Business context and reporting period
The supplied filing is Eyenovia, Inc.’s unaudited Form 10-Q for the quarter ended March 31, 2021; it does not identify Hyperion DeFi, Inc. Eyenovia is a clinical-stage ophthalmic company developing drug-delivery technology and therapies. It reported no product sales; quarterly revenue arose from licensing arrangements.
Key financial metrics
| Metric | Q1 2021 | Q1 2020 / comparison |
|---|---|---|
| Revenue | $2.0 million | $0 |
| Cost of revenue / gross profit | $0.8 million / $1.2 million; 60% gross margin | $0 / $0 |
| Research and development expense | $4.25 million | $3.63 million |
| General and administrative expense | $2.30 million | $1.84 million |
| Operating loss / net loss | $5.35 million / $5.35 million | $5.47 million / $5.45 million |
| Net loss per share, basic and diluted | $0.21 | $0.31 |
| Net cash used in operations | $4.57 million | $5.92 million |
| Cash and cash equivalents | $24.91 million at March 31 | $28.37 million at December 31, 2020 |
| Working capital | $11.7 million | Prior comparable value not stated here |
| Total debt | $1.09 million | $0.46 million at December 31, 2020 |
| Total assets / liabilities / stockholders’ equity | $28.85 million / $16.71 million / $12.14 million | At December 31, 2020: $33.91 million / $18.60 million / $15.30 million |
Material changes versus the prior period
- Revenue of $2.0 million and related cost of revenue of $0.8 million were recognized for the first time, after MicroPine trial data was submitted to Arctic Vision and half of its upfront license fee became earned.
- R&D expense increased 17%, mainly due to increased MydCombi production and testing, MicroLine formulation work, and fewer COVID-19 restrictions; personnel costs also rose. G&A increased 25%, reflecting hiring, sales and marketing, and directors’ and officers’ insurance costs.
- Net loss narrowed slightly, while operating cash use declined by about $1.34 million. Cash fell by $3.46 million during the quarter; warrant exercises generated $1.53 million of financing proceeds.
- Shares outstanding rose from 24.98 million at year-end to 25.62 million at quarter-end, primarily from warrant exercises.
Outlook, risks and unusual items
- Management stated that the company had no recurring revenue, had not achieved profitability, expected continuing operating cash outflows and rising R&D and G&A costs, and disclosed substantial doubt about its ability to continue as a going concern for at least one year from issuance of the statements. Continued operations depend on raising additional capital; failure to do so could require R&D cuts and other cost reductions.
- No formal financial guidance was provided. Management said R&D and G&A expenses were expected to increase. The company had completed two Phase III trials for MydCombi and reported positive results; the FDA accepted its NDA in March 2021, with a stated PDUFA date of October 28, 2021. MicroLine’s first of two planned Phase III trials began in December 2020. The CHAPERONE MicroPine study had resumed enrollment after pandemic-related delays.
- License economics remain contingent: Arctic Vision may provide up to $41.75 million in additional milestone payments; Bausch Health may provide up to approximately $35 million. No related milestones or royalties had been earned by March 31, 2021. The company owes Senju a share of certain Arctic Vision-related payments.
- Subsequent to quarter-end, warrant exercises generated $573,001. On May 7, 2021, Eyenovia received a $7.5 million initial tranche under a Silicon Valley Bank facility of up to $25 million; another $17.5 million is available in milestone-dependent tranches. The loan matures May 1, 2025, carries interest at the greater of 1.25% plus prime or 5%, and involved warrants for 91,884 shares.
- The company had applied for forgiveness of its $463,353 Paycheck Protection Program loan; forgiveness was not assured. It also disclosed that $24.66 million of cash deposits exceeded FDIC insurance limits. Management reported effective disclosure controls as of March 31, 2021 and no material change in internal control over financial reporting during the quarter. No legal proceedings were reported.
Most important facts for investors to verify
- Confirm the issuer: the supplied filing is for Eyenovia, Inc., not the company named in the request metadata.
- Track cash burn, available liquidity, and the implications of the disclosed going-concern uncertainty, including whether the subsequent SVB facility’s additional tranches are drawn and on what terms.
- Verify the FDA’s action and timing for MydCombi, and progress, enrollment, and costs for the MicroPine and MicroLine programs.
- Monitor whether license milestones, royalties, or supply revenue are achieved, and the related payment obligations to Senju.
- Assess potential dilution from outstanding options and warrants, subsequent warrant exercises, and the SVB warrants.