KOSDAQBiotech & Pharma278650

HLB bioStep

₩2,875▼ 5.89%2026-10-02 close
Market Cap
₩50.1B
Turnover
₩500M
Volume
170,000 shares
Shares out.
17.4M
PER
—
PBR
0.5×
EPS
-₩1,103
Dividend Yield
0.00%

PER, EPS, PBR and BPS are calculated in-house from the last 4 quarters (2025Q3–2026Q2) · Dividend yield is based on ₩0 per share · Prices as of the 2026-10-02 close

01

Report overview

Revenue Recovers, Losses Persist Amid CRO Transition

HLB Biostep has shown revenue recovery and improved cash flow, but net losses have continued for four straight years as the company pursues a business restructuring toward animal-testing alternative technologies.

  1. 1

    2025 revenue rose sharply to KRW 74.05bn from KRW 58.17bn, but operating losses persisted for a fourth straight year

  2. 2

    The company briefly turned operating and net profitable in Q3 2025 before posting a large net loss in Q4 2025

  3. 3

    Following its entry into HLB Group, the company built an integrated preclinical service system through the acquisition of HLB Biocode (GLP toxicity testing)

  4. 4

    The company is securing organoid and alternative-testing technologies (including an MOU with Nexcell) in response to the global shift away from animal testing

  5. 5

    A 5-for-1 share consolidation was carried out in 2026, and the stock trades below book value relative to shareholders' equity

02

Business structure

HLB Biostep operates on two main pillars: a preclinical contract research organization (CRO) business and a bio-infrastructure business that designs and builds animal testing facilities and alternative testing labs.

The preclinical CRO segment conducts efficacy, pharmacokinetic, and safety evaluations for new drug candidates, with pharmaceutical companies and university research institutes as its main clients.

According to the 2024 business report, bio-infrastructure services such as animal facility design, construction, and maintenance accounted for more than half of revenue (51.15%), while animal-based preclinical CRO services made up 28.24%, meaning most revenue stemmed from animal-testing-related businesses.

In 2024 the company acquired HLB Biocode, a GLP toxicity testing specialist, as a subsidiary, adding toxicity testing to its efficacy and safety evaluation capabilities to build a one-stop service system. The company maintains a dominant number-one position in domestic efficacy evaluation by number of trials conducted.

It joined HLB Group in 2021, shifting its controlling shareholder to the HLB affiliate structure, and in 2023 acquired a 6.69% stake (KRW 11.0bn) in molecular diagnostics platform company Panagene to pursue synergies in animal diagnostics and vaccines.

The company also runs a companion animal medicine distribution and development business, supporting preclinical trials for the companion-animal indication expansion of anticancer drug rivoceranib being developed by affiliate HLB Life Science.

Most recently, it signed a memorandum of understanding with organoid specialist Nexcell to collaborate on alternative testing and preclinical services, expanding into integrated offerings that combine animal testing with alternative methods.

03

Earnings trend

Quarterly revenue · Operating profit
RevenueOperating profit
Annual revenue · Operating profit
RevenueOperating profit
Quarterly results · Last 5 quarters
QuarterRevenueOperating profitOp. margin
2025Q2₩17.8B-₩4.3B−24.2%
2025Q3₩24B₩500M1.9%
2025Q4₩18.7B-₩2.2B−11.8%
2026Q1₩13.5B-₩2.6B−19.4%
2026Q2₩16B-₩1.9B−11.9%
Annual results
YearRevenueOperating profitNet income (parent)Op. marginROEDebt-to-equity
2022₩86.3B₩6.4B-₩3B7.4%−4.4%142.4%
2023₩52.8B-₩1.3B-₩200M−2.4%−0.2%65.8%
2024₩58.2B-₩13B-₩8.6B−22.3%−7.7%44.1%
2025₩74.1B-₩8.6B-₩19B−11.6%−19.7%54.1%

Consolidated basis (financial statements including subsidiaries) · Final figures from DART filings · Net income attributable to owners of the parent · Data as of 2026-08-23

04

Earnings analysis

Consolidated revenue in 2025 reached KRW 74.05bn, up sharply from KRW 58.17bn in 2024, while the operating loss narrowed to KRW 8.62bn from KRW 12.97bn, improving the operating margin from -22.3% to -11.6%.

However, net loss attributable to owners widened to KRW 18.96bn in 2025 from KRW 8.56bn in 2024, a divergence between improving operating performance and worsening bottom-line results.

On a quarterly basis, Q3 2025 revenue of KRW 23.97bn came with an operating profit of KRW 455mn and owners' net profit of KRW 1.05bn, marking a brief return to profitability, but Q4 2025 revenue of KRW 18.73bn was accompanied by an operating loss of KRW 2.22bn and a much larger owners' net loss of KRW 14.11bn, which drove the full-year net loss expansion.

In 2026, Q1 posted revenue of KRW 13.49bn with an operating loss of KRW 2.61bn and net loss of KRW 1.95bn, while Q2 recorded revenue of KRW 15.97bn with an operating loss of KRW 1.89bn and net loss of KRW 3.42bn — operating losses moderated somewhat, but net losses widened again.

Over the trailing four quarters (Q3 2025 through Q2 2026), the cumulative owners' net loss reached KRW 18.43bn. On the cash flow side, operating cash flow turned positive at KRW 3.09bn in 2025, a marked improvement from the KRW -11.67bn outflow in 2024.

Equity attributable to owners declined from KRW 111.87bn in 2024 to KRW 96.27bn in 2025, and the debt ratio rose modestly from 44.1% to 54.1%, though it remains well below the 142.4% level seen in 2022.

05

Industry analysis

The domestic preclinical CRO market is estimated by the company at KRW 300–400bn, with toxicity testing outsourcing representing the largest share, while HLB Biostep holds the number-one position in the efficacy evaluation segment.

The industry's biggest variable is the phased move away from mandatory animal testing led by the US FDA, with organoids and organ-on-chip technologies gaining recognition as officially accepted new approach methodologies (NAMs) for toxicity and efficacy verification.

In Korea, institutional groundwork is also progressing, including efforts to enact an animal-testing-alternative promotion law and registration of officially recognized test methods led by the Ministry of Food and Drug Safety.

Competitor Corestem Chemon (formerly Chemon) operates an organoid team and alternative testing center, while Kolmar Biotech (formerly Woojung Bio) has diversified into cosmetics and health-functional foods while expanding an ADC-specialized preclinical strategy and organoid collaboration with Next&Bio, indicating an industry-wide shift toward combining animal testing with alternative methods.

Some industry participants have suggested that the animal-testing phase-out debate could represent an opportunity to reshape a market previously marked by intense low-price competition, rather than simply shrinking it.

Within HLB Group, the three healthcare affiliates including HLB Biostep (along with HLB Pep and HLB Genex) accounted for roughly 18% of the group's total 2025 revenue, forming one pillar of group performance alongside its drug development affiliates.

06

Outlook

The company recently signed a memorandum of understanding with organoid specialist Nexcell to collaborate on alternative-testing and preclinical services, preparing an integrated offering that verifies hiPSC-derived organoid evaluation results through its own preclinical trials, alongside plans for joint sales and marketing and joint R&D on new alternative testing services.

Earlier, it obtained a general construction license from the Ministry of Land, Infrastructure and Transport, giving it the capability to directly construct large-scale alternative testing labs beyond simple interior fit-outs, and it won a consulting contract from the Korea Environment Corporation for building alternative-testing-based labs.

The CEO has stated in coverage of the group's affiliate value-up strategy that the company aims to secure a new growth pillar through M&A within the third quarter, making progress on this front a point to monitor going forward.

Expansion of primate preclinical testing services has also been discussed, as the company builds out a full-spectrum pharmacokinetic testing portfolio that includes primates.

Group-level collaboration continues through the Panagene stake for animal diagnostics and vaccine synergies and joint development with HLB Life Science on companion-animal drug indications.

A 5-for-1 share consolidation was completed in 2026, reducing shares outstanding from about 87.16 million to about 17.43 million, a measure aimed at maintaining an appropriate float and enhancing corporate value.

07

Valuation

PER
—
PBR
0.5×
ROE
-18.6%
EPS
-₩1,103
BPS
₩5,539
Dividend per share
₩0

The current share price trades below the company's accounting book value per share, placing the price-to-book ratio in a sub-1x range.

Because net losses have persisted for several years, the price-to-earnings ratio cannot be meaningfully calculated in the conventional way, and there is no clear comparable band relative to the pre-2023 period when the company was still operating profitably.

No dividends have been paid in recent years, and the no-dividend status continues. The 2026 5-for-1 share consolidation also changed the basis for share count and per-share metrics, which should be considered when comparing against historical figures.

Over the multi-year period, performance moved from an operating profit in 2022 to widening operating losses in 2023–2024 and then a narrowing of operating losses in 2025, and whether this partial profit recovery trend continues is a point worth watching.

PER, EPS, PBR and BPS are all calculated in-house (the same method as Naver and Toss) · Dividend yield = cash dividend per share from DART filings (supplemented by KRX) ÷ current price · As of 2026-08-23

08

Bull factors

Revenue Recovery and Improved Cash Flow

Revenue increased significantly in 2025 versus the prior year, operating margin improved, and operating cash flow turned positive after a large outflow in 2024.

Expanded design and construction projects in the animal facility business, along with increased preclinical CRO orders, are cited as drivers of the revenue recovery. If this trend continues, it could contribute to improved financial stability.

Business Diversification and One-Stop Service System

The acquisition of HLB Biocode gave the company a one-stop preclinical service including toxicity testing, and the Nexcell partnership is building organoid-based alternative testing capabilities.

The general construction license enables direct construction of large-scale alternative testing labs, and expansion into higher-value services such as primate testing is also underway. This portfolio expansion could reduce reliance on any single business line.

Position as HLB Group's Core CRO Affiliate

Since joining HLB Group in 2021, the company has become the largest-revenue healthcare affiliate in the group, performing preclinical trials for the group's drug development subsidiaries.

Group-level synergies continue through the Panagene equity stake and joint development with HLB Life Science on companion-animal drug indications. The company may benefit from expansion opportunities under the group's broader affiliate value-up strategy.

09

Bear factors

Four Consecutive Years of Net Losses

Net losses attributable to owners have continued from 2022 through 2025, and in 2025 the net loss actually widened year-over-year despite a narrower operating loss. In Q4 2025 the net loss far exceeded the operating loss, suggesting non-operating factors had a substantial impact on results. This kind of earnings volatility reduces the visibility of future performance.

Structural Pressure from Animal-Testing Reduction Policies

A significant portion of the company's revenue comes from animal-testing-based CRO services and animal facility construction, and regulatory momentum toward phasing out animal testing is intensifying, particularly in the United States.

There are also indications that standardization of alternative testing methods remains at an early stage, creating uncertainty during the transition. Delayed adaptation could constrain growth in the company's traditional core revenue sources.

Low-Price Competition in the Industry

An industry source has noted that a proliferation of preclinical CRO firms has led to intense low-price competition. As numerous competitors expand investment in alternative testing infrastructure, competition over service pricing and profitability could intensify further. This has been cited as one reason margin improvement has lagged despite revenue growth.

10

Risk factors

Earnings Volatility

If a net loss far larger than the operating loss, as seen in Q4 2025, recurs, confidence in annual earnings forecasts could weaken. With net losses persisting for four straight years, any additional non-operating loss factors could heighten concerns about capital erosion. Investors need to continuously monitor the gap between quarterly operating and net results.

Industry and Policy Risk

As global regulators including the US FDA finalize animal-testing phase-out roadmaps, pressure to transform the company's traditional animal-testing-based revenue structure could increase.

Conversely, if standardization of alternative testing methods is delayed, the timing of revenue generation from new investments could also be pushed back. Policy uncertainty exists in both directions simultaneously.

Affiliate and Investment Asset Risk

Equity investments in other companies such as Panagene represent a sizable portion of shareholders' equity, meaning fluctuations in those companies' share prices or performance could affect the company's financial statements.

The possibility of risk spillover from across HLB Group's broader affiliate structure cannot be ruled out. If the stated plan to enter new businesses through M&A is executed, the target's business viability and integration risk would also need to be evaluated.

11

What to watch next

  1. Around late September 2026

    This is the point to check whether the CEO's stated plan to secure a new growth pillar through M&A within the third quarter is executed, and what the specific target is.

  2. Around mid-November 2026

    The Q3 2026 quarterly report should be checked to see whether the trend of improving operating and net results continues, and whether non-operating factors similar to the large Q4 net loss recur.

  3. In the second half of 2026

    This is a point to check whether tangible outcomes, such as new service launches or joint contract wins, emerge from the organoid alternative-testing collaboration with Nexcell.

  4. On an ongoing basis as regulations develop

    Progress on enacting Korea's animal-testing-alternative promotion law and registration of officially recognized test methods by the Ministry of Food and Drug Safety could affect the pace of the company's alternative-testing lab construction business expansion, warranting ongoing monitoring.

12

Overall view

HLB Biostep showed signs of improving financial structure in 2025, including revenue recovery, a narrower operating loss, and a return to positive operating cash flow, but a large Q4 net loss caused the full-year net loss attributable to owners to widen versus the prior year.

In the first half of 2026, operating losses moderated somewhat but net losses widened again, highlighting significant earnings volatility.

On the business side, the company is expanding its one-stop service system by adding GLP toxicity testing, primate testing, and organoid-based alternative testing to its existing preclinical CRO and bio-infrastructure pillars, while maintaining its position as a core healthcare affiliate within HLB Group.

The broader industry is in a phase where standardization of alternative testing methods and market restructuring are both underway amid the global regulatory shift away from animal testing, a structure that could present opportunities for companies with proactive response infrastructure and pressure for those slower to adapt.

The stock trades below its accounting book value and pays no dividend, so valuation assessment should weigh the multi-year direction of earnings recovery alongside the volatility introduced by non-operating items.

Near-term items to watch include execution of the stated within-quarter M&A plan, concrete outcomes from the Nexcell collaboration, and whether the gap between operating and net results seen in Q4 2025 recurs in upcoming quarters. This report contains no buy or sell recommendation and is provided for informational purposes only.

13

Sources

  1. Korea Exchange (KRX) — Prices · Market Cap · Volume
  2. FSS electronic disclosure system (DART) — Financial statements · Dividend filings
Show 18 more articles and sources
  1. alphasquare.co.kr
  2. goinsider.kr
  3. hlbbiostep.com
  4. news.nate.com
  5. m.irgo.co.kr
  6. comp.fnguide.com
  7. view.asiae.co.kr
  8. mt.co.kr
  9. dart.fss.or.kr
  10. judal.co.kr
  11. kind.krx.co.kr
  12. m.irgo.co.kr
  13. thinkpool.com
  14. m.thinkpool.com
  15. markets.hankyung.com
  16. mpharm.edaily.co.kr
  17. pharm.edaily.co.kr
  18. hlbbiostep.com

Report written 2026-09-05 · Data as of 2026-09-04

This content is AI analysis of market data and web search results, provided for information only. It is not a solicitation or recommendation to invest. Investment decisions and their consequences are the investor's own responsibility. Data may be delayed or contain errors.