EPS of $-0.15 increased by 92.5% from previous year
Net income of -2.79M
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BioVie Inc (BIVI) QQ3 2025 Results - Q3 2025 Performance, Pipeline Commentary, and Investment Outlook
Executive Summary
BioVie reported a Q3 2025 loss with no recognized revenue, consistent with early-stage clinical biotechnology companies still advancing pipeline assets. The quarter shows a modest sequential improvement versus the prior period in operating metrics, driven primarily by lower operating losses despite continued R&D investment. The company maintains a robust cash position and a very light balance sheet on the debt side, placing it in a favorable liquidity position to fund ongoing NE3107 Phase III development and BIV201-related activities. However, the lack of revenue and reliance on successful clinical outcomes for a small-cap biotech underscore meaningful execution risk and the need for additional financing if pipeline milestones are not achieved in the near term.
Key near-term drivers include NE3107's Phase III progression for Alzheimer’s disease and potential partner deals or licensing for its ascites program (BIV201). Investors should monitor clinical milestones, regulatory timelines, and any financing actions that could impact liquidity or equity dilution. The current cash balance provides runway, but sustained cash burn and continued dependence on successful R&D milestones dictate a cautious, event-driven investment approach.
Key Performance Indicators
Operating Income
-2.99M
QoQ: 59.03% | YoY:61.38%
Net Income
-2.79M
QoQ: 61.05% | YoY:68.86%
EPS
-0.15
QoQ: 67.39% | YoY:92.50%
Revenue Trend
Margin Analysis
Key Insights
Revenue: None reported for QQ3 2025 (nil), consistent with a clinical-stage biotech with pre-commercial assets.
Gross Profit / Gross Margin: -$57,344 gross loss with gross margin effectively 0% (revenue nil in Q3; cost of revenue incurred).
Operating Expenses: R&D $1.345 million; SG&A $1.586 million; total operating expenses $2.931 million; cost of expenses $2.988 million including depreciation.
EBITDA / Operating Income: EBITDA is negative $2.726 million; Operating income negative $2.988 million, reflecting ongoing R&D and corporate expenses.
Net Income / EPS: Net loss of $2.788 million; basic and diluted EPS of -$0.15.
Financial Highlights
Overview of financial performance and notable metric trends:
- Revenue: None reported for QQ3 2025 (nil), consistent with a clinical-stage biotech with pre-commercial assets.
- Gross Profit / Gross Margin: -$57,344 gross loss with gross margin effectively 0% (revenue nil in Q3; cost of revenue incurred).
- Operating Expenses: R&D $1.345 million; SG&A $1.586 million; total operating expenses $2.931 million; cost of expenses $2.988 million including depreciation.
- EBITDA / Operating Income: EBITDA is negative $2.726 million; Operating income negative $2.988 million, reflecting ongoing R&D and corporate expenses.
- Net Income / EPS: Net loss of $2.788 million; basic and diluted EPS of -$0.15.
- YoY / QoQ trends (where data available):
• Operating income YoY: +61.38%; QoQ: +59.03% (improved from prior quarter but still negative).
• Net income YoY: +68.86%; QoQ: +61.05% (loss narrowed QoQ).
• EPS YoY: +92.50%; QoQ: +67.39% (loss per share improving QoQ).
- Cash flow and liquidity: Net cash used in operating activities of approximately -$1.253 million; free cash flow is -$1.253 million; cash balance at period-end: $23.152 million; net debt position shows a net cash position (~-$22.788 million) after accounting for debt.
- Balance sheet snapshot: Total assets $24.660 million; total liabilities $2.842 million; stockholders’ equity $21.818 million; cash and equivalents $23.152 million; minimal debt ($0.366 million total debt) and negligible current liabilities relative to liquidity; retained earnings deeply negative at about -$348.655 million, highlighting accumulated losses from prior periods.
Income Statement
Metric
Value
YoY Change
QoQ Change
Gross Profit
-57.34K
0.00%
0.00%
Operating Income
-2.99M
61.38%
59.03%
Net Income
-2.79M
68.86%
61.05%
EPS
-0.15
92.50%
67.39%
Key Financial Ratios
currentRatio
9.32
returnOnAssets
-11.3%
returnOnEquity
-12.8%
debtEquityRatio
0.02
operatingCashFlowPerShare
$-0.07
freeCashFlowPerShare
$-0.07
dividendPayoutRatio
-13.3%
priceToBookRatio
0.83
priceEarningsRatio
-1.63
Net Income vs. Revenue
Expense Breakdown
Management Commentary
Note: The transcripts field for QQ3 2025 is empty in the provided data. Consequently, no management quotes from an earnings call are available in this dataset. When transcripts are accessible, key themes typically include program updates (NE3107 Phase III progress, BIV201 pipeline milestones), capital allocation strategy, and commentary on runway and fundraising needs. Recommend adding direct quotes and management context once the transcript is obtained to enrich the themes below:
- Strategy: Discussion of pipeline prioritization, potential partnerships for NE3107 or BIV201, and capital structure optimization.
- Operations: Updates on enrollment milestones, safety signals, and any ancillary data from NE3107 Phase III that impact risk profile.
- Market conditions: Commentary on competitive landscape in Alzheimer’s and related conditions, and potential commercial viability timelines for de-risked assets.
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Forward Guidance
No formal forward guidance is presented in the QQ3 2025 filing. Given the absence of revenue and the ongoing reliance on pivotal clinical milestones, BioVie’s near-term outlook is inherently milestone-driven. Investors should monitor:
- NE3107 Phase III results: Any top-line efficacy/safety data, trial design changes, or interim analyses that could influence approval timelines and partnering opportunities.
- BIV201 program progress for ascites due to chronic liver cirrhosis: Enrollment rates, safety signals, and potential readouts or regulatory interactions.
- Capital strategy: Any planned financings, collaborations, or licensing deals that could bolster liquidity or reduce dilution risk.
- Competitive dynamics: Advancements by other biotech companies in neurodegenerative diseases and liver-related ascites therapies that could influence market positioning.
Assessment: The absence of revenue necessitates a favorable view on successful clinical milestones or strategic partnerships to translate pipeline progress into meaningful equity value. The probability of significant equity dilution or debt issuance remains a key variable investors should monitor.
Competitive Position
Company
Gross Margin
Operating Margin
Return on Equity
P/E Ratio
BIVI Focus
0.00%
0.00%
-12.80%
-1.63%
INZY
0.00%
0.00%
-29.70%
-3.37%
DAWN
98.30%
31.60%
6.67%
9.09%
TERN
0.00%
0.00%
-6.02%
-7.39%
ELDN
0.00%
0.00%
1.01%
42.00%
Gross Profit Margin
Operating Profit Margin
Return on Equity
P/E Ratio Comparison
Investment Outlook
Given BioVie's lack of current revenue and reliance on future pipeline milestones, the stock presents a high-risk, high-potential profile typical of early-stage biotech. The near-term thesis depends on NE3107 Phase III outcomes and potential strategic deals for either NE3107 or BIV201. The company’s liquidity position mitigates near-term funding risk, but sustained negative earnings and ongoing burn remain key headwinds. A constructive stance would be contingent on clear, positive Phase III data or strategic partnerships that de-risk future capital needs. Investors should monitor milestone timing, safety signals, and any announced financing arrangements. In the absence of near-term catalysts, risk-adjusted recommendations may skew toward cautious positions with close attention to upcoming trial readouts and liquidity events.
Key Investment Factors
Growth Potential
Catalysts hinge on NE3107 Phase III outcomes for Alzheimer's disease and potential licensing deals around NE3107 or BIV201. A successful Phase III readout or a strategic collaboration could unlock substantial value given NE3107’s clinical profile and the addressable AD market; ascites program could attract partnerships contingent on safety and early efficacy signals.
Profitability Risk
Clinical trial risk remains the principal driver of value; no revenue yet; significant dependence on a limited number of programs; potential need for additional financing to fund ongoing trials; regulatory risk and competition in AD and liver-related diseases; dilution risk if equity financings are pursued.
Financial Position
Strong liquidity relative to debt with approximately $23.15 million in cash and equivalents and negligible current liabilities; net debt is negative, indicating net cash. However, deep cumulative losses (retained earnings negative) reflect ongoing burn and dependency on future milestones to create shareholder value.
SWOT Analysis
Strengths
Healthy cash position (~$23.15 million) with negligible debt, providing runway to advance NE3107 Phase III and BIV201 development.
Pre-commercial pipeline with two assets (NE3107 in Phase III for Alzheimer's; BIV201 ascites program) offering multiple value levers upon success.
Strong balance sheet metrics (very high current ratio ~9.32) and solid liquidity relative to liabilities.
Low debt burden and a history of negative net debt, reducing near-term financing pressure.
Weaknesses
No revenue in QQ3 2025; ongoing and sizable R&D and SG&A burn with negative earnings.
Dependence on a small number of pipeline programs; regulatory and clinical risk high for a biotech at this stage.
Significant accumulated losses (retained earnings deeply negative) indicating ongoing capital consumption and potential dilution risk.
Opportunities
NE3107 Phase III readouts could unlock substantial value and potential licensing or collaboration opportunities.
BIV201 program may attract strategic partnerships for liver-related ascites therapy if early signals are favorable.
Possible out-licensing or milestone-based collaborations could de-risk funding needs and provide non-dilutive or less-dilutive financing.
Threats
Clinical trial failures or slower-than-expected enrollment could delay value realization.
Competitive landscape in Alzheimers and related indications with many biotech programs; regulatory hurdles are non-trivial.
Capital market volatility may necessitate raising capital, potentially diluting existing shareholders.