Full Press Release Details
Eyenovia Reports Third Quarter 2023 Financial
Results and Provides Business Update
Acquired U.S. commercial rights to APP13007,
currently under FDA review for post-surgical ocular pain and inflammation, from Formosa Pharmaceuticals
Announced FDA approval of Coastline International
as contract manufacturer for Mydcombi cartridge subassemblies and preparations for national launch
Company to host conference call and webcast
today, November 13th, at 4:30 pm ET
NEW YORK-November 13, 2023-Eyenovia,
Inc. (NASDAQ: EYEN), a commercial-stage, topical ophthalmic company leveraging its Optejet dispensing technology for both internally
developed and acquired programs as well as out-licensing for additional indications, today announced its financial and operating results
for the third quarter ended September 30, 2023.
Third Quarter 2023 and Recent Business Developments
Michael Rowe, Chief Executive Officer, commented,
"During the third quarter, we expanded our near-term commercial product portfolio with our acquisition of the commercial rights
to APP13007 from Formosa Pharmaceuticals. This unique, twice-a-day steroid will compete against products that are typically used four
times a day, with a desirable efficacy and safety profile. Together with Mydcombi, we expect the two products to increase the capability
of our planned ten-person sales force to generate near-term revenue for our company which in turn will help fund the completion of our
internal development programs. APP13007 has the additional benefit of potential use in the Optejet for the treatment of dry eye disease,
and after recent positive discussions with the FDA, we are evaluating the timing and value of this potential program.
"We were also pleased to announce recently
that Coastline International was approved by the FDA as a contract manufacturer for certain elements of Mydcombi in the Optejet. With
Coastline, we expect to initiate manufacturing imminently in preparation for a broader launch in early 2024.
"We have made the strategic decision to prioritize
our current Gen-2 Optejet manufacturing capabilities to ensure that our partners, Bausch and Lomb and Arctic Vision, have this advanced
product for their pediatric myopia studies by the end of this year. This will shift the manufacture of registration batches of our pre-NDA
presbyopia candidate, Apersure, to the first quarter of 2024. We see no downside to this change as the nascent presbyopia market continues
to evolve and mature, as evidenced by the disappointing performance of the only available eye drop product for this indication. As new
entrants come into the presbyopia market and revitalize it, we look forward to introducing Apersure in the highly differentiated and desirable
"We are also excited to announce today the
appointment of Mr. Michael Geltzeiler to our Board as an independent director and Chair of our Audit Committee. Mike has a strong track
record of successful value creation for shareholders, including over 17 years of CFO experience at companies including ADT Corporation,
Euronext and Readers Digest. We are fortunate to have Mike with his extensive finance background join us at this time, and I know that
he is as excited as I am about the potential that Eyenovia represents.
"With three distinct sources of potential
growth - internally developed programs, complementary product acquisitions that can be further developed in the Optejet, and strategic
partnerships that license the Optejet for additional indications - I believe we have firmly established ourselves as a leader in
topical ophthalmic medication delivery, and I am excited about the many opportunities that are in front of us," Mr. Rowe concluded.
Third Quarter 2023 Financial Review
For the third quarter of 2023, net loss was approximately
$(7.3) million, or $(0.18) per share compared to a net loss of approximately $(7.3) million, or $(0.21) per share, for the third quarter
Research and development expenses totaled approximately
$3.6 million for the third quarter of 2023 as compared to $3.9 million for the third quarter of 2022.
For the third quarter of 2023, general and administrative
expenses were approximately $2.9 million, compared to $3.4 million for the third quarter of 2022.
Total operating expenses for the third quarter
of 2023 were approximately $6.5 million compared to $7.2 million for the third quarter of 2022.
As of September 30, 2023, the Company's
cash and cash equivalents were approximately $20.7 million compared to $22.9 million as of December 31, 2022.
Conference Call and Webcast
The conference call is scheduled to begin at 4:30
pm ET today, November 13th. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470 (international), and reference
conference ID 13741898.
To access the Call me feature, which avoids
having to wait for an operator, click here.
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.
IMPORTANT SAFETY INFORMATION for MYDCOMBI (tropicamide
and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%
MYDCOMBI is indicated to induce mydriasis
for diagnostic procedures and in conditions where short term pupil dilation is desired
CONTRAINDICATIONS: In patients
with known hypersensitivity to any component of the formulation
WARNINGS AND PRECAUTIONS
FOR TOPICAL OPHTHALMIC
USE. NOT FOR INJECTION
This preparation may
cause CNS disturbances which may be dangerous in pediatric patients. The possibility of psychotic reaction and behavioral disturbance
due to hypersensitivity to anticholinergic drugs should be considered.
Mydriatics may produce
a transient elevation of intraocular pressure.
Significant elevations
in blood pressure have been reported. Caution in patients with elevated blood pressure.
Rebound miosis has been
reported one day after installation.
Remove contact lenses
Atropine-like Drugs:
May exaggerate the adrenergic pressor response
Cholinergic Agonists
and Ophthalmic Cholinesterase Inhibitors: May interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic
cholinesterase inhibitors
Anesthetic Agents: May potentiate cardiovascular depressant effects of some inhalation anesthetic agents
To report SUSPECTED ADVERSE REACTIONS,
contact Eyenovia, Inc. At 1-833-393-6684 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch)
Please go to www.mydcombi.com
for FULL PRESCRIBING INFORMATION
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ:
EYEN) is a commercial-stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics based
on its Optejet platform. Eyenovia is currently focused on the commercialization of Mydcombi (tropicamide+phenylephrine ophthalmic spray)
In addition to commercializing
Mydcombi, in August 2023, Eyenovia acquired the U.S. commercial rights to APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%)
from Formosa Pharmaceuticals. APP13007, which is currently under review by the FDA, is a potent steroid being developed to reduce pain
and inflammation following ocular surgery. The agency has assigned a Prescription Drug User Fee Act (PDUFA) action date for APP13007 of
Eyenovia is also advancing
late-stage development of medications in the Optejet device for presbyopia and myopia progression (partnered with Bausch+Lomb in the U.S.
and Canada and Arctic Vision in China and South Korea).
For more information,
visit www.eyenovia.com.