KOSDAQBiotech & Pharma042520

Hans Biomed

₩21,500▼ 4.66%2026-10-02 close

Market Cap

₩303.1B

Turnover

₩1.7B

Volume

80,000 shares

Shares out.

14.3M

PER

—

PBR

—

EPS

-₩1,941

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

Report overview

CellREDM Growth Meets Post-Litigation Reset

Human tissue graft maker Hans Biomed is passing through an earnings inflection point, moving from a large FY2025 loss to a profitable quarter in 2026 as the ECM skin booster 'CellREDM' grows rapidly and the 'Bellagel' breast implant litigation is settled.

1
Most of the FY2025 operating loss of KRW 25.89bn stemmed from a one-off reclassification of roughly KRW 21.5bn in Bellagel damages into SG&A expenses
2
Q3 FY2026 (Apr-Jun) revenue reached KRW 36.35bn with operating profit of KRW 4.10bn, marking a return to quarterly profitability
3
CellREDM monthly production capacity expanded from 15,000 units in late 2025 to 42,000 units by March 2026, alongside expanded Japan and Hugel distribution
4
Total equity roughly halved following the first-instance Bellagel loss, and the auditor flagged going-concern uncertainty
5
Chinese NMPA import approval enabled orthopedic allograft bone exports, while the exclusive dental bone graft supply deal with Ostem Implant runs through September 2027

Business structure

Founded in 1999, Hans Biomed is a tissue-engineering based biomedical device company that holds Korea's first human tissue bank license and has built its business around bone and skin graft products.

Flagship products include the allograft bone graft 'SureOss' for dental and orthopedic use, a range of skin graft materials, the facial thread lifting product 'MINT Lift', and the silicone breast implant 'Bellagel.' The ECM (extracellular matrix)-based skin booster 'CellREDM,' launched in September 2025, has emerged as a new growth engine driving a broader business transformation.

Domestic sales are handled through subsidiaries HansCare (tissue grafts) and Mint Medical (devices), while cosmetics operations run through HansPharma.

The company has maintained an exclusive domestic dental bone graft supply agreement with Ostem Implant; the contract signed in 2009 runs through September 2027 and is structured to auto-renew, making an extension likely absent special circumstances.

Overseas, a joint venture called Rebirth with China's WEGO Group is preparing local production and sales of bone graft products, and the company operates multiple foreign subsidiaries and branches across the United States, China, and Thailand, among others.

Having operated a human tissue bank for more than 20 years is a strength, and the multiple conditions required to run such a bank act as an entry barrier for other companies.

Over the past three years, the R&D-to-sales ratio on a standalone basis rose to 7.93%, 8.01%, and 10.55%, notably above the roughly 5% average seen across the industry.

Earnings trend

Quarterly revenue · Operating profit

₩22B₩40,796,55925Q3₩23.7B-₩27B25Q426Q126Q2₩36.3B₩4.1B26Q3

RevenueOperating profit

Annual revenue · Operating profit

₩74.5B₩1.3B2022₩78B-₩4.2B2023₩81.1B₩600M2024₩89.8B-₩25.9B2025

RevenueOperating profit

Quarterly results · Last 5 quarters
Quarter	Revenue	Operating profit	Op. margin
2025Q3	₩22B	₩40,796,559	0.2%
2025Q4	₩23.7B	-₩27B	−113.6%
2026Q1	—	—	—
2026Q2	—	—	—
2026Q3	₩36.3B	₩4.1B	11.3%

Annual results
Year	Revenue	Operating profit	Net income (parent)	Op. margin	ROE	Debt-to-equity
2022	₩74.5B	₩1.3B	₩6.1B	1.7%	13.5%	177.5%
2023	₩78B	-₩4.2B	-₩23B	−5.3%	−46.9%	145.0%
2024	₩81.1B	₩600M	-₩7.2B	0.8%	−10.8%	81.3%
2025	₩89.8B	-₩25.9B	-₩31.3B	−28.8%	−93.0%	273.0%

Consolidated basis (financial statements including subsidiaries) · Final figures from DART filings · Net income attributable to owners of the parent · Data as of 2026-09-04

Earnings analysis

In 2022, revenue was KRW 74.46bn with operating profit of KRW 1.29bn (a 1.7% operating margin) and owners' net income of KRW 6.15bn, a profitable year. In 2023, revenue rose to KRW 78.03bn, but the company swung to an operating loss of KRW 4.15bn (-5.3%) and an owners' net loss of KRW 23.04bn.

FY2024 saw revenue of KRW 81.14bn and an operating profit of KRW 0.63bn (0.8%), yet owners' net loss still came to KRW 7.22bn.

In FY2025, revenue grew to KRW 89.78bn, but the operating loss widened sharply to KRW 25.89bn (-28.8%) and the owners' net loss expanded to KRW 31.34bn; the company reclassified a provision from non-operating losses into SG&A expenses, which pushed the operating loss up sharply from about KRW 3.0bn to KRW 25.9bn, largely reflecting one-off Bellagel damages.

By quarter, Q3 FY2025 (April-June) revenue was KRW 22.03bn with a near-breakeven operating profit of KRW 0.04bn, while Q4 FY2025 (July-September) revenue reached KRW 23.71bn but the operating loss ballooned to KRW 26.95bn, pushing the net loss to KRW 27.62bn.

Q3 FY2026 (April-June) then showed a clear turnaround, with revenue of KRW 36.35bn, operating profit of KRW 4.10bn (roughly an 11.3% margin), and owners' net income of KRW 1.93bn.

Still, the trailing four quarters from Q3 FY2025 through Q2 FY2026 combined for an owners' net loss of about KRW 24.85bn, weighed down heavily by the Q4 FY2025 one-off charge.

Individual figures for Q1 and Q2 FY2026 have not yet been finalized in disclosures; Sangsangin Securities estimated in a May 20, 2026 report that Hans Biomed posted consolidated Q2 FY2026 revenue of KRW 34.5bn and operating profit of KRW 4.4bn, up 42.8% and 148.9% year-on-year, respectively, though this remains a preliminary estimate pending official confirmation.

Industry analysis

The human tissue graft market has grown steadily on the back of an aging population and expanding demand for reconstructive and orthopedic procedures, with domestic imports of human tissue (raw materials and finished products) rising from 759,374 units in 2021 to 942,908 units in 2023.

The current center of growth is the ECM (extracellular matrix)-based skin booster category; according to a report DB Securities issued on May 27, 2026, domestic ECM skin booster penetration is expected to rise rapidly from 3.9% in 2025 to 16.7% in 2026.

Competition centers on Hans Biomed's CellREDM, L&C Biomed's Rituo, and PN/PDRN-based Rejuran from Pharma Research; CellREDM, containing 160mg of active ingredient per 5cc, carries an average procedure price of about KRW 600,000, roughly double that of existing products.

In the domestic allograft bone graft market, Hans Biomed holds market leadership with over 50% share of a roughly KRW 50bn market, and new export channels into China are opening up.

On the regulatory front, in March 2026 the Ministry of Food and Drug Safety reaffirmed that acellular dermal matrix-derived ECM skin boosters should be treated as human tissue, meaning they do not require separate clinical trials unlike medical devices, while simultaneously pre-announcing amendments to human tissue safety regulations that would require stating purpose in usage reports, restricting cosmetic advertising, and mandating that medical institutions disclose that products are human-tissue derived.

New entrants are increasing competitive intensity, and regulatory uncertainty has not fully cleared, as illustrated by an October 2025 National Assembly Health and Welfare Committee audit session where a lawmaker argued that using ECM-based skin boosters for cosmetic rather than therapeutic purposes could violate the Human Tissue Safety Act.

Outlook

CellREDM production capacity was expanded from 15,000 units per month to 42,000 units (single shift) by mid-March 2026, with immediate scalability to 80,000 units per month possible without securing additional facilities.

Domestic distribution was strengthened when Hugel announced on April 1 that it had signed a domestic distribution agreement with Hans Biomed for CellREDM, and the joint sales push with Hugel slated for July was flagged as the key battleground determining the next stage of growth.

Overseas, the company signed an exclusive supply agreement with Japanese aesthetic distributor INFIX in January 2026, launching CellREDM under the Japanese brand name 'SKIN PLUS'.

The new breast implant product 'Bounce' launched in late April, and while yield is currently low in the early production stage, sales were expected to ramp up from July onward as yield improves.

In China, the company completed the import approval process for the orthopedic allograft bone graft ExFuse from the National Medical Products Administration and began full-scale exports to the Chinese allograft market, with dental grafts distributed through Ostem Implant's China unit.

The Bellagel breast implant was reported to have a relaunch planned for March 2026 after the company resolved damages through one-off fundraising to block further financial risk, though the actual restart timing and initial sales contribution require further confirmation from subsequent disclosures.

Over the medium term, the joint venture established with China's WEGO Group is reportedly ready for immediate commercialization once regulatory approval is granted, leaving approval timing as a key variable for overseas revenue expansion.

Valuation

PER

—

PBR

—

ROE

-35.6%

EPS

-₩1,941

BPS

—

Dividend per share

₩0

Because the large FY2025 loss cut total equity to roughly half of the prior year's level, the stock continues to trade at a premium relative to net asset value.

While the most recent quarter turned profitable, the trailing four quarters combined still sit in a net loss position, meaning earnings-based valuation metrics cannot yet be applied on a fully stable basis.

A corporate research report published by the Korea IR Service in early 2024 noted that, based on then-expected results, the stock traded at a multiple above the average of peer human tissue graft and lifting-device companies, illustrating how growth expectations have historically been priced in ahead of realized earnings.

Dividends have not been paid in recent years amid persistent net losses, which is another factor worth weighing when interpreting valuation metrics.

Whether new businesses such as CellREDM can sustain a stable earnings contribution, and whether the litigation-related one-off loss booked last year does not recur, stand as the key variables for normalizing the company's financial metrics going forward.

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 2026-09-04

Bull factors

CellREDM's Rapid Growth and Capacity Expansion

CellREDM sales have grown rapidly since launch, and a sharp near-term expansion in production capacity has eased supply constraints. Hana Securities analyst Park Chan-sol said demand for ECM skin boosters currently exceeds supply.

Distribution partnerships with Hugel domestically and an exclusive supply agreement with INFIX in Japan are simultaneously expanding sales channels, giving the new business structural potential to grow its revenue contribution.

Bellagel Litigation Settlement and Relaunch Preparation

The confirmed first-instance Bellagel damages were settled using funds raised through treasury stock sales and a third-party rights offering, and the parties jointly filed a waiver of appeal after reaching a settlement, closing out the litigation.

The company has stated plans to relaunch Bellagel, aiming to reactivate a product that was once a core cash generator, which is cited as a factor that could support earnings stability alongside CellREDM's growth.

Expanding Overseas Channels in China and Japan

Chinese exports have begun in earnest after the company completed the import approval process for the orthopedic allograft bone graft ExFuse from China's NMPA, while dental graft distribution is expanding through Ostem Implant's China unit.

In Japan, the company is accelerating market entry by leveraging a structure that allows initial shipments without separate approval, creating a more diversified overseas revenue base.

Bear factors

Litigation-Driven Equity Erosion and Going-Concern Uncertainty

Total equity was roughly halved last year to about KRW 33.9bn from KRW 67.1bn the prior year, reflecting equity erosion from proactively booking litigation-related provisions combined with the recognition of large losses.

The external auditor noted in its audit report a material uncertainty that raises significant doubt about the company's ability to continue as a going concern. The possibility of additional lawsuits being filed has not been entirely ruled out.

Rising Regulatory Scrutiny of Cosmetic Use of Human Tissue

Lawmaker Lee Su-jin pointed out that using ECM-based skin boosters for cosmetic rather than therapeutic purposes could violate the Human Tissue Safety Act, citing US FDA standards requiring minimal manipulation for tissue used in injectable applications.

The Ministry of Food and Drug Safety has pre-announced regulatory amendments strengthening adverse-event reporting and restricting advertising, and any further tightening could affect the pace of marketing and sales expansion.

Intensifying Competition in ECM Skin Boosters

With L&C Biomed's 'Lituo' already established in the market and new entrants continuing to appear, the potential for intensifying price competition has been raised.

L&C Biomed expanded Lituo's market share and posted consolidated revenue of KRW 85.5bn last year, up 18.5% year-on-year, underscoring how rapidly rival companies are also growing and how fierce the competition for market share has become.

Risk factors

Legal Risk (Litigation)

The first Bellagel lawsuit concluded without an appeal, but if similar additional suits are filed, financial pressure could resurface.

The possibility of additional Bellagel-related lawsuits remains an uncertainty, and while some view any additional suits as manageable within the company's earnings capacity if they do not greatly exceed the scale of the first case, both the scale and timing remain uncertain.

Regulatory Risk

The Ministry of Food and Drug Safety has pre-announced amendments to human tissue safety rules covering advertising restrictions and stronger reporting obligations, and the eventual severity of the final rule could affect marketing activity and the pace of sales growth.

The fact that the Ministry of Health and Welfare, which oversees human tissue, and the Ministry of Food and Drug Safety, which oversees medical devices, have each deferred jurisdiction over human tissue skin boosters to the other also adds to uncertainty around the eventual regulatory framework.

Financial Structure and Liquidity Risk

The external auditor added that if the company's fundraising plans through a rights offering and treasury stock disposal encounter setbacks, continuing as a going concern would be difficult.

If additional capital is needed, the possibility of equity dilution through further rights offerings cannot be ruled out, making the pace and method of balance-sheet repair an ongoing point to monitor.

What to watch next

Around November 2026
Check the Q4 and full-year FY2026 (fiscal year 28) results disclosure for Hans Biomed, a September fiscal-year-end company – key items to verify are whether annual revenue and operating profit targets were met and whether any large one-off losses recur.
Q4 2026 to early 2027
Confirm the final adoption status and specific content (advertising restrictions, strengthened reporting obligations, etc.) of the human tissue safety rule amendment pre-announced by the Ministry of Food and Drug Safety.
Ongoing, at each disclosure
Continue monitoring for any additional or secondary Bellagel-related lawsuits and the actual sales contribution following its relaunch.
From Q4 2026 onward
Track the timing of regulatory approval and the start of local commercialization for the Rebirth joint venture with China's WEGO Group.

Overall view

Hans Biomed is a company in transition, simultaneously carrying a new growth product in CellREDM, its core human tissue graft business, and the financial burden of the Bellagel litigation.

FY2025 recorded a large operating loss due to the one-off recognition of Bellagel damages, but Q3 FY2026 results showed a clear recovery in both revenue and operating profit, signaling early normalization.

Expanded CellREDM production capacity and strengthened distribution both domestically through Hugel and overseas in Japan form the core of the growth story, though it is worth noting that the trailing four quarters combined still sit in a net loss position.

Given that total equity fell sharply after the litigation and going-concern uncertainty was explicitly noted in the audit report, the pace and manner of balance-sheet repair, along with the possibility of further litigation, remain variables to watch.

On the regulatory front, policy direction from the Ministry of Food and Drug Safety on the cosmetic use of human tissue has not been fully settled, leaving industry-wide uncertainty in place.

Overall, this is a phase where growth momentum coexists with financial and regulatory risk, and the continuity of earnings over the coming quarters along with litigation- and regulation-related disclosures are likely to be the key variables shaping how the company's value is assessed going forward.

Sources

Korea Exchange (KRX) — Prices · Market Cap · Volume
FSS electronic disclosure system (DART) — Financial statements · Dividend filings

Show 18 more articles and sources

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.