Filing summary
Entity note: The supplied filing is Eyenovia, Inc.’s Form 10-Q, not a filing for Hyperion DeFi, Inc. It covers the quarter ended March 31, 2023; the interim financial statements are unaudited.
Business context
Eyenovia is an ophthalmic technology company developing its Optejet drug-delivery system and related drug-device products. Its pipeline includes Mydcombi, MicroPine and MicroLine. The company reported no recurring revenue and had not achieved profitability.
Financial results and liquidity
| Metric | Q1 2023 | Q1 2022 / prior date |
|---|---|---|
| Revenue | None reported | None reported |
| Research and development expense | $2.52 million | $3.71 million |
| General and administrative expense | $2.94 million | $3.47 million |
| Total operating expenses | $5.46 million | $7.19 million |
| Net loss | $5.74 million | $7.34 million |
| Basic and diluted loss per share | $0.15 | $0.24 |
| Cash used in operating activities | $6.96 million | $8.18 million |
| Cash and cash equivalents | $18.47 million | $22.86 million at Dec. 31, 2022 |
| Working capital | $20.02 million | $23.13 million at Dec. 31, 2022 |
| Gross notes payable | $10.93 million | $10.43 million at Dec. 31, 2022 |
There was no revenue base from which to assess gross or operating margins. Net loss improved year over year, while cash declined by $4.40 million during the quarter. Financing provided $3.40 million, principally from an at-the-market stock offering; investing activities used $0.84 million. Interest expense rose to $454,000 from $145,000.
Material changes and developments
- Research and development expense fell 32.1%, mainly because the VISION-2 study concluded in 2022 and clinical activity declined.
- General and administrative expense fell 15.5%, mainly due to nonrecurring legal and recruiting costs from 2022.
- The company sold 1,299,947 shares through its at-the-market offering for approximately $3.50 million net proceeds.
- In February, Eyenovia extended three Redwood City leases through August 2025.
- After quarter-end, on May 5, 2023, the FDA approved Mydcombi. Eyenovia said it was preparing a targeted commercial launch, with expansion expected in 2024 when internal manufacturing capabilities were expected to come online.
Outlook, risks and contingencies
Management stated that the company expects continued operating cash outflows and that research and development and general and administrative expenses are expected to increase. The filing says the company’s recurring losses and cash needs raise substantial doubt about its ability to continue as a going concern for at least one year from issuance of the financial statements. Continued operations depend on raising additional capital or completing licensing or business-development transactions; without funding, the company may need to curtail research and development or reduce costs. The filing does not provide a clear cash runway estimate.
Near-term contractual commitments include approximately $2.5 million for accounts payable and accrued liabilities, $0.5 million for operating leases, and $2.2 million of note payments. Management reported no material legal proceedings, no material change to previously disclosed risk factors, and no material change in internal control over financial reporting. Disclosure controls were assessed as effective at a reasonable assurance level.
Key facts for investors to verify
- Confirm the issuer: the filing identifies Eyenovia, Inc. (ticker EYEN), not Hyperion DeFi, Inc.
- Assess the going-concern warning, cash burn, funding needs, and availability and terms of future financing.
- Track Mydcombi’s commercial launch, manufacturing readiness, and any resulting revenue or milestone payments.
- Review the composition, terms, maturities and interest costs of the reported $10.93 million gross notes payable.
- Monitor clinical, regulatory and commercialization progress for MicroPine, MicroLine and the Optejet platform.