KOSDAQBiotech & Pharma387570

Finemedix

₩6,430▲ 2.06%2026-10-02 close
Market Cap
₩35.2B
Turnover
₩21,516,470
Volume
3,437 shares
Shares out.
5.6M
PER
—
PBR
1.9×
EPS
-₩111
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

Q2 Swings to Profit, Durability in Question

Fine Medix swung to a quarterly operating profit in Q2 2026 with revenue growth, but given the loss that persisted through the prior quarter and its still-small revenue base, whether this marks a sustained turnaround needs confirmation in coming quarters.

  1. 1

    Q2 2026 revenue reached KRW 4.03 billion with operating profit of KRW 790 million, a sharp swing from the prior quarter's operating loss of KRW 751 million.

  2. 2

    Full-year 2025 revenue was KRW 9.52 billion (down 4.4% year over year) with an operating loss of KRW 2.58 billion, a sharp widening from the prior year.

  3. 3

    Expanded direct sales to tertiary hospitals and entry into endoscope equipment distribution (SonoScape's HD-550 series from China) have been cited as key drivers of recent top-line growth.

  4. 4

    Initial orders and certification transitions for flagship products such as ClearTip and ClearCut Knife are underway in the US, Japan, and Europe, and the company decided on its first share buyback (KRW 1 billion) since listing.

  5. 5

    Net income over the trailing four quarters (Q3 2025 to Q2 2026) totaled roughly negative KRW 600 million, with losses narrowing versus prior periods but quarter-to-quarter volatility remaining high.

02

Business structure

Fine Medix was founded in 2009 by Dr. Jeon Seong-woo, a practicing gastroenterologist, to break the dominance of foreign companies in endoscopic instruments, and listed on KOSDAQ in December 2024 under the technology growth special listing track.

The company develops and manufactures 27 product lines and 549 models of instruments used across the full range of gastrointestinal endoscopic procedures, including ESD, EMR, EUS, and ERCP.

Its flagship products are the ClearCut Knife (a cutting device), the ClearTip tissue-sampling needle, plus snares, injectors, biopsy forceps, and hemostatic devices, and it recently expanded into endoscope equipment distribution through an exclusive domestic distribution agreement with China's SonoScape Medical for the HD-550 series.

Per Q1 2026 disclosures, the Clear Grasp Snare accounted for the largest share of revenue at 22.34%, followed by the ClearCut Knife at 17.83% and the Clear-Jet Injection Catheter at 12.49%, with therapeutic endoscopy products overall representing 62.6% of revenue.

Domestically, the company supplies about 800 hospitals and clinics, including 22 tertiary general hospitals such as Kyungpook National University Hospital, Seoul Asan Hospital, and Severance Hospital, and has been strengthening a direct-sales system centered on Seoul-area tertiary hospitals.

Internationally, it supplies 45 companies across 48 countries in Europe, the United States, and Asia, focusing in the US on building hospital references for the ClearTip tissue-sampling device and in Japan on preparing the formal launch of the recently approved ClearCut Knife.

The global market for endoscopic procedural instruments is viewed as a high-barrier industry long dominated by a small number of multinational players, and Fine Medix, as a later entrant, has sought to expand share through localization and price competitiveness.

It has also recently discussed ODM cooperation on tissue-biopsy instruments with UK-based Creo Medical as part of efforts to secure distribution channels through partnerships with global companies.

03

Earnings trend

Quarterly revenue · Operating profit
RevenueOperating profit
Annual revenue · Operating profit
RevenueOperating profit
Quarterly results · Last 5 quarters
QuarterRevenueOperating profitOp. margin
2025Q2₩2.5B-₩500M−21.3%
2025Q3₩2.2B-₩1.1B−48.9%
2025Q4₩3B-₩100M−4.4%
2026Q1₩2.2B-₩800M−33.7%
2026Q2₩4B₩800M19.6%
Annual results
YearRevenueOperating profitNet income (parent)Op. marginROEDebt-to-equity
2023₩10.2B₩900M₩1.2B8.6%9.3%46.8%
2024₩10B-₩29,192,239-₩24,152,328−0.3%−0.1%29.4%
2025₩9.5B-₩2.6B-₩1.9B−27.1%−9.9%34.3%

Consolidated basis (financial statements including subsidiaries) · Final figures from DART filings · Net income attributable to owners of the parent · Data as of 2026-09-05

04

Earnings analysis

On an annual basis, the company posted revenue of KRW 10.15 billion, operating profit of KRW 874 million (an 8.6% operating margin), and net income of KRW 1.18 billion in 2023, but in 2024 revenue stagnated at KRW 9.96 billion while the company slipped to a small operating loss of KRW 29 million and a net loss of KRW 24 million, close to breakeven.

In 2025, revenue declined 4.4% year over year to KRW 9.52 billion, and the operating loss widened sharply to KRW 2.58 billion (a -27.1% operating margin), with a net loss of KRW 1.88 billion.

On a quarterly basis, losses peaked in Q3 2025 with revenue of KRW 2.20 billion, an operating loss of KRW 1.07 billion, and a net loss of KRW 996 million, before Q4 revenue rose to KRW 2.97 billion, the operating loss narrowed to KRW 131 million, and net income turned positive at KRW 372 million.

Revenue fell again to KRW 2.23 billion in Q1 2026 with the operating loss continuing at KRW 751 million and a net loss of KRW 753 million, but Q2 revenue jumped to KRW 4.03 billion, delivering an operating profit of KRW 790 million and net income of KRW 777 million, a clear swing to profitability.

Combining the two quarters, first-half 2026 revenue reached KRW 6.26 billion (up 43.7% year over year) with operating profit of KRW 39 million, marking a first-half swing to profit.

The company attributed the Q2 turnaround to expanded domestic direct sales, the ramp-up of endoscope equipment sales, entry into new overseas markets, and reduced selling and administrative expenses.

Over the trailing four quarters from Q3 2025 through Q2 2026, cumulative revenue totaled roughly KRW 11.43 billion and cumulative net income was roughly negative KRW 600 million, showing high quarter-to-quarter volatility but a narrowing loss trend compared with earlier periods.

05

Industry analysis

The market for gastrointestinal endoscopic procedural instruments is viewed as a high-barrier industry long dominated by a handful of global players, and domestic later entrants such as Fine Medix have sought to expand share through localization and price competitiveness.

The market for bronchial ultrasound endoscopy (EBUS-TBNA) tissue-sampling instruments is likewise viewed as a high-barrier segment centered on a small number of global companies.

In May, Fine Medix exhibited at a standalone booth at DDW 2026, the world's largest gastroenterology conference held in Chicago, where it discussed ODM cooperation with UK-based Creo Medical on two variants of its ClearTip tissue-biopsy device.

In Europe, the company recently completed the transition to CE certification under the Medical Device Regulation (MDR) for its next-generation instrument lineup, laying groundwork for ODM and OEM cooperation with global device makers.

Domestically, the company is expanding from consumables into equipment by strengthening direct sales to tertiary hospitals and entering endoscope equipment distribution through SonoScape's HD-550 series from China.

Underlying demand for gastrointestinal endoscopy procedures is linked to expanding health screening and early cancer detection, and the company expects seasonal health-checkup demand in the second half to support sales.

Within the competitive landscape, large global companies continue to lead the endoscope scope and high-value instrument markets, while Fine Medix, operating from a comparatively small revenue base, is pursuing growth through a combination of expanded domestic direct sales and entry into new overseas markets.

06

Outlook

The company has stated it will focus in the second half on expanding usage of its flagship products at domestic tertiary hospitals and securing repeat orders in key overseas markets such as the US and Japan, aiming to pursue top-line growth and profitability improvement simultaneously.

In a June 2026 report, Korea Investment & Securities analyst Kang Eun-ji stated that growth would become visible from Q2 as endoscope equipment sales ramp up and overseas revenue increases, projecting full-year 2026 revenue of KRW 15.4 billion and operating profit of KRW 1.0 billion (a forecast as of that date, which may differ from actual results).

Domestically, the company said revenue from the K-Medi Hub medical technology training center endoscope equipment project, won in April, began to be reflected in results from Q2.

Overseas, the company plans to ramp up supply of the ClearTip TBNA tissue-sampling device through US distribution partner GI Matrix and build initial clinical references in the second half, while in Japan it is preparing pricing coordination and the formal launch of the ClearCut Knife, which received product approval earlier in the year.

In Europe, the company is pursuing ODM and OEM cooperation with global device makers based on its recently obtained CE MDR certification. In July, the company signed its first share buyback trust agreement since listing, worth KRW 1 billion (July 2026 to July 2027), signaling a commitment to responsible management.

However, many of these initiatives remain at the stage of initial orders or contract negotiations, so the timing and scale of their eventual revenue contribution will need to be confirmed through future quarterly disclosures.

07

Valuation

PER
—
PBR
1.9×
ROE
-3.1%
EPS
-₩111
BPS
₩3,525
Dividend per share
₩0

Given that Fine Medix posted annual losses through 2025 and only swung to profit in Q2 2026 after a loss in Q1, it remains early to apply conventional earnings-based valuation metrics with confidence.

Relative to net asset value, the stock has traded at a premium, which can be interpreted as reflecting some market expectation of future growth. On dividends, the company has not yet built a track record of dividend payments, though its recent first share buyback since listing is a notable shareholder-return gesture.

In terms of earnings direction, the shift from widening losses in 2025 to a quarterly operating profit in Q2 2026 stands out, but given the still-small revenue base and high quarter-to-quarter volatility, whether this trend continues will need to be judged based on upcoming quarterly results.

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 2026-09-05

08

Bull factors

Q2 Earnings Turnaround

Q2 2026 revenue rose sharply from the prior quarter, delivering a clear swing to an operating profit of KRW 790 million and net income of KRW 777 million. This was attributed to a combination of expanded domestic direct sales, the ramp-up of endoscope equipment sales, and reduced selling and administrative expenses. First-half revenue overall grew 43.7% year over year, confirming top-line growth.

Expanding Global Market Entry

The company is progressing supply of ClearTip TBNA through US distribution partner GI Matrix and preparing the formal launch of the ClearCut Knife in Japan. In Europe, it completed CE MDR certification for its next-generation product lineup, laying groundwork for ODM and OEM cooperation with global companies. First-half overseas revenue grew 51% year over year, reflecting the effect of entering new markets.

Business Diversification and Shareholder Return Efforts

The distribution agreement with China's SonoScape has broadened the business from procedural instruments into endoscope equipment, and new revenue sources such as the K-Medi Hub training equipment project have been secured.

The company's first share buyback trust agreement since listing, worth KRW 1 billion, can also be read as a signal of stronger commitment to responsible management.

09

Bear factors

History of Losses and Volatile Quarterly Results

The 2025 full-year operating loss widened sharply to KRW 2.58 billion from the prior year, and losses continued through Q1 2026. Cumulative net income over the four quarters from Q3 2025 through Q2 2026 remains negative at roughly KRW 600 million. Whether the single quarter of profit in Q2 will continue as a trend has not yet been confirmed.

Constrained Revenue Scale

Full-year 2025 revenue was KRW 9.52 billion, down 4.4% year over year, and Q1 2026 revenue remained around KRW 2.23 billion.

Because the absolute revenue base is small, fixed-cost burden creates significant earnings volatility, and there is a risk that growth could stall again if initial orders in new overseas markets fail to convert into repeat orders.

Certification and Approval Delay Risk

One factor cited for the 2025 earnings deterioration was a temporary increase in costs tied to overseas certification transitions such as CE MDR.

Each new market entry requires country-specific approvals and distribution-partner negotiations, and delays in these processes could push back the timing of revenue recognition.

10

Risk factors

Earnings Volatility

Operating results have swung between losses and profits across the last five quarters, showing very high volatility. With a small revenue base and continued fixed spending on personnel and marketing, the possibility of reverting to losses if revenue falls short of expectations cannot be ruled out.

Overseas Market Dependency Risk

Revenue from new overseas markets such as the US, Japan, and Europe often remains at the initial-order stage.

Overseas sales could be delayed or reduced relative to expectations depending on local distribution partners' sales capability, regulatory changes, or regional conditions, as illustrated by a past instance of contraction in Middle East sales.

Financing and Dilution Risk

The company issued private exchangeable bonds in December 2025, and part of its treasury shares are earmarked for employee stock options and as the exchange target for those bonds. Future additional financing or exercise of these options could lead to share dilution.

11

What to watch next

  1. Around November 2026 (Q3 earnings disclosure)

    Check whether the Q2 swing to profit continues into Q3, and whether revenue and operating margin are sustained.

  2. During the second half of 2026

    Watch for whether the formal launch of the ClearCut Knife in Japan and initial supply of ClearTip TBNA through US partner GI Matrix translate into actual revenue.

  3. Through July 2027

    Track the execution progress and eventual completion of the KRW 1 billion share buyback trust agreement signed in July 2026.

  4. During the second half of 2026

    Monitor the status of local product approvals for ClearTip and other key products in China, and whether domestic equipment revenue expands through the SonoScape endoscope equipment distribution business.

12

Overall view

Fine Medix moved from a profit in 2023 through widening losses in 2024 and 2025 and continued losses into Q1 2026, before Q2 brought a joint improvement in revenue and operating profit and a swing to a quarterly profit.

Expanded direct sales to domestic tertiary hospitals, the ramp-up of endoscope equipment sales, and entry into new overseas markets in the US, Japan, and Europe have driven recent growth, and the company's first share buyback decision since listing is also notable from a shareholder-return perspective.

However, given the still-small revenue base and the high volatility in operating results—swinging between losses and profits across the last five quarters—whether the Q2 swing to profit is a one-off or a sustained improvement will require further confirmation in subsequent quarters.

Overseas revenue in many countries remains at the initial-order stage, making conversion into repeat orders a key variable for future results. On valuation, the stock trades at a premium to net asset value, and this should be weighed alongside the fact that earnings have not yet stabilized.

Ahead of any investment decision, it would be prudent to continue monitoring upcoming quarterly disclosures and the timing of revenue recognition across each overseas market.

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. markets.hankyung.com
  2. v.daum.net
  3. m.irgo.co.kr
  4. m.thinkpool.com
  5. pharm.edaily.co.kr
  6. hankyung.com
  7. edaily.co.kr
  8. finance.finup.co.kr
  9. kr.investing.com
  10. pharm.edaily.co.kr
  11. mt.co.kr
  12. medigatenews.com
  13. edaily.co.kr
  14. sedaily.com
  15. judal.co.kr
  16. stockplus.com
  17. m.thinkpool.com
  18. littlebproject.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.