KOSDAQBiotech & Pharma338220

Vuno

₩8,310▲ 0.48%2026-10-02 close
Market Cap
₩116.9B
Turnover
₩2.3B
Volume
280,000 shares
Shares out.
14M
PER
—
PBR
2.1×
EPS
-₩789
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

VUNO Recapitalizes as DeepCARS Faces Setbacks

VUNO posted its first-ever quarterly operating profit in Q3 2025 but has since returned to losses for four straight quarters, and is now restructuring its finances through a KRW 31.4 billion rights offering amid delayed U.S. clearance and slowing domestic sales for its core DeepCARS product.

  1. 1

    2025 consolidated revenue rose sharply year-over-year to KRW 34.8 billion, but the company has posted operating losses for a fifth straight year.

  2. 2

    Q3 2025 revenue of KRW 10.8 billion and operating profit of KRW 1.0 billion marked its first quarterly profit since listing, but the company swung back to losses for four consecutive quarters from Q4 2025 through Q2 2026.

  3. 3

    DeepCARS, which accounts for 86% of revenue, received a Not Substantially Equivalent (NSE) decision from the U.S. FDA, delaying clearance.

  4. 4

    On August 28, the company approved a KRW 31.4 billion rights offering that will increase share count by approximately 45%.

  5. 5

    The company has identified the Q4 2026 domestic new health technology assessment outcome for DeepCARS as its most important catalyst of the year.

02

Business structure

Founded in 2014, VUNO listed on KOSDAQ in 2021 under the technology special listing track as a medical artificial intelligence software company.

Its core revenue driver is VUNO Med-DeepCARS, a vital-signs-based solution that predicts cardiac arrest risk within 24 hours for hospitalized patients, which accounted for roughly KRW 10.4 billion of the company's approximately KRW 12.2 billion in first-half 2026 revenue.

The company also offers imaging-assist products including Chest X-ray Triage, DeepBrain (brain quantification), Lung CT AI, and Fundus AI, as well as HATIV, a portable ECG device.

Domestically, VUNO operates a B2B subscription-style model targeting hospitals, and DeepCARS entered the market on a non-reimbursed basis under Korea's new health technology assessment grace-period system. Overseas, DeepBrain and Chest X-ray Triage have already received U.S.

FDA 510(k) clearance, and the company has secured approvals from Japan's PMDA, the EU's CE MDR, and Brazil's ANVISA, among others. VUNO is currently focused on expanding DeepCARS internationally, including validation work with university hospitals in Europe including Germany.

Domestically, the medical AI market features specialized-AI competitors such as Lunit, JLK, Coreline Soft, Airs Medical, and Neurophet, each focused on specific disease areas or data types.

An increasing number of competitors are also leveraging the new health technology grace-period system to enter the non-reimbursed market, intensifying competition for hospital adoption.

03

Earnings trend

Quarterly revenue · Operating profit
RevenueOperating profit
Annual revenue · Operating profit
RevenueOperating profit
Quarterly results · Last 5 quarters
QuarterRevenueOperating profitOp. margin
2025Q2₩9.3B-₩200M−1.8%
2025Q3₩10.8B₩1B9.4%
2025Q4₩7.2B-₩2.4B−32.5%
2026Q1₩6B-₩4.1B−67.9%
2026Q2₩6.1B-₩4.2B−68.9%
Annual results
YearRevenueOperating profitNet income (parent)Op. marginROEDebt-to-equity
2022₩8.3B-₩15.4B-₩15.7B−185.7%−83.8%89.3%
2023₩13.3B-₩15.7B-₩15.6B−118.1%−311.3%349.4%
2024₩25.9B-₩12.5B-₩13B−48.1%−42.4%63.5%
2025₩34.8B-₩4.9B-₩5.8B−14.2%−16.0%39.5%

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

VUNO's consolidated revenue grew for four consecutive years, from roughly KRW 8.27 billion in 2022 to KRW 13.28 billion in 2023, KRW 25.87 billion in 2024, and KRW 34.85 billion in 2025.

Over the same period, operating losses widened from about KRW 15.37 billion in 2022 to KRW 15.68 billion in 2023 before narrowing to KRW 12.45 billion in 2024 and KRW 4.93 billion in 2025, with the operating margin improving from -185.7% in 2022 to -14.2% in 2025.

On a quarterly basis, Q3 2025 revenue reached about KRW 10.82 billion with operating profit of roughly KRW 1.02 billion and owner net income of about KRW 1.03 billion, marking the company's first quarterly profit since its listing.

However, Q4 2025 revenue fell to about KRW 7.23 billion with an operating loss of roughly KRW 2.35 billion and a net loss of about KRW 2.71 billion, reversing back into deficit.

Revenue remained low in Q1 and Q2 2026 at about KRW 6.05 billion and KRW 6.11 billion respectively, while operating losses widened to roughly KRW 4.11 billion and KRW 4.21 billion, with the Q2 net loss reaching about KRW 5.38 billion.

Cumulative owner net loss over the most recent four quarters (Q3 2025 through Q2 2026) totaled about KRW 11.05 billion, reflecting a pattern of losses widening again after the single profitable quarter.

This reversal is linked to slowing domestic non-reimbursed sales of DeepCARS, which makes up 86% of revenue, with first-half 2026 revenue reported to have fallen 28% year-over-year.

On the balance sheet, equity fell to about KRW 5.02 billion in 2023, pushing the debt ratio up to 349.4%, before capital raised through perpetual convertible bonds and other measures improved equity to about KRW 36.11 billion and the debt ratio to 39.5% by the end of 2025.

05

Industry analysis

Korea's medical AI industry relies heavily on the new health technology assessment grace-period system, which allows companies with regulatory clearance to bill hospitals on a non-reimbursed basis for up to four years.

VUNO's DeepCARS entered the non-reimbursed market through this system, with non-reimbursed billing reportedly expanding to roughly 80 hospitals within three years.

However, once the grace period expires, products must pass the formal new health technology assessment to secure permanent reimbursement, representing an upcoming institutional turning point.

Korea's medical AI market is led by specialized-AI companies such as Lunit in imaging-based cancer diagnosis and treatment, VUNO in medical imaging and vital-signs analysis, and JLK in stroke AI, each focused on specific disease areas or data domains.

Coreline Soft, Airs Medical, and Neurophet also compete with similar business models. In overseas markets, securing country-specific regulatory approval is a prerequisite for revenue growth, and VUNO has already obtained U.S. FDA clearance for products including DeepBrain and Chest X-ray Triage.

By contrast, DeepCARS, its largest revenue contributor, faces delayed U.S. clearance due to requirements for multi-ethnic data validation, leaving it a variable in the race with competitors expanding overseas.

06

Outlook

The company has identified the Q4 2026 domestic new health technology assessment outcome for DeepCARS as its 'most important catalyst this year.' Passing this assessment would shift the product from non-reimbursed to formal reimbursement status, potentially stabilizing revenue, while failing it could raise concerns about a revenue gap once the grace period expires.

In the U.S., DeepCARS' 510(k) application received a Not Substantially Equivalent (NSE) decision from the FDA on April 30, requiring supplementation before resubmission. However, the U.S.

CMS including DeepCARS in its FY2027 NTAP (New Technology Add-on Payment) proposed rule is cited as a reference point for eventual U.S. market entry. The company has stated it will pursue overseas business expansion alongside operational efficiency gains through company-wide AI transformation.

Financially, of the KRW 31.4 billion raised through the rights offering, KRW 20 billion is earmarked for early repayment of the third-series perpetual convertible bond before its rate steps up, with the remaining roughly KRW 11.4 billion allocated to R&D and overseas subsidiary operations for growth investment.

The rights offering schedule runs from the October 2 shareholder record date through existing shareholder subscription (November 9-10) and public subscription for unclaimed shares (November 12-13), concluding with new share listing on November 30.

07

Valuation

PER
—
PBR
2.1×
ROE
-35.5%
EPS
-₩789
BPS
₩2,550
Dividend per share
₩0

VUNO continues to post net losses, making profit-based valuation multiples difficult to apply. Its shares tend to trade at a premium relative to net asset value, which can be interpreted as reflecting some degree of expectation for future growth.

The pattern of a single profitable quarter in Q3 2025 followed by widening losses again has been a factor shaping assessments of earnings continuity. The company pays no dividend, limiting comparisons on dividend-related metrics.

Once the KRW 31.4 billion rights offering scheduled for November is completed, shares outstanding will increase by approximately 45%, a capital structure change that should be considered alongside any interpretation of per-share 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 2026-08-23

08

Bull factors

Improving Earnings Trend and a Track Record of Quarterly Profit

Revenue grew steadily from about KRW 8.2 billion to KRW 34.8 billion between 2022 and 2025, while the operating margin improved sharply from -185.7% to -14.2%. In Q3 2025, revenue of KRW 10.8 billion and operating profit of KRW 1.0 billion marked the company's first quarterly profit since listing.

This resulted from a combination of expanded non-reimbursed sales, R&D service revenue, and cost reductions, demonstrating that the business model can achieve breakeven under certain conditions.

Diversified Overseas Regulatory Portfolio

Multiple products including DeepBrain and Chest X-ray Triage have already obtained U.S. FDA clearance, alongside approvals in Japan (PMDA), the EU (CE MDR), and Brazil (ANVISA). The U.S. CMS including DeepCARS in its FY2027 NTAP proposed rule is also cited as a notable reference point. Portfolio expansion is underway that reduces reliance on any single product or market.

Proactive Balance Sheet Restructuring

On August 26, VUNO fully repaid about KRW 9.3 billion of its second-series perpetual convertible bond, and on August 28 approved a KRW 31.4 billion rights offering partly aimed at repaying the third-series bond before its interest rate steps up.

The debt ratio has declined from 349.4% in 2023 to 39.5% in 2025 as capital was raised to improve the balance sheet. Such proactive measures could be expected to reduce interest burden and repayment risk.

09

Bear factors

Delays and Slowing Sales for the Core Product

DeepCARS, which makes up 86% of revenue, faces delayed U.S. clearance after receiving a Not Substantially Equivalent decision from the FDA, while domestic first-half 2026 revenue fell 28% year-over-year.

Additional data supplementation requirements, including multi-ethnic validation, make it difficult to pinpoint an approval timeline.

Losses Widening Again After a Profitable Quarter

After posting a quarterly operating profit in Q3 2025, the company returned to losses for four consecutive quarters through Q2 2026. The Q2 2026 operating loss widened to about KRW 4.21 billion and net loss to about KRW 5.38 billion. Whether the single profitable quarter represents sustainable growth has yet to be confirmed.

Dilution and Governance Concerns from the Large Rights Offering

The KRW 31.4 billion rights offering will increase shares outstanding by approximately 45%, diluting existing shareholders. The planned issue price was set at a 32% discount to the closing price the day before the announcement.

The controversy centers on Board Chairman and largest shareholder Ye-ha Lee's stated plan to subscribe to only 7% of his allotted shares, drawing market criticism.

10

Risk factors

Regulatory and Approval Risk

U.S. FDA 510(k) clearance for DeepCARS has been repeatedly delayed, initially expected in 2024, then pushed to 2025, and now to 2026. Domestically, as the grace period for the new health technology assessment approaches expiration, the Q4 assessment outcome will determine whether non-reimbursed sales can continue. Repeated approval delays could push back the timing of revenue growth further.

Financial and Funding Risk

The company has posted annual operating losses for five straight years, with operating cash flow also negative every year, including a cash outflow of about KRW 4.68 billion in 2025.

It decided on a KRW 31.4 billion rights offering to repay perpetual convertible bonds and fund growth investment, and the possibility of further capital raises cannot be ruled out. As of end-September 2025, consolidated cash and equivalents stood at about KRW 22.5 billion.

Competitive Intensity Risk

Korea's medical AI market features multiple competitors—Lunit, JLK, Coreline Soft, Airs Medical, and Neurophet—competing across specific disease and data domains.

Competing products leveraging the same new health technology grace-period system are increasingly entering the non-reimbursed market, which could affect the pace of DeepCARS' hospital adoption. Competitors are also accelerating their own overseas regulatory approvals at a pace similar to VUNO's.

11

What to watch next

  1. October 2, 2026

    Rights offering shareholder record date, on which existing shareholders' new share allotment rights are finalized.

  2. November 4-17, 2026

    Sequence of finalizing the issue price, existing shareholder and public subscriptions, and payment date, allowing confirmation of the final funds raised and any unclaimed share volume.

  3. November 30, 2026

    Scheduled listing date for new shares from the rights offering, when the roughly 45% increase in shares outstanding takes effect and per-share metrics can be reassessed.

  4. During Q4 2026

    Release of the domestic new health technology assessment result for DeepCARS, described by the company as its 'most important catalyst this year' and a gauge of non-reimbursed revenue sustainability.

  5. Around November 2026

    Timing of Q3 2026 earnings release, when it can be checked whether the widening loss trend since Q4 2025 has stabilized.

12

Overall view

VUNO achieved simultaneous revenue growth and narrowing operating losses through 2025, culminating in its first quarterly operating profit since listing in Q3 2025, but has since returned to losses for four consecutive quarters from Q4 2025 through Q2 2026.

DeepCARS, which accounts for the bulk of revenue, has seen slowing non-reimbursed sales domestically and repeated delays in U.S. clearance after an FDA Not Substantially Equivalent decision.

The company proactively repaid its second-series perpetual convertible bond last month and approved a KRW 31.4 billion rights offering to restructure its finances ahead of a scheduled interest rate increase.

This large rights offering will increase shares outstanding by roughly 45%, with a schedule running from the early-October record date through late-November new share listing.

The company has flagged the Q4 2026 domestic new health technology assessment outcome as its key catalyst, and this result along with progress on U.S. DeepCARS reapproval are likely to be key variables shaping subsequent earnings trends.

Going forward, it will be important to monitor potential changes in the regulatory approval timeline alongside the dilution effects of the rights offering.

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. m.thinkpool.com
  3. kr.investing.com
  4. view.asiae.co.kr
  5. investing.com
  6. stocks.pluconnect.com
  7. littlebproject.com
  8. paxnet.co.kr
  9. comp.wisereport.co.kr
  10. vuno.co
  11. medicaltimes.com
  12. paxetv.com
  13. medigatenews.com
  14. msale.mimint.co.kr
  15. biospectator.com
  16. v.daum.net
  17. m.thebell.co.kr
  18. saramin.co.kr

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.