Healios KK (4593) AI Stock Analysis

• Market Cap: ¥44.28B
• Dividend Yield: N/A
• Average Volume (3M): 8.21M
• Price to Earnings (P/E): ―
• Beta (1Y): 1.03
• Revenue Growth: 374.19%
• EPS Growth: 35.53%
• Country: JP
• Employees: 65
• Sector: Healthcare
• Sector Strength: 39
• Industry: Biotechnology
• EPS (TTM): -26.72
• Shares Outstanding: 104,681,600
• 10 Day Avg. Volume: 5,140,800
• 30 Day Avg. Volume: 8,211,446
• PEG Ratio: 1.02
• Price to Book (P/B): 3.49
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -3.14
• Enterprise Value/Market Cap: N/A
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: N/A
• Enterprise Value/Ebitda: N/A
• 1Y Price Target: ¥630.00
• Price Target Upside: 48.94% Upside
• Rating Consensus: Moderate Buy
• Number of Analyst Covering: 2

• Rating: 37 Underperform
• Price Target: ¥392.00 ▼(-7.33%Downside)

Healios KK's stock score is primarily hindered by its financial performance challenges, including significant losses and negative cash flows. The lack of technical and valuation appeal further contributes to the low score. Strategic improvements are essential to enhance the financial position and investor confidence.

Healios KK Business Overview & Revenue Model

Company Description

Healios KK (4593) is a biotechnology company based in Japan, specializing in the development and commercialization of regenerative medicine products. The company focuses on leveraging stem cell technology and gene therapy to create innovative treatments for a range of medical conditions, including age-related macular degeneration, ischemic stroke, and organ transplantation. Healios KK aims to address unmet medical needs by advancing its proprietary platforms in stem cell and regenerative medicine therapies.

How the Company Makes Money

Healios KK generates revenue primarily through the development and commercialization of its regenerative medicine products. The company engages in research and development partnerships, licensing agreements, and collaborations with pharmaceutical and biotechnology firms to advance its product pipeline. Revenue streams include milestone payments, royalties from licensed products, and potential sales of its proprietary therapies upon regulatory approval. The company also actively seeks strategic alliances to enhance its technological capabilities and expand its market reach, contributing to its overall earnings.

Healios KK Financial Statement Overview

Summary

Healios KK demonstrates revenue growth but is burdened by significant financial challenges such as persistent losses, high leverage, and negative cash flows. The negative net profit margin and poor cash flow metrics highlight difficulties in profitability and operational efficiency.

Income Statement

Healios KK has shown consistent revenue growth, with a notable increase from ¥27M in 2020 to ¥588M TTM (Trailing-Twelve-Months) in 2025. However, the company struggles with profitability, as evidenced by negative EBIT and net profit margins over the years. The TTM gross profit margin stands at 61.73%, which is strong, yet the negative net profit margin of -743.54% indicates significant challenges in managing operational costs and other expenses.

Balance Sheet

The company's financial leverage is relatively high, with a debt-to-equity ratio of 1.35 TTM. While the equity ratio of 12.46% TTM is low, suggesting limited shareholder funding relative to total assets, the company maintains a solid cash position with negative net debt, indicating more cash and short-term investments than total debt. Return on equity remains negative, reflecting ongoing struggles in generating profits from shareholders' investments.

Cash Flow

Healios KK faces challenges in cash flow management, as indicated by negative operating and free cash flows. The TTM free cash flow of -¥2,278M shows deterioration compared to previous periods. The operating cash flow to net income ratio is negative, reflecting inefficiencies in converting revenue into cash flow. The free cash flow to net income ratio is also negative, underscoring the company's difficulty in generating cash from its operations.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	588.00M	560.00M	121.00M	90.00M	41.00M	27.00M
Gross Profit	363.00M	432.00M	108.00M	90.00M	41.00M	27.00M
EBITDA	-1.81B	-2.54B	-2.70B	-4.52B	-3.61B	-3.97B
Net Income	-4.37B	-4.24B	-3.82B	-5.17B	-4.91B	-5.51B
Balance Sheet
Total Assets	15.69B	14.19B	15.15B	15.03B	23.97B	23.17B
Cash, Cash Equivalents and Short-Term Investments	5.46B	3.67B	6.72B	7.32B	15.13B	13.92B
Total Debt	2.63B	2.66B	4.53B	7.15B	11.96B	11.40B
Total Liabilities	13.71B	12.11B	11.29B	10.65B	15.33B	15.32B
Stockholders Equity	1.96B	2.06B	3.86B	4.38B	8.64B	7.84B
Cash Flow
Free Cash Flow	-2.28B	-1.83B	-2.85B	-4.86B	-5.39B	-4.26B
Operating Cash Flow	-1.96B	-1.82B	-2.82B	-4.60B	-5.09B	-3.94B
Investing Cash Flow	-1.33B	-1.42B	-1.12B	-909.00M	-736.00M	-1.22B
Financing Cash Flow	752.00M	77.00M	3.34B	-2.50B	6.99B	803.00M

Healios KK Technical Analysis

• Technical Analysis Sentiment: Neutral
• Last Price: 423.00
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Positive
• MACD: Positive
• RSI: Neutral
• STOCH: Positive

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For JP:4593, the sentiment is Neutral. The current price of 423 is below the 20-day moving average (MA) of 463.15, above the 50-day MA of 399.70, and above the 200-day MA of 276.67, indicating a neutral trend. The MACD of 4.95 indicates Positive momentum. The RSI at 47.52 is Neutral, neither overbought nor oversold. The STOCH value of 14.04 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for JP:4593.

Healios KK Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
7774	58 Neutral	¥23.07B	―		―	-2.34%	-278.32%
Sector *	52 Neutral	$7.50B	0.31	-61.87%	2.27%	17.10%	1.59%
4978	49 Neutral	¥18.76B	179.65		―	8.46%	49.97%
4599	47 Neutral	¥18.89B	―		―	-100.00%	-1079.89%
7776	45 Neutral	¥15.88B	―		―	-4.04%	-0.88%
4593	37 Underperform	¥44.28B	―		―	374.19%	35.53%
4894	33 Underperform	¥46.24B	―		―	-12.82%	-19.87%

Healios KK Corporate Events

Healios KK Advances Global Phase 3 Trial for ARDS Treatment

Healios KK has completed regulatory consultations in Japan for its investigational ARDS treatment and is preparing for a global Phase 3 trial, REVIVE-ARDS, primarily in the United States. This agreement with the Pharmaceuticals and Medical Devices Agency (PMDA) to include Japanese patients is expected to accelerate the trial’s progress, potentially enhancing the company’s position in the global biotechnology market and offering new hope for ARDS patients worldwide.

Healios K.K. Pursues Conditional Approval for Ischemic Stroke Treatment in Japan

Healios K.K. has announced its decision to file for conditional and time-limited approval for its ischemic stroke treatment, HLCM051, in Japan. Despite not meeting the primary endpoint in the TREASURE study, the treatment showed significant improvements in patients’ daily living activities and independence. The company plans to leverage a registry system for post-marketing studies, aiming for a streamlined path to full approval. This approach aligns with Japan’s regulatory guidance and involves collaboration with prominent universities and medical institutions to ensure effective data collection and analysis.

Healios K.K. Joins NEDO Project to Enhance Stroke Treatment Verification

Healios K.K. has been selected as a co-implementing partner in a NEDO project aimed at verifying and validating the safety of treatments for acute ischemic stroke using large language model technology. This initiative involves collaboration with several universities and institutions to develop a system for automatic data collection from electronic medical records, enhancing post-marketing studies and potentially strengthening Healios’s position in the regenerative medicine industry.