BioVie Inc. (BIVI) Bundle
You're looking at BioVie Inc. (BIVI) and seeing a clinical-stage biopharma with zero revenue, so the financial health boils down to one thing: runway. The good news is that for the fiscal year ending June 30, 2025, the company managed to cut its net loss significantly, reporting a loss of approximately $17.5 million, a marked improvement from the $32.1 million loss the previous year. Here's the quick math: they achieved this by slashing Research and Development (R&D) expenses to just $9.3 million, down from $23.1 million, reflecting the completion of key clinical trials. Still, the core challenge remains-as of June 30, 2025, BioVie Inc. held only $17.5 million in cash and cash equivalents, and with no revenue on the books, that cash is a finite resource. This is a pre-revenue company, defintely a bet on the pipeline. To be fair, that reduced burn rate buys them time to execute on their promising Long COVID and Parkinson's disease programs, but it also underscores the critical need for successful clinical data to justify the next capital raise.
Revenue Analysis
You need to understand the core financial reality of a clinical-stage biopharmaceutical company like BioVie Inc. (BIVI): their revenue is essentially a placeholder for future potential. The direct takeaway is that for the fiscal year ending June 30, 2025, BioVie Inc. reported $0.00 in product revenue.
This isn't a surprise or a red flag in this sector; it's the standard for a company focused on drug development. BioVie Inc. is entirely in the research and development (R&D) phase, meaning they are spending capital to run clinical trials, not selling approved drugs. Therefore, the year-over-year revenue growth rate is technically 0% because they had no product sales in the prior year either.
Primary Revenue Sources: Clinical Pipeline, Not Sales
When analyzing BioVie Inc., you must swap the concept of a revenue stream with a 'pipeline value' stream. The company's primary focus-and the source of its future revenue, if successful-is its two main drug candidates. Their current contribution to overall revenue is $0.00, but their clinical progress is the real value driver.
- Neurodegenerative Disease Program: Developing bezisterim (NE3107) for diseases like mild-to-moderate Alzheimer's disease (Phase III) and Parkinson's disease (Phase IIb).
- Liver Disease Program: Developing BIV201 for ascites due to chronic liver cirrhosis (preparing for Phase III).
Here's the quick math on their current financial profile for the fiscal year 2025, which shows where the focus truly lies:
| Financial Metric (FY 2025) | Amount | Insight |
|---|---|---|
| Product Revenue | $0.00 | Standard for a pre-commercial biopharma |
| Net Loss | Approximately $17.5 million | Improved from $32.1M loss in FY2024 |
| R&D Expenses | Approximately $9.3 million | Down from $23.1M in FY2024, reflecting trial completion |
The Critical Shift: Funding as the Near-Term Cash Flow
The significant change in BioVie Inc.'s financial picture isn't in revenue, but in how they fund operations. Since there are no sales, the company relies on equity offerings and grants. This is defintely the number to watch.
A major non-revenue factor in FY 2025 was the $13.1 million clinical trial grant secured from the U.S. Department of Defense (DOD) in April 2024 to evaluate bezisterim for neurological symptoms associated with long COVID. This grant is critical; it offsets R&D expenses and extends the cash runway without shareholder dilution, unlike the approximately $18.9 million raised through multiple equity offerings during the year.
What this estimate hides is the inherent risk: the entire valuation hinges on positive clinical trial data, not on current sales performance. For a deeper dive into the company's valuation and strategic outlook, check out Breaking Down BioVie Inc. (BIVI) Financial Health: Key Insights for Investors.
Profitability Metrics
When we look at BioVie Inc. (BIVI), the traditional profitability analysis-Gross Profit, Operating Profit, and Net Profit-needs a significant caveat. This is a clinical-stage biopharmaceutical company, meaning it is focused on drug development and clinical trials, not commercial sales. So, the direct takeaway is simple: BioVie Inc. is a pre-revenue company, and its profitability metrics are deep in the red, which is typical for its stage.
For the fiscal year 2025, BioVie Inc. reported $0.00 in revenue. This immediately sets the Gross Profit, Operating Profit, and Net Profit Margins to 0% or effectively 'Not Applicable' (N/A). Any gross profit margin calculation is meaningless when the top line is zero. The focus must shift to the net loss and the company's burn rate, which is the speed at which it uses its cash reserves.
Here's the quick math on the bottom line for the 2025 fiscal year and its near-term trend:
- Fiscal Year 2025 Net Loss: The company reported an annual net loss of -$17.9 million for the fiscal year ending June 30, 2025.
- Trailing 12-Month Net Loss: For the trailing 12 months ending September 30, 2025, the net loss was slightly higher at -$18.6 million.
Still, the trend in the near-term quarterly data shows a positive movement in expense control. In the third quarter of fiscal year 2025 (ending March 31, 2025), the company managed to reduce its net loss to -$2.8 million, a substantial improvement from the -$8.1 million loss reported in the same quarter the prior year. That's a defintely encouraging sign of tighter cost management.
The operational efficiency gains are a key factor in this trend. BioVie Inc.'s total operating expenses dropped significantly to $3.0 million in Q3 FY2025, down from $7.7 million year-over-year. This reduction primarily stems from a sharp decline in Research and Development (R&D) expenses, which fell from $5.7 million to $1.3 million as clinical trials were completed and workforce adjustments were made. This shows an ability to scale down costs following key trial milestones.
When we compare BioVie Inc.'s financial health to its peers in the US Biotechnology industry, the picture remains challenging, which is a near-term risk. A key profitability ratio, Return on Equity (ROE), highlights the capital-intensive nature of this business and the current unprofitability. BioVie Inc.'s ROE stands at -82.8%, which is significantly lower than the industry's average ROE of -20.2%. This gap underscores the higher relative financial risk and the distance to commercialization compared to the average biotech firm. You can read more about the full financial picture in Breaking Down BioVie Inc. (BIVI) Financial Health: Key Insights for Investors.
To summarize the core profitability data for investors, here is a breakdown of the key metrics for the 2025 fiscal year (FY2025) and recent TTM/Q3 data:
| Profitability Metric | Value (FY 2025 / TTM) | Insight |
|---|---|---|
| Revenue | $0.00 | Clinical-stage, pre-revenue company. |
| Gross Profit Margin | N/A (Effectively 0%) | Zero revenue means no gross profit. |
| Net Loss (FY 2025) | -$17.9 million | The total cost of operations for the year. |
| Q3 2025 Net Loss | -$2.8 million | Significant reduction from Q3 FY2024 loss of -$8.1 million. |
| Operating Expenses (Q3 2025) | $3.0 million | Demonstrates strong cost control, down from $7.7M YoY. |
| Return on Equity (ROE) | -82.8% | Significantly below the industry average of -20.2%. |
Debt vs. Equity Structure
You're looking at BioVie Inc. (BIVI)'s balance sheet to understand their financial footing, and the immediate takeaway is clear: this is a company running on equity, not debt. In the high-risk, high-reward world of clinical-stage biopharma, that's a common, and often necessary, capital structure.
As of the most recent reporting period in 2025, BioVie Inc.'s total debt is remarkably low, sitting at just $332,730. For a public company, that's practically debt-free. Their total shareholder equity, the money investors have put in, is around $24.9 million. Here's the quick math on what that means for their leverage:
- Total Debt (MRQ 2025): $332,730
- Total Equity (MRQ 2025): $24.9 million
- Debt-to-Equity Ratio (MRQ 2025): Approximately 0.01 (or 1.34%)
This tiny debt-to-equity (D/E) ratio, which measures a company's financial leverage, is a massive deviation from the industry norm. The average D/E ratio for the Biotechnology sector is around 0.17 (or 17%). BioVie Inc. is operating with nearly zero financial leverage, which means they aren't using borrowed money to fund their clinical trials and operations. That reduces the risk of default, but it shifts the risk to shareholders through dilution.
To be fair, a clinical-stage company with no revenue-which is BioVie Inc.'s situation-often struggles to secure traditional debt financing anyway. Banks and lenders prefer collateral and consistent cash flow, which a company focused solely on R&D doesn't have. So, they have to rely on equity funding, which is a less dilutive way to raise capital than straight debt in this environment.
The company's financing strategy in 2025 confirms this equity-heavy approach. In August 2025, BioVie Inc. closed a public offering, raising approximately $12 million in gross proceeds. This was an issuance of units consisting of common stock and warrants, essentially selling more pieces of the company to fund its pipeline, including the Phase 3 trial for NE3107 in Alzheimer's disease. This is a clear trade-off: lower credit risk for higher shareholder dilution. For more on their long-term goals, you can check out their Mission Statement, Vision, & Core Values of BioVie Inc. (BIVI).
What this financial structure hides is the constant need for cash. While their long-term liabilities are only about $254.4 thousand, their cash burn for R&D is significant. Their ability to continue operations hinges on their ability to raise non-debt capital, like the recent $12 million equity raise, or a successful clinical trial outcome that attracts a major partnership. This is the core risk for investors: not debt default, but the need for perpetual equity raises until a drug hits the market.
Liquidity and Solvency
You're looking at BioVie Inc. (BIVI), a clinical-stage biotech, so the rules for assessing liquidity are different than for a revenue-generating company. The key takeaway is this: BioVie has a massive cash cushion relative to its immediate obligations, but it's burning cash fast, which is the real liquidity challenge.
As of September 30, 2025, BioVie Inc. (BIVI) had an exceptionally strong short-term liquidity position. Its Current Ratio stood at a remarkable 15.83, and the Quick Ratio was nearly identical at 15.30. This tells you two things: first, the company's current assets (what they can convert to cash in a year) are more than 15 times their current liabilities (what they owe in a year). Second, the small difference between the two ratios confirms that BioVie has virtually no inventory or significant accounts receivable, which is typical for a clinical-stage firm.
Breaking Down BioVie Inc. (BIVI) Financial Health: Key Insights for Investors is a good resource if you want to dive deeper into the valuation models. Honestly, a ratio this high simply means they have very few short-term bills-total liabilities were only about $1.9 million at quarter-end.
Working Capital and Cash Flow Overview
The core of BioVie Inc.'s financial health lies in its cash position and burn rate. Working capital, the capital available for day-to-day operations, was approximately $24.4 million as of September 30, 2025. This positive trend was directly bolstered by recent financing activities.
The cash flow statement paints the picture of a company in clinical development:
- Operating Cash Flow (OCF): Net cash used in operations for the third quarter of 2025 was approximately $3.0 million. This is the cash burn rate, driven by research and development (R&D) costs for trials like the Phase 2b study for Parkinson's disease.
- Investing Cash Flow (ICF): This is typically negligible for a biotech, reflecting minimal purchases or sales of long-term assets, with a $0.00 million figure reported for the most recent fiscal year.
- Financing Cash Flow (FCF): This is the lifeblood. The company raised net proceeds of roughly $10.5 million from a public equity offering in August 2025. This is how they fund the negative OCF.
Here's the quick math: The $24.98 million in cash and cash equivalents as of September 30, 2025, is what pays for the $3.0 million quarterly operating loss.
Near-Term Liquidity Strengths and Concerns
The strength is clear: a large cash balance and negligible debt. The liquidity improved significantly from the prior quarter due to the August 2025 capital raise. However, the critical risk is the 'going concern' disclosure. BioVie Inc. explicitly stated there is substantial doubt about its ability to continue as a going concern, a standard warning for clinical-stage companies that rely entirely on external financing.
What this estimate hides is the reliance on future funding rounds. Analysts estimate the current cash runway is sufficient for about 1.3 years based on the historical cash burn, but that clock is ticking. The company must either secure another financing round or achieve a major clinical milestone soon to maintain operations beyond late 2026. Your action, as an investor, is to monitor the timing and size of their next capital raise defintely.
Valuation Analysis
You are looking at BioVie Inc. (BIVI), and the first question is always: Is this stock overvalued or undervalued? The quick answer is that it's a highly speculative biotech play that looks dramatically undervalued on one metric but carries the massive risk of a company with no revenue and negative earnings. It's a classic case where traditional valuation tools, like the Price-to-Earnings ratio, simply break down.
For the 2025 fiscal year, BioVie's valuation multiples tell a story of deep distress and potential asset value. Since the company is pre-revenue and posted a loss of roughly $18 million in profit after tax, the Price-to-Earnings (P/E) and Enterprise Value-to-EBITDA (EV/EBITDA) ratios are not meaningful-they are negative or simply marked as 'n/a'. You can't value a biotech purely on earnings that don't exist yet. The Enterprise Value (EV) itself is even negative at approximately -$14.02 million, which means the company's cash exceeds its market capitalization plus debt.
Here's the quick math on the tangible asset value:
- Price-to-Book (P/B) Ratio: This is the key number. BioVie's P/B ratio stands at a low 0.43. This suggests the stock is trading for less than half its book value (assets minus liabilities), a strong indicator of being fundamentally undervalued based on its balance sheet.
- P/E Ratio: Not Applicable (n/a). The company is not profitable.
- EV/EBITDA: Not Applicable (n/a).
Still, you have to look at the stock price trend to understand the market's current sentiment. Over the last 12 months, the stock has plummeted by a staggering 95.33%. This massive drop is the market pricing in the high risk associated with clinical-stage drug development, especially given the 52-week high was $36.19 and the stock is now trading around $1.41 as of November 2025. That's a brutal reality check, defintely. You need to understand the company's core strategy to gauge the long-term potential, which you can read more about here: Mission Statement, Vision, & Core Values of BioVie Inc. (BIVI).
As for investor payouts, BioVie Inc. is not a dividend stock. It does not pay a dividend, so the dividend yield is 0.00%. The company is in a capital-intensive development phase, meaning every dollar goes back into research and clinical trials, not shareholder distributions.
Finally, let's look at the analyst consensus. Wall Street analysts currently give BioVie Inc. a Moderate Buy consensus rating. The average one-year price target is approximately $6.33. To be fair, that target implies a massive upside from the current price, but it's based on the successful outcome of their clinical programs, which is a significant gamble. Here is a summary of the key valuation metrics:
| Metric | 2025 Fiscal Year Value | Implication |
|---|---|---|
| Current Stock Price (Nov 2025) | $1.41 | Extreme volatility following a major decline. |
| 12-Month Price Change | -95.33% | Significant market de-rating due to clinical risk. |
| Price-to-Book (P/B) Ratio | 0.43 | Potentially undervalued relative to book assets. |
| Dividend Yield | 0.00% | No current income for investors. |
| Analyst Consensus Rating | Moderate Buy | High potential upside, but based on future success. |
| Consensus Price Target | $6.33 | Implies substantial upside if clinical trials succeed. |
The clear action here is to treat BioVie Inc. as a high-risk, high-reward biotech stock. The low P/B ratio is a glimmer of value, but the steep price decline and lack of earnings show the market is focused on the execution risk of their pipeline. You are betting on the science, not the current financials.
Risk Factors
You're looking for the clear risks in BioVie Inc. (BIVI)'s story, and honestly, they boil down to two core issues: a tight cash position and the high-stakes, all-or-nothing nature of drug development.
The company is a clinical-stage biotech, meaning it has no commercial revenue. So, every financial decision is a race against the clock. The most critical risk is the 'going concern' warning-BioVie Inc. explicitly disclosed 'substantial doubt' about its ability to continue operations without securing more financing, according to the quarterly report for the period ending September 30, 2025. That's the plain English translation of a company needing to raise capital just to keep the lights on and trials running.
Operational and Financial Headwinds
The financial risks are real, despite a recent improvement in net loss. For the fiscal year ending June 30, 2025, BioVie Inc. reported a net loss of approximately $17.5 million, a significant reduction from the $32.1 million loss in the prior year. Total operating expenses were still around $18.1 million for FY 2025. The company's financial health is precarious; one analysis places its probability of financial distress over the next two fiscal years at over 84%.
Here's the quick math on their liquidity: cash and cash equivalents stood at $25.0 million as of September 30, 2025, up from $17.5 million at the end of the fiscal year. This cash increase was largely due to an August 2025 underwritten offering that brought in net proceeds of about $10.5 million. Still, with net cash used in operations at $3.0 million for that quarter alone, the cash runway is forecasted at only about 1.3 years if the burn rate continues at historical rates. They need a big win, and fast.
- Going Concern: Substantial doubt about long-term viability.
- Cash Burn: Net loss of $17.5 million in FY 2025.
- Dilution Risk: Constant reliance on equity offerings to fund operations.
Clinical and Regulatory Pitfalls
The biggest strategic risk is the success of their lead investigational drug, bezisterim (NE3107). The Phase 3 Alzheimer's disease trial for NE3107 failed to meet its co-primary endpoints.
This failure wasn't just about the drug's efficacy; it was an operational disaster. BioVie Inc. had to exclude data from over 80% of the trial participants-originally 439 patients-due to 'significant deviation from protocol and Good Clinical Practice violations' at 15 of the 39 sites. The company even referred the sites suspected of improprieties to the U.S. Food and Drug Administration (FDA)'s investigations unit.
That kind of clinical integrity issue is a massive setback, both for the drug's path to market and for investor confidence. It shows a vulnerability in their trial oversight. The entire investment thesis hinges on NE3107's success in other ongoing trials, like the Phase 2b study in Parkinson's disease, which commenced in April 2025, or the DOD-funded Long COVID Phase 2 study.
Mitigation and Clear Actions
BioVie Inc. is taking clear steps to manage the financial and clinical risks, but they are not guarantees. The recent capital raise of $10.5 million is a short-term fix, buying them time to execute on their clinical pipeline. The company is also actively pursuing non-dilutive funding, having recognized $336,000 in grant reimbursements from the Department of Defense (DOD)-funded Long COVID Phase 2 study in the quarter ending September 30, 2025.
On the clinical front, the focus shifts entirely to the Parkinson's and Long COVID trials, where initial data has shown promise. They are also trying to salvage the Alzheimer's data by emphasizing a small subset of 57 per-protocol patients, claiming the results are comparable to approved therapies. To understand their long-term vision beyond these immediate hurdles, you should review their Mission Statement, Vision, & Core Values of BioVie Inc. (BIVI).
The bottom line for you: the August 2025 financing bought a little breathing room, but the next clinical readout is the defintely the most important catalyst. The stock's volatility, with a 52-week high of $38.50 and a low of $1.37, reflects this binary risk profile.
Growth Opportunities
You're looking at BioVie Inc. (BIVI) and trying to map out a growth trajectory, but let's be real: for a clinical-stage biotech, growth isn't about sales today; it's entirely about clinical milestones and pipeline de-risking. The near-term opportunity hinges on their lead drug candidate, bezisterim (NE3107), and the ability to secure a partnership for BIV201.
Our analysis for the 2025 fiscal year reflects this reality. Wall Street consensus projects BioVie Inc.'s revenue at a flat $0, which is typical before a drug launch. The focus is on the bottom line burn rate, with the estimated net loss for 2025 sitting around -$18,565,613. Here's the quick math: your investment thesis rests on the successful execution of their clinical calendar, not on current financials. That's the whole game in this space.
The key growth drivers for BioVie Inc. are directly tied to their pipeline progression, which is heavily weighted toward neurological disorders and advanced liver disease. Their strategic initiatives are focused on moving these candidates through the final clinical hurdles and building investor awareness.
- Parkinson's Disease (PD) Catalyst: Topline results from the NE3107 PD trial are expected by mid-2025.
- Alzheimer's Disease (AD) Advancement: Completing the once-daily (QD) formulation of NE3107 in early-to-mid 2025, which will be used to launch a repeat Phase 3 AD trial.
- BIV201 Partnership: Actively exploring a partnership to fund the Phase 3 trial for BIV201, a potential first-in-class treatment for refractory ascites.
- Investor Outreach: A multi-platform media campaign, including placements on the Nasdaq Tower and FOX Business Network, launched in January 2025 to boost visibility with accredited investors.
The financial picture for a company like BioVie Inc. is all about cash runway and the magnitude of the potential market once a product hits. The August 2025 public offering, which closed for $12 million, helps fund these critical 2025 milestones, but the BIV201 program is still dependent on external funding from a partner.
To be fair, the competitive advantage for BioVie Inc. is compelling because it centers on a novel mechanism of action (MOA). Bezisterim (NE3107) is an orally available small molecule that inhibits the inflammatory activation of ERK and NFkB, which are drivers of Alzheimer's and Parkinson's diseases, without disrupting their essential homeostatic functions. This is a crucial distinction. It suggests a potential for efficacy with a defintely better side-effect profile than less-targeted anti-inflammatories. BIV201, a late-stage Orphan Drug with FDA Fast Track status, also offers a significant advantage as it could be the first therapeutic for ascites, a condition with a grim 50% mortality rate within 12 months.
Here is a snapshot of the near-term financial landscape based on analyst forecasts:
| Metric | 2025 Fiscal Year Forecast | Significance |
|---|---|---|
| Revenue | $0 | Clinical-stage; pre-commercialization. |
| Net Earnings (Loss) | -$18,565,613 | Reflects R&D spend and clinical trial costs. |
| EPS (TTM as of 11/07/2025) | -$12.12 | High burn rate relative to share count. |
What this estimate hides is the potential for a massive upside if the NE3107 PD trial results in mid-2025 are positive, as that could be the first new therapy for Parkinson's Disease in over five decades. That kind of catalyst changes the whole valuation overnight. You should also take a deeper dive into the shareholder base by Exploring BioVie Inc. (BIVI) Investor Profile: Who's Buying and Why?

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