KOSDAQBiotech & Pharma028300

HLB

₩40,600▲ 0.12%2026-10-02 close

Market Cap

₩5.4T

Turnover

₩27.8B

Volume

690,000 shares

Shares out.

130M

PER

—

PBR

13.0×

EPS

-₩1,615

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

September Bile-Duct Verdict, Fourth Try in Liver Cancer

With the liver-cancer candidate rivoceranib blocked by a third complete response letter, the US decision date for the bile-duct cancer drug lirafugratinib falls at the end of September.

1
US subsidiary Elevar Therapeutics received a third complete response letter (CRL) for the rivoceranib new drug application on July 9, 2026 local time, citing cGMP inspection findings (Form 483) at the Hengrui manufacturing site.
2
Lirafugratinib, an FGFR2-targeted agent, is under priority review with a PDUFA target action date of September 25, 2026.
3
Second-quarter 2026 revenue rose to KRW 28.0bn from KRW 15.7bn a year earlier, but the operating loss persisted at KRW 22.5bn and the net loss attributable to owners of KRW 77.0bn was the largest of the past five quarters.
4
The debt-to-equity ratio climbed to 88.1% at end-2025 from 36.1% at end-2024, while total equity fell from KRW 652.1bn to KRW 494.4bn.
5
Reports indicate the outstanding convertible and warrant bond balance has moved above KRW 300bn, with potential dilution calculated at about 5.18% of existing shares outstanding.

Business structure

HLB began in 1985 as a ship and lifeboat manufacturer, listed on KOSDAQ in 1999, and shifted its center of gravity to biotech after acquiring LSK BioPartners of the US in 2013.

Revenue today splits across drug development run through overseas subsidiaries, a healthcare division that makes and sells in-vitro diagnostic devices and quasi-drugs such as alcohol swabs, and HLB E&G, which produces vessels and shipbuilding equipment.

In other words, the bio segment that drives the profit-and-loss line still has no product revenue, while actual sales come from shipbuilding and healthcare.

The core asset is rivoceranib, a targeted oncology agent for which the company holds global rights excluding China, paired with camrelizumab, an immuno-oncology drug developed by Jiangsu Hengrui Pharmaceuticals.

The second pillar, the bile-duct cancer drug lirafugratinib, was licensed globally by US subsidiary Elevar Therapeutics from Relay Therapeutics in December 2024 in a deal worth up to USD 500m. The company signed that exclusive global license in 2024 as part of pipeline diversification.

At group level, consolidated subsidiaries numbered 13 as of end-2025 with 10 listed affiliates, and restructuring proceeded including the absorption of HLB Science at the end of 2025.

The competitive backdrop is demanding: first-line liver cancer is already occupied by multiple regimens including Tecentriq plus Avastin and Imfinzi plus Imjudo.

Looking toward commercialization, the company reshuffled management in late 2025, bringing in Kim Tae-han, formerly of Samsung Biologics, as chairman of the group bio division and replacing the head of Elevar.

Earnings trend

Quarterly revenue · Operating profit

₩15.7B-₩23.1B25Q2₩22.1B-₩23B25Q3₩28.7B-₩29.4B25Q4₩18.7B-₩23.2B26Q1₩28B-₩22.5B26Q2

RevenueOperating profit

Annual revenue · Operating profit

₩179.7B-₩74.7B2022₩42.9B-₩125B2023₩68.1B-₩118.5B2024₩84.2B-₩104.2B2025

RevenueOperating profit

Quarterly results · Last 5 quarters
Quarter	Revenue	Operating profit	Op. margin
2025Q2	₩15.7B	-₩23.1B	−146.6%
2025Q3	₩22.1B	-₩23B	−104.1%
2025Q4	₩28.7B	-₩29.4B	−102.5%
2026Q1	₩18.7B	-₩23.2B	−124.1%
2026Q2	₩28B	-₩22.5B	−80.4%

Annual results
Year	Revenue	Operating profit	Net income (parent)	Op. margin	ROE	Debt-to-equity
2022	₩179.7B	-₩74.7B	-₩78.2B	−41.5%	−12.3%	38.4%
2023	₩42.9B	-₩125B	-₩189.1B	−291.4%	−36.1%	29.1%
2024	₩68.1B	-₩118.5B	-₩92B	−174.0%	−16.0%	36.1%
2025	₩84.2B	-₩104.2B	-₩220.5B	−123.8%	−52.7%	88.1%

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

Annual revenue plunged from KRW 179.7bn in 2022 to KRW 42.9bn in 2023, then recovered to KRW 68.1bn in 2024 and KRW 84.2bn in 2025. Given continuous group-level M&A and affiliate restructuring over that span, year-to-year revenue comparisons should be read alongside changes in the consolidation scope.

Operating losses ran near KRW 100bn for four straight years - KRW 74.7bn in 2022, KRW 125.0bn in 2023, KRW 118.5bn in 2024 and KRW 104.2bn in 2025 - with the 2025 operating margin at -123.8%.

The 2025 net loss attributable to owners widened sharply to KRW 220.5bn from KRW 92.0bn in 2024; because the net loss grew in a year when the operating loss actually shrank, non-operating items clearly weighed heavily.

The balance-sheet shift is even more visible: total equity fell from KRW 652.1bn in 2024 to KRW 494.4bn in 2025 while total liabilities rose from KRW 235.3bn to KRW 435.8bn, lifting the debt-to-equity ratio from 36.1% to 88.1%.

Operating cash flow was negative every year - KRW 61.8bn in 2022, KRW 111.6bn in 2023, KRW 114.3bn in 2024 and KRW 92.6bn in 2025 - for cumulative outflows above KRW 380bn.

On a quarterly basis, revenue grew from KRW 15.7bn in 2Q25 to KRW 28.0bn in 2Q26, while the operating loss narrowed slightly from KRW 23.1bn to KRW 22.5bn. The net loss attributable to owners, however, widened again to KRW 38.0bn in 1Q26 and KRW 77.0bn in 2Q26, the largest of the five reported quarters.

Summing the four quarters from 3Q25 through 2Q26 gives revenue of KRW 97.5bn against an operating loss of KRW 98.1bn - the two figures being roughly equal captures the current profit-and-loss structure in one line.

Industry analysis

For Korean drug developers entering the US market, chemistry-manufacturing-controls and cGMP inspections have repeatedly proven the real gate rather than clinical data.

In HLB's case, both the 2024 and 2025 CRLs were reportedly driven not by clinical efficacy or safety concerns but by manufacturing facility issues at partner Hengrui, and the third CRL in July 2026 likewise stemmed from cGMP inspection findings at a Hengrui site.

On the other hand, there is a domestic precedent: Hugel's botulinum toxin Letybo won final approval on its third attempt after two CRLs tied to manufacturing facilities.

The regulatory backdrop itself is shifting - from 2026 the FDA has been sequentially publishing roughly 200 CRLs issued between 2020 and 2025 under a transparency policy, and the Elevar and Hengrui letters were disclosed in that process.

In the end market, first-line liver cancer is already an arena of intense competition among global pharma immuno-oncology combinations, and industry voices caution that approval alone does not translate into commercial success.

Bile-duct cancer, by contrast, is classified as a hard-to-treat disease with high unmet need: incidence keeps rising while early detection is difficult and prognosis poor.

Structurally, rare indications with few patients and limited options are easier to advance via priority review and breakthrough designation than large indications with entrenched standards of care.

Adding to this, US pharmaceutical tariffs take effect from September 29, 2026 - a proclamation set a 100% tariff in principle on patented drugs and related ingredients, with Korea reportedly capped at 15% under the bilateral trade agreement.

Outlook

The nearest checkpoint is lirafugratinib. It is an oral small-molecule agent that selectively inhibits FGFR2, designated an orphan drug by the FDA in 2022 and a breakthrough therapy in 2023, with its 2026 new drug application granted priority review and a target action date of September 25, 2026.

Elevar held a late-cycle meeting with the FDA on July 23, 2026 local time to discuss post-marketing requirements and commitments, and the company said no particular disagreements or new review issues affecting approval were raised.

That said, whether pre-approval inspections will be conducted at the active ingredient and finished product plants was not separately addressed at the meeting; the two sites are located in Canada and the US and both underwent routine cGMP inspections in 2025.

On the clinical side, global phase 1/2 data in 114 patients showed an objective response rate of 46.5%, median duration of response of 11.8 months, median progression-free survival of 11.3 months and median overall survival of 22.8 months.

Indication expansion is also under way, with the first patient dosed in June 2026 in a global phase 2 study for tumor-agnostic use.

Rivoceranib now enters a fourth attempt: the company said it has begun follow-up procedures for resubmission alongside analysis of the manufacturing findings, and the head of Elevar stated that the CRL contained no findings on clinical efficacy or safety and no request for additional trials, pledging the fastest possible resubmission.

The active-ingredient site was reportedly closed out as VAI, but remediation at the finished-product plant and the resubmission date remain variables.

Separately, the company has flagged phase 3 results for the ophthalmic candidate RGN-259 and clinical data for the next-generation CAR-T candidate SynKIR-310 within 2026.

Valuation

PER

—

PBR

13.0×

ROE

-54.4%

EPS

-₩1,615

BPS

₩2,591

Dividend per share

₩0

HLB has posted operating and net losses for four consecutive years and remained in the red across the most recent four quarters, so earnings-based multiples cannot be computed.

The market is therefore effectively pricing expectations for future pipeline cash flows, and the shares trade at a multiple of several times book value, well above the range typical for Korean pharma and biotech names.

No dividend is paid, so no dividend yield can be calculated, and financial policy centers on funding research and clinical work rather than shareholder returns.

For reference, in 2023 and 2024 the company targeted a 50% share of the first-line liver cancer market for the rivoceranib-camrelizumab combination and projected third-year sales of KRW 2,402.2bn and operating profit of KRW 2,046.9bn, but reports in early 2026 said that sales target was being re-examined against market conditions.

Ultimately, whichever multiple is used, the denominator depends entirely on approval and commercialization, which limits the usefulness of conventional valuation comparisons.

One industry source said HLB group share moves are hard to explain by the intrinsic value of the drugs alone, making future price direction impossible to guarantee.

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

September 25 Decision on the Bile-Duct Drug

Lirafugratinib carries priority review with a target action date of September 25, 2026, and the company said the late-cycle meeting produced no particular disagreements and no new review issues bearing on approval.

That meeting, typically held near the end of review, is a formal step for aligning labeling and post-marketing commitments on the assumption approval is possible. The clinical basis includes a 46.5% objective response rate and median overall survival of 22.8 months in 114 patients.

Approval would be the company's first US new drug clearance, making the outcome a reference point for how the market assesses group development capability.

A Manufacturing Issue Rather Than a Data Issue

The repeated approval failures for rivoceranib have been attributed not to clinical efficacy or safety but to manufacturing facility issues at the partner. According to the head of Elevar, the third CRL again contained no findings on clinical efficacy or safety and no request for additional trials.

The active-ingredient plant was reportedly closed out by the FDA as Voluntary Action Indicated. Manufacturing findings are in principle remediable, and a domestic precedent exists in which approval followed on a third attempt after two facility-related CRLs.

Widening Revenue Base and Pipeline Diversification

Annual revenue rose from KRW 42.9bn in 2023 to KRW 68.1bn in 2024 and KRW 84.2bn in 2025, and quarterly revenue of KRW 28.0bn in 2Q26 far exceeded the KRW 15.7bn a year earlier.

Per the company, growth in the shipbuilding segment came from stronger demand for lifeboats and davits plus expansion of the GRP/GRE pipe market, while the healthcare division sustained steady sales of in-vitro diagnostic devices and alcohol swabs.

On the pipeline, follow-on events flagged for 2026 beyond rivoceranib include lirafugratinib, the ophthalmic candidate RGN-259 and the CAR-T candidate SynKIR-310. The direction of reduced dependence on a single asset can be read as a structural change.

Bear factors

A Third CRL and Partner Risk Outside Its Control

On July 9, 2026 local time Elevar received a third CRL for the rivoceranib application, and the FDA stated it cannot approve the filing until the site's findings are resolved and cGMP compliance is confirmed.

The letter added that a pre-approval inspection may still be conducted after cGMP issues are cleared, and that satisfactory outcomes are required in both inspections for approval.

The company said the inspection was a routine cGMP audit rather than a review-related pre-approval inspection, so it was not informed in advance of the inspection or the Form 483 issuance. This repeatedly confirms a structure in which timing hinges on the partner's response speed.

Falling Cash and a Growing Bond Balance

The debt-to-equity ratio rose to 88.1% at end-2025 from 36.1% a year earlier, while total equity fell from KRW 652.1bn to KRW 494.4bn. Operating cash flow was negative for four consecutive years from 2022 to 2025, with cumulative outflows above KRW 380bn.

Press reports say consolidated cash and equivalents stood at KRW 26.3bn in 2Q26, down 35.69% from KRW 40.9bn at end-2025, while short- and long-term borrowings expanded to about KRW 277.2bn.

A board meeting on August 5, 2026 approved a 44th private convertible bond issue of KRW 30bn, and analysis suggests the outstanding bond balance including it rises to about KRW 315.6bn.

Approval and Commercialization Are Separate Questions

First-line liver cancer is already contested by multiple regimens such as Tecentriq plus Avastin and Imfinzi plus Imjudo, and observers note camrelizumab has low recognition in the US and Europe with potentially limited prescribing preference.

Industry voices argue that after three CRLs the odds of approval cannot be viewed with pure optimism, and that even approval would not equal commercial success. A direct sales strategy also carries heavy fixed costs plus reimbursement listing and price negotiation, implying a lag before revenue actually appears. Because rivoceranib is prescribed as part of a combination, its share of total regimen revenue may be limited.

Risk factors

Regulatory and Approval

Rivoceranib has been delayed by three CRLs across 2024, 2025 and 2026. Analysts note that remediation at the finished-product plant and the FDA's judgment on it will determine the resubmission timetable and the pace of the approval process.

For lirafugratinib as well, whether pre-approval inspections will occur at the active-ingredient and finished-product sites was not separately addressed at the late-cycle meeting. Regulatory timing is outside company control, and outcomes can materially change how pipeline value is perceived.

Financing and Dilution

The company has recorded operating losses and negative operating cash flow for four straight years, with the 2025 debt-to-equity ratio reaching 88.1%. Reports indicate that full conversion of outstanding convertible and warrant bonds would create 6,900,151 shares, equal to 5.18% of existing shares outstanding.

It was recently disclosed that the conversion price on the 39th convertible bond was adjusted downward following a decline in the market price. The company argues convertible bonds allow long-term funding at lower rates than ordinary loans or straight bonds.

Commercialization and Policy

Even after approval, reimbursement listing, price negotiation and distribution structures remain, implying a lag before revenue materializes. The company said it is weighing options including direct sales, a contract sales organization and partnerships, but no specific strategy has been finalized publicly.

Externally, US pharmaceutical tariffs take effect from September 29, 2026, and under a proclamation imposing 100% duties on patented drugs Korea was reportedly capped at 15%. Profitability effects will vary with production footprint and supply-chain structure.

What to watch next

September 25, 2026 (US Eastern Time)
This is the FDA target action date for lirafugratinib. Watch whether the outcome is approval, delay or a complete response letter, and what indication scope and post-marketing requirements appear on the label.
From September 29, 2026
US pharmaceutical tariffs begin to apply in earnest. Watch for company commentary on how the active-ingredient and finished-product supply chain and production footprint feed into costs under a US sales scenario.
October to November 2026
Watch for disclosure of the specific timing and strategy for the fourth rivoceranib resubmission. The company said it would explain the resubmission schedule and response plan to the market once it confirms the Form 483 details and Hengrui's remediation plan.
November 2026 (third-quarter results)
This is the point to check whether the revenue recovery trend holds and how the operating loss, cash and equivalents, and borrowings move. Because the 2Q26 net loss attributable to owners widened even as the operating loss narrowed, the composition of non-operating items also warrants review.
By December 2026
The company has flagged phase 3 results for the ophthalmic candidate RGN-259 and clinical data for the next-generation CAR-T candidate SynKIR-310 within the year. Progress in the tumor-agnostic phase 2 study of lirafugratinib is another item to track.

Overall view

HLB's profit and loss still comes from shipbuilding and healthcare rather than new drugs, with the bio segment functioning purely as a cost center.

The confirmed numbers make that structure plain: 2025 revenue of KRW 84.2bn against an operating loss of KRW 104.2bn and a net loss attributable to owners of KRW 220.5bn, while in 2Q26 revenue grew to KRW 28.0bn alongside an operating loss of KRW 22.5bn and a net loss attributable to owners of KRW 77.0bn.

On the balance sheet, shrinking equity, a rising debt-to-equity ratio (36.1% in 2024 to 88.1% in 2025), four consecutive years of negative operating cash flow and an expanding outstanding convertible and warrant bond balance are all unfolding together.

On the other side sit the FDA action date for lirafugratinib on September 25, 2026 and the company's account that no new review issues arose at the late-cycle meeting.

Rivoceranib is preparing a fourth resubmission after a third CRL in July 2026; the active-ingredient site was closed out as VAI, but finished-product plant remediation and resubmission timing remain the open variables.

In short, this name currently sits in a phase defined by regulatory dates rather than reported results, with bullish factors (a potential first US approval, a more diversified pipeline) and bearish factors (recurring manufacturing issues, cash burn, dilution) placed on the same calendar. This report compiles publicly available facts for informational purposes only.

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.