-in-class topical treatment for progressive myopia, a back-of-the-eye condition commonly known as nearsightedness.
Progressive myopia is estimated to affect close to 5 million children in the United States who suffer from uncontrolled axial
elongation of the sclera leading to increasing levels of myopia and in some cases major pathologic changes such as retinal atrophy,
macular staphylomas, retinal detachment and visual impairment. MicroPine has been developed for comfort and ease-of-use in children.
Microdose administration of MicroPine is anticipated to result in low systemic and ocular drug exposure. A recent therapeutic
evidence assessment and review by the American Academy of Ophthalmology indicates Level 1 (highest) evidence of efficacy for the
role of low dose atropine for progressive myopia (Ophthalmology 2017;124:1857-1866; Ophthalmology
2016; 123(2) 391:399).
Feasibility Dose-finding Atropine Studies:
ATOM 1; ATOM 2; LAMP (Independent Collaborative
Anticipated Milestone: Complete Enrollment
of the Phase III CHAPERONE Study in 2020
About MicroStat for Mydriasis
is Eyenovia's first-in-class fixed-combination micro-formulation product (phenylephrine 2.5% -tropicamide 1%) candidate for pharmacologic
mydriasis (eye dilation), which is targeted to improve the efficiency of the estimated 80 million office-based comprehensive and
diabetic 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, we are developing MicroStat to improve the efficacy and tolerability
of pharmacologic mydriasis.
Anticipated Milestone: File NDA in 2020
About Optejet and MicroRx Ocular
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 market opportunities
in the United States for our product candidates. 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