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UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13
or 15(d)
of the Securities Exchange
Act of 1934
Date of Report (Date
of earliest event reported): November 10, 2023
EYENOVIA, INC.
(Exact Name of Registrant
as Specified in its Charter)
Delaware |
|
001-38365 |
|
47-1178401 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification No.) |
295 Madison Avenue, Suite 2400, New York, NY
10017
(Address of Principal Executive Offices, and
Zip Code)
(833) 393-6684
Registrant’s Telephone Number, Including
Area Code
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section
12(b) of the Act:
(Title of each class) |
|
(Trading
Symbol) |
|
(Name of each exchange
on which registered) |
Common stock, par value $0.0001 per share |
|
EYEN |
|
The Nasdaq Stock Market
(Nasdaq Capital Market) |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities
Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging
growth company x
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02. | Results of Operations and Financial Condition. |
On November 13, 2023,
Eyenovia, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended September 30,
2023. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein
by reference.
The information contained
in this Item 2.02, including Exhibit 99.1, is being “furnished” and shall not be deemed “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability
of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The
information contained in this Item 2.02, including Exhibit 99.1, shall not be incorporated by reference into any registration statement
or other document pursuant to the Securities Act or into any filing or other document pursuant to the Exchange Act, except as otherwise
expressly stated in any such filing.
Item 5.02. | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers;
Compensatory Arrangements of Certain Officers. |
On November 10, 2023,
the Board of Directors (the “Board”) of the Company appointed Michael Geltzeiler to serve on the Board and as the Chair of
the Audit Committee of the Board (the “Audit Committee”), in each case, effective November 14, 2023. Mr. Geltzeiler
will serve as a director until the Company’s 2024 annual meeting of stockholders and thereafter until his successor has been elected
and qualified or until his earlier death, resignation or removal.
There is no arrangement or
understanding between Mr. Geltzeiler and any other person pursuant to which he was selected as a director of the Company. There are
no related party transactions with regard to Mr. Geltzeiler that are reportable under Item 404(a) of Regulation S-K.
In accordance with the Company’s
Non-Employee Director Compensation Policy (the “Policy”), Mr. Geltzeiler will receive an initial equity award valued
at $49,534 issued half in options (with an exercise price equal to the closing price of the Company’s common stock on November 14,
2023, valued under the Black-Scholes model), and half in restricted stock units (“RSUs”). The options and RSUs will each
vest in full on the date of the Company’s 2024 annual meeting of stockholders; provided, however, that the settlement of the RSUs
will be deferred until Mr. Geltzeiler ceases to be a director. Mr. Geltzeiler will also be entitled to (1) annual cash
retainers of $40,000 for service on the Board and $20,000 for service as the Chair of the Audit Committee, in each case, paid quarterly
and prorated to reflect Mr. Geltzeiler’s tenure; and (2) indemnification pursuant to the standard indemnification agreement
between the Company and each of its directors.
Item 7.01. | Regulation FD Disclosure. |
On November 13, 2023,
the Company began using an updated corporate presentation with various investors and analysts. A copy of the presentation is furnished
as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
The information contained
in this Item 7.01, including Exhibit 99.2, is being “furnished” and shall not be deemed “filed” for purposes
of Section 18 of the Exchange Act, or otherwise subject to the liability of that Section or Sections 11 and 12(a)(2) of
the Securities Act. The information contained in this Item 7.01, including Exhibit 99.2, shall not be incorporated by reference into
any registration statement or other document pursuant to the Securities Act or into any filing or other document pursuant to the Exchange
Act, except as otherwise expressly stated in any such filing.
Item 9.01. | Financial Statements and Exhibits. |
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
EYENOVIA, INC. |
|
|
Date: November 13, 2023 |
/s/ John Gandolfo |
|
John Gandolfo |
|
Chief Financial Officer |
Exhibit 99.1
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
| · | Acquired the U.S. commercial rights to APP13007 for post-surgical ocular pain and inflammation from Formosa
Pharmaceuticals. If approved, APP13007 would complement Eyenovia’s commercially approved mydriasis product, Mydcombi, and allow
for the generation of additional near-term revenue. A New Drug Application (NDA) for APP13007 is currently under review by the FDA, which
has assigned a PDUFA action date of March 4, 2024. |
| · | Announced the appointment of senior finance executive Mr. Michael Geltzeiler to Eyenovia’s Board
as an independent director and Chair of the Audit Committee. |
| · | Announced FDA approval of Coastline International as contract manufacturer for Mydcombi cartridge subassemblies,
enabling a national launch in early 2024. |
| · | Initiated training of ophthalmic technicians in the use of Mydcombi through sponsorship of a course at
the International Joint Commission on Allied Health Personnel in Ophthalmology (IJCAHPO) 51st Annual Continuing Education (ACE) program. |
| · | Advanced its Gen-2 Optejet device and anticipates shipping to MicroPine partners Bausch and Lomb and Arctic
Vision by year-end 2023. |
| · | Continued to validate its manufacturing facilities in Redwood City, CA and Reno, NV, the former having
a PDUFA date in February 2024 for use as a commercial facility. |
| · | Presented data from a study of the preservative-free microbial integrity of the Optejet® at the American
Academy of Optometry’s “Academy 2023 New Orleans” Annual Meeting in October. The study successfully demonstrated the
Optejet’s ability to maintain product sterility even when exposed to a microbial load that exceeds typical environmental conditions. |
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
Optejet dispenser.
“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
of 2022.
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%
INDICATIONS
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
before using.
DRUG INTERACTIONS
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
Potent Inhalation
Anesthetic Agents: May potentiate cardiovascular depressant effects of some inhalation anesthetic agents
ADVERSE REACTIONS
| · | Most common ocular adverse reactions include transient blurred
vision, reduced visual acuity, photophobia, superficial punctate keratitis, and mild eye discomfort. Increased intraocular pressure has
been reported following the use of mydriatics. |
| · | Systemic adverse reactions including dryness of the mouth,
tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been
reported with the use of tropicamide. |
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)
for mydriasis.
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
March 4, 2024.
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.
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 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 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.
Eyenovia Contact:
Eyenovia, Inc.
John Gandolfo
Chief Financial Officer
jgandolfo@eyenovia.com
Eyenovia Investor Contact:
Eric Ribner
LifeSci Advisors, LLC
eric@lifesciadvisors.com
(646) 751-4363
Eyenovia
Media Contact:
Eyenovia, Inc.
Norbert Lowe
Vice President, Commercial Operations
nlowe@eyenovia.com
EYENOVIA, INC.
Condensed Balance Sheets
| |
September 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
(unaudited) | | |
| |
Assets | |
| | | |
| | |
| |
| | | |
| | |
Current Assets | |
| | | |
| | |
Cash and cash equivalents | |
$ | 20,702,212 | | |
$ | 22,863,520 | |
Inventories | |
| 50,296 | | |
| - | |
Deferred clinical supply costs | |
| 3,622,687 | | |
| 2,284,931 | |
License fee and expense reimbursements
receivable | |
| 397,014 | | |
| 1,183,786 | |
Security deposits, current | |
| - | | |
| 119,550 | |
Prepaid expenses
and other current assets | |
| 1,760,824 | | |
| 1,190,719 | |
| |
| | | |
| | |
Total Current Assets | |
| 26,533,033 | | |
| 27,642,506 | |
| |
| | | |
| | |
Property and equipment, net | |
| 3,531,365 | | |
| 1,295,115 | |
Security deposits, non-current | |
| 198,674 | | |
| 80,874 | |
Intangible assets | |
| 2,122,945 | | |
| - | |
Operating lease right-of-use asset | |
| 1,792,667 | | |
| 1,291,592 | |
Equipment deposits | |
| 686,753 | | |
| 726,326 | |
| |
| | | |
| | |
Total Assets | |
$ | 34,865,437 | | |
$ | 31,036,413 | |
| |
| | | |
| | |
Liabilities and Stockholders' Equity | |
| | | |
| | |
| |
| | | |
| | |
Current Liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 1,426,028 | | |
$ | 1,428,283 | |
Accrued compensation | |
| 1,375,832 | | |
| 1,747,191 | |
Accrued expenses and other current
liabilities | |
| 295,703 | | |
| 503,076 | |
Operating lease liabilities - current
portion | |
| 444,616 | | |
| 484,882 | |
Notes payable
- current portion, net of debt discount of $327,217 and $33,885 as of September 30, 2023 and December 31, 2022, respectively |
|
|
3,006,116 |
|
|
|
174,448 |
|
Convertible
notes payable - current portion, net of debt discount of $0 and $33,885 as of September 30, 2023 and December 31, 2022, respectively |
|
|
- |
|
|
|
174,448 |
|
| |
| | | |
| | |
Total Current Liabilities | |
| 6,548,295 | | |
| 4,512,328 | |
| |
| | | |
| | |
Operating lease liabilities - non-current portion | |
| 1,441,081 | | |
| 907,644 | |
Notes payable
- non-current portion, net of debt discount of $754,919 and $813,229 as of September 30, 2023 and December 31, 2022, respectively |
|
|
6,549,248 |
|
|
|
4,190,938 |
|
Convertible
notes payable - non-current portion, net of debt discount of $452,920 and $813,229 as of September 30, 2023 and December 31, 2022,
respectively |
|
|
4,547,080 |
|
|
|
4,190,938 |
|
| |
| | | |
| | |
Total Liabilities | |
| 19,085,704 | | |
| 13,801,848 | |
| |
| | | |
| | |
Stockholders' Equity: | |
| | | |
| | |
Preferred
stock, $0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022 |
|
|
- |
|
|
|
- |
|
Common stock,
$0.0001 par value, 90,000,000 shares authorized; 42,898,246 and 36,668,980 shares issued and outstanding as of September 30, 2023 and
December 31, 2022, respectively |
|
|
4,290 |
|
|
|
3,667 |
|
Additional paid-in capital | |
| 153,299,865 | | |
| 135,461,361 | |
Accumulated
deficit | |
| (137,524,422 | ) | |
| (118,230,463 | ) |
| |
| | | |
| | |
Total Stockholders'
Equity | |
| 15,779,733 | | |
| 17,234,565 | |
| |
| | | |
| | |
Total Liabilities
and Stockholders' Equity | |
$ | 34,865,437 | | |
$ | 31,036,413 | |
EYENOVIA, INC.
Condensed Statements of Operations
(unaudited)
| |
For the Three Months Ended | | |
For the Nine Months Ended |
|
| |
September 30, | | |
September 30, |
|
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Operating Income | |
| | | |
| | | |
| | | |
| | |
Revenue | |
$ | 1,198 | | |
$ | - | | |
$ | 1,198 | | |
$ | - | |
Cost of revenue | |
| (1,198 | ) | |
| - | | |
| (1,198 | ) | |
| - | |
Gross Profit | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | |
Operating Expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 3,578,113 | | |
| 3,876,876 | | |
| 8,911,124 | | |
| 11,176,326 | |
General and administrative | |
| 2,942,073 | | |
| 3,353,352 | | |
| 9,028,768 | | |
| 10,362,907 | |
Total Operating Expenses | |
| 6,520,186 | | |
| 7,230,228 | | |
| 17,939,892 | | |
| 21,539,233 | |
Loss From Operations | |
| (6,520,186 | ) | |
| (7,230,228 | ) | |
| (17,939,892 | ) | |
| (21,539,233 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other Income (Expense): | |
| | | |
| | | |
| | | |
| | |
Other income (expense), net | |
| (348,226 | ) | |
| 70,277 | | |
| (157,783 | ) | |
| 96,580 | |
Interest expense | |
| (679,222 | ) | |
| (177,138 | ) | |
| (1,691,228 | ) | |
| (475,811 | ) |
Interest income | |
| 208,901 | | |
| 28,093 | | |
| 494,944 | | |
| 30,703 | |
Total Other Income (Expense) | |
| (818,547 | ) | |
| (78,768 | ) | |
| (1,354,067 | ) | |
| (348,528 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net Loss | |
$ | (7,338,733 | ) | |
$ | (7,308,996 | ) | |
$ | (19,293,959 | ) | |
$ | (21,887,761 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net Loss Per Share - Basic and Diluted | |
$ | (0.18 | ) | |
$ | (0.21 | ) | |
$ | (0.50 | ) | |
$ | (0.67 | ) |
| |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Shares Outstanding | |
| | | |
| | | |
| | | |
| | |
- Basic and Diluted | |
| 40,139,697 | | |
| 34,631,774 | | |
| 38,563,074 | | |
| 32,778,551 | |
Exhibit 99.2
| November 2023
FOCUS: INCREASING VALUE
NOW AND IN THE FUTURE |
| Forward-looking Statements
Except for historical information, all the statements, expectations and assumptions contained in this presentation 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 for our 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 due to numerous factors
discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission.
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 advantages of our product
candidates and platform technology and the potential for approval of APP13007; the rate and degree of market acceptance and clinical
utility of our product candidates; our estimates regarding the potential market opportunity for our product candidates; reliance on third
parties to develop and commercialize our product candidates; the risk of defects in, or returns of, our products; the ability of us and our
partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our
product candidates; intellectual property risks; changes in legal, regulatory, legislative and geopolitical environments in the markets in which
we operate and the impact of these changes on our ability to obtain regulatory approval for our products; and our competitive position.
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.
2 |
| 3
• Horizontal delivery
• Precision dose
• Digital compliance capabilities
Optejet® with microdose array print technology
• Patented digital device platform technology
• Exciting and diverse product pipeline
• Multi-faceted business model that combines
partnerships, licensing agreements, internal
product development and sales
Eyenovia (NASDAQ | EYEN) is a US based medical Eyenovia at a Glance device and ocular therapeutics company |
| 4
Today’s Eyedropper Bottle Designed for manufacturing ease, not patient ease
Over the past 125 years, changes
in eyedropper design have done
little to improve the usability of
topical ophthalmic medications
1800’s
Glass Pipette
1900’s
Glass Pipette with Bulb
and Separate Vial
Today
Integrated Bottle with Dropper Tip
1. Survey conducted in January 2023 with 100 people (19 - 65+ Age Range, Mean Age = 51YO) who regularly take eye drop medications. Respondents were asked to rank common drug forms from easiest to most
difficult to administer on a 0-10 scale (0 meaning no difficulty, 10 meaning extremely difficult). Of the 11 medication types ranked, eye drops were the third most difficult behind suppositories and eye ointments.
The topical ointments were ranked the easiest to administer with an average score of 1.1, and suppositories ranked the most difficult with a score of 6.48. Eye drops received an average score of 4.6.
In a recent survey conducted by J. Reckner and Associates, consumers reported that
taking eye drops was among the most difficult ways to self-administer medication1 |
| 5
Introducing the Optejet®
Optejet® with replaceable drug cartridge
Spray nozzle with
109 laser-drilled ports
Shutter
Activation button
Ergonomic design
Proprietary, pre-filled drug cartridge
manufactured by Eyenovia
Optejet is a drug-device combination product manufactured
with a sterile-filled, replaceable drug cartridge |
| 6
MydCombi Utilizes the Optejet® Technology
Spray nozzle with
109 laser-drilled ports
Mist button
Proprietary, pre-filled and
replaceable drug cartridge
containing tropicamide and
phenylephrine
Fill button
Base Unit with
rechargeable battery
Cartridge Base
Proprietary, pre-filled drug
cartridge manufactured
by Eyenovia |
| 7
The Optejet®
Cartridge Has Been
Through Extensive
Sterility Testing |
| 8
Ergonomic Design to Improve Usability
Eye Dropper Bottle administration
requires head-tilting, squeezing,
and reliance on gravity
Eye Dropper Bottle tips
can touch the eye surface
Optejet administration can be done
horizontally with the push of a button
Horizontal delivery, push button
dosing and no protruding tip
Optejet has a recessed nozzle,
protected by a shutter when
not in use to prevent cross-contamination |
| 9
Minimal Sufficient Dosing May Improve Therapeutic Index
1 Wirta D. et al, Presentation at 2019 ASCRS meeting | 2 Ianchulev T. et al, Therapeutic Delivery 2018 | 3 Hamrah, P. et al. Cytotoxicity Evaluation for BAK-preserved Latanoprost Delivered By Drop vs.
Microdose Array Print Technology. ARVO 2023 poster. New Orleans, LA| 4 The impact of precision spray dosing of netarsudil 0.02% can be seen when compared to a single drop of the same drug. 5 Arias A. et
al, Patient persistence with first-line antiglaucomatous monotherapy. Clin Ophthalmol. 2010
Netarsudil 0.02%
delivered via Optejet®
Netarsudil 0.02% delivered
via Eye Dropper Bottle
Minimizes Impact of Preservatives
on Ocular Tissues
Minimizes Excessive Drug
Exposure to Ocular Tissues
When tolerability is poor, patients are very likely to
discontinue their medication or put pressure on the
ophthalmologist to change their treatment5
3
4
With 80% less dose volume, reduces excessive exposure to both drugs and preservatives 1,2 |
| 10
Optejet Digital Technology to Improve Delivery of Care
The Optejet® is capable of
automatically tracking usage
Remote Patient Monitoring:
More Data May Benefit All Parties
PATIENT
• Reminders to take medicine
• Ability to track compliance progress
• Opportunity for brand-specific encouragement
PHYSICIAN
• Ability for quicker action with more
accurate data
• Opportunity for billing: CPT Code (98980)
for monthly check of compliance data
PAYER
• Cost savings: Less likely to have patient on
second medication if compliance is the issue
• Better outcomes: Compliance with drug
therapy shown to slow disease progression1
1 Shu YH et al. Topical Medication Adherence and Visual Field Progression in Open-angle Glaucoma. J Glaucoma 2021 |
| 11
Pipeline
Target Market Optejet Targeted Differentiation
United States
Addressable
Population
United States
Market $USD*
China
Addressable
Population
US Status Licensee
PROPRIETARY
Pupil dilation
(Mydriasis)
Ease of use, well tolerated, less systemic
absorption, fast recovery time
Procedures:
108M1
$250M 650M8
Eyenovia Commercializing
USA
China
Ocular Surgery Pain
and Inflammation
Eyedrop:
2X day dosing, low AE incidence10
Procedures:
7M2
$200M N/A PDUFA March 2024 USA
Alternative to glasses
for early presbyopia
Ease of use, convenience,
low side effect incidence 7M3 $850M 12M9 Manufacturing registration
batches 1Q 2024
USA
China
Eye Hydration High technology delivery system 117M4 $3.1B N/A FDA device registration discussions USA
PARTNERED
Treatment of childhood
progressive Myopia
Ease of use, digital monitoring
technology, pediatrics self-dosing 3M5 $4.5B 50M9A USA Ph3 study enrollment may be
completed in 2024
USA
China
POTENTIAL
Glaucoma
Digital monitoring technology,
ease of use, low side effect incidence 3M6 $3B 20M9 Biocompatibility testing of potential
partner’s drug product - -
Dry Eye New drug class, ease of use,
fast onset 31M7 $3.6B 235M9
Positive feedback from FDA received;
exploring partnership options - -
1. https://bit.ly/44BK4Zf | https://bit.ly/44IwR0K | 2. 2022 Delve Insights, Acute Ocular Pain Report | 3. Population of 40-55YO in the US = 60.8M A , 35% of this population has never needed corrected vision, Assumes product works in 33% of patients BA. Published by Erin Duffin, & 30, S. (2022, September 30). Population of the U.S. by sex and age 2021. Statista.
Retrieved February 3, 2023, from https://bit.ly/45Rv3U6 B. What is 20/20 vision? University of Iowa Hospitals & Clinics. (n.d.). Retrieved February 3, 2023, from https://bit.ly/482g6jT | 4. https://bit.ly/3r2iOFu | 5. Theophanous C, Modjtahedi BS, Batech M, Marlin DS, Luong TQ, Fong DS. Myopia prevalence and risk factors in children. Clin Ophthalmol. 2018 Aug
29;12:1581-1587. doi: 10.2147/OPTH.S164641. PMID: 30214142; PMCID: PMC6120514. U.S. Census Bureau, Current Population Survey, Annual Social and Economic Supplement, 2021.| Banashefski B, Rhee MK, Lema GMC. High Myopia Prevalence across Racial Groups in the United States: A Systematic Scoping Review. J Clin Med. 2023 Apr 21;12(8):3045. doi:
10.3390/jcm12083045 | 6.https://bit.ly/3Rcqdwz. | 7. Frost & Sullivan, Prospectus, World Bank 370M Adjusted to fit patient criteria | 8. J&J Global Eye Health Survey 2020 | https://bit.ly/45EsCEM | 9. Frost & Sullivan, Prospectus, World Bank | 9A. Frost & Sullivan, Prospectus, World Bank 150M adjusted for the highest at risk patients, 1/3rd of children |
10. Korenfeld M, Walters T, Martel J, Nunez D, Wang L. A Phase 3 Study of APP13007 (Clobetasol Propionate Ophthalmic Nanosuspension 0.05%) to Treat Inflammation and Pain after Cataract Surgery. ASCRS presentation. San Diego. May 5-8 2023.
US and China Markets |
| 12
MydCombi™
● MydCombi is the first and only FDA-approved fixed-dose
combination ophthalmic spray indicated for inducing mydriasis
for diagnostic procedures and in conditions where short term
pupil dilation is desired
● Pupil dilation (mydriasis) is part of a comprehensive eye exam
and ocular surgery
○ - Estimated 108 million dilations in US annually
○ - Estimated $250 million US market opportunity1
● Eyedrops are the current standard of care and ripe for innovation
○ - Multiple eyedrops usually needed
○ - Patient discomfort and avoidance
○ - Time consuming administration and slow recovery to “normal”
○ - Cross-contamination risk
1. $200M annual sales of pharmaceutical mydriatic products used during 108M office-based exams ($2 * 100M) + $50M of single bottle mydriatic agents
used cataract replacement surgery ($12.5 x 4M)
For pupil dilation and Mydriasis |
| 13
MydCombi™
1
Indication: MYDCOMBI (tropicamide 1% and phenylephrine HCl 2.5%) ophthalmic spray is indicated to induce mydriasis for routine diagnostic procedures and in conditions where short term pupil dilation is desired. IMPORTANT SAFETY INFORMATION. CONTRAINDICATIONS: 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 before using. DRUG INTERACTIONS. 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. Potent Inhalation Anesthetic Agents: May potentiate cardiovascular depressant effects of some inhalation anesthetic agents. ADVERSE REACTIONS. Most common ocular adverse reactions include transient blurred vision, reduced visual acuity, photophobia,
superficial punctate keratitis, and mild eye discomfort. Increased intraocular pressure has been reported following the use of mydriatics. Systemic adverse reactions including dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system
disturbances and muscle rigidity have been reported with the use of tropicamide. To report SUSPECTED ADVERSE REACTIONS, contact Eyenovia, Inc. At 1-833-393-6684 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch) www.mydcombi.comfor FULL PRESCRIBING INFORMATION
The only FDA approved fixed-dose combination of the
leading pupil dilating drugs
Reliable time to peak efficacy and dilation resolution
In clinical studies 97% of patients reported zero side
effects1
To check on availability in your area, please go to
MydCombi.com
1. Wirta DL, Walters TR, Flynn WJ, Rathi S, Ianchulev T. Mydriasis with micro-array print touch-free tropicamide-phenylephrine fixed combination MIST: pooled randomized Phase III trials.
Ther Deliv. 2021 Mar;12(3):201-214.
Speed and simplicity with each spray |
| 14
MydCombi™
First and only FDA Approved ophthalmic spray for mydriasis
• Two Phase 3 clinical trials evaluated the
efficacy of MYDCOMBI for achievement
of mydriasis.
• MYDCOMBI was statistically superior to
tropicamide administered alone and
phenylephrine administered alone.
• Nearly all (94%) subject eyes achieved
clinically significant effect by achieving
pupil diameter of ≥ 6 mm at 35-minute
post-dose compared to 78% of eyes
administered tropicamide alone and 1.6%
of eyes administered phenylephrine alone.
• Clinically effective mydriasis was observed
as early as 20 minutes. |
| APP13007
15
(Clobetasol Propionate Nanosuspension 0.05%, BID)
An Important Advancement in Ocular
Post-Surgical Pain and Inflammation Control
FDA PDUFA date in March 2024 for the Treatment of Inflammation and Pain after Cataract Surgery
• Short and mid-term revenue
opportunity ($1.3B market)
• Synergistic commercialization
with MydCombi
2024
Post-ocular surgery treatment
2027
• Potential dry eye product in
the Optejet ($3.6B market)
Dry eye treatment |
| 16
When it Comes to Post-Surgical Pain and Inflammation Management
Efficacy and Dosing Matter Most
Top 3 Attributes Ranking
Efficacy 1.6
BID dosing 2.2
Low IOP spikes 2.4
There is an unmet medical and market need for an effective, twice-a-day therapy
1 = most important; 4 = least important
J. Reckner and Associates survey conducted August 2023 with 100 Ophthalmologists performing at least 10 ocular surgeries per week. Respondents were asked to consider the description of the product mentioned with the following
description: “There is a new corticosteroid that may be available next year. This new steroid would be dosed twice-daily post-ocular surgery by patients. In clinical trials, it has shown to be very effective in reducing inflammation and
pain and well tolerated with a low (<2%) incidence of IOP spikes over a 14-day usage period.” What part of this description is most important to you? |
| 17
Technology Enables This Profile
- High uniformity and purity in particle size
- Improved stability
- Improved dispersion properties
- Improved bioavailability
Patented APNT nanolization provides many benefits
in topical ophthalmic drug development*
* https://www.formosapharma.com/technology/ |
| 18
APP13007 Demonstrates Rapid and Sustained Ocular Pain Relief*
0%
10%
20%
30%
40%
50%
60%
APP13007 Placebo
Percentage of Subjects Needing Rescue Meds
Subjects in the clinical study experienced significant
pain, with over half requiring rescue from placebo.
77% 82% 91%
44% 43% 42%
0.0%
20.0%
40.0%
60.0%
80.0%
100.0%
POD4 POD8 POD15
PAIN
% of Subjects Pain Free
Sustained to Day 15
APP13007 Placebo
*Korenfeld ASCRS Presentation 2023 | CPN-301 A Phase 3 Study of APP13007 (Clobetasol Propionate Ophthalmic Nanosuspension 0.05%) to Treat Inflammation and Pain after Cataract Surgery
(Phase 3 study CPN-302 resulted in similar safety and efficacy result but is not displayed here) |
| 19
APP13007 Demonstrates Rapid Clearance of Inflammation*
0%
33%
59%
12% 16%
0.0%
20.0%
40.0%
60.0%
80.0%
POD1 POD8 POD15
INFLAMMATION
% of subjects with ACC Grade=0
Sustained to Day 15
APP13007 Placebo
*Korenfeld ASCRS Presentation 2023 | CPN-301 A Phase 3 Study of APP13007 (Clobetasol Propionate Ophthalmic Nanosuspension 0.05%) to Treat Inflammation and Pain after Cataract Surgery
(Phase 3 study CPN-302 resulted in similar safety and efficacy result but is not displayed here) |
| 20
Twice-A-Day Dosing Matters
Preferred posology for post-cataract
surgery: antibiotic, NSAID and steroid
once in the morning and evening
Doctors look to simplify the two week post surgical therapy to improve outcomes
Post-Surgical Steroid Posology
Dexamethasone 4x daily
Difluprednate 4x daily
Flurometholone 4x daily
Loteprednol 2x-4x daily
Prednisolone 2x-4x daily
APP13007 2x daily
https://pi.bausch.com/globalassets/pdf/PackageInserts/Pharma/Rx-Generics/Dexamethasone-Sodium-Phosphate-A-9100202-9100302.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022212lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016851s063lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202872lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017011s047lbl.pdf |
| 21
Well Tolerated with Low Incidence of IOP Spikes
No Need to Taper Dosing
Post-surgical patients need to avoid elevated IOP
All Adverse Events ≥ 2.0% APP13007
(N=181)
Placebo
(N=197)
Adverse Events n (%) # of Events n (%) # of Events
Subjects with at ≥ 1 Ocular Adverse Event 29 (16.0%) 33 34 (17.3%) 50
Anterior chamber inflammation 7 (3.9%) 7 3 (1.5%) 33
Corneal oedema 3 (1.7%) 3 10 (5.1%) 10
*Korenfeld ASCRS Presentation 2023 | A Phase 3 Study of APP13007 (Clobetasol Propionate Ophthalmic Nanosuspension 0.05%) to Treat Inflammation and Pain after Cataract Surgery
In the clinical trial CPN-301, one patient in the treatment group
experienced an incident of elevated IOP > 21mmHg (1/181)* |
| 22
Eyenovia Will Focus on Eyecare Professional-Centric Distribution
✓ E-prescribing to a specialty pharmacy
✓ Ensures all patients receive the product for $50 to $60
✓ No substitutions
✓ No insurance issues
✓ No call-backs to physicians
E-Prescription sent from doctor to specialty pharmacy and delivered overnight to patient |
| 23
APP13007 – A Potential for Multiple Indications
October 2023
FDA Meeting
2024 2027
March 2026
NDA filing
Dry eye phase 3 studies
March 2024
PDUFA
Potential dry eye program
2025
May 2024
APP13007
National Launch
January 2027
Dry eye approval
Post surgical pain and inflammation
2026 |
| 24
Apersure™ for Presbyopia
• Presbyopia is the age-related loss of near vision
that occurs as the lens becomes inelastic
• 18 million people aged 40 – 55 in the
US have presbyopia, with roughly half never
having to use glasses earlier in their lives
• Apersure is a lifestyle product designed to avoid the
appearance and inconvenience of reading glasses
– Use “as needed” with rapid onset
improvement of near vision
– Easy to administer
– Discreet – compatible with modern lifestyle |
| 25
Apersure™
1. https://clinicaltrials.gov/ct2/show/NCT04657172 | 2. https://clinicaltrials.gov/ct2/show/NCT05114486
3. Cohort of subjects with baseline DCNVA < 0.6 logMAR | 4. Resolved by 3-hours post dose | 5. Data on file
Apersure delivered
via Optejet
• Vision-1
1 and Vision-2
2 clinical studies
• 6.0x more patients achieved ≥ 3-line gain on
a vision chart in the active group vs.
placebo3,5
• Well-tolerated with fewer than 2% of patients
reporting moderate hyperemia4
, instillation
discomfort, or brow ache
• People prefer Apersure over eyedrops
• Among 100 presbyopic patients aged 40-55,
80% said they would prefer Apersure over
the traditional eyedrop bottle5
• Price sensitivity tests indicate approximately
$100 for 80 doses would be well accepted
Phase 3 clinical results |
| 26
Apersure™
• Existing and future presbyopia eye drops do
not fit with the business model of
optometrists who use eye glass frames as a
revenue source for their practice
• With Apersure, optometrists can sell this
Optejet based product alongside glasses as
an additional benefit for their patients
• Easy and neat application
• Discreet on-demand dosing that lasts for
4 hours
• In a market research survey consisting of 100
Optometrists across the US, Apersure was
predicted to have the largest market share of
approved and potential products
The invisible second set of glasses
12% 15% 18% 25% 30%
Apersure | Eyenovia
Vuity | Abbvie
CSF-1 | Orasis
Acelcedine | Lenz Therapeutics
Nyxol and Pilocarpine | Ocuphire
Market Share of Products Predicted by Optometrists
Apersure
Vuity
CSF-1
Acelcedine
Nyxol and
Pilocarpine
1. VISION-1 & 2 Studies, data on file. 2, 3. Survey conducted in May 2022 by J. Reckner and Associates, data on file. |
| 27
Apersure™
The only presbyopia treatment with the Optejet that may enhance office economics
1. Population of 40-55YO in the US = 60.8MA , 35% of this population has never needed corrected visionB, assumes product will work for 33% of the remaining population
A. Published by Erin Duffin, & 30, S. (2022, September 30). Population of the U.S. by sex and age 2021. Statista. Retrieved February 3, 2023, from https://www.statista.com/statistics/241488/population-of-the-us-by-sex-and-age/ | B. What is 20/20 vision? University of Iowa Hospitals & Clinics. (n.d.). Retrieved February 3, 2023, from https://uihc.org/health-topics/what-2020-vision
Market Receptivity
High among optometrists who are intrigued by the
ability to sell the device through their offices; high
among patients who are attracted to the benefits of
the device
Potential Market Size 3.5 million people1 @ $250 per year = $877M
Pricing
Approximately $100 per cartridge (similar to Vuity on
a per-use basis); market research indicates patients
would use 2.5 cartridges/year on average
Reimbursement
Status
Cash-pay cosmeceutical; can be purchased with
HSA/FSA funds |
| 28
Apersure™ NDA Timeline NDA Filing Targeted for 1Q 2025
March 28th 2023
FDA Meeting 2024
Gen-2 Line Validation
Q2 to Q3
Commercial Product (Gen-2)
Manufacturing
2025
NDA Filing
1Q 2025
12-month Registration Stability
Q1 2024 to Q2 2025 |
| 29
• Begins in early childhood, with
genetic link1
• Elongation of sclera/retina with
morbidity and vision problems2
• Urgent need for FDA-approved drug
therapies to slow myopia progression
• Atropine may slow myopia
progression by at least 60%3
Progression of Myopic Maculopathy
Normal Macula Myopic Maculopathy
Affects ~25M children in the US alone,
with ~5M considered to have high myopia risk4
1 Jones LA, Sinnott LT, Mutti DO, Mitchell GL, Moeschberger ML, Zadnik K. Parental history of myopia, sports and outdoor activities, and future myopia. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3524-32.
2 Eye and Contact Lens. 2004; 30
3 Chia A, Chua WH, Cheung YB, et al. Atropine for the treatment of childhood Myopia: Safety and efficacy of 0.5%, 0.1%, and 0.01% doses (Atropine for the Treatment of Myopia 2). Ophthalmology 2012;119:347-354
4 Theophanous C. Myopia Prevalence and Risk Factors in Children. Clinical Ophthalmology. December 2018. U.S. Census Bureau, Current Population Survey, Annual Social and Economic Supplement, 2019.
MicroPine for Delaying Progression of Myopia in Children |
| 30
MicroPine for Delaying Progression of Myopia in Children
• Precision-dosed atropine spray
developed specifically for children
• Easy, daily use by children1
• Lower drug volume exposure to enhance
comfort and minimize systemic exposure
• Can communicate with smart devices to
track treatment adherence and provide
family reminders
• Compliance data shows promise
compared with historical treatments
1 Data on file with Eyenovia. 2 Naito 2018: Naito T, Yoshikawa K, Namiguchi K, Mizoue S, Shiraishi A, et al. (2018) Comparison of success rates in eye drop instillation between sitting position and supine position. PLOS ONE 13(9):
e0204363. Patel 1995: Patel SC, Spaeth GL. Compliance in patients prescribed eyedrops for glaucoma. Ophthalmic Surg. 1995 May-Jun;26(3):233-6. Winfield, 1990: Winfield AJ, Jessiman D, Williams A, Esakowitz L. A study of the causes
of non-compliance by patients prescribed eyedrops. Br J Ophthalmol. 1990 Aug;74(8):477-80. 3. Matsui, 1997: Matsui DM. Drug compliance in pediatrics. Clinical and research issues. Pediatr Clin North Am. 1997 Feb;44(1):1-14.
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
0 5 10 15 20 25
Six-Month Daily Treatment Compliance
28 Children Age 6 – 13 YO1
Subject number
Correctly Administered Doses / Total Potential Doses
Average of compliance rates from published ophthalmic studies2
Average of compliance rates from published pediatric studies3 |
| 31
MicroPine
Market Receptivity
Very high to the device due to the potential benefits
it may offer; well accepted by children in the
CHAPERONE study
Potential Market Size
If one assumes the annual cost of these drugs is
$2,400, then with 1.9 million children treated1,2
,
a market size of over $4.5 billion in the US alone.
Potential royalty stream of several hundred
million dollars
Pricing Licensed to Bausch + Lomb
Reimbursement Status Licensed to Bausch + Lomb. We expect coverage to
be like other ophthalmic prescription medications
1. Theophanous, C., Modjtahedi, B. S., Batech, M., Marlin, D. S., Luong, T. Q., & Fong, D. S. (2018, August 29). Myopia prevalence and risk factors in children. Clinical ophthalmology
(Auckland, N.Z.). Retrieved February 3, 2023, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6120514/
2. Bureau, U. S. C. (2022, April 7). Children data. Census.gov. Retrieved February 3, 2023, from https://www.census.gov/topics/population/children/data.html
A Pediatric Therapy Designed with Children in Mind |
| 32
Multiple Commercialization Partners
Arctic Vision – A China-based ophthalmic
biotech focusing on breakthrough therapies,
with a leading portfolio covering pre-clinical
stage to commercial stage products
Licenses – MicroPine, MicroLine and
MydCombi licensed for Greater China and
South Korea; clinical study enrollment
underway
Bausch+Lomb – One of the world's largest
suppliers of contact lenses, lens care products,
prescription pharmaceuticals, intraocular lenses
and other eye care products
Licenses– MicroPine licensed for the US
and Canada
License agreements with a total value of over $90M in potential payments + royalties
Ongoing discussions with multiple partners in glaucoma and dry eye |
| 33
Broad Intellectual Property Portfolio
• Key claims covered with multiple patents
– 16 US Patents Issued; 1 pending
– 95 foreign issued; 32 pending
– Many in effect beyond 2031
• Clinical data and regulatory approval
adds another layer of IP |
| 34
Financial Snapshot (September 2023)
Nasdaq: EYEN
Common Shares Outstanding 42.9M
Equity Grants Outstanding Under Stock Plans 5.3M
Warrants 13.2M
Fully Diluted Shares 61.4M
Cash $20.7M
Debt $14.1M |
| 35
Experienced Leadership Team
Bren Kern
Chief Operating Officer
Michael Rowe
Chief Executive Officer
John Gandolfo
Chief Financial Officer
Norbert Lowe
VP, Commercial Operations
Greg Bennett
VP, Clinical Program
Strategy and Development
Malini Batheja, PhD
VP, Pharm R&D and
CMC Regulatory
Enrico Brambilla
VP, Device R&D and
Engineering
Lauren Gidden
VP, Quality and
Regulatory Affairs
Rob Richardson
VP, Manufacturing |
| 36
Investment Summary
• Optejet platform technology with ergonomic design facilitates ease
of use and delivers precise doses
• Addresses many long-term unmet clinical needs surrounding the use of
conventional eye drops
• Protected with a strong intellectual property portfolio
• Eyenovia owns a pipeline of products in large therapeutic categories
• With multiple commercial partnerships in place and more being developed
• Poised for leadership as a technology partner and therapy provider
in potentially huge markets
• First FDA approved product May 2023
• MydCombi (tropicamide and phenylephrine HCl ophthalmic spray) 1%/2.5%
• Validates the underlying Optejet technology |
v3.23.3
Cover
|
Nov. 10, 2023 |
Cover [Abstract] |
|
Document Type |
8-K
|
Amendment Flag |
false
|
Document Period End Date |
Nov. 10, 2023
|
Entity File Number |
001-38365
|
Entity Registrant Name |
EYENOVIA, INC.
|
Entity Central Index Key |
0001682639
|
Entity Tax Identification Number |
47-1178401
|
Entity Incorporation, State or Country Code |
DE
|
Entity Address, Address Line One |
295 Madison Avenue
|
Entity Address, Address Line Two |
Suite 2400
|
Entity Address, City or Town |
New York
|
Entity Address, State or Province |
NY
|
Entity Address, Postal Zip Code |
10017
|
City Area Code |
833
|
Local Phone Number |
393-6684
|
Written Communications |
false
|
Soliciting Material |
false
|
Pre-commencement Tender Offer |
false
|
Pre-commencement Issuer Tender Offer |
false
|
Title of 12(b) Security |
Common stock, par value $0.0001 per share
|
Trading Symbol |
EYEN
|
Security Exchange Name |
NASDAQ
|
Entity Emerging Growth Company |
true
|
Elected Not To Use the Extended Transition Period |
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