HYPERION DEFI, INC. quarterly report, Q3 FY2020

Abrir documento

Filing summary

Registrant and period: The supplied filing is Eyenovia, Inc.’s unaudited Form 10-Q for the quarter ended September 30, 2020, signed November 12, 2020. This does not match the request metadata naming Hyperion DeFi, Inc.; verify the intended issuer.

Business context

Eyenovia is a clinical-stage ophthalmic biopharmaceutical company developing microdose therapies delivered using its Optejet technology. Its pipeline includes MicroPine for progressive myopia, MicroLine for presbyopia, and MicroStat for mydriasis. The company had no product-sales revenue and had not completed development of a product candidate.

Financial performance and liquidity

  • Revenue: No product-sales revenue was generated. The $4.0 million Arctic Vision upfront payment was recorded as a deferred license fee, not earned revenue, at September 30.
  • Third-quarter results: R&D expense was $3.36 million versus $3.20 million a year earlier; G&A was $1.73 million versus $1.49 million. Operating loss was $5.09 million and net loss was $5.10 million, compared with net loss of $4.65 million in Q3 2019. Basic and diluted loss per share was $0.23 versus $0.29.
  • Nine-month results: R&D expense was $9.91 million, down from $10.78 million; G&A was $5.67 million, up from $5.24 million. Net loss was $15.56 million versus $15.92 million in 2019; loss per share was $0.79 versus $1.19. Margins are not meaningful because the company reported no product revenue.
  • Cash flow: Operating cash use was $11.85 million for the nine months, down from $14.90 million. Investing cash use was $0.20 million. Financing provided $20.77 million, primarily from equity offerings, warrant exercises, and a PPP loan. Cash increased by $8.71 million to $22.86 million.
  • Balance sheet: At September 30, cash was $22.86 million, working capital $18.63 million, total assets $25.85 million, and stockholders’ equity $18.65 million. Total liabilities were $7.20 million, including $0.57 million of notes payable and a $4.0 million deferred license fee. Accumulated deficit was $73.23 million.

Material changes and notable items

  • Cash increased from $14.15 million at December 31, 2019, supported by approximately $18.3 million of net equity proceeds and $2.6 million from warrant exercises during the nine months. Common shares outstanding rose from 17.10 million to 24.88 million.
  • R&D expense declined year over year for the nine-month period, primarily reflecting reduced clinical activity and supply spending during early-2020 COVID-19 disruptions. Q3 R&D rose as activity on MicroPine and MicroLine studies increased. G&A rose, including business-development, patent, and insurance expenses.
  • In August, Arctic Vision obtained regional rights to MicroPine and MicroLine in Greater China and South Korea. Eyenovia received $4.0 million upfront and may receive up to $41.75 million in additional milestone-related payments, plus supply revenue or royalties. The company paid Senju $1.6 million, recorded as deferred license costs; Senju is entitled to a share of certain proceeds.
  • After quarter-end, on October 9, Eyenovia licensed MicroPine rights in the United States and Canada to Bausch Health. Eyenovia received $10.0 million upfront, may receive approximately $35.0 million in additional milestone payments, and is eligible for tiered royalties on gross profits. Bausch assumed oversight and costs of the CHAPERONE study. Bausch may terminate for convenience on 90 days’ notice.
  • The company received a $463,353 PPP loan at 1% interest; forgiveness is uncertain. The company also had a directors’ and officers’ insurance premium loan.

Outlook, risks, and controls

Management expected available cash, including the subsequent Bausch payment and warrant-exercise proceeds, to fund operations and capital needs for at least 12 months from issuance of the statements. Additional financing may be needed thereafter; if unavailable, Eyenovia may curtail R&D or reduce costs. Management expected R&D spending to increase as development advances.

Development and commercialization remain subject to clinical, regulatory, manufacturing, funding, and market risks. COVID-19 had delayed clinical trial activity, though CHAPERONE enrollment resumed. At the filing date, the company said it remained on track to submit a MicroStat NDA in 2020 and anticipated initiating MicroLine Phase III trials in 2020, subject to pandemic impacts. These are historical expectations, not confirmation that milestones were achieved. Management reported disclosure controls were effective as of September 30, 2020 and no material third-quarter change in internal control over financial reporting. No legal proceedings were reported.

Important facts for investors to verify

  • Confirm the intended issuer: the filing is for Eyenovia, not Hyperion DeFi.
  • Check subsequent filings for the status and timing of the MicroStat NDA, MicroLine trials, and CHAPERONE study.
  • Verify the Bausch and Arctic Vision agreements’ milestones, termination provisions, royalties, and any revenue recognition; the upfront payments were not ordinary product sales.
  • Assess cash burn, the duration of the stated 12-month liquidity runway, and the need for further financing.
  • Review dilution from equity offerings, warrants, options, and other potential share issuance; also verify PPP loan forgiveness and remaining debt.