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Eyenovia Reports Third Quarter 2024 Financial Results and Provides Corporate Update

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Eyenovia (NASDAQ: EYEN) reported Q3 2024 financial results and corporate updates. Key developments include the U.S. launch of clobetasol propionate ophthalmic suspension 0.05% for post-operative inflammation, advancement of Phase 3 CHAPERONE study for MicroPine in pediatric myopia, and commencement of Mydcombi registration batches in second-generation Optejet device. The company reported a net loss of $7.9 million ($0.11 per share) compared to $7.3 million in Q3 2023. Operating expenses increased 10.6% to $7.2 million. Cash position stood at $7.2 million, with $10.7 million raised in combined net proceeds. The company expanded Mydcombi's reach to 230 new offices from April through September 2024.

Eyenovia (NASDAQ: EYEN) ha riportato i risultati finanziari del terzo trimestre del 2024 e aggiornamenti aziendali. I principali sviluppi includono il lancio negli Stati Uniti della sospensione oftalmica di clobetasolo propionato allo 0,05% per l'infiammazione post-operatoria, l'avanzamento dello studio di Fase 3 CHAPERONE per MicroPine nella miopia pediatrica e l'inizio dei lotti di registrazione di Mydcombi nel dispositivo Optejet di seconda generazione. L'azienda ha riportato una perdita netta di 7,9 milioni di dollari ($0,11 per azione) rispetto ai 7,3 milioni del terzo trimestre del 2023. Le spese operative sono aumentate del 10,6% attestandosi a 7,2 milioni di dollari. La posizione di liquidità era di 7,2 milioni di dollari, con 10,7 milioni di dollari raccolti in proventi netti combinati. L'azienda ha ampliato la portata di Mydcombi a 230 nuovi uffici da aprile a settembre 2024.

Eyenovia (NASDAQ: EYEN) reportó los resultados financieros del tercer trimestre de 2024 y actualizaciones corporativas. Los desarrollos clave incluyen el lanzamiento en EE. UU. de la suspensión oftálmica de clobetasol propionato al 0.05% para la inflamación postoperatoria, el avance del estudio de Fase 3 CHAPERONE para MicroPine en miopía pediátrica y el inicio de los lotes de registro de Mydcombi en el dispositivo Optejet de segunda generación. La compañía reportó una pérdida neta de 7.9 millones de dólares ($0.11 por acción) en comparación con 7.3 millones en el tercer trimestre de 2023. Los gastos operativos aumentaron un 10.6% hasta 7.2 millones de dólares. La posición de efectivo se situó en 7.2 millones de dólares, con 10.7 millones de dólares recaudados en ingresos netos combinados. La compañía amplió el alcance de Mydcombi a 230 nuevas oficinas desde abril hasta septiembre de 2024.

Eyenovia (NASDAQ: EYEN)는 2024년 3분기 재무 결과 및 기업 업데이트를 발표했습니다. 주요 개발 사항으로는 수술 후 염증을 위한 0.05% 클로베타솔 프로피온산 염산염 안과 현탁액의 미국 출시, 소아 근시를 위한 MicroPine의 3상 CHAPERONE 연구 진행, 2세대 Optejet 장치에서 Mydcombi 등록 배치의 시작이 포함됩니다. 이 회사는 790만 달러의 순손실을 보고했으며 ($0.11 주당) 이는 2023년 3분기의 730만 달러와 비교됩니다. 운영 비용은 10.6% 증가하여 720만 달러에 달했습니다. 현금 보유액은 720만 달러로, 1,070만 달러의 순 수익이 모집되었습니다. 이 회사는 2024년 4월부터 9월까지 Mydcombi의 범위를 230개의 새로운 사무소로 확대했습니다.

Eyenovia (NASDAQ: EYEN) a annoncé ses résultats financiers pour le troisième trimestre 2024 et des mises à jour sur l'entreprise. Parmi les principales évolutions, on note le lancement aux États-Unis de la suspension ophtalmique de propionate de clobétasol à 0,05 % pour l'inflammation post-opératoire, l'avancement de l'étude CHAPERONE de phase 3 pour MicroPine dans la myopie pédiatrique et le lancement des lots d'enregistrement de Mydcombi dans le dispositif Optejet de deuxième génération. L'entreprise a enregistré une perte nette de 7,9 millions de dollars (0,11 $ par action) par rapport à 7,3 millions de dollars au troisième trimestre 2023. Les charges d'exploitation ont augmenté de 10,6 % pour atteindre 7,2 millions de dollars. La position de trésorerie s'élevait à 7,2 millions de dollars, avec 10,7 millions de dollars de produits nets combinés. L'entreprise a étendu la portée de Mydcombi à 230 nouveaux bureaux d'avril à septembre 2024.

Eyenovia (NASDAQ: EYEN) berichtete über die finanziellen Ergebnisse des dritten Quartals 2024 und Unternehmensupdates. Zu den wichtigsten Entwicklungen gehören die Markteinführung der Clobetasol-Propionat-Augensuspension mit 0,05% in den USA zur Behandlung von postoperativen Entzündungen, der Fortschritt der Phase-3-Studie CHAPERONE für MicroPine zur Behandlung von pädiatrischer Myopie und der Beginn der Registrierungscharge von Mydcombi im zweiten Optejet-Gerät. Das Unternehmen meldete einen netto Verlust von 7,9 Millionen US-Dollar (0,11 US-Dollar pro Aktie) im Vergleich zu einem Verlust von 7,3 Millionen im dritten Quartal 2023. Die Betriebskosten stiegen um 10,6% auf 7,2 Millionen US-Dollar. Die Barposition betrug 7,2 Millionen US-Dollar, mit 10,7 Millionen US-Dollar an kombinierten Nettoerlösen. Das Unternehmen erweiterte die Reichweite von Mydcombi auf 230 neue Büros von April bis September 2024.

Positive
  • Launch of clobetasol propionate ophthalmic suspension 0.05%, first new ocular steroid in 15+ years
  • Expansion of Mydcombi to 230 new offices
  • Secured collaboration agreements for dry eye disease treatments in $5B global market
  • Myopia market valued at over $3.0B annually in U.S. and China
Negative
  • Net loss increased to $7.9M from $7.3M year-over-year
  • Operating expenses increased 10.6% to $7.2M
  • SG&A expenses increased 27.3% to $3.7M
  • Low cash position of $7.2M requiring evaluation of long-term financing options

Insights

The Q3 results reveal concerning financial metrics with a $7.9 million net loss, widening from $7.3 million year-over-year. Operating expenses increased by 10.6% to $7.2 million, while SG&A expenses jumped 27.3% due to sales force expansion. With only $7.2 million in cash reserves and increasing expenses, the company's runway appears , necessitating additional financing. The commercialization of Mydcombi and clobetasol, while promising, hasn't yet translated into meaningful revenue to offset costs.

The pipeline developments show strategic positioning in high-value markets. The MicroPine program targets a $3 billion myopia market, with a important interim analysis pending. The dry eye disease collaborations tap into a $5 billion global market opportunity. The Gen-2 Optejet platform advancement with registration batch manufacturing marks significant progress, though FDA approval timeline extending to 2026 suggests a lengthy path to market. The commercial expansion to 230 offices for Mydcombi demonstrates steady but modest market penetration.

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, Nov. 12, 2024 (GLOBE NEWSWIRE) -- 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 30, 2024.

Third Quarter 2024 and Recent Business Developments

  • Advanced the Phase 3 CHAPERONE study of MicroPine for pediatric progressive myopia with plans to conduct an interim analysis this quarter. External sources have valued the myopia market at over $3.0 billion annually in the U.S. and China.
  • Announced the U.S. launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05%, which is FDA approved for the treatment of post-operative inflammation and pain following ocular surgery.
  • Announced collaboration agreements with Formosa Pharmaceuticals, Senju Pharmaceutical Co., Ltd. and SGN Nanopharma to develop novel therapeutics for use with Eyenovia’s Optejet® dispenser as potential treatments for dry eye disease, estimated to be a $5 billion global addressable market.
  • Commenced the manufacture of registration batches of Mydcombi in its second generation Optejet device, a key step in the FDA approval process for its state-of-the-art Gen-2 Optejet dispensing platform.
  • Reported training and shipping Mydcombi to 230 new offices from April through September 30th,2024.
  • Appointed Andrew Jones as Chief Financial Officer.
  • Raised combined net proceeds of $10.7 million.

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. Rowe concluded.

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 financing.

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 ID 13748714.

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 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 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.

Eyenovia Contact:
Eyenovia, Inc.
Andrew Jones
Chief Financial Officer
ajones@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,
  2024   2023 
 (unaudited)  
Assets   
    
Current Assets   
Cash and cash equivalents$7,188,129  $14,849,057 
Inventories 2,967,256   109,798 
Deferred clinical supply costs 408,832   4,256,793 
License fee and expense reimbursements receivable 137,594   123,833 
Security deposits, current -   1,506 
Prepaid expenses and other current assets 987,754   1,365,731 
    
 Total Current Assets 11,689,565   20,706,718 
    
Property and equipment, net 2,752,404   3,374,384 
Security deposits, non-current 197,526   197,168 
Intangible assets 6,122,945   2,122,945 
Prepaid expenses, non-current 46,520   - 
Operating lease right-of-use asset 1,275,690   1,666,718 
Equipment deposits 711,441   711,441 
    
  Total Assets $22,796,091  $28,779,374 
    
Liabilities and Stockholders' Equity   
    
Current Liabilities:   
Accounts payable$1,573,940  $1,753,172 
Accrued compensation 1,656,832   1,658,613 
Accrued expenses and other current liabilities 2,518,086   287,928 
Operating lease liabilities - current portion 604,647   501,250 
Notes payable - current portion, net of debt discount of $562,711   
and $503,914 as of September 30, 2024 and December 31, 2023, respectively 6,168,593   5,329,419 
Convertible notes payable - current portion, net of debt discount of   
$72,467 and $0 as of September 30, 2024 and December 31, 2023, respectively 3,260,866   - 
    
 Total Current Liabilities 15,782,964   9,530,382 
    
Accrued expenses and other non-current liabilities 316,275   - 
Operating lease liabilities - non-current portion 836,434   1,292,667 
Notes payable - non-current portion, net of debt discount of $0 and   
$448,367 as of September 30, 2024 and December 31, 2023, respectively 637,500   4,355,800 
Convertible notes payable - non-current portion, net of debt discount of $163,051   
and $398,569 as of September 30, 2024 and December 31, 2023, respectively 1,503,615   4,601,431 
    
Total Liabilities 19,076,788   19,780,280 
    
    
Stockholders' Equity:   
Preferred stock, $0.0001 par value, 6,000,000 shares authorized;   
0 shares issued and outstanding as of September 30, 2024 and December 31, 2023 -   - 
Common stock, $0.0001 par value, 300,000,000 shares authorized;   
86,375,958 and 45,553,026 shares issued and outstanding   
as of September 30, 2024 and December 31, 2023, respectively 8,638   4,555 
Additional paid-in capital 179,065,877   154,486,098 
Accumulated deficit (175,355,212)  (145,491,559)
    
 Total Stockholders' Equity 3,719,303   8,999,094 
    
 Total Liabilities and Stockholders' Equity$22,796,091  $28,779,374 
    



EYENOVIA, INC. 
Condensed Statements of Operations 
(unaudited) 
         
         
 For the Three Months Ended For the Nine Months Ended 
 September 30, September 30, 
  2024   2023   2024   2023  
Operating Income        
Revenue$1,625  $1,198  $29,243  $1,198  
Cost of revenue (132,522)  (13,416)  (825,910)  (13,416) 
 Gross Loss (130,897)  (12,218)  (796,667)  (12,218) 
         
Operating Expenses:        
Research and development 3,471,939   3,578,113   12,500,713   8,911,124  
Selling, general and administrative 3,729,091   2,929,855   11,125,115   9,016,550  
Reacquisition of license rights -   -   4,864,600   -  
 Total Operating Expenses 7,201,030   6,507,968   28,490,428   17,927,674  
 Loss From Operations (7,331,927)  (6,520,186)  (29,287,095)  (17,939,892) 
         
Other Income (Expense):        
Other income (expense), net 1,184   (348,226)  (93,394)  (157,783) 
Change in fair value of equity consideration payable -   -   1,240,800   -  
Interest expense (602,109)  (679,222)  (1,954,768)  (1,691,228) 
Interest income 44,999   208,901   230,804   494,944  
 Total Other Expense (555,926)  (818,547)  (576,558)  (1,354,067) 
         
 Net Loss $(7,887,853) $(7,338,733) $(29,863,653) $(19,293,959) 
         
         
Net Loss Per Share - Basic and Diluted$(0.11) $(0.18) $(0.53) $(0.50) 
         
Shares Outstanding - Basic and Diluted 69,558,325   40,139,697   56,476,876   38,563,074  
         

FAQ

What was Eyenovia's (EYEN) net loss in Q3 2024?

Eyenovia reported a net loss of $7.9 million ($0.11 per share) in Q3 2024, compared to $7.3 million ($0.18 per share) in Q3 2023.

How many new offices did EYEN's Mydcombi reach in 2024?

Eyenovia reported training and shipping Mydcombi to 230 new offices from April through September 30th, 2024.

What is the status of EYEN's MicroPine Phase 3 CHAPERONE study?

Eyenovia is advancing the Phase 3 CHAPERONE study of MicroPine for pediatric progressive myopia and preparing for an interim analysis in Q4 2024.

What was EYEN's cash position as of September 30, 2024?

Eyenovia's unrestricted cash and cash equivalents were approximately $7.2 million as of September 30, 2024.

Eyenovia, Inc.

NASDAQ:EYEN

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Biotechnology
Pharmaceutical Preparations
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United States of America
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