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
NextBioMedical continues to roughly double annual revenue on the back of global exports of its endoscopic hemostatic powder Nexpowder, but operating losses persist as it invests in the Nexsphere-F US clinical trial and new product pipeline.
2025 revenue rose sharply to KRW 16.5 billion, with Nexpowder as the core revenue driver
Q2 2026 revenue hit a record KRW 4.94 billion, though the operating loss widened
Nexsphere-F is undergoing a US FDA pivotal trial, while Japan rights were licensed to Asahi Intecc
The company recovered from negative equity in 2023 to positive equity after its 2024 listing, improving its financial structure
Some brokerages have cited Nexpowder growth and Nexsphere-F partnerships as the basis for their price targets
NextBioMedical develops drug-device combination products based on drug delivery system technology, with its core products being the endoscopic hemostatic powder Nexpowder and the vascular embolization treatment agent Nexsphere-F.
Nexpowder is sprayed onto gastrointestinal bleeding sites, forming an instant gel upon contact with moisture to achieve hemostasis and prevent rebleeding, and has obtained all four major global approvals from Korea's Ministry of Food and Drug Safety, the US FDA, the European CE-MDR, and Japan's PMDA.
As of the second quarter of 2026, Nexpowder accounted for about 83% of total revenue, with roughly 97% of that from exports, split by region into the United States at 53%, Europe at 41%, and Japan at 5%.
In the United States and Europe, global device leader Medtronic holds exclusive distribution rights and has formed a dedicated sales organization to support market expansion, and Medtronic management has stated on an earnings call that Nexpowder holds meaningful market share within its gastrointestinal business unit.
Nexsphere-F is a resorbable embolic agent used for musculoskeletal pain such as osteoarthritis, already approved in Korea and certified under Europe's CE-MDD with commercial sales underway in parts of Europe, and in April 2026 the company signed an exclusive distribution agreement with Asahi Intecc for the Japanese market.
Although still a smaller contributor, Nexsphere-F revenue grew 157% year over year in 2025, emerging as a second growth pillar alongside Nexpowder.
Both products are viewed as offering greater procedural convenience and safety compared with conventional hemostatic and interventional methods, with clinical results published in international journals.
The company's strategy centers on expanding indications and entering new geographies across its gastrointestinal and interventional product lines.
| Quarter | Revenue | Operating profit | Op. margin |
|---|---|---|---|
| 2025Q2 | ₩4B | ₩20,641,115 | 0.5% |
| 2025Q3 | ₩4.9B | ₩400M | 7.5% |
| 2025Q4 | ₩3.8B | -₩400M | −11.6% |
| 2026Q1 | ₩4.1B | -₩1.2B | −28.9% |
| 2026Q2 | ₩4.9B | -₩1B | −20.9% |
| Year | Revenue | Operating profit | Net income (parent) | Op. margin | ROE | Debt-to-equity |
|---|---|---|---|---|---|---|
| 2023 | ₩4.9B | -₩5.2B | -₩7.5B | −107.1% | — | −602.3% |
| 2024 | ₩9.5B | -₩3.6B | ₩2.9B | −37.5% | 6.3% | 30.2% |
| 2025 | ₩16.5B | -₩700M | -₩300M | −4.4% | −0.6% | 23.2% |
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
Annual revenue expanded steadily from KRW 4.88 billion in 2023 to KRW 9.54 billion in 2024 and KRW 16.48 billion in 2025. Operating losses, meanwhile, narrowed each year from KRW 5.23 billion in 2023 to KRW 3.57 billion in 2024 and KRW 0.72 billion in 2025, trending toward breakeven.
Net income turned positive at KRW 2.86 billion in 2024 but reverted to a net loss of KRW 0.31 billion in 2025, a swing driven largely by non-operating items rather than the underlying operating trend.
On a quarterly basis, the company posted an operating profit of KRW 0.37 billion and net income of KRW 1.06 billion in the third quarter of 2025, but slipped back into loss from the fourth quarter of 2025 onward, with operating losses of KRW 1.19 billion in the first quarter of 2026 and KRW 1.03 billion in the second quarter of 2026.
Revenue alone reached a quarterly record of KRW 4.94 billion in the second quarter of 2026, up from KRW 3.97 billion a year earlier, but the operating loss also widened over the same period from KRW 0.02 billion to KRW 1.03 billion.
This reflects rising selling and administrative expenses tied to the expanded US FDA pivotal trial for Nexsphere-F, increased R&D spending, and higher advertising costs to support overseas market expansion.
On the balance sheet, total equity stood at a negative KRW 5.90 billion at the end of 2023, indicating full capital impairment, before recovering to KRW 45.19 billion following the 2024 listing and rising further to KRW 48.11 billion in 2025.
Operating cash flow also turned positive for the first time in 2025 at KRW 1.25 billion, following negative figures of KRW 4.16 billion in 2023 and KRW 1.20 billion in 2024, suggesting some of the revenue growth is beginning to convert into cash generation.
The endoscopic hemostat market in which Nexpowder competes is at an early stage of global adoption, as powder-based products address the procedural limitations of conventional clips or thermal coagulation methods.
Medtronic, the world's largest medical device company, has publicly stated that Nexpowder holds meaningful market share within its gastrointestinal business unit, underscoring the product's position in this market.
Post-market clinical studies underway in the United States, Canada, France, and Singapore are mostly funded by Medtronic, indicating the partner's active investment in building clinical evidence.
The embolization treatment market that Nexsphere-F targets is an emerging area expanding indications into musculoskeletal pain such as knee osteoarthritis, where large competitors have limited presence while early clinical evidence is still being accumulated.
In both markets, accumulation of clinical evidence and inclusion as a global standard of care are key variables for driving prescription adoption.
While the company started from a relatively small revenue base compared with domestic peers, it has secured over 90% of revenue from overseas exports, giving it an unusually high global revenue mix for a Korean device maker at this early stage.
The company has stated that, supported by continued global sales growth of Nexpowder and the effects of its official Japan launch in September 2025, it aims for annual operating profitability building on a growth pattern of roughly doubling revenue each year.
Nexsphere-F is undergoing a US FDA pivotal clinical trial, with about 50% of target patients enrolled as of early July 2026, and the company completed a pre-review of technical documentation with the FDA through the Total Product Lifecycle Advisory Program (TAP) in the same month.
The company has said it plans to submit a final approval application, including trial results, once the trial is completed as planned. For US distribution rights, the company stated it is in due diligence and negotiations with a global partner in the embolization field, targeting a licensing agreement within the year.
In Japan, the company signed an exclusive distribution agreement with Asahi Intecc for Nexsphere-F in April 2026, laying the groundwork for market entry, with expectations for a smooth start given the partner's prior experience selling embolic products in Europe.
For Nexpowder, large-scale post-market clinical studies in the United States and Europe are ongoing, and how the effects of Medtronic's newly formed dedicated sales organization flow through to revenue in the second half is seen as a key point to watch.
However, some analysis suggests that with Nexsphere-F trial costs continuing to rise, whether Nexpowder's revenue growth can offset that spending is a key determinant of earnings.
The company's shares tend to trade at a significant premium to net asset value, which can be interpreted as partly reflecting revenue growth and expectations for the commercialization of its new product, Nexsphere-F.
However, given that quarterly earnings have swung between profit and loss, comparing the share price to earnings carries considerable volatility that should be taken into account. The company currently pays no dividend, meaning valuation is centered more on growth expectations than on income appeal.
Some brokerages have issued price targets citing Nexpowder's global sales expansion and the value of Nexsphere-F partnerships: Daol Investment & Securities set a target price of KRW 120,000 in its June 2026 report, while DB Securities set a target price of KRW 90,000 in its April 2026 report.
These targets reflect each brokerage's assessment at the time of analysis and are subject to change depending on subsequent clinical and sales developments.
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
Nexpowder's 2025 revenue grew 66% year over year to KRW 13.7 billion, and it continued to grow in the second quarter of 2026, rising about 19% quarter over quarter to KRW 4.1 billion. With 97% of revenue coming from exports, global expansion centered on the United States and Europe remains the core driver of results.
Medtronic's formation of a dedicated sales organization is cited as a favorable factor for future revenue growth.
Nexsphere-F revenue grew 157% year over year in 2025 and rose 144% year over year to KRW 0.52 billion in the second quarter of 2026. About 50% of target patients have been enrolled in the US FDA pivotal trial, and an exclusive distribution agreement with Asahi Intecc in Japan has laid the groundwork for a new market.
As indications and geographies expand, it has the potential to grow into a second revenue pillar alongside Nexpowder.
Total equity, which stood at negative KRW 5.90 billion (full capital impairment) at the end of 2023, recovered to KRW 48.11 billion by 2025 following the 2024 listing. Total liabilities also declined sharply from KRW 35.54 billion in 2023 to KRW 11.16 billion in 2025.
Operating cash flow turned positive for the first time in 2025 at KRW 1.25 billion, reflecting improving financial stability.
The operating loss reached KRW 1.19 billion in the first quarter of 2026 and KRW 1.03 billion in the second quarter, both wider than the same periods in 2025.
This reflects expanded Nexsphere-F trial costs, R&D spending, and overseas marketing expenses, illustrating that revenue growth may take time to convert into profit.
Net income swung from a profit of KRW 1.06 billion in the third quarter of 2025 to losses of KRW 0.05 billion in the fourth quarter, KRW 0.15 billion in the first quarter of 2026, and KRW 0.63 billion in the second quarter. On an annual basis, it also reverted from a profit in 2024 to a loss in 2025. The frequent shifts in quarterly profit direction leave limited visibility into future earnings.
US distribution rights for Nexsphere-F remain at the due diligence and negotiation stage with a large partner, with the timing and terms of any agreement not yet finalized. The FDA approval trial is also still in progress, meaning additional time will be needed before an approval application can be filed and cleared.
The US FDA pivotal trial for Nexsphere-F is still ongoing and must pass through several stages, including patient enrollment, trial data collection, and submission and review for approval. Any delays in the trial or unexpected data outcomes could push back the commercialization timeline.
A significant portion of Nexpowder revenue depends on the sales capability of a single global partner, Medtronic. Nexsphere-F also relies on Asahi Intecc in Japan and a large partner still under negotiation in the United States, meaning any strategic shift or delay on the partner's side could directly affect results.
As seen in the widening operating loss in the first half of 2026, profit and loss could deteriorate again in the near term as long as new-product trials and overseas marketing investment continue.
With revenue still at a relatively small scale, rising R&D and SG&A spending could increase the need for additional external funding.
The third-quarter 2026 earnings disclosure is expected around this time, warranting a check on whether Nexpowder revenue growth continues and how Nexsphere-F trial costs affect the operating profit and loss trend.
This is the timeframe the company has targeted for finalizing a Nexsphere-F US distribution agreement, and it is worth checking whether the negotiation concludes and on what terms.
It is worth checking whether patient enrollment for the Nexsphere-F US FDA pivotal trial is completed and how the subsequent approval application process progresses.
It is worth monitoring whether Nexsphere-F sales through Asahi Intecc in Japan begin to meaningfully contribute to revenue, and whether the effect of Medtronic's dedicated sales organization becomes visible in Nexpowder revenue.
NextBioMedical is a growth-stage medical device company centered on Nexpowder that has posted sharply higher revenue for three consecutive years, and in 2025 its operating loss narrowed to KRW 0.72 billion while operating cash flow turned positive for the first time, reflecting an improving financial structure.
However, in the first half of 2026 the operating loss widened again due to the expanded Nexsphere-F trial and overseas marketing investment, and quarterly net income has continued to swing between profit and loss.
The Nexsphere-F US FDA pivotal trial, a potential US distribution agreement, and the Japan partnership with Asahi Intecc are cited as key variables for future results. On the balance sheet, the company recovered from full capital impairment in 2023 to a stable equity position following its 2024 listing.
Some brokerages have issued price targets citing Nexpowder's global expansion and the value of Nexsphere-F partnerships, though these reflect each firm's assessment at the time and are subject to change depending on subsequent clinical and sales developments.
Overall, the company is at a transitional stage requiring both continued revenue growth and earnings stabilization, and the outcomes of upcoming clinical and contract milestones are likely to shape its next phase.
Report written 2026-09-05 · Data as of 2026-09-04
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