KOSDAQBiotech & Pharma082800

Vivozon Pharmaceutical

₩2,960▲ 0.17%2026-10-02 close

Market Cap

₩179.7B

Turnover

₩300M

Volume

110,000 shares

Shares out.

60.7M

PER

—

PBR

1.8×

EPS

-₩641

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

Anafra Prescription Growth, US Trial Funding in Focus

Vivozon Pharmaceutical is seeing quarterly revenue improve as domestic prescriptions of its non-opioid painkiller Anafra (opiranserin), Korea's 38th approved new drug, expand, but the company remains in an annual net loss position, with funding for a resumed US Phase 3 trial standing as a key challenge.

1
Anafra revenue rose from about KRW 300 million in April 2026 to roughly KRW 1 billion in June, reaching about KRW 2 billion in Q2, up 229% quarter-on-quarter.
2
Full-year 2025 revenue fell to KRW 59.3 billion, with an operating loss of KRW 19.2 billion and an owners' net loss of KRW 32.4 billion, widening losses versus the prior year.
3
Operating losses narrowed to KRW -3.0 billion in Q1 2026 and KRW -1.9 billion in Q2 2026, compared to KRW -10.2 billion in Q3 2025.
4
The company is targeting a resumption of the US Phase 3 trial, but negotiations with US regulators and securing trial funding remain outstanding tasks.
5
The company raised KRW 32.5 billion via a rights offering in early 2026, while partial capital impairment persists, making balance-sheet repair a parallel task.

Business structure

Vivozon Pharmaceutical is a listed affiliate of the Vivozon Group, which focuses on developing new drugs for pain and central nervous system disorders, and is classified in the KOSDAQ pharmaceutical sector.

The company's core asset is 'Anafra' (ingredient name opiranserin, VVZ-149), a non-opioid injectable analgesic approved by Korea's Ministry of Food and Drug Safety in December 2024 for moderate-to-severe acute postoperative pain, registered as Korea's 38th domestically developed new drug.

The drug operates through a dual-target mechanism combining glycine transporter type 2 (GlyT2) inhibition and serotonin 2A receptor (5-HT2A) antagonism, distinguishing it from conventional opioid or NSAID-class analgesics.

Commercialization accelerated following the October 2025 launch, with Boryung Pharmaceutical partnered for distribution and sales, and Hanmi Pharmaceutical joining as a co-marketing partner for hospitals with fewer than 300 beds from late February 2026.

The competing product is Maxigesic IV, a non-opioid combination injectable analgesic marketed by Kyungbo Pharm under an exclusive supply agreement with New Zealand's AFT Pharmaceuticals, and the company estimates the domestic non-opioid analgesic market at roughly KRW 70-80 billion.

The company also maintains an existing prescription drug lineup including the bowel-cleansing tablet Lalapang. On the pipeline expansion front, affiliate Vivozon is conducting a US Phase 1 trial for the oral candidate VVZ-2471, and is co-developing a transdermal patch formulation with iCure.

Earnings trend

Quarterly revenue · Operating profit

₩17.8B-₩2.7B25Q2₩6.8B-₩10.2B25Q3₩16.2B-₩3.7B25Q4₩14.1B-₩3B26Q1₩13.3B-₩1.9B26Q2

RevenueOperating profit

Annual revenue · Operating profit

₩59.1B-₩18.5B2022₩71.3B₩2.6B2023₩87.6B₩2.9B2024₩59.3B-₩19.2B2025

RevenueOperating profit

Quarterly results · Last 5 quarters
Quarter	Revenue	Operating profit	Op. margin
2025Q2	₩17.8B	-₩2.7B	−15.3%
2025Q3	₩6.8B	-₩10.2B	−151.0%
2025Q4	₩16.2B	-₩3.7B	−23.0%
2026Q1	₩14.1B	-₩3B	−21.4%
2026Q2	₩13.3B	-₩1.9B	−14.6%

Annual results
Year	Revenue	Operating profit	Net income (parent)	Op. margin	ROE	Debt-to-equity
2022	₩59.1B	-₩18.5B	-₩38.5B	−31.4%	−36.3%	76.8%
2023	₩71.3B	₩2.6B	-₩3.4B	3.6%	−3.2%	66.9%
2024	₩87.6B	₩2.9B	-₩10B	3.3%	−9.4%	73.3%
2025	₩59.3B	-₩19.2B	-₩32.4B	−32.3%	−44.6%	127.7%

Consolidated basis (financial statements including subsidiaries) · Final figures from DART filings · Net income attributable to owners of the parent · Data as of 2026-08-22

Earnings analysis

Full-year 2025 revenue came to KRW 59.3 billion, down roughly 32% from KRW 87.6 billion in 2024, with an operating loss of KRW 19.2 billion and an owners' net loss of KRW 32.4 billion, a marked deterioration from 2024's operating profit of KRW 2.9 billion and net loss of KRW 10.0 billion.

The company had posted operating profits in both 2023 (revenue KRW 71.3 billion, operating profit KRW 2.6 billion) and 2024 after winding down underperforming businesses such as cosmetics, but reverted to a large loss in 2025.

Recall issues affecting existing prescription drugs, including a cognitive-function treatment, have been cited as one factor behind the deterioration.

On a quarterly basis, revenue bottomed at KRW 6.8 billion with an operating loss of KRW 10.2 billion in Q3 2025, before recovering to KRW 16.2 billion (loss KRW 3.7 billion) in Q4 2025, KRW 14.1 billion (loss KRW 3.0 billion) in Q1 2026, and KRW 13.3 billion (loss KRW 1.9 billion) in Q2 2026, with operating losses progressively narrowing.

Net losses have also eased, from KRW -11.6 billion in Q3 2025 to KRW -2.8 billion in Q2 2026. Within this window, Anafra's own product revenue rose from about KRW 300 million in April 2026 to roughly KRW 1 billion in June, totaling about KRW 2 billion for Q2, up 229% quarter-on-quarter as disclosed by the company.

On a consolidated basis, 2025 equity stood at KRW 72.7 billion, down from KRW 106.4 billion in 2024, while the debt ratio jumped to 127.7% from 73.3%, and operating cash flow swung to KRW -6.9 billion in 2025 from KRW +5.7 billion in 2024.

Industry analysis

Korea's non-opioid analgesic market is drawing attention as an alternative amid growing concerns over opioid misuse and side effects, with the company estimating the addressable market at roughly KRW 70-80 billion.

The first-mover product Maxigesic IV, launched in Q2 2022, posted growth of 79.2% between 2023 and 2024, serving as a reference point for gauging Anafra's potential market penetration path.

The domestic market structure requires products to first pass Drug Committee (DC) reviews at tertiary hospitals before expanding to smaller hospitals, a process that tends to slow initial prescription uptake.

Globally, particularly in the United States, ongoing opioid abuse concerns have prompted the FDA and CDC to encourage development of non-opioid analgesics, and interest from global pharmaceutical companies has grown following recent FDA approval of an oral non-opioid analgesic from Vertex Pharmaceuticals.

However, entering the US market requires substantial Phase 3 trial funding, and Vivozon is working to resume a US Phase 3b trial that was halted due to COVID-19, with regulatory negotiations and financing remaining key hurdles.

In terms of competitive positioning, Kyungbo Pharm holds a first-mover advantage domestically by distributing the AFT Pharmaceuticals product, while Vivozon Pharmaceutical is pursuing a co-marketing agreement with Hanmi Pharmaceutical to bolster its sales network.

Outlook

The company has stated a target of capturing over 20% annual market share for Anafra domestically, with a reported 2026 revenue target of KRW 15 billion.

To meet growing prescription demand, it recently placed an additional production order of roughly 120,000 vials, and is working to expand Drug Committee reviews from reference sites such as Samsung Medical Center and Yonsei Severance Hospital to general hospitals and facilities with fewer than 300 beds.

To pursue expanded repeat-dosing indications, an investigator-initiated Phase 2 trial testing short-interval 30-minute repeat dosing was completed at Asan Medical Center, providing a basis for exploring multi-dose indication expansion.

The US Phase 3 trial is targeted for resumption within the year, though as of a June 2026 media report, negotiations with US regulators and securing trial financing remain the key outstanding tasks.

Affiliate Vivozon has leveraged a policy tailwind favoring non-opioid analgesics, with its oral candidate VVZ-2471 selected for support under the US National Institute on Drug Abuse (NIDA), and has also pursued European patent registration.

The company has stated its intent to expand development scope overseas following domestic commercialization, while exploring various partnership possibilities including licensing-out or finished-product supply agreements.

Valuation

PER

—

PBR

1.8×

ROE

-33.8%

EPS

-₩641

BPS

₩1,690

Dividend per share

₩0

Vivozon Pharmaceutical trades at a premium to its owners' equity, with its price-to-book ratio positioned toward the upper end of its historical trading range.

Because net losses have persisted over the most recent four quarters, a price-to-earnings ratio cannot be calculated, a characteristic common among early-stage new-drug commercialization companies. The company has no recent dividend payment history, limiting appeal from a yield perspective.

Against a backdrop where the 2025 annual net loss widened from 2024, the progressive narrowing of quarterly net losses through 2026 is a notable shift worth monitoring.

Whether this trend toward smaller losses continues toward a fuller earnings recovery will likely hinge on the pace of Anafra prescription growth and the resolution of US trial financing.

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 2026-08-22

Bull factors

Accelerating Anafra Prescription Growth

Anafra revenue expanded month-over-month from about KRW 300 million in April 2026 to roughly KRW 1 billion in June, suggesting a move past an initial launch slowdown toward a growth trajectory.

Following reference adoption at tertiary hospitals such as Samsung Medical Center and Yonsei Severance Hospital, Drug Committee reviews are expanding to general hospitals and facilities under 300 beds.

A co-marketing agreement with Hanmi Pharmaceutical is also reinforcing the sales network for smaller and mid-sized hospitals. The recent additional production order of roughly 120,000 vials reflects the company's confidence in continued demand growth.

Gradually Narrowing Quarterly Losses

Operating losses narrowed from KRW -10.2 billion in Q3 2025 to KRW -1.9 billion in Q2 2026, while owners' net losses shrank from KRW -11.6 billion to KRW -2.8 billion over the same period.

This suggests that the growing contribution from Anafra revenue has been accompanied by improvements in the existing cost structure. Revenue has also shown a recovery trend across four consecutive quarters since bottoming at KRW 6.8 billion in Q3 2025.

Global Expansion Potential of a First-in-Class New Drug

Anafra is regarded as the first non-opioid analgesic to demonstrate efficacy in a Phase 3 trial since a 1990s-era anti-inflammatory drug, and its mechanism-of-action findings have been published in the international journal Nature Communications, adding to its scientific evidence base.

The United States has fostered a policy environment favorable to non-opioid analgesic development amid opioid abuse concerns, meaning that a successful resumption of the Phase 3 trial could strengthen prospects for licensing-out or overseas rights discussions.

A parallel formulation diversification strategy spanning oral and patch delivery also leaves room for indication expansion.

Bear factors

Continued Large Annual Losses

Full-year 2025 revenue fell about 32% to KRW 59.3 billion, with the operating loss widening to KRW 19.2 billion and the owners' net loss to KRW 32.4 billion, a significant deterioration from 2024.

The small operating profits recorded in 2023-2024 may have partly reflected one-off effects from winding down underperforming businesses such as cosmetics, and the return to losses in 2025 leaves questions about the sustainability of profitability.

Equity declined from KRW 106.4 billion in 2024 to KRW 72.7 billion in 2025, while the debt ratio rose from 73.3% to 127.7%.

Uncertainty Over US Trial Financing

Resumption of the US Phase 3 trial is considered a value-defining event for the company, but as of a June 2026 report, whether FDA discussions have taken place or the final trial design timeline had not yet been disclosed.

The need for external financing to cover substantial late-stage trial costs has also been raised, suggesting that domestic revenue alone may not be sufficient.

Given that the company already completed a KRW 32.5 billion rights offering in early 2026, further financing raises the possibility of additional equity dilution.

Volatility in Early-Stage Prescription Uptake

Anafra showed volatility in its prescription ramp-up, with Q1 2026 revenue declining from the prior quarter after follow-up account development slowed following initial supply to new accounts in November-December 2025.

Given a sales structure centered on large medical institutions, the process from Drug Committee review through code registration to active prescribing takes time, and industry observers suggest that whether the revenue target of KRW 15 billion is met can only be confirmed by tracking results beyond Q3.

Risk factors

Balance Sheet Risk

The 2025 debt ratio rose sharply to 127.7% from the prior year, and operating cash flow registered a net outflow of KRW -6.9 billion. Partial capital impairment is reported to be ongoing, meaning that if Anafra's revenue growth falls short of expectations, pressure for additional financing could intensify.

Clinical and Regulatory Risk

The US Phase 3 trial was previously halted due to COVID-19, and even after resumption, finalizing FDA discussions and trial design may take time. Additional trials for expanded multi-dose indications are also underway, and their outcomes could delay the indication expansion timeline.

Competitive and Market Penetration Risk

First-mover Maxigesic IV has already established references in Korea's non-opioid analgesic market, meaning Anafra's target of over 20% market share will depend on the pace of hospital Drug Committee reviews and sales competitiveness.

If expansion to hospitals with fewer than 300 beds does not proceed as planned, achieving the revenue target could be delayed.

What to watch next

Around Q3 2026 earnings release (expected November)
Check Anafra's Q3 prescription and revenue trend against the annual revenue target of KRW 15 billion. Whether the growth momentum from Q2 is sustained will be a key point to watch.
Upcoming disclosures on the US Phase 3 trial
Monitor whether progress in FDA negotiations, final trial design confirmation, and financing plans become concrete. This is a key indicator of the company's global commercialization direction.
Follow-up disclosures on Drug Committee review expansion to sub-300-bed hospitals
Check the performance of the co-marketing partnership with Hanmi Pharmaceutical and the pace of prescription expansion into small and mid-sized hospitals, an indicator of improving market penetration for Anafra.
Follow-up disclosures on repeat-dosing indication expansion trials/approval
Check whether an indication expansion application and subsequent procedures follow from the completed Phase 2 trial on short-interval 30-minute repeat dosing at Asan Medical Center.

Overall view

Vivozon Pharmaceutical is showing positive signs of revenue growth and narrowing quarterly losses as it moves past the initial commercialization phase of Anafra, Korea's 38th domestically developed new drug.

However, on a full-year 2025 basis, the company showed clear financial strain including declining revenue, a widened net loss, and a rising debt ratio, with ongoing partial capital impairment keeping financing pressure elevated.

Resumption of the US Phase 3 trial is considered a value-defining event, but two outstanding tasks—regulatory negotiations and securing funding—remain unresolved.

Domestically, prescription base expansion is underway through the co-marketing partnership with Hanmi Pharmaceutical and outreach to smaller hospitals, with the pace of this expansion determining whether the annual revenue target of KRW 15 billion is met.

Overall, the stock displays characteristics typical of an early-stage new-drug commercialization biopharmaceutical company—a structure combining revenue growth potential with ongoing capital needs—warranting continued monitoring through upcoming earnings releases and US trial-related disclosures.

Sources

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

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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.