EPS of $-2.00 increased by 53.5% from previous year
Net income of -8.95M
"N/A" - N/A
BioVie Inc (BIVI) QQ3 2024 Results Analysis: Cash Richness Supports Pipeline-Building in a High-Rocus Biotech Landscape
Executive Summary
BioVie reported a non-revenue QQ3 2024 quarter characterized by continued clinical-stage investment and a meaningful cash runway. Operating losses remained elevated as R&D activity and pre-commercial costs persisted, but the company entered the period with a robust cash balance and a net cash position, aided by financing activity. The absence of reported revenue underscores the company’s status as a clinical-stage biotechnology company, with value drivers concentrated in its pipeline (notably NE3107 in Phase III for Alzheimer's disease and BIV201 for ascites) and potential strategic partnerships or licensing milestones. Management commentary around upcoming clinical milestones and ongoing capital discipline will be critical for gauging the trajectory toward potential milestone-driven value creation.
Key quantitative takeaways include a net loss of $8.95 million for the quarter and an EPS of -$2.00, with operating loss of $7.737 million. Cash and equivalents totaled $30.35 million at quarter-end, supported by net cash provided by financing activities of $15.98 million, yielding a net cash increase of about $10.12 million for the period. The company carries low near-term debt and a solid liquidity profile (current ratio ~2.45, cash ratio ~2.43) but remains reliant on external financing and clinical milestones for value realization. Investors should monitor pipeline progression, cost control, and potential milestone-related data readouts that could alter the risk-reward profile from a speculative biotechnology lens.
Key Performance Indicators
Operating Income
-7.74M
QoQ: 11.89% | YoY:43.83%
Net Income
-8.95M
QoQ: -6.58% | YoY:40.47%
EPS
-2.00
QoQ: 9.09% | YoY:53.49%
Revenue Trend
Margin Analysis
Key Insights
Revenue: Not reported in QQ3 2024; the quarter shows a cost structure aligned with drug development activity and pre-commercial operations rather than product sales. Implication: ongoing reliance on external funding and non-operating cash flows to sustain operations.
Gross Profit / Gross Margin: -$57,344 gross profit; gross margin effectively 0% (no revenue reported). Implication: cost of revenue is minimal in the quarter; the negative gross profit reflects the absence of product sales rather than a sustained margin issue.
Operating Expenses: R&D $5.70 million; SG&A $1.98 million; Total operating expenses $7.68 million. Implication: continued emphasis on pipeline development (notably NE3107 and BIV201) with a high burn rate typical of clinical-stage biotech.
EBITDA / Operating Income: EBITDA -$7.382 million; Operating income -$7.737 million. Implication: substantial pre-revenue burn, as expected for a company advancing late-stage (Phase III) assets and early-stage programs.
Net Income / EPS: Net income -$8.954 million; EPS -$2.00. Implication: persistent loss driven by non-cash and cash operating activities; valuation should reflect future revenue potential rather than current profitability.
Financial Highlights
Summary of the QQ3 2024 metrics and what they imply for BioVie's health and trajectory:
- Revenue: Not reported in QQ3 2024; the quarter shows a cost structure aligned with drug development activity and pre-commercial operations rather than product sales. Implication: ongoing reliance on external funding and non-operating cash flows to sustain operations.
- Gross Profit / Gross Margin: -$57,344 gross profit; gross margin effectively 0% (no revenue reported). Implication: cost of revenue is minimal in the quarter; the negative gross profit reflects the absence of product sales rather than a sustained margin issue.
- Operating Expenses: R&D $5.70 million; SG&A $1.98 million; Total operating expenses $7.68 million. Implication: continued emphasis on pipeline development (notably NE3107 and BIV201) with a high burn rate typical of clinical-stage biotech.
- EBITDA / Operating Income: EBITDA -$7.382 million; Operating income -$7.737 million. Implication: substantial pre-revenue burn, as expected for a company advancing late-stage (Phase III) assets and early-stage programs.
- Net Income / EPS: Net income -$8.954 million; EPS -$2.00. Implication: persistent loss driven by non-cash and cash operating activities; valuation should reflect future revenue potential rather than current profitability.
- Cash Flow: Operating cash flow -$5.852 million; Financing cash flow +$15.975 million; Net change in cash +$10.123 million; Cash ending balance $30.350 million. Implication: financing activity is a key determinant of liquidity; the company currently funds operations through external capital while maintaining a solid cash runway.
- Balance Sheet: Cash & equivalents $30.35 million; Total assets $31.77 million; Total liabilities $12.85 million; Stockholders’ equity $18.93 million; Net debt = -$21.93 million (net cash). Implication: a strong liquidity position with modest leverage for a biotech; ability to weather extended clinical timelines absent interim financing.
- Leverage & Ratios: Current ratio 2.45; Debt-to-capitalization ~0.308; Price-to-book ~2.66; Enterprise value multiple ~-3.84 (negative due to cash-rich balance sheet); Cash per share $3.39. Implication: favorable liquidity profile; valuation metrics reflect pre-revenue status and negative earnings, but a healthy balance sheet cushions execution risk on pipeline milestones.
Income Statement
Metric
Value
YoY Change
QoQ Change
Gross Profit
-57.34K
N/A
0.00%
Operating Income
-7.74M
43.83%
11.89%
Net Income
-8.95M
40.47%
-6.58%
EPS
-2.00
53.49%
9.09%
Key Financial Ratios
currentRatio
2.45
returnOnAssets
-28.2%
returnOnEquity
-47.3%
debtEquityRatio
0.45
operatingCashFlowPerShare
$-0.65
freeCashFlowPerShare
$-0.65
priceToBookRatio
2.66
priceEarningsRatio
-1.4
Net Income vs. Revenue
Expense Breakdown
Management Commentary
Transcript excerpts and management commentary would typically provide color on pipeline milestones, regulatory expectations, and strategic financing considerations. However, no earnings call transcript data is included in the provided dataset. Consequently, this section cannot quote management directly. If transcript data becomes available, expected themes would likely include:
- Pipeline milestones: NE3107 Phase III readouts and potential companion studies; BIV201 ascites program progress; timelines for data readouts and potential regulatory interactions.
- Capital allocation: emphasis on preserving liquidity, optionality to partner or license non-core assets, and any planned equity raises or debt facilities.
- Commercial prospects: discussion of potential commercialization considerations, manufacturing readiness, and early payer dynamics for late-stage assets.
Note: In the absence of quotes, the analysis relies on reported financials and disclosed pipeline status.
N/A
— N/A
N/A
— N/A
Forward Guidance
No formal forward guidance was provided in the QQ3 2024 filing. Given the clinical-stage nature of BioVie, the near-term trajectory hinges on pipeline milestones and external financing. Our assessment:
- Base case: The company maintains liquidity via periodic equity financing if required, with ongoing R&D for NE3107 and BIV201. Value realization depends on positive Phase III readouts and potential strategic partnerships.
- Upside case: Positive NE3107 Phase III results or successful BIV201 expansions could unlock licensing or collaboration revenues and improve perception of future profitability.
- Risks: Clinical trial failures or delays, dilution from future financings, regulatory setbacks, and longer-than-expected timelines to potential revenue. Key catalysts to watch include upcoming Phase III data readouts, any regulatory interactions, and potential partnerships that could provide near-term non-dilutive capital or milestone payments.
- Monitoring factors for investors: trial milestones (NE3107 Phase III), progress in BIV201, runway length given quarterly burn, and any strategic financing actions that could affect ownership or valuation.
Competitive Position
Company
Gross Margin
Operating Margin
Return on Equity
P/E Ratio
BIVI Focus
0.00%
0.00%
-47.30%
-1.40%
INZY
0.00%
0.00%
-10.40%
-3.58%
DAWN
0.00%
0.00%
11.40%
-5.71%
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
BioVie remains a high-risk, high-upside biotechnology investment. The QQ3 2024 results confirm a pre-revenue profile with meaningful R&D spending and an ongoing need for external capital to sustain operations. The near-term investment thesis depends on pipeline milestones rather than current earnings, with NE3107 and BIV201 serving as the primary catalysts. The company’s strong liquidity provides a cushion as it de-risks execution risk, but the absence of revenue and the binary nature of pivotal trial outcomes mean returns are contingent on successful trial readouts and potential business development activity. Investors seeking exposure to high-potential Alzheimer's or liver-disease assets could consider BioVie as a speculative position, with explicit attention to milestone timelines, financing activity, and any strategic partnerships that could alter the runway or unlock near-term value.
Key Investment Factors
Growth Potential
BioVie’s growth potential centers on NE3107 (Phase III for mild-to-moderate Alzheimer’s disease) and BIV201 (ascites due to chronic liver cirrhosis) with the potential for milestone payments, licensing deals, or eventual commercialization if trials succeed and regulatory approvals are secured.
Profitability Risk
Clinical and regulatory risk inherent to a clinical-stage biotechnology company; dependence on successful Phase III outcomes; potential dilution from future financings; competition in neurodegenerative and liver-related therapeutic areas; and the timing of any meaningful revenue realization.
Financial Position
Strong liquidity relative to peers for a pre-revenue biotech, evidenced by a ~$30.35 million cash balance and a net cash position (~$21.93 million). Low debt and a healthy current ratio (~2.45) provide resilience against extended trial timelines, but the business remains heavily reliant on equity financing or licensing deals to extend its cash runway.
SWOT Analysis
Strengths
Healthy liquidity with cash and cash equivalents of $30.35 million and a net cash position (~$21.93 million).
Two late-stage and near-term pipeline assets (NE3107 in Phase III for Alzheimer's disease and BIV201 for ascites) provide potential catalysts.
Low leverage (short-term debt and long-term debt modest) relative to typical biotech capital needs.
Structured financing history that has supported runway without immediate distress.
Weaknesses
No current revenue; ongoing heavy R&D and pre-commercial costs drive quarterly losses.
Reliance on external financing and milestone-based payments for funding new programs.
Clinical-stage risk: outcomes of pivotal trials are uncertain and can materially alter the equity value.
Opportunities
Positive Phase III readouts for NE3107 could unlock licensing or collaboration opportunities and potential milestone/royalty revenues.
Strategic partnerships or licensing for non-core assets could de-risk the pipeline and provide non-dilutive funding.
Addressable markets for Alzheimer's disease therapeutics and ascites management remain sizable if efficacy signals translate into approved therapies.
Threats
Clinical trial failures or delays could erode investor confidence and increase the need for dilutive financing.
Regulatory hurdles and safety concerns could stall or derail development timelines.
Competitive landscape in neurodegenerative disease and liver disease therapeutics, including established players and other biotech entrants.