EX-99.1 2 tm2315261d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

 

Eyenovia Reports First Quarter 2023 Financial Results and Provides Business Update

 

Announced FDA approval of Mydcombi™, a fixed dose combination of tropicamide and phenylephrine for mydriasis, the first FDA approved product to utilize the Optejet®

 

Received feedback from FDA on its Phase 3 Microline presbyopia candidate that provides a clear and efficient path forward for the program

 

Entered into co-development agreement with Formosa Pharmaceuticals for the potential development of new topical ophthalmic therapeutics

 

Company to host conference call and webcast today, May 11, at 4:30 pm ET

 

NEW YORK—May 11, 2023—Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company developing the Optejet delivery system for use both in combination with its own drug-device therapeutic programs for mydriasis, presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced its financial and operating results for the first quarter ended March 31, 2023.

 

First Quarter 2023 and Recent Business Developments

 

•Announced U.S. Food and Drug Administration (FDA) approval of Mydcombi, the Company’s proprietary combination microdose formulation of tropicamide and phenylephrine for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. Please see the full prescribing information at www.mydcombi.com.

 

•Received feedback from FDA on its Phase 3 Microline presbyopia candidate that provides a clear and efficient path forward for the program.

 

•Entered into a development collaboration agreement with Formosa Pharmaceuticals to combine Eyenovia’s Optejet with Formosa’s APNT nanoparticle formulation platform for the potential development of new topical ophthalmic therapeutics.

 

•Announced positive results from a research study, conducted in collaboration with Tufts Medical Center, demonstrating the superiority of the Optejet versus standard eye drops in the administration of the anti-glaucoma medication latanoprost preserved with benzalkonium chloride (BAK). Optejet was found to achieve a therapeutic dose of latanoprost with significantly less exposure to excess drug and harmful preservatives than can be achieved using conventional drops. These results were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2023 annual meeting in April.

 

 

 

 

 

•Continued to build out its manufacturing facilities in Redwood City, CA and Reno, NV, which is on track to come online during the third quarter of 2023.

 

•Licensing partners Bausch+Lomb and Arctic Vision continued to enroll patients in their respective Phase 3 studies of Micropine (US and China) and Microline (China).

 

•Ended the first quarter of 2023 with approximately $18.5 million in total cash and cash equivalents. In addition, with the approval of Mydcombi, the Company has the ability to draw down an additional $5 million on its credit facility with Avenue Capital before July 31, 2023.

 

Michael Rowe, Chief Executive Officer, commented, "We are proud to be delivering on our commitments in 2023 with the recently announced FDA approval of Mydcombi, our first approved product dispensed using our Optejet technology. We believe the Optejet will transform the way that topical eye drugs are developed and delivered, and this FDA approval marks a significant milestone in its evolution. It is also an important achievement in the context of our current and future partnerships, providing a template for the development of additional ophthalmic therapies administered via the Optejet in high-value ophthalmic indications."

 

"Regarding our pre-NDA Microline program for presbyopia, we received clear feedback from the FDA that provides an efficient path forward for the program. We are in the process of completing the build-out and validation of our Redwood City manufacturing facility and remain on track to commence the manufacture of launch batches early next year. In the interim, we plan to conduct supportive human factors testing and clinical work demonstrating the usability of the Gen-2 Optejet device, which has been optimized for in-home use.”

 

“With one product approved, and line-of-sight toward a second, we have reached a true inflection point in the evolution of our company. Having an FDA approved product not only provides critical validation of our Optejet technology for our own advanced clinical programs, but also our partnerships as well. To that end, we continue to advance discussions with additional partners that could potentially assess the utility of Optejet in very large indications such as glaucoma and dry eye, among others. I am pleased with our progress to date and look forward to initial commercial sales of Mydcombi this summer together with continued clinical and regulatory progress for us and our partners.”

 

First Quarter 2023 Financial Review

 

For the first quarter of 2023, net loss was approximately $(5.7) million, or $(0.15) per share compared to a net loss of approximately $(7.3) million, or $(0.24) per share, for the first quarter of 2022.

 

Research and development expenses totaled approximately $2.5 million for the first quarter of 2023 as compared to $3.7 million for the first quarter of 2022.

 

 

 

 

 

For the first quarter of 2023, general and administrative expenses were approximately $2.9 million, compared to $3.5 million for the first quarter of 2022.

 

Total operating expenses for the first quarter of 2023 were approximately $5.5 million compared to $7.2 million for the first quarter of 2022.

 

As of March 31, 2023, the Company’s cash and cash equivalents were approximately $18.5 million compared to $22.9 million as of December 31, 2022. In addition, with the approval of Mydcombi, the Company has the ability to draw down an additional $5 million on its credit facility with Avenue Capital before July 31, 2023.

 

Conference Call and Webcast

 

The conference call is scheduled to begin at 4:30 pm ET today, May 11. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470 (international). 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.

 

To access the Call me™ feature, which avoids having to wait for an operator, click here.

 

After the live webcast, the event will be archived on Eyenovia’s website for one year.

 

About Eyenovia, Inc.

 

Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the commercialization of Mydcombi and the late-stage development of microdosed medications for presbyopia and myopia progression. For more information, visit www.eyenovia.com.

 

The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations.

 

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

 

   March 31,   December 31, 
   2023   2022 
   (unaudited)     
Assets          
Current Assets:          
Cash and cash equivalents  $18,466,322   $22,863,520 
Deferred clinical supply costs   3,352,645    2,284,931 
License fee and expense reimbursements receivable   973,677    1,183,786 
Security deposits, current   119,550    119,550 
Prepaid expenses and other current assets   2,011,884    1,190,719 
Total Current Assets   24,924,078    27,642,506 
           
Property and equipment, net   2,152,861    1,295,115 
Security deposits, non-current   80,874    80,874 
Operating lease right-of-use asset   1,508,158    1,291,592 
Equipment deposits   643,513    726,326 
Total Assets  $29,309,484   $31,036,413 
           
Liabilities and Stockholders' Equity          
Current Liabilities:          
Accounts payable  $1,402,076   $1,428,283 
Accrued compensation   637,189    1,747,191 
Accrued expenses and other current liabilities   460,143    503,076 
Operating lease liabilities - current portion   472,901    484,882 
Notes payable - current portion, net of debt discount of $123,480 and $33,885 as of March 31, 2023 and December 31, 2022, respectively   1,218,963    174,448 
Convertible notes payable - current portion, net of debt discount of $123,480 and $33,885 as of March 31, 2023 and December 31, 2022, respectively   709,853    174,448 
Total Current Liabilities   4,901,125    4,512,328 
           
Operating lease liabilities - non-current portion   1,133,948    907,644 
Notes payable - non-current portion, net of debt discount of $648,889 and $813,229 as of March 31, 2023 and December 31, 2022, respectively   3,730,278    4,190,938 
Convertible notes payable - non-current portion, net of debt discount of $648,889 and $813,229 as of March 31, 2023 and December 31, 2022, respectively   3,730,278    4,190,938 
Total Liabilities   13,495,629    13,801,848 
           
Stockholders' Equity:          
Preferred stock, $0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of March 31, 2023 and December 31, 2022   -    - 
Common stock, $0.0001 par value, 90,000,000 shares authorized; 37,991,746 and 36,668,980 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively   3,799    3,667 
Additional paid-in capital   139,779,885    135,461,361 
Accumulated deficit   (123,969,829)   (118,230,463)
Total Stockholders' Equity   15,813,855    17,234,565 
Total Liabilities and Stockholders' Equity  $29,309,484   $31,036,413 

  

 

 

 

 

EYENOVIA, INC.

Condensed Statements of Operations

(unaudited)

 

    For the Three Months Ended
March 31,		 
   2023   2022 
Operating Expenses:          
Research and development  $2,521,950   $3,712,584 
General and administrative   2,936,886    3,474,965 
Total Operating Expenses   5,458,836    7,187,549 
           
Loss From Operations   (5,458,836)   (7,187,549)
           
Other Income (Expense):          
Other income (expense), net   70,993    (7,073)
Interest expense   (454,003)   (145,237)
Interest income   102,480    194 
           
Net Loss  $(5,739,366)  $(7,339,665)
           
Net Loss Per Share - Basic and Diluted  $(0.15)  $(0.24)
           
Weighted Average Number of Common Shares Outstanding          
- Basic and Diluted   37,410,587    30,008,194