Noile-Immune Biotech Inc. FY2025 Q3 Earnings Report

Financial Highlights

• Net Sales: ¥5M
• Operating Income: ¥-608M
• Net Income: ¥-605M
• EPS: ¥-13.97

Income Statement

Balance Sheet

Profitability Ratios

Year-over-Year Comparison

Share Information

Dividend Information

Full Year Forecast

Disclaimer

This data was automatically extracted from XBRL files. Please refer to the original disclosure documents for accuracy.

AI Financial Analysis

Executive Summary

Noile-Immune Biotech (TSE: 48930) reported FY2025 Q3 single-entity JGAAP results that continue to reflect a pre-commercial, R&D-stage biotech profile with minimal revenue and sizable operating losses. Revenue was ¥5 million (-8.2% YoY), highlighting the absence of a commercialized product and the likelihood that sales consist of grants, collaboration income, or minor services rather than product revenue. Operating loss was ¥608 million (flat YoY per disclosure), and ordinary loss was ¥602 million, suggesting limited non-operating items. Net loss was ¥605 million (also disclosed as flat YoY), implying the cost base is largely fixed and R&D-driven with limited variability during the period. The calculated DuPont ROE of -14.68% is driven by an extreme net margin (-12,100%), very low asset turnover (0.001x), and low financial leverage (1.02x), consistent with a cash-rich, pre-revenue biotech structure. Balance sheet data indicate total assets of ¥4,194 million and total liabilities of ¥74.7 million, implying a very strong net cash/equity position with low leverage. However, current assets are disclosed at ¥4,775 million, which exceeds total assets, and the equity ratio is listed as 0.0% despite equity of ¥4,120 million; these inconsistencies suggest reporting or XBRL mapping anomalies. Liquidity appears ample with a disclosed current ratio of 6,876.9% and working capital of ¥4,705.9 million, which would be typical of a cash-heavy biotech prior to commercialization. Cash flow statements show zeros across operating, investing, and financing cash flows, which should be interpreted as not disclosed rather than true zero values. EPS is -¥13.97, but outstanding shares are shown as zero (undisclosed), limiting per-share analytics. There is no dividend, consistent with a development-stage profile and capital conservation. The company’s cost structure likely reflects R&D, clinical trial preparation/advancement, and G&A to build platform capabilities; absence of COGS and depreciation disclosures limits margin and non-cash expense analysis. The effective tax line shows ¥1.9 million of tax expense despite losses, which can occur due to non-deductible expenses or minimum/local taxes. Overall, funding headroom looks strong relative to the current run-rate loss, but the lack of cash flow detail and the asset inconsistencies complicate runway precision. Near-term value drivers are expected to be clinical progress, regulatory milestones, and partnering progress rather than financial metrics. We therefore focus on cash runway, burn discipline, and milestone cadence as the primary lenses for assessing sustainability and outlook.

Profitability Analysis

ROE_decomposition: DuPont indicates Net Profit Margin -12,100%, Asset Turnover 0.001x, and Financial Leverage 1.02x, resulting in ROE -14.68%. The negative margin is a function of negligible revenue and meaningful R&D/G&A expenses. Asset turnover is exceptionally low, as expected for a pre-commercial biotech with large cash balances and no product sales. Low leverage magnifies the impact of operating losses directly onto equity without debt-induced amplification. margin_quality: Gross profit is undisclosed (0 reported). With revenue at ¥5 million and no COGS reported, revenue quality likely reflects non-product income (grants, collaborations) rather than recurring commercial sales. Operating loss of ¥608 million suggests that expenses are primarily R&D and fixed overhead; without depreciation disclosure, the mix of cash vs non-cash cost remains unclear. operating_leverage: Given the tiny revenue base, reported operating leverage metrics are not meaningful. As commercialization is absent, incremental revenue would theoretically improve margins materially, but timing is contingent on clinical and regulatory progress rather than sales execution.

Growth Assessment

revenue_sustainability: Revenue of ¥5 million (-8.2% YoY) is de minimis and likely non-recurring or milestone/grant related; sustainability is uncertain and not indicative of commercial traction. profit_quality: Net loss of ¥605 million aligns with operating loss, indicating limited non-operating noise. Tax expense of ¥1.9 million despite losses likely reflects non-deductible items or minimum taxes. Absence of D&A and COGS disclosure constrains assessment of non-cash vs cash components. outlook: Growth hinges on clinical milestone delivery, partnering, and eventual regulatory approvals. Near-term financials will likely remain loss-making with modest top-line until pivotal clinical inflections or collaboration payments. Any expansion of trials or manufacturing scale-up could increase operating expenses before revenue materializes.

Financial Health

liquidity: Current assets of ¥4,775.4 million and current liabilities of ¥69.4 million imply a very high current ratio (6,876.9%). Working capital is ¥4,705.9 million, indicating ample short-term liquidity for ongoing R&D. Note the inconsistency where current assets exceed total assets. solvency: Total liabilities are ¥74.7 million vs equity of ¥4,120 million, implying very low leverage (Debt-to-Equity ~0.02x). Equity ratio is disclosed as 0.0% despite the balance sheet indicating ~98% equity; treat the disclosed 0.0% as a data anomaly. capital_structure: The company appears predominantly equity-financed with minimal debt. This structure reduces financial risk but shifts funding risk to equity markets if additional capital is needed for later-stage trials or commercialization build-out.

Cash Flow Quality

earnings_quality: OCF, investing CF, and financing CF are undisclosed (reported as zero). Consequently, OCF/Net Income and FCF cannot be interpreted. Earnings quality assessment is limited; however, losses likely reflect cash operating outflows given the R&D-stage nature and lack of depreciation disclosure. FCF_analysis: Free cash flow is not available. With limited revenue and ongoing R&D, FCF is likely negative, but the magnitude is unknown without OCF and capex data. working_capital: Working capital is strong at ¥4,705.9 million. Without cash and receivables detail, we assume current assets are largely cash and equivalents or short-term investments typical for early-stage biotechs, but this cannot be confirmed from the disclosed data.

Dividend Sustainability

payout_ratio_assessment: Annual DPS is ¥0 and payout ratio is 0%, consistent with a development-stage biotech preserving cash. With net losses and likely negative FCF, dividends are not expected near term. FCF_coverage: FCF coverage is not meaningful due to undisclosed cash flows; operationally, dividends would be uncovered by FCF even if imposed. policy_outlook: Policy likely remains retention-focused until sustained profitability and cash generation post-approval/commercialization. No indication of near-term shareholder return distributions.

Risk Assessment

Business Risks:

• Clinical development risk (efficacy and safety outcomes in trials)
• Regulatory approval risk and timelines in Japan and ex-Japan
• Manufacturing scale-up and CMC readiness for cell therapy products
• Commercialization execution risk post-approval, including pricing and reimbursement
• IP protection and freedom-to-operate in cell therapy modalities
• Partnering/milestone dependency risk for funding and development support
• Talent/key-person dependency and specialized hiring needs

Financial Risks:

• Funding/dilution risk if external capital is required before commercialization
• Cost escalation from expanded trials or manufacturing investments
• FX exposure for overseas trial sites, materials, or collaborations
• Cash flow visibility risk due to limited disclosures (OCF/CapEx not provided)
• Potential milestone volatility in revenue recognition

Key Concerns:

• Inconsistent balance sheet disclosures (current assets exceed total assets; equity ratio shown as 0.0%)
• Cash flow statements not disclosed, limiting runway analysis
• Minimal revenue base and continued operating losses
• EPS reported with outstanding shares undisclosed

Investment Implications

Key Takeaways:

• Results remain consistent with a pre-revenue, R&D-focused biotech: negligible revenue and sizeable operating loss (¥608 million).
• Balance sheet appears strong with low liabilities (¥74.7 million) and large equity (¥4,120 million), implying a sizable cash buffer.
• Liquidity is ample (working capital ¥4,705.9 million; current ratio ~68.8x), supporting near-term development plans.
• DuPont ROE of -14.68% is driven by extreme negative margin and minimal asset turnover, typical for the stage.
• Data inconsistencies (CA > TA; equity ratio 0%) and undisclosed cash flows limit precision of analysis and runway estimation.
• Dividend remains unlikely near term given losses and reinvestment needs.

Metrics to Watch:

• Cash and equivalents balance and quarterly burn rate (once disclosed)
• Operating cash flow and capex to refine FCF and runway
• Clinical milestones (trial initiations, readouts, safety/efficacy signals)
• Regulatory interactions and designations that could expedite timelines
• Partnerships/licensing and associated upfront/milestone payments
• R&D expense trajectory and hiring trends (operating leverage signal)
• Any updates to share count and equity financing activities

Relative Positioning: Within the Japan-listed cell therapy/biotech cohort, the company exhibits a typical early-stage financial profile: strong liquidity, minimal leverage, negligible revenue, and persistent operating losses. Its positioning will be defined more by clinical and partnering progress than by near-term financial metrics, with funding runway appearing solid but not precisely quantifiable due to disclosure gaps.

Disclaimer

This analysis was auto-generated by AI. Please note the following:

• No Guarantee of Accuracy: The accuracy and completeness of this analysis are not guaranteed. For accurate financial data, please refer to the original disclosure documents published on TDnet or other official sources
• Not Investment Advice: This analysis is for general informational purposes only and does not constitute investment advice under applicable securities laws. It is not a recommendation to buy or sell any specific securities
• At Your Own Risk: Investment decisions should be made at your own discretion and risk. We assume no liability for any losses incurred based on this analysis