Filing summary
Entity discrepancy: Request metadata identifies HYPERION DEFI, INC., but the supplied Form 10-Q is for Eyenovia, Inc. (Nasdaq: EYEN), for the quarter ended June 30, 2021. The summary below reflects the filing text.
Business context and reporting period
Eyenovia is a clinical-stage ophthalmic company developing drug candidates using its Optejet microdose-delivery platform. Its pipeline includes MicroPine for progressive myopia, MicroLine for presbyopia, and MydCombi for pupil dilation. The unaudited report covers the three and six months ended June 30, 2021, with comparisons to 2020.
Key financial metrics
| Metric | Three months ended June 30, 2021 | Six months ended June 30, 2021 |
|---|---|---|
| Revenue | $2.0 million | $4.0 million |
| Cost of revenue / gross profit | $0.8 million / $1.2 million | $1.6 million / $2.4 million |
| Gross margin | 60% | 60% |
| Research and development expense | $3.6 million | $7.9 million |
| General and administrative expense | $2.3 million | $4.6 million |
| Operating loss | $4.8 million | $10.1 million |
| Net loss | $4.8 million | $10.2 million |
| Net loss per share, basic and diluted | $0.19 | $0.40 |
Revenue was recognized from the Arctic Vision license agreement, not from product sales. The company reported no product-sale revenue and said it had not completed development of a product candidate. For the six months, operating cash use was $9.9 million, investing cash use was $0.6 million, and financing provided $9.4 million; cash declined by $1.2 million to $27.2 million.
At June 30, 2021, current assets were $29.5 million and current liabilities were $14.6 million, for reported working capital of $14.9 million. Total debt was $8.0 million, versus $0.5 million at December 31, 2020. Stockholders’ equity was $9.0 million and accumulated deficit was $87.6 million.
Material changes versus the prior comparable period
- Revenue increased from zero to $2.0 million for the quarter and $4.0 million for the six-month period, following recognition of Arctic Vision license fees as trial data was delivered. Related cost of revenue was $0.8 million and $1.6 million, respectively.
- Six-month net loss narrowed slightly to $10.2 million from $10.5 million, while operating expenses increased to $12.5 million from $10.5 million.
- Six-month R&D expense rose 20% to $7.9 million, mainly due to clinical/commercialization work on MydCombi, personnel growth, and higher facility and travel costs. G&A expense rose 18% to $4.6 million, including increased marketing, staffing, and insurance costs.
- Cash at period-end was $27.2 million, compared with $10.2 million a year earlier. The company received $7.5 million from its new SVB facility and $2.1 million from warrant exercises during the first half.
- Debt rose substantially following the SVB borrowing. Common shares outstanding increased to 25.9 million at June 30, 2021 from 25.0 million at December 31, 2020.
Outlook, risks, contingencies, and unusual items
- Going concern: Management stated that substantial doubt exists about Eyenovia’s ability to continue as a going concern for at least one year from issuance of the financial statements. The company expects continued operating cash outflows and higher R&D and G&A spending; continued operations depend on raising additional capital. If it cannot, it may need to curtail R&D and reduce costs.
- Development outlook: The company reported positive topline results from the Phase III VISION-1 MicroLine study and planned to initiate VISION-2 later in 2021, with topline results anticipated in mid-2022. MydCombi’s NDA was accepted by the FDA, with a stated PDUFA date of October 28, 2021. These are management expectations as of the filing, not assurances of approval or success.
- Financing: The SVB agreement provides up to $25.0 million, but only the initial $7.5 million tranche had been drawn. The remaining $17.5 million is conditional on milestones. The loan is secured by tangible assets, bears interest at the greater of prime plus 1.25% or 5%, and includes a 5% final payment. The company also had an unused at-the-market program permitting up to $30 million of common-stock sales.
- License commitments: Bausch paid a $10.0 million upfront fee that remained deferred and unearned at quarter-end; up to about $35.0 million in additional milestone payments may be available. Arctic Vision may provide up to $41.75 million in milestone payments. No Bausch milestones or royalties had been earned by June 30, 2021; Arctic Vision milestone amounts and royalties also remained unearned during the period.
- PPP loan: The company had applied for forgiveness of its $0.46 million PPP loan, but stated that forgiveness was not assured.
- The filing reported no legal proceedings and no material change in internal control over financial reporting. Management concluded disclosure controls were effective at a reasonable-assurance level.
Important facts for investors to verify
- Confirm the filing’s issuer: the supplied document is Eyenovia, Inc., not the company named in the request metadata.
- Review subsequent FDA action on MydCombi relative to the stated October 28, 2021 PDUFA date, and progress and results for VISION-2.
- Track cash burn, access to additional capital, SVB milestone conditions, and any use of the at-the-market offering given the going-concern disclosure.
- Verify the status of Bausch and Arctic Vision performance obligations, milestone receipts, royalties, and payments owed to Senju.
- Confirm the outcome of the PPP forgiveness application and the timing and servicing requirements of outstanding debt.