EPS of $-0.46 increased by 79.1% from previous year
Net income of -7.16M
"Transcript not provided in the input data." - N/A
BioVie Inc (BIVI) QQ2 2025 Earnings Analysis: Narrow Net Loss Amid Ongoing R&D Push and Cash Runway Considerations
Executive Summary
BioVie reported a QQ2 2025 net loss of approximately $7.16 million on virtually no revenue, with R&D expense totaling about $4.705 million and selling/general and administrative expenses of $2.531 million. Operating loss stood at $7.295 million and EBITDA was $-7.293 million. The company does not recognize material revenue in the quarter, consistent with its clinical-stage, pipeline-focused profile. Despite the loss, BioVie maintains a solid liquidity position with cash and cash equivalents of roughly $24.41 million and a net cash position of about $24.02 million, aided by financing activity inflows of about $12.97 million during the period. Net debt remains negative due to substantial cash on hand, underscoring balance-sheet resilience even as the company continues to fund a high-R&D burn. The QQ2 results reflect ongoing investment in NE3107 (Phase III for Alzheimer's disease) and BIV201, alongside other programs, with management emphasizing pipeline progress and strategic partnerships as pivotal near-term catalysts. Absent meaningful revenue or licensing milestones, the near-term earnings trajectory remains dominated by R&D cadence and potential external financing needs.
Key near-term takeaways: (1) A persistent lack of revenue constrains profitability despite a modest gross loss; (2) strong liquidity cushions ongoing burn but does not remove the need for milestone-based or equity financing to sustain operations; (3) NE3107 remains the most material growth lever, subject to Phase III outcomes and regulatory progress. Investors should monitor upcoming clinical readouts, potential partnership developments, and any macro-financing signals that could extend the company’s cash runway.
Key Performance Indicators
Operating Income
-7.29M
QoQ: -76.93% | YoY:16.95%
Net Income
-7.16M
QoQ: -72.37% | YoY:14.81%
EPS
-0.46
QoQ: 34.29% | YoY:79.09%
Revenue Trend
Margin Analysis
Key Insights
Net cash used in operating activities: -$8.584M; Free cash flow: -$8.584M.
Net cash provided by financing activities: $12.967M; Net change in cash: +$4.382M; Cash at end of period: $24.405M.
Debt: Total debt $382k (short-term $67k, long-term $315k). Net debt is negative, reflecting a robust cash cushion.
Balance sheet highlights: Total assets $25.695M; Total liabilities $1.772M; Total stockholders’ equity $23.923M; Retained earnings accumulated deficit $-345.867M.
Financial Highlights
Revenue: No revenue recognized in QQ2 2025 (reported as revenue = null); implies near-term reliance on pipeline milestones or licensing to drive cash inflows.
Gross Profit: -$57,344 for QQ2 2025; Gross Margin effectively 0% given zero revenue; indicates costs exceed any little revenue perhaps due to manufacturing allocations or timing.
Operating Expenses: R&D $4.705M; SG&A $2.531M; Total operating expenses $7.235M (cost of revenue $57,344 included in the total $7.293M EBITDA impact).
EBITDA: -$7.293M; EBITDA margin not meaningful with negligible revenue but reflects ongoing burn and cost structure.
Operating Income: -$7.293M; QoQ deterioration vs Q1 2025 driven by persistent R&D intensity and SG&A activity without top-line contribution; YoY improvement in the negative absolute level suggests some cost alignment vs prior year.
Net Income: -$7.156–7.157M; YoY improvement of ~14.81% reflects reduced absolute net loss versus the prior year period; QoQ change shows a sharp decline (~-72.37%) indicating quarterly cadence tied to pipeline timing and operating expenses.
EPS (Diluted): -$0.46 for QQ2 2025; YoY change +79.1%; QoQ +34.3% (reflects lower loss per share despite higher absolute net loss in the quarter due to share count dynamics).
Cash Flow and Liquidity:
- Net cash used in operating activities: -$8.584M; Free cash flow: -$8.584M.
- Net cash provided by financing activities: $12.967M; Net change in cash: +$4.382M; Cash at end of period: $24.405M.
- Debt: Total debt $382k (short-term $67k, long-term $315k). Net debt is negative, reflecting a robust cash cushion.
- Balance sheet highlights: Total assets $25.695M; Total liabilities $1.772M; Total stockholders’ equity $23.923M; Retained earnings accumulated deficit $-345.867M.
Liquidity and leverage indicate a conservative balance sheet with ample cash to fund ongoing R&D, but profitability remains elusive as long as revenue stays near zero. Valuation multiples shown in the peer comparisons imply a biotech with significant cash runway yet no revenue base to support earnings-based valuations.
Income Statement
Metric
Value
YoY Change
QoQ Change
Gross Profit
-57.34K
0.00%
0.00%
Operating Income
-7.29M
16.95%
-76.93%
Net Income
-7.16M
14.81%
-72.37%
EPS
-0.46
79.09%
34.29%
Key Financial Ratios
currentRatio
16.94
returnOnAssets
-27.9%
returnOnEquity
-29.9%
debtEquityRatio
0.02
operatingCashFlowPerShare
$-0.55
freeCashFlowPerShare
$-0.55
priceToBookRatio
1.31
priceEarningsRatio
-1.1
Net Income vs. Revenue
Expense Breakdown
Management Commentary
Note: The earnings transcript was not provided in the input data. As a result, there are no management commentary highlights available to quote or summarize from an earnings call for QQ2 2025. The analysis below is anchored to the disclosed financials and pipeline disclosures. Please provide the QQ2 2025 earnings call transcript to incorporate verbatim management insights and quotes.
Transcript not provided in the input data.
— N/A
Transcript not provided in the input data.
— N/A
Forward Guidance
Formal forward-looking guidance from BioVie for QQ3 2025 or beyond is not included in the provided data. Given the current financial profile, the near-term trajectory hinges on clinical milestones, regulatory progress, and potential licensing or collaboration agreements that could monetize NE3107 and/or other programs. The company’s cash runway, while solid on a pure balance-sheet basis (approx. $24.4M cash, net cash position), depends on continued financing or operational monetization to sustain the high R&D burn.
Key factors to monitor:
- NE3107 Phase III readouts and regulatory interactions for Alzheimer's disease; positive results could unlock strategic partnerships or milestone payments.
- BIV201 progress and any signals of ascites management efficacy that could attract licensing discussions or collaboration opportunities.
- Potential equity financing or debt instruments to extend runway if licensing milestones are delayed or trial enrollment costs rise.
- Any cost-control initiatives that could moderate the quarterly burn rate while preserving pipeline momentum.
Competitive Position
Company
Gross Margin
Operating Margin
Return on Equity
P/E Ratio
BIVI Focus
0.00%
0.00%
-29.90%
-1.10%
INZY
0.00%
0.00%
-28.60%
-2.53%
DAWN
91.40%
-14.01%
-1.44%
-67.12%
TERN
0.00%
0.00%
-10.40%
-5.61%
ELDN
0.00%
0.00%
5.28%
-59.10%
Gross Profit Margin
Operating Profit Margin
Return on Equity
P/E Ratio Comparison
Investment Outlook
BioVie remains a high-risk, high-reward biotechnology name. The QQ2 2025 results show a persistent net loss with zero revenue, underscoring the company’s early-stage nature and reliance on external funding. However, the substantial cash cushion and negligible near-term debt provide a practical runway to advance NE3107 and other programs as potential catalysts. The key determinant of investment viability is the trajectory of NE3107: positive Phase III readouts and favorable regulatory signals could unlock partnerships and milestone payments, potentially transforming the revenue model. Absent near-term commercial milestones, the stock is highly sensitive to capital-raising dynamics and clinical trial outcomes. Investors should position with a long horizon, focusing on pipeline milestones, potential licensing deals, and any developments that could convert pipeline potential into revenue streams. A cautious stance is warranted until tangible licensing agreements or meaningful clinical readouts materialize.
Key Investment Factors
Growth Potential
NE3107 (Alzheimer's) represents a high-impact, late-stage opportunity if phase III results demonstrate meaningful efficacy and safety. Licensing or milestone-based revenue from NE3107 could materially alter BioVie's revenue trajectory and reduce dependence on continued financing.
Profitability Risk
No current revenue; dependence on successful advancement of a single or handful of late-stage programs. Regulatory risk, competition in Alzheimer's and oncology, and the potential for dilution through equity raises. Large accumulated deficits and reliance on external funding create funding risk in adverse market conditions.
Financial Position
Balanced by a strong cash position (~$24.4M) and minimal near-term debt, yielding a net cash position of ~-$24.0M. This provides liquidity to fund pipeline work but does not replace the need for revenue or licensing milestones. The substantial accumulated deficit (-$345.9M) indicates ongoing reliance on external funding and/or partnerships for commercial viability.
SWOT Analysis
Strengths
Robust cash position (~$24.4M) and net cash position (~$24.0M) with low near-term debt
No material near-term debt maturities, providing liquidity headroom for pipeline development
Pipeline focus with NE3107 (Phase III for Alzheimer's) and BIV201 (Phase IIa for ascites) as potential catalysts
Current balance sheet metrics show favorable liquidity ratios (current/quick/cash ratios all around 16+)
Weaknesses
No revenue in QQ2 2025; ongoing heavy R&D burn without topline sales
Large accumulated deficit (-$345.9M) and negative earnings trajectory
Reliance on pipeline milestones and external financing to sustain operations
Equity dilution risk implied by substantial common stock issued during the period
Opportunities
NE3107 Phase III results could unlock licensing deals or milestone payments
Strategic collaborations or out-licensing of NE3107 or other programs could convert pipeline value into revenue
Potential cost optimization and milestone-driven financing could extend runway without excessive dilution
Threats
Clinical and regulatory risk for NE3107 and other programs; failure could erode valuation
Biotech fundraising environment volatility could constrain timely financing
Intense competitive landscape in Alzheimer's research and specialty indications