Healios KK (4593) AI Stock Analysis

• Market Cap: ¥35.51B
• Dividend Yield: N/A
• Average Volume (3M): 5.80M
• Price to Earnings (P/E): ―
• Beta (1Y): 0.94
• Revenue Growth: 374.19%
• EPS Growth: 35.53%
• Country: JP
• Employees: 65
• Sector: Healthcare
• Sector Strength: 43
• Industry: Biotechnology
• EPS (TTM): -26.72
• Shares Outstanding: 101,461,600
• 10 Day Avg. Volume: 4,999,270
• 30 Day Avg. Volume: 5,799,273
• PEG Ratio: -0.17
• Price to Book (P/B): 12.11
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -12.83
• 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: ¥365.00
• Price Target Upside: 4.29% Upside
• Rating Consensus: Moderate Buy
• Number of Analyst Covering: 2

• Rating: 49 Neutral
• Price Target: ―

Healios KK's overall stock score is driven by its concerning financial performance, marked by persistent losses and cash flow issues. Positive technical indicators provide some optimism for short-term price movement, but valuation concerns due to negative earnings weigh heavily on the score.

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

Income Statement

Balance Sheet

Cash Flow

Breakdown
Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement		Total Revenue
560.00M	121.00M	90.00M	41.00M	27.00M
	Gross Profit
432.00M	108.00M	90.00M	41.00M	27.00M
	EBIT
-2.90B	-3.38B	-5.18B	-5.38B	-4.18B
	EBITDA
-2.54B	-2.70B	-4.52B	-3.61B	-3.97B
	Net Income Common Stockholders
-4.24B	-3.82B	-5.17B	-4.91B	-5.51B
Balance Sheet		Cash, Cash Equivalents and Short-Term Investments
3.67B	6.72B	7.32B	15.13B	13.92B
	Total Assets
14.19B	15.15B	15.03B	23.97B	23.17B
	Total Debt
2.66B	4.53B	7.15B	11.96B	11.40B
	Net Debt
-1.01B	-2.19B	-101.00M	-3.17B	-2.52B
	Total Liabilities
12.11B	11.29B	10.65B	15.33B	15.32B
	Stockholders Equity
2.06B	3.86B	4.38B	8.64B	7.84B
Cash Flow		Free Cash Flow
-1.83B	-2.85B	-4.86B	-5.39B	-4.26B
	Operating Cash Flow
-1.82B	-2.82B	-4.60B	-5.09B	-3.94B
	Investing Cash Flow
-1.42B	-1.12B	-909.00M	-736.00M	-1.22B
	Financing Cash Flow
77.00M	3.34B	-2.50B	6.99B	803.00M

Healios KK Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 350.00
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Positive
• MACD: Negative
• RSI: Neutral
• STOCH: Neutral

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For JP:4593, the sentiment is Positive. The current price of 350 is above the 20-day moving average (MA) of 325.80, above the 50-day MA of 287.94, and above the 200-day MA of 238.09, indicating a bullish trend. The MACD of 18.89 indicates Negative momentum. The RSI at 62.94 is Neutral, neither overbought nor oversold. The STOCH value of 73.53 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for JP:4593.

Healios KK Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
4503	79 Outperform	$2.46T	48.14	3.22%	5.25%	19.25%	294.48%
4543	78 Outperform	¥4.00T	34.27	8.56%	0.97%	14.23%	26.82%
4901	74 Outperform	$3.84T	14.73	7.89%	1.93%	7.29%	4.85%
4523	65 Neutral	¥1.09T	23.55	5.34%	3.93%	5.63%	30.61%
Sector *	53 Neutral	$5.14B	3.06	-43.57%	2.81%	16.81%	-0.12%
4593	49 Neutral	¥35.51B	―		―	374.19%	35.53%
4563	43 Neutral	$21.98B	―	-193.61%	―	179.79%	-204.13%

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.

Healios K.K. Announces Executive Management Changes

Healios K.K. has announced changes in its executive management team, effective March 27, 2025. Hardy TS Kagimoto remains Chairman and CEO, while Richard P. Kincaid takes on additional responsibilities as Executive Officer and CFO, overseeing business development, finance, and legal affairs. Hironobu Kimura will manage research, manufacturing, and human resources. The resignation of Masanori Sawada as Executive Vice President and CMO marks a significant shift in the company’s leadership structure, potentially impacting its strategic direction and operational focus.

Healios KK’s ONE-BRIDGE Trial Data Published in Japan

Healios KK announced the publication of clinical data from the ONE-BRIDGE trial in a leading Japanese journal, enhancing the credibility of their application for conditional approval of HLCM051 for ARDS treatment. The study showed promising results, including an extension of ventilator-free days and reduced mortality, supporting the therapeutic potential of their product.