Eyenovia Reports Second Quarter 2024 Financial Results and Provides Corporate Update
Eyenovia Inc (NASDAQ: EYEN) reported its Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Plans for validation of the Gen-2 Optejet® device with 2025 regulatory submission for Mydcombi™.
2. Advancement of Phase 3 CHAPERONE study for MicroPine in pediatric progressive myopia.
3. Collaboration agreements with Formosa, Senju, and SGN for dry eye disease treatments.
4. Expanded Mydcombi sales to 63 new offices in Q2, targeting 263 by Q3 end.
Financially, Eyenovia reported a net loss of $11.1 million ($0.21 per share) for Q2 2024, compared to $6.2 million ($0.16 per share) in Q2 2023. The company had $2.3 million in cash as of June 30, 2024, excluding $5.8 million from subsequent equity offerings.
Eyenovia Inc (NASDAQ: EYEN) ha riportato i risultati finanziari per il secondo trimestre del 2024 e fornito un aggiornamento aziendale. I punti salienti includono:
1. Piani per la validazione del dispositivo Gen-2 Optejet® con la presentazione regolatoria prevista per il Mydcombi™ nel 2025.
2. Progresso nello studio di Fase 3 CHAPERONE per MicroPine nel trattamento della miopia progressiva pediatrica.
3. Accordi di collaborazione con Formosa, Senju e SGN per i trattamenti della sindrome dell'occhio secco.
4. Vendite di Mydcombi espanse a 63 nuovi uffici nel secondo trimestre, con l'obiettivo di raggiungere 263 entro la fine del terzo trimestre.
Dal punto di vista finanziario, Eyenovia ha riportato una perdita netta di 11,1 milioni di dollari (0,21 dollari per azione) per il secondo trimestre del 2024, rispetto a 6,2 milioni di dollari (0,16 dollari per azione) nel secondo trimestre del 2023. L'azienda aveva 2,3 milioni di dollari in contante al 30 giugno 2024, escludendo 5,8 milioni di dollari derivanti da offerte azionarie successive.
Eyenovia Inc (NASDAQ: EYEN) reportó sus resultados financieros del segundo trimestre de 2024 y proporcionó una actualización corporativa. Los puntos destacados incluyen:
1. Planes para la validación del dispositivo Gen-2 Optejet® con la presentación regulatoria para Mydcombi™ en 2025.
2. Avance en el estudio de Fase 3 CHAPERONE para MicroPine en miopía progresiva pediátrica.
3. Acuerdos de colaboración con Formosa, Senju y SGN para tratamientos de la enfermedad del ojo seco.
4. Ventas de Mydcombi ampliadas a 63 nuevas oficinas en el segundo trimestre, con un objetivo de 263 para finales del tercer trimestre.
Financieramente, Eyenovia reportó una pérdida neta de 11,1 millones de dólares (0,21 dólares por acción) para el segundo trimestre de 2024, en comparación con 6,2 millones de dólares (0,16 dólares por acción) en el segundo trimestre de 2023. La compañía tenía 2,3 millones de dólares en efectivo al 30 de junio de 2024, excluyendo 5,8 millones de dólares de ofertas de acciones posteriores.
Eyenovia Inc (NASDAQ: EYEN)는 2024년 2분기 재무 결과를 보고하고 기업 업데이트를 제공했습니다. 주요 하이라이트는 다음과 같습니다:
1. Mydcombi™를 위한 2025년 규제 제출과 함께 Gen-2 Optejet® 기기의 검증 계획.
2. 소아 진행성 근시를 위한 MicroPine의 3상 CHAPERONE 연구의 진전.
3. 건성안 질환 치료를 위한 Formosa, Senju, SGN과의 협력 계약.
4. 2분기에 Mydcombi 판매를 63개 새로운 사무소로 확대하였으며, 3분기 말까지 263개를 목표로 하고 있습니다.
재무적으로, Eyenovia는 2024년 2분기에 1,110만 달러(주당 0.21 달러)의 순손실을 보고했습니다. 이는 2023년 2분기의 620만 달러(주당 0.16 달러)와 비교됩니다. 이 회사는 2024년 6월 30일 기준으로 230만 달러의 현금을 보유하고 있었습니다. 이는 이후 주식공급을 통한 580만 달러는 제외한 것입니다.
Eyenovia Inc (NASDAQ: EYEN) a annoncé ses résultats financiers pour le deuxième trimestre 2024 et a fourni une mise à jour de l'entreprise. Les principaux points forts incluent :
1. Plans pour la validation du dispositif Gen-2 Optejet® avec une soumission réglementaire prévue pour Mydcombi™ en 2025.
2. Avancement de l'étude de Phase 3 CHAPERONE pour MicroPine dans la myopie progressive pédiatrique.
3. Accords de collaboration avec Formosa, Senju et SGN pour les traitements de la sécheresse oculaire.
4. Ventes de Mydcombi étendues à 63 nouveaux bureaux au 2e trimestre, visant 263 d'ici la fin du 3e trimestre.
Financièrement, Eyenovia a enregistré une perte nette de 11,1 millions de dollars (0,21 dollar par action) pour le 2e trimestre 2024, contre 6,2 millions de dollars (0,16 dollar par action) pour le 2e trimestre 2023. L'entreprise avait 2,3 millions de dollars en liquidités au 30 juin 2024, excluant 5,8 millions de dollars provenant d'offres d'actions ultérieures.
Eyenovia Inc (NASDAQ: EYEN) hat die finanziellen Ergebnisse für das zweite Quartal 2024 veröffentlicht und ein Unternehmensupdate bereitgestellt. Wichtige Highlights umfassen:
1. Pläne zur Validierung des Gen-2 Optejet®-Geräts mit einer regulatorischen Einreichung für Mydcombi™ im Jahr 2025.
2. Fortgeschrittene Phase-3-CHAPERONE-Studie für MicroPine bei pädiatrischer progressiver Myopie.
3. Kooperationsvereinbarungen mit Formosa, Senju und SGN zur Behandlung von Trockenaugen.
4. Erweiterung der Mydcombi-Verkäufe auf 63 neue Büros im 2. Quartal, mit dem Ziel, bis Ende des 3. Quartals 263 zu erreichen.
Finanziell berichtete Eyenovia im 2. Quartal 2024 einen Nettoverlust von 11,1 Millionen US-Dollar (0,21 US-Dollar pro Aktie), verglichen mit 6,2 Millionen US-Dollar (0,16 US-Dollar pro Aktie) im 2. Quartal 2023. Das Unternehmen verfügte am 30. Juni 2024 über 2,3 Millionen US-Dollar in bar, ohne 5,8 Millionen US-Dollar aus nachfolgenden Aktienangeboten zu berücksichtigen.
- Plans for Gen-2 Optejet device validation and 2025 regulatory submission
- Advancement of Phase 3 CHAPERONE study for MicroPine in pediatric progressive myopia
- Collaboration agreements with Formosa, Senju, and SGN for dry eye disease treatments
- Expanded Mydcombi sales to 63 new offices in Q2, targeting 263 by Q3 end
- Completed equity placement with two largest shareholders
- Net loss increased to $11.1 million in Q2 2024 from $6.2 million in Q2 2023
- Research and development expenses increased by 63.5% to $4.6 million
- General and administrative expenses increased by 19.3% to $3.8 million
- Total operating expenses increased by 88.2% to $11.2 million
- Cost of revenue write-off of $0.5 million to adjust finished goods inventory
Insights
Eyenovia's Q2 2024 results reveal a widening net loss of
The advancement of MicroPine's Phase 3 CHAPERONE study for pediatric progressive myopia is a significant milestone. With a
Following FDA consultation, announced plans for validation of the Gen-2 Optejet® device and 2025 regulatory submission with Mydcombi™ as lead product
Advanced Phase 3 CHAPERONE study of MicroPine as a treatment of pediatric progressive myopia with preparations for analysis in Q4
Commenced sales activities with focus on Mydcombi in 260+ offices and preparations for launch of clobetasol propionate ophthalmic suspension
Announced development collaborations with Formosa, Senju and SGN to leverage the Optejet for the
Company to host conference call and webcast today, August 12th, at 4:30 pm ET
NEW YORK, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced its financial and operating results for the second quarter ended June 30, 2024.
Second Quarter 2024 and Recent Business Developments
- Following an FDA meeting in July, announced plans for validation of the advanced Gen-2 Optejet device with production anticipated to begin in Q4 and submission in 2025 for Mydcombi as the lead product. The Gen-2 device was developed to be easier to use and manufacture, bringing the cost of goods for the monthly cartridge towards the company’s goal of
$20. - Advanced the Phase 3 CHAPERONE study of MicroPine for pediatric progressive myopia. External sources have valued the pediatric progressive myopia market at over
$3.0 billion annually in the U.S. and China. - 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. - Reported training and shipping Mydcombi to 63 new offices from April 2024 through June 30, prior to the hiring and onboarding of its sales force; on-track to reach 263 new offices by the end of the third quarter.
- Completed an equity placement with two of the Company’s largest shareholders.
Michael Rowe, Chief Executive Officer, commented, “During the second quarter, we made significant progress both advancing our commercial initiatives and furthering co-development agreements that can potentially address new, multi-billion-dollar underserved markets. Our plans to finalize the Gen-2 device are now set following a meeting with the FDA and we look forward to submitting this advanced technology with Mydcombi as the lead product in 2025. Meanwhile, our Mydcombi launch continues to track to plan, with this innovative mydriasis product now available in 63 new ophthalmic offices since launch, with many more coming onboard during the third quarter as momentum accelerates.”
“Regarding MicroPine, which we are developing for pediatric progressive myopia, we are preparing for analysis of the Phase 3 CHAPERONE data in the fourth quarter that, if successful, would meaningfully accelerate its remaining development path. We also executed several co-development agreements to evaluate novel therapeutics in our Optejet dispenser as potential treatments for dry eye disease, which is estimated to be a
“Also, during the second quarter, we completed a registered direct equity offering with two of our largest shareholders at the market price. These additional funds, together with cash on-hand and other currently available capital resources, are expected to fund our operations through the Phase 3 CHAPERONE data, which we view as a significant upcoming milestone for our company.”
“We continue to take steps to increase the tangible value of our company, which currently includes two FDA-approved products, a third in late Phase 3 development, and co-development agreements that leverage our novel Optejet technology in large market indications. We believe we are very well positioned to be a leading partner to ophthalmic offices by addressing a broad spectrum of physician and patient needs with a portfolio of highly differentiated products.”
Second Quarter 2024 Financial Review
For the second quarter of 2024, net loss was approximately
Research and development expenses totaled approximately
For the second quarter of 2024, general and administrative expenses were approximately
Total operating expenses for the second quarter of 2024 were approximately
As of June 30, 2024, the Company’s unrestricted cash and cash equivalents were approximately
Conference Call and Webcast
The conference call is scheduled to begin at 4:30 pm ET today, August 12th. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470 (international), and reference conference ID 13747356.
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)
PLEASE GO TO CLOBETASOLBID.COM FOR IMPORTANT SAFETY INFORMATION for Clobetasol Proprionate Ophthalmic Suspension
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ: EYEN) is a commercial-stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics based on its Optejet platform. Eyenovia is currently focused on the commercialization of Mydcombi (tropicamide+phenylephrine ophthalmic spray) for mydriasis, as well as clobetasol propionate ophthalmic suspension
Eyenovia is also advancing late-stage development of MicroPine for pediatric progressive myopia (partnered with Arctic Vision in China and South Korea).
For more information, 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: 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 | |||||||||||
| June 30, | December 31, | ||||||||||
| 2024 | 2023 | ||||||||||
| (unaudited) | |||||||||||
| Assets | |||||||||||
| Current Assets | |||||||||||
| Cash and cash equivalents | $ | 2,300,852 | $ | 14,849,057 | |||||||
| Inventories | 3,052,142 | 109,798 | |||||||||
| Deferred clinical supply costs | 412,140 | 4,256,793 | |||||||||
| License fee and expense reimbursements receivable | 124,173 | 123,833 | |||||||||
| Security deposits, current | - | 1,506 | |||||||||
| Prepaid expenses and other current assets | 1,394,313 | 1,365,731 | |||||||||
| Total Current Assets | 7,283,620 | 20,706,718 | |||||||||
| Property and equipment, net | 3,041,462 | 3,374,384 | |||||||||
| Deferred offering costs | 170,632 | - | |||||||||
| Security deposits, non-current | 197,168 | 197,168 | |||||||||
| Intangible assets | 6,122,945 | 2,122,945 | |||||||||
| Prepaid expenses, non-current | 58,693 | - | |||||||||
| Operating lease right-of-use asset | 1,408,999 | 1,666,718 | |||||||||
| Equipment deposits | 711,441 | 711,441 | |||||||||
| Total Assets | $ | 18,994,960 | $ | 28,779,374 | |||||||
| Liabilities and Stockholders' (Deficiency) Equity | |||||||||||
| Current Liabilities: | |||||||||||
| Accounts payable | $ | 1,436,665 | $ | 1,753,172 | |||||||
| Accrued compensation | 1,278,178 | 1,658,613 | |||||||||
| Accrued expenses and other current liabilities | 2,988,128 | 287,928 | |||||||||
| Operating lease liabilities - current portion | 600,379 | 501,250 | |||||||||
| Notes payable - current portion, net of debt discount of | |||||||||||
| and | 8,730,043 | 5,329,419 | |||||||||
| Convertible notes payable - current portion, net of debt discount of | |||||||||||
| 815,216 | - | ||||||||||
| Total Current Liabilities | 15,848,609 | 9,530,382 | |||||||||
| Operating lease liabilities - non-current portion | 983,839 | 1,292,667 | |||||||||
| Notes payable - non-current portion, net of debt discount of | |||||||||||
| 637,500 | 4,355,800 | ||||||||||
| Convertible notes payable - net of debt discount of | |||||||||||
| and | 3,894,915 | 4,601,431 | |||||||||
| Total Liabilities | 21,364,863 | 19,780,280 | |||||||||
| Stockholders' (Deficiency) Equity: | |||||||||||
| Preferred stock, | |||||||||||
| 0 shares issued and outstanding as of June 30, 2024 and December 31, 2023 | |||||||||||
| 2022 | - | - | |||||||||
| Common stock, | |||||||||||
| 55,817,921 and 45,553,026 shares issued and outstanding | |||||||||||
| as of June 30, 2024 and December 31, 2023, respectively | 5,582 | 4,555 | |||||||||
| Additional paid-in capital | 165,091,874 | 154,486,098 | |||||||||
| Accumulated deficit | (167,467,359 | ) | (145,491,559 | ) | |||||||
| Total Stockholders' (Deficiency) Equity | (2,369,903 | ) | 8,999,094 | ||||||||
| Total Liabilities and Stockholders' (Deficiency) Equity | $ | 18,994,960 | $ | 28,779,374 | |||||||
| EYENOVIA, INC. | |||||||||||||||||
| Condensed Statements of Operations | |||||||||||||||||
| (unaudited) | |||||||||||||||||
| For the Three Months Ended | For the Six Months Ended | ||||||||||||||||
| June 30, | June 30, | ||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||
| Operating Income | |||||||||||||||||
| Revenue | $ | 22,625 | $ | - | $ | 27,618 | $ | - | |||||||||
| Cost of revenue | (490,361 | ) | - | (693,388 | ) | - | |||||||||||
| Gross Loss | (467,736 | ) | - | (665,770 | ) | - | |||||||||||
| Operating Expenses: | |||||||||||||||||
| Research and development | 4,597,173 | 2,811,061 | 9,028,774 | 5,333,011 | |||||||||||||
| General and administrative | 3,758,835 | 3,149,809 | 7,396,024 | 6,086,695 | |||||||||||||
| Reacquisition of license rights | 2,864,600 | - | 4,864,600 | - | |||||||||||||
| Total Operating Expenses | 11,220,608 | 5,960,870 | 21,289,398 | 11,419,706 | |||||||||||||
| Loss From Operations | (11,688,344 | ) | (5,960,870 | ) | (21,955,168 | ) | (11,419,706 | ) | |||||||||
| Other Income (Expense): | |||||||||||||||||
| Other income (expense), net | 2,980 | 119,450 | (94,578 | ) | 190,443 | ||||||||||||
| Change in fair value of equity consideration payable | 1,240,800 | - | 1,240,800 | - | |||||||||||||
| Interest expense | (674,001 | ) | (558,003 | ) | (1,352,659 | ) | (1,012,006 | ) | |||||||||
| Interest income | 64,866 | 183,563 | 185,805 | 286,043 | |||||||||||||
| Total Other Income (Expense) | 634,645 | (254,990 | ) | (20,632 | ) | (535,520 | ) | ||||||||||
| Net Loss | $ | (11,053,699 | ) | $ | (6,215,860 | ) | $ | (21,975,800 | ) | $ | (11,955,226 | ) | |||||
| Net Loss Per Share - Basic and Diluted | $ | (0.21 | ) | $ | (0.16 | ) | $ | (0.44 | ) | $ | (0.32 | ) | |||||
| Shares Outstanding - Basic and Diluted | 53,121,760 | 38,093,826 | 49,864,275 | 37,753,694 | |||||||||||||
FAQ
What were Eyenovia's (EYEN) Q2 2024 financial results?
What are Eyenovia's (EYEN) plans for the Gen-2 Optejet device?
How many new offices has Eyenovia (EYEN) reached with Mydcombi sales?
What collaborations did Eyenovia (EYEN) announce for dry eye disease treatments?
