Eyenovia, Inc. (EYEN) Q4 2023 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call reveals mixed financial performance with increased operating expenses and a significant decrease in cash balance, raising concerns about financial health. The Q&A section shows management's reluctance to provide specific revenue guidance and uncertainties regarding product launches, contributing to a negative sentiment. Despite potential positive developments like partnerships and product improvements, the lack of clear financial guidance and significant cash burn overshadow these factors, leading to a likely negative stock price movement.
Key Financial Performance
Net Loss (Q4 2023) $8 million, or $0.18 per share, compared to a net loss of $6.1 million, or $0.17 per share in Q4 2022. The increase in net loss was attributed to a one-time repatriation cost of $0.02 per share for bringing MicroPine back to Eyenovia.
Net Loss (Full Year 2023) $27.3 million, or $0.66 per share, compared to a net loss of $28 million, or $0.83 per share in 2022. The decrease in net loss was due to a reduction in weighted average shares outstanding.
Research and Development Expenses (Q4 2023) $4.1 million, an increase of 84.6% compared to $2.2 million in Q4 2022. The increase was driven by higher clinical and nonclinical expenses.
Research and Development Expenses (Full Year 2023) $13 million, a decrease of approximately 3% compared to $13.4 million in 2022. The decrease was driven by lower direct clinical and nonclinical expenses.
General and Administrative Expenses (Q4 2023) $3.4 million, an increase of 7.3% compared to $3.2 million in Q4 2022.
General and Administrative Expenses (Full Year 2023) $12.4 million, a decrease of approximately 8.1% compared to $13.5 million in 2022. The decrease was driven by reductions in legal expenses and executive recruitment costs.
Total Operating Expenses (Q4 2023) $7.5 million, an increase of approximately 39% compared to $5.4 million in Q4 2022.
Total Operating Expenses (Full Year 2023) $25.4 million, a decrease of approximately 5.6% compared to $26.9 million in 2022.
Cash Balance (as of December 31, 2023) $14.8 million, compared to $22.9 million as of December 31, 2022. The decrease in cash balance indicates a need for evaluating structures to increase cash resources.
License Fees Generated (to date) Approximately $16 million from licensing agreements, with potential to earn an additional $25 million in net license and development milestones from Arctic Vision.
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Operating Highlights
FDA Approved Products: Eyenovia has two FDA approved products: clobetasol propionate ophthalmic nanosuspension, 0.05%, and Mydcombi.
New Product Launch: Clobetasol was approved on March 04, 2024, and is indicated for pain and inflammation following ocular surgery.
Market Opportunity: The U.S. market for ocular surgeries is estimated at $1.3 billion, with Eyenovia targeting a mid-single digit market share.
Mydcombi Progress: Mydcombi is the first FDA approved fixed combination of two pupillary dilation drugs and is now licensed for sale in 16 states.
MicroPine Development: Eyenovia reacquired rights to MicroPine, an investigational treatment for pediatric progressive myopia, and is advancing its Phase III study.
Market Expansion: Eyenovia has entered into agreements with Vision Source and NovaBay to enhance sales efforts for Mydcombi and clobetasol.
International Licensing: Eyenovia's licensing agreement with Arctic Vision covers MicroPine, MicroLine, and Mydcombi for China and South Korea.
Manufacturing Capabilities: Eyenovia's Redwood City facility is now FDA approved for commercial manufacturing, supporting Mydcombi production.
Sales Force Deployment: Eyenovia has deployed half of its 10-person sales force for Mydcombi and clobetasol.
Strategic Partnerships: Eyenovia has formed a co-promotion agreement with NovaBay to enhance sales reach for clobetasol and Avenova.
Future Development Plans: Eyenovia plans to engage with the FDA regarding a formulation of clobetasol for dry eye treatment.
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Risk or Challenges
Regulatory Risks: Eyenovia is developing products that have yet to receive FDA approval, which introduces uncertainty regarding their market entry and potential revenue generation.
Competitive Pressures: The company faces competition in the ophthalmic market, particularly in the areas of pupil dilation and post-surgical treatments, which could impact market share and pricing.
Supply Chain Challenges: Eyenovia relies on contract manufacturers for drug substances and has recently expanded its manufacturing capabilities, which may pose risks related to production reliability and capacity.
Financial Risks: The company reported a net loss of approximately $27.3 million for 2023 and is exploring various structures to increase cash resources, indicating potential financial instability.
Market Risks: The potential market for clobetasol and Mydcombi is significant, but achieving a mid-single digit market share in a competitive landscape poses challenges.
Development Risks: The ongoing Phase III CHAPERONE study for MicroPine carries inherent risks associated with clinical trials, including the possibility of unfavorable results.
Economic Factors: Economic conditions may affect the company's ability to secure funding and impact overall market demand for its products.
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Guidance & Outlook
FDA Approved Products: Eyenovia has two FDA approved products: clobetasol propionate ophthalmic nanosuspension and Mydcombi, with plans for a robust commercial launch.
Market Opportunity for Clobetasol: Eyenovia aims to capture a mid-single digit market share of the $1.3 billion market for ocular steroids over the next 3-4 years.
Sales Force Expansion: Eyenovia has hired and trained half of its 10-person field sales force to promote Mydcombi and clobetasol.
Co-Promotion Agreement: Eyenovia entered a co-promotion agreement with NovaBay to enhance sales reach for clobetasol and Avenova.
MicroPine Development: Eyenovia has reacquired rights to MicroPine and is advancing its Phase III CHAPERONE study, exploring options for expedited development.
Manufacturing Capabilities: Eyenovia's Redwood City facility is now FDA approved for commercial manufacturing, supporting Mydcombi and future products.
Financial Performance: Eyenovia reported a net loss of approximately $27.3 million for 2023, with plans to explore options to reach breakeven.
Cash Resources: As of December 31, 2023, Eyenovia had a cash balance of approximately $14.8 million and is evaluating alternatives to increase cash resources.
Licensing Agreements: Eyenovia's licensing agreement with Arctic Vision could generate an additional $25 million in milestones over the next 3-4 years.
Future Revenue Expectations: Eyenovia anticipates significant revenue potential from MicroPine, clobetasol, and Mydcombi, with ongoing efforts to expand its product pipeline.
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Shareholder Return Plan
Net Loss: For the fourth quarter of 2023, we reported net loss of approximately $8 million, or $0.18 per share.
Share Repurchase Costs: This includes a $0.02 loss related to the one-time repatriation costs for bringing MicroPine back to Eyenovia.
Weighted Average Shares Outstanding: Approximately 45.4 million weighted average shares outstanding.
Full Year Net Loss: For the full year of 2023, we reported net loss of approximately $27.3 million, or $0.66 per share.
Full Year Weighted Average Shares Outstanding: Approximately 41 million weighted average shares outstanding.
License Fees Generated: To date, our license agreements have generated approximately $16 million in license fees.
Potential Additional Milestones: We have the potential to earn an additional $25 million in net license and development milestones from Arctic Vision over the next three to four years.
Sales Royalties Potential: If our products are approved upon commercialization, Eyenovia is also eligible to earn significant sales royalties.
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Key Q&A
Q:Can you talk about this accelerating the development of the MicroPine program?
A:Our intent is to do a protocol amendment and put in an interim analysis later this year when we believe we would have sufficient power to detect a significant result from one of the arms of this study. We'll be talking to the FDA about that as well.
Q:Regarding the half dose study, do you need to submit an SNDA to get this on to the label?
A:To get that on to the label, we would have to submit to the FDA.
Q:Can you scope out what capabilities NovaBay is bringing to the market of clobetasol?
A:They are bringing an in-house sales force that's very experienced doing telephone sales into cataract surgeons.
Q:Can you help us understand the potential launch trajectories for both clobetasol and Mydcombi?
A:We haven't given guidance, but we're comfortable with the analyst estimates that are out there for the balance of 2024.
Q:Should we expect more or additional deals or collaborations as you continue to launch Mydcombi and clobetasol?
A:Absolutely. We do have others that are in the signature phase.
Q:Can you tell us more about your second generation device and when it will be used with Mydcombi?
A:Our Gen 2 product offers simplification from a manufacturing capability, enabling us to produce these more easily with a higher reliability.
Q:Can you tell us more about your dry eye program and when you expect to move that into the clinic?
A:We have three things that we're working on... All of that takes anywhere between four and six months.
Q:Are there any comparable advantages to utilizing Optejet within the approved indication for postoperative pain?
A:Yes, it would be a lot easier for cataracts and other post-surgical patients to use the Optejet.
Q:Did you give any sense of the current cash runway, just for the near term?
A:We're actually evaluating all different opportunities that we have in order to raise cash.
Q:What needs to change for you to start advancing the Apersure program again?
A:Right now, that market is pretty stable... So to be successful in this market is going to require a strong promotional effort.
Q:What's the gating factor with the uptake of clobetasol, given its superior dosing?
A:We do have the better product, but we're always going to be up against people who will want to go with the generic option.
Q:Have you started speaking with payers? Do you have any progress report yet?
A:We're doing the entire thing cash... so there's no insurance issues.
Q:Review of Unclear Management Responses
A:Management avoided giving a direct answer regarding the current cash runway, only stating they are evaluating opportunities to raise cash without providing specific details.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
Clobetasol
Coastline
NDA
Optejet eye
Phase III
Vision Source
agent
agreement NovaBay
analysis
analyst
approval Redwood
care
cataract
clobetasol
collaboration
contract manufacturer
decrease
dose
field
increase
installation
lever
manufacturing capability
molecule
moment
mydriasis
opinion
order
pain inflammation
part
percentage
portfolio
post
right
sale force
sale people
side
steroid
surgery
thing
EYEN Transcript
Eyenovia, Inc. (EYEN) Q3 2024 Earnings Call Transcript
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The earnings call reveals several concerns: a net loss increase, financial challenges, and resistance to new technology adoption. The Q&A section highlights management's vague responses, particularly concerning the CHAPERONE trial's power calculation and data review timeline, which may further unsettle investors. Despite the positive licensing agreement with Arctic Vision, the net proceeds from securities offerings and the potential for sales royalties, the financial health and market acceptance issues overshadow these positives. Overall, the sentiment leans negative, suggesting a potential stock price decline of -2% to -8%.
Eyenovia, Inc. (EYEN) Q2 2024 Earnings Call Transcript
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Eyenovia, Inc. (EYEN) Q4 2023 Earnings Call Transcript
Unknown3-19
The earnings call reveals mixed financial performance with increased operating expenses and a significant decrease in cash balance, raising concerns about financial health. The Q&A section shows management's reluctance to provide specific revenue guidance and uncertainties regarding product launches, contributing to a negative sentiment. Despite potential positive developments like partnerships and product improvements, the lack of clear financial guidance and significant cash burn overshadow these factors, leading to a likely negative stock price movement.
Eyenovia, Inc. (EYEN) Q3 2023 Earnings Call Transcript
Neutral11-14
EYEN Report
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