BioVie Inc. — Form 10-K Summary
Reporting period: Fiscal year ended June 30, 2021. The filing is an annual report, not a quarterly report; the “2020 Q4” metadata does not match the period covered. Amounts are in U.S. dollars.
Business context and reporting period
BioVie is a clinical-stage biopharmaceutical company with no approved products and no revenue. Its programs are BIV201, continuous-infusion terlipressin for complications of advanced liver cirrhosis, and NE3107, acquired in June 2021 and being developed for neurodegenerative conditions including Alzheimer’s disease.
Financial performance, cash flow and liquidity
| Metric | FY2021 | FY2020 |
|---|---|---|
| Revenue | None | None |
| Operating expenses | $138.1 million | $2.7 million |
| Research and development expense | $133.2 million, including $130.6 million of acquired in-process R&D | $1.2 million |
| Selling, general and administrative expense | $4.6 million | $1.3 million |
| Operating loss | $138.1 million | $2.7 million |
| Net loss | $130.2 million | $16.7 million |
| Net loss attributable to common stockholders | $183.8 million, including $53.6 million of deemed dividends | $33.8 million, including $17.1 million of deemed dividends |
| Net cash used in operating activities | $10.5 million | $1.6 million |
| Cash at year-end | $4.5 million | $37,195 |
Margins are not meaningful because the company generated no revenue. Other income, net was $7.8 million in FY2021, chiefly reflecting an $8.3 million gain from changes in derivative fair value; FY2020 had $14.0 million of other expense, including derivative-related charges and interest. The related-party convertible debenture and derivative liabilities were settled or extinguished in September 2020; no such debt or derivative liabilities remained at June 30, 2021. Total liabilities were $1.0 million, primarily accounts payable and accrued expenses. Working capital was approximately $3.6 million, stockholders’ equity was $5.1 million, and accumulated deficit was $224.9 million at year-end.
On August 11, 2021, after year-end, BioVie raised approximately $17.8 million net by issuing 2.5 million shares at $8 per share. The filing says planned spending could exhaust available cash within 12 months; conserving cash by delaying research spending could extend runway but slow clinical programs. Management and the auditor identified substantial doubt about the company’s ability to continue as a going concern. The auditor issued an unqualified opinion on the financial statements, while noting that it did not audit internal control over financial reporting.
Material changes versus the prior comparable period
- Net loss increased by approximately $113.6 million, mainly because of the $130.6 million NE3107-related acquired in-process R&D charge, partly offset by derivative fair-value changes and lower interest expense.
- Operating expenses increased by approximately $135.4 million. Outside the acquisition charge, R&D increased with BIV201 trial preparation, while SG&A rose largely due to director stock compensation and costs associated with national-exchange listing.
- Cash rose from $37,195 to $4.5 million, supported by financing during the year; operating cash use also increased. The company issued 8.36 million shares for the related-party asset acquisition, and total shares outstanding were 22.33 million at June 30, 2021.
- The August 2021 offering increased cash after year-end but also added 2.5 million shares. The filing also describes up to 18 million additional contingent shares tied to four acquisition milestones.
Outlook, management commentary and key risks
- BIV201—ascites: A randomized Phase 2b trial was underway, with top-line results expected in early 2022 and a proposed potentially pivotal Phase 3 trial to follow. As of July 2021, two patients had enrolled and seven of nine planned U.S. sites were activated. BIV201 has FDA Fast Track status and Orphan Drug designations for ascites and hepatorenal syndrome; designation does not guarantee approval or exclusivity.
- BIV201—HRS-AKI: Following FDA feedback in June 2021, the company planned to revise the proposed trial and begin a Phase 3 study in late 2021; it also planned to seek a Special Protocol Assessment. Timing and trial design remained subject to FDA guidance and funding.
- NE3107: The FDA had authorized a potentially pivotal Phase 3 Alzheimer’s trial; the filing reports initiation on August 5, 2021 and targets primary completion in late 2022/early 2023. Parkinson’s and oncology programs were prospective plans, not established clinical results in this filing.
- Financing and dilution: BioVie has no product revenue, expects continuing losses, and depends on additional equity, debt, licensing, or partnership financing. Financing may be unavailable or dilutive. The NE3107 acquisition was from related-party affiliates; the auditor identified related-party transactions as a critical audit matter. Verify the transaction valuation, approvals, contingent-share terms, and resulting ownership effects.
- Development and regulatory risk: Clinical safety or efficacy results, enrollment, FDA requirements, manufacturing, competition, intellectual-property challenges, and COVID-19 disruption could delay or prevent development. The company disclosed that a prior BIV201 patent was found unpatentable in an inter partes review; pending applications and other protections may not provide adequate coverage.
- Governance and controls: Management reported effective disclosure controls and internal control over financial reporting. Directors and officers were reported to own approximately 79.7% of shares as of August 17, 2021, creating concentrated voting control. The filing also describes related-party relationships and potential conflicts of interest.
Important facts for investors to verify
- Whether the August 2021 financing and subsequent cash use provide adequate runway for the stated clinical plans, and the latest cash balance and burn rate.
- Phase 2b BIV201 enrollment, top-line results, FDA feedback, and whether the planned ascites and HRS-AKI trials proceed on the stated timetable.
- NE3107 Phase 3 enrollment, trial milestones, and whether its clinical rationale is supported by human data rather than preclinical evidence.
- The terms and potential dilution from up to 18 million contingent acquisition shares, the related-party nature of the acquisition, and the basis for the $130.6 million recorded charge.
- Current patent status and exclusivity prospects for BIV201 and NE3107, including the impact of the invalidated BIV201 patent and competing terlipressin programs.