Full Press Release Details
Eyenovia Reports Second Quarter 2024 Financial
Results and Provides Corporate Update
Following FDA consultation, announced plans
for validation of the Gen-2 Optejet device and 2025 regulatory submission with Mydcombi as lead product
Advanced Phase 3 CHAPERONE study of MicroPine
as a treatment of pediatric progressive myopia with preparations for analysis in Q4
Commenced sales activities with focus on Mydcombi
in 260+ offices and preparations for launch of clobetasol propionate ophthalmic suspension 0.05%, the first new ophthalmic steroid to
enter the market in 15 years
Announced development collaborations with Formosa,
Senju and SGN to leverage the Optejet for the $5 billion global dry eye disease market
Company to host conference call and webcast
today, August 12th, at 4:30 pm ET
NEW YORK-August 12, 2024-Eyenovia, Inc.
(NASDAQ: EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia,
today announced its financial and operating results for the second quarter ended June 30, 2024.
Second Quarter 2024 and Recent Business Developments
Michael Rowe, Chief Executive Officer, commented,
"During the second quarter, we made significant progress both advancing our commercial initiatives and furthering co-development
agreements that can potentially address new, multi-billion-dollar underserved markets. Our plans to finalize the Gen-2 device are now
set following a meeting with the FDA and we look forward to submitting this advanced technology with Mydcombi as the lead product in 2025.
Meanwhile, our Mydcombi launch continues to track to plan, with this innovative mydriasis product now available in 63 new ophthalmic offices
since launch, with many more coming onboard during the third quarter as momentum accelerates."
"Regarding MicroPine, which we are developing
for pediatric progressive myopia, we are preparing for analysis of the Phase 3 CHAPERONE data in the fourth quarter that, if successful,
would meaningfully accelerate its remaining development path. We also executed several co-development agreements to evaluate novel therapeutics
in our Optejet dispenser as potential treatments for dry eye disease, which is estimated to be a $5 billion addressable market."
"Also, during the second quarter, we completed
a registered direct equity offering with two of our largest shareholders at the market price. These additional funds, together with cash
on-hand and other currently available capital resources, are expected to fund our operations through the Phase 3 CHAPERONE data, which
we view as a significant upcoming milestone for our company."
"We continue to take steps to increase the
tangible value of our company, which currently includes two FDA-approved products, a third in late Phase 3 development, and co-development
agreements that leverage our novel Optejet technology in large market indications. We believe we are very well positioned to be a leading
partner to ophthalmic offices by addressing a broad spectrum of physician and patient needs with a portfolio of highly differentiated
Second Quarter 2024 Financial Review
For the second quarter of 2024, net loss was approximately
$11.1 million, or $0.21 per share, as compared to a net loss of $6.2 million, or $0.16 per share, for the second quarter of 2023. The
second quarter 2024 net loss includes $2.9 million of expense, or $0.05 loss per share, associated with the reacquisition of the license
rights for MicroPine from Bausch + Lomb. The Company recorded a cost of revenue write-off of $0.5 million to adjust finished goods commercial
inventory to net realizable value in the second quarter of 2024. In addition, other income includes a gain of approximately $1.2 million
associated with the change in fair value of equity consideration granted in the Bausch + Lomb and Formosa transactions.
Research and development expenses totaled approximately
$4.6 million for the second quarter of 2024, compared to $2.8 million for the second quarter of 2023, an increase of approximately 63.5%
due largely to increased clinical expenses from the reacquisition of Micropine license rights from Bausch + Lomb.
For the second quarter of 2024, general and administrative
expenses were approximately $3.8 million, compared to $3.1 million for the second quarter of 2023, an increase of approximately 19.3%
reflecting the establishment of the Company's sales force in 2024.
Total operating expenses for the second quarter
of 2024 were approximately $11.2 million, including the previously referenced $2.9 million of expenses associated with the Bausch transaction
compared to approximately $6.0 million for the second quarter of 2023. This represents an increase of approximately 88.2%. The second
quarter 2024 operating expense figure includes approximately $3.8 million of non-cash expenses.
As of June 30, 2024, the Company's
unrestricted cash and cash equivalents were approximately $2.3 million. This excludes approximately $5.8 million in gross proceeds from
equity offerings completed after June 30, 2024.
Conference Call and Webcast
The conference call is scheduled to begin at 4:30
pm ET today, August 12th. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470 (international), and reference conference
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 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.
PLEASE GO TO MYDCOMBI.COM
FOR IMPORTANT SAFETY INFORMATION for MYDCOMBI (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%
PLEASE GO TO CLOBETASOLBID.COM
FOR IMPORTANT SAFETY INFORMATION for Clobetasol Proprionate Ophthalmic Suspension 0.05%
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)
for mydriasis, as well as clobetasol propionate ophthalmic suspension 0.05% to reduce pain and inflammation following ocular surgery,
which was approved by the FDA on March 4, 2024.
Eyenovia is also advancing
late-stage development of MicroPine for pediatric progressive myopia (partnered with Arctic Vision in China and South Korea).
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 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 statements regarding the plans,
strategies and objectives of management, statements regarding future capital requirements, and estimated market opportunities for our
products, 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 in some cases are
likely to, differ materially from what is expressed or forecasted in the forward-looking statements. In addition, such statements could
be affected by risks and uncertainties related to, among other things: risks of our clinical trials, including, but not limited to, the
costs, design, initiation and enrollment, timing, progress and results of such trials; the timing of, and our ability to submit applications
for, obtaining and maintaining regulatory approvals for our product candidates; the potential impacts of any disruptions on our supply
chain, including the availability of sufficient components and materials used in our products and product candidates; the potential advantages
of our products, product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our products
and product candidates; our estimates regarding the potential market opportunity for our products and product candidates; reliance on
third parties to develop and commercialize our products and product candidates; the ability of us and our partners to timely develop,
implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products and product candidates;
the risk of defects in, or returns of, our products; intellectual property risks; changes in legal, regulatory and legislative environments
in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; our
competitive position; and other risks described from time to time in the "Risk Factors" section of our filings with the U.S.
Securities and Exchange Commission, including those described in our Annual Report on Form 10-K as well as our Quarterly Reports