Full Press Release Details
Eyenovia Reports Third Quarter 2024 Financial
Results and Provides Corporate Update
Advanced Phase 3 CHAPERONE study of MicroPine
as a treatment of pediatric progressive myopia with preparations for interim analysis this quarter
Commenced the manufacture of registration batches
of Mydcombi in its second generation Optejet device
Announced the U.S. launch and commercial availability
of clobetasol propionate ophthalmic suspension 0.05% for the treatment of inflammation and pain following ocular surgery
Appointed Andrew Jones as Chief Financial Officer
Company to host conference call and webcast
today, November 12th, at 4:30 pm ET
NEW YORK-November 12, 2024-Eyenovia,
Inc. (NASDAQ: EYEN), an ophthalmic technology company developing and commercializing advanced products leveraging its proprietary Optejet
topical ophthalmic medication dispensing platform, today announced its financial and operating results for the third quarter ended September
Third Quarter 2024 and Recent Business Developments
Michael Rowe, Chief Executive Officer, commented,
"We achieved another significant commercial milestone during the third quarter with the U.S. launch of clobetasol, the first new
ocular steroid approved in over 15 years. Clobetasol perfectly complements our mydriasis product, Mydcombi, and allows us to further leverage
our sales force while adding significant value to eye doctors and surgeons. We also experienced accelerating sales momentum with Mydcombi,
now having reached 230 offices as of September 30th.
"We also took a meaningful step forward
in the development of our Gen-2 Optejet device with the commencement of manufacture of registration batches, with Mydcombi as our lead
product. We look forward to submitting for FDA approval of this advanced technology with Mydcombi in 2025, and a possible approval in
2026, if successful.
"Regarding MicroPine, which we are developing
for pediatric progressive myopia, we are preparing for an interim analysis of the Phase 3 CHAPERONE data this quarter that, if successful,
we expect will 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. Together, these indications represent multi-billion-dollar
addressable markets in the U.S. alone."
"With two differentiated commercial products,
another in late Phase 3 development, multiple opportunities in dry eye, and the advanced Gen-2 Optejet technology platform, I believe
we are creating a foundation from which we can drive significant growth and value creation in the months and years to come," Mr.
Third Quarter 2024 Financial Review
For the third quarter of 2024, net loss was approximately
$7.9 million, or $0.11 per share, as compared to a net loss of $7.3 million, or $0.18 per share, for the third quarter of 2023.
Research and development expenses totaled approximately
$3.5 million for the third quarter of 2024, which was relatively consistent with $3.6 million reported for the third quarter of 2023.
For the third quarter of 2024, selling, general
and administrative expenses were approximately $3.7 million, compared to $2.9 million for the third quarter of 2023, an increase of approximately
27.3% reflecting the establishment of the Company's sales force in 2024.
Total operating expenses for the third quarter
of 2024 were approximately $7.2 million, compared to approximately $6.5 million for the third quarter of 2023. This represents an increase
of approximately 10.6%. The third quarter 2024 operating expense figure includes approximately $1.2 million of non-cash expenses.
As of September 30, 2024, the Company's
unrestricted cash and cash equivalents were approximately $7.2 million. Eyenovia continues to evaluate a range of options to secure long-term
Conference Call and Webcast
The conference call is scheduled to begin at 4:30
pm ET today, November 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 an ophthalmic technology company developing and commercializing advanced products leveraging its proprietary Optejet topical
ophthalmic medication dispensing platform. The Optejet is especially useful in chronic front-of-the-eye diseases due to its ease of use,
enhanced safety and tolerability, and potential for superior compliance versus standard eye drops. Together, these benefits may combine
to produce better treatment options and outcomes for patients and providers. The company's pre-NDA candidate, MicroPine, is being
developed for pediatric progressive myopia, a global epidemic impacting hundreds of millions of children worldwide and representing a
multi-billion-dollar addressable market. The company's current commercial portfolio includes clobetasol propionate ophthalmic suspension,
0.05%, for post-surgical pain and inflammation, and Mydcombi for mydriasis. Eyenovia has also secured licensing and development agreements
for additional multi-billion-dollar indications where the Optejet may be advantageous, including dry eye. For more information, visit
The Eyenovia Corporate Information slide
deck may be found at ir.eyenovia.com/events-and-presentations.
Forward-Looking Statements
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: the availability of sufficient financial resources to continue clinical development and commercialization of our products;
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 on Form 10-Q, and supplemented from time to time by our Current Reports on Form 8-K. Any forward-looking statements speak
only as of the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not
undertake any obligation to update any forward-looking statements.
Chief Financial Officer
Eyenovia Investor Contact:
LifeSci Advisors, LLC
Eyenovia Media Contact: