KOSPIBiotech & Pharma009420

Hanall Biopharma

₩46,300▼ 4.54%2026-10-02 close
Market Cap
₩2.4T
Turnover
₩12B
Volume
260,000 shares
Shares out.
52.2M
PER
—
PBR
17.2×
EPS
-₩490
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

Clinical Catalysts Collide With One-Off Charges

The core pharmaceutical business has pushed quarterly revenue to record levels, yet pipeline impairments and arbitration-related costs booked in the first half of 2026 have split operating momentum and bottom-line results in opposite directions.

  1. 1

    Second-quarter 2026 revenue of KRW 44.28bn and operating profit of KRW 5.60bn showed improvement on both lines, yet the owners' net loss came to KRW 19.23bn.

  2. 2

    The operating improvement reflected recognition of remaining deferred revenue upon completion of the thyroid eye disease Phase 3 trial, while the net loss stemmed from one-off items including development asset impairment.

  3. 3

    Batoclimab's thyroid eye disease Phase 3 missed its primary endpoints in April 2026, shifting attention to the next-generation asset imeroprubart.

  4. 4

    Interim analysis in difficult-to-treat rheumatoid arthritis showed ACR20, ACR50 and ACR70 response rates of 72.7%, 54.5% and 35.8%, with final topline data due in the second half of 2026.

  5. 5

    The pharmaceutical division keeps growing around Biotop, Normix and Eligard, but annual operating margins have stayed below 2% in each of the past four years.

02

Business structure

Hanall Biopharma combines a domestic prescription drug business with an R&D franchise that licenses autoimmune, ophthalmic and neurological candidates to global partners in exchange for milestones and royalties. The pharmaceutical division posted KRW 133.8bn in 2025 revenue, up 13% year on year, leading topline growth.

Core products include the probiotic drug Biotop and the non-absorbable antibiotic Normix, while Eligard, used in prostate cancer and central precocious puberty, continues to expand prescriptions. In the first half of 2026, cumulative sales surpassed KRW 14.8bn for Biotop and KRW 10.0bn for Normix.

The centerpiece of the R&D portfolio is the FcRn inhibitor HL161; in December 2017 the company licensed it to Roivant Sciences for North America, Latin America, Europe and the Middle East, receiving a non-refundable upfront payment of USD 30m.

Clinical work is now led by partner Immunovant, and the next-generation molecule imeroprubart is designed to achieve deeper IgG reduction at lower doses than batoclimab, using an autoinjector format.

The Greater China rights holder relationship changed course as the Harbour BioMed agreement was terminated in January 2025 and moved into International Chamber of Commerce arbitration.

In ophthalmology, the dry eye candidate tanfanercept is in Phase 3, with topline data from the third Phase 3 study, VELOS-4, targeted for 2026. Competitively, the company faces approved same-mechanism drugs such as argenx's Vyvgart and Johnson & Johnson's Imaavy.

03

Earnings trend

Quarterly revenue · Operating profit
RevenueOperating profit
Annual revenue · Operating profit
RevenueOperating profit
Quarterly results · Last 5 quarters
QuarterRevenueOperating profitOp. margin
2025Q2₩40.7B₩1.1B2.8%
2025Q3₩40.8B₩300M0.9%
2025Q4₩37.5B-₩2B−5.4%
2026Q1₩40B₩800M2.1%
2026Q2₩44.3B₩5.6B12.6%
Annual results
YearRevenueOperating profitNet income (parent)Op. marginROEDebt-to-equity
2022₩110B₩1.5B₩300M1.4%0.1%26.9%
2023₩134.9B₩2.2B₩3.5B1.6%1.9%28.7%
2024₩138.9B₩200M-₩1.8B0.2%−1.1%26.5%
2025₩155.2B-₩900M-₩5.6B−0.6%−3.4%39.3%

Consolidated basis (financial statements including subsidiaries) · Final figures from DART filings · Net income attributable to owners of the parent · Data as of 2026-09-04

04

Earnings analysis

On an annual basis, revenue rose for four consecutive years: KRW 109.995bn in 2022, KRW 134.910bn in 2023, KRW 138.944bn in 2024 and KRW 155.185bn in 2025.

Profitability moved the other way: operating profit of KRW 1.506bn in 2022 and KRW 2.211bn in 2023 fell to KRW 0.230bn in 2024 and turned into an operating loss of KRW 0.916bn in 2025, with operating margins of 1.4%, 1.6%, 0.2% and -0.6% respectively.

Owners' net income followed a similar path, from a KRW 3.509bn profit in 2023 to losses of KRW 1.805bn in 2024 and KRW 5.559bn in 2025. Cash flow tells a comparable story: operating cash flow of KRW 25.204bn in 2022 and KRW 29.643bn in 2023 narrowed to KRW 9.360bn in 2024 and swung to an outflow of KRW 2.340bn in 2025.

Quarterly, the trough was the fourth quarter of 2025 with revenue of KRW 37.549bn, an operating loss of KRW 2.016bn and a net loss of KRW 6.249bn; the first quarter of 2026 returned to an operating profit of KRW 0.839bn on revenue of KRW 40.031bn, and the company said drug sales rose 12% to KRW 35.5bn while Biotop set a quarterly record at KRW 7.6bn.

The second quarter of 2026 improved sharply to revenue of KRW 44.276bn and operating profit of KRW 5.598bn, which the company attributed to recognition of previously deferred residual revenue following completion of the batoclimab thyroid eye disease Phase 3 trial.

Even so, the owners' net loss for that quarter was KRW 19.229bn, reflecting one-off costs such as impairment of development assets, and first-half figures included a KRW 15.3bn intangible asset impairment tied to HL161 plus KRW 10.2bn in payables arising from the Harbour BioMed arbitration ruling.

On the cost side, first-half inventory disposal losses of KRW 7.9bn, versus KRW 0.7bn a year earlier, weighed on margins.

The balance sheet showed equity of KRW 161.681bn and liabilities of KRW 63.543bn at end-2025, lifting the debt-to-equity ratio to 39.3% from 26.5% in 2024 while remaining modest in absolute terms; across the four quarters from the third quarter of 2025 through the second quarter of 2026, the cumulative owners' net loss was KRW 24.904bn.

05

Industry analysis

FcRn inhibitors work by reducing pathogenic autoantibodies, binding immunoglobulin G and interrupting its recycling pathway, and are being tested across multiple autoimmune indications. Because commercialized drugs already exist in this class, later entrants must differentiate indication by indication.

Thyroid eye disease has proven difficult for the class as a whole: argenx's FcRn inhibitor also failed in a thyroid eye disease trial. Rheumatoid arthritis, by contrast, is an indication that approved rivals have not secured, making data there a key determinant of class positioning.

On the partner side, Immunovant raised USD 550m in an equity offering with heavy participation from majority holder Roivant, and said the proceeds fund operations through the anticipated Graves' disease launch, which matters for development continuity.

Sentiment toward Korean immunology-focused biotechs tracks global M&A flows closely; in June 2026, Immunovant's 52-week high on Nasdaq was cited as having cushioned downside pressure on the Korean shares.

The domestic pharmaceutical market itself grows gradually on prescription expansion and new launches, and the company's portfolio sits in relatively cycle-insensitive areas such as probiotics, antibiotics and hormone therapies.

That said, a heavy reliance on in-licensed products leaves margins exposed to cost of goods, currency moves and demand-forecast errors.

06

Outlook

Management has framed 2026 as a year concentrated with clinical readouts. CEO Chung Seung-won said five global clinical results would be released sequentially in 2026 across three core assets: batoclimab, imeroprubart and tanfanercept.

Among these, topline data from the difficult-to-treat rheumatoid arthritis registrational (Phase 2b) study and from the cutaneous lupus erythematosus Phase 2 study are slated for the second half, while the dry eye Phase 3 VELOS-4 study targets a 2026 topline.

Beyond 2026, registrational toplines in Graves' disease, myasthenia gravis and difficult-to-treat rheumatoid arthritis are targeted for 2027, with Sjogren's disease and chronic inflammatory demyelinating polyneuropathy toplines planned for 2028.

For the Parkinson's disease program, the company said HL192 is being developed with the goal of entering its next clinical stage within the year. In the base business, the company outlined a plan to expand its portfolio with eight new product launches in 2026.

On costs, investors should weigh the company's comment that legal expenses which had hurt profitability fell sharply from the prior year and should have limited earnings impact against the concentration of impairments, arbitration-related costs and inventory write-offs booked in the first half.

The two things to verify in the second half therefore separate cleanly: the direction of the clinical toplines, and the operating margin level once one-off items wash out.

07

Valuation

PER
—
PBR
17.2×
ROE
-15.7%
EPS
-₩490
BPS
₩3,181
Dividend per share
₩0

Because the owners' net result over the most recent four quarters was a loss, earnings-based multiples cannot be calculated and are not displayed.

That leaves the multiple against net assets as effectively the only relative gauge, and the current level sits in a zone of very large premium to book value, both against the Korean pharma and biotech sector average and against the company's own historical band.

This suggests that royalty expectations tied to the Immunovant-run FcRn pipeline, rather than base-business profits, are substantially embedded in the price, making the second-half clinical toplines the variable that either reinforces or undercuts that basis.

There is no per-share dividend in the latest disclosures, so no dividend yield is computed, which makes the stock hard to compare from an income perspective.

For reference, Shinhan Securities said in a May 29, 2026 report that it maintained a Buy rating and raised its target price to KRW 130,000 from KRW 48,000, with analyst Eom Min-yong citing the first demonstration globally of treatment potential in difficult-to-treat rheumatoid arthritis via an anti-FcRn mechanism. That is the brokerage's view; this report offers no opinion of its own alongside it.

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

08

Bull factors

Interim data in an unmet indication

On May 20, 2026, Immunovant reported 16-week interim results for imeroprubart in difficult-to-treat rheumatoid arthritis with ACR20, ACR50 and ACR70 response rates of 72.7%, 54.5% and 35.8%. The company said no new drug-related safety signals were observed in that study.

Since approved same-mechanism drugs have not secured the rheumatoid arthritis indication, replication in the final topline would form a class-differentiation argument.

Steady topline growth in the base business

Revenue grew for four straight years from KRW 109.995bn in 2022 to KRW 155.185bn in 2025, and expanded further to KRW 44.276bn in the second quarter of 2026.

The company said Biotop and Normix passed KRW 14.8bn and KRW 10.0bn respectively in first-half cumulative sales, approaching annual run rates in the KRW 30bn and KRW 20bn ranges. A plan for eight new product launches in 2026 was also presented as a diversification lever.

Partner funding and development pace

Immunovant completed a USD 550m equity raise with heavy participation from majority holder Roivant, and said this secured operating funds through the anticipated Graves' disease commercialization.

The topline timing for the difficult-to-treat rheumatoid arthritis registrational study was pulled forward to 2026 from 2027. Because the partner carries development spending, Hanall Biopharma's direct trial outlays remain limited.

09

Bear factors

Phase 3 failure in the lead asset and asset impairment

Batoclimab failed to confirm its primary endpoint in a global Phase 3 study, and with statistical significance not achieved, the commercialization path for that indication was assessed as effectively closed. As a result, a KRW 15.3bn intangible asset impairment tied to HL161 was booked in the first half. Some media outlets also raised the possibility that the partner could return the asset.

Structurally thin operating margins

Operating margins failed to exceed 2% in any of the past four years: 1.4% in 2022, 1.6% in 2023, 0.2% in 2024 and -0.6% in 2025. The sharp improvement in the second quarter of 2026 was also characterized by recognition of deferred revenue upon completion of a Phase 3 trial, so its repeatability warrants care.

Analysis has also noted that KRW 7.9bn of first-half inventory disposal losses directly pressured gross profit and the operating margin.

Cash flow and dispute costs

Operating cash flow narrowed from KRW 29.643bn in 2023 to KRW 9.360bn in 2024 and then turned to an outflow of KRW 2.340bn in 2025. Payables of KRW 10.2bn arising from the International Chamber of Commerce arbitration ruling with Harbour BioMed were recognized in the first half.

The debt-to-equity ratio rose from 26.5% in 2024 to 39.3% in 2025; the absolute level is low, but the direction points to increasing burden.

10

Risk factors

Clinical failure risk

The second-half topline readouts for the difficult-to-treat rheumatoid arthritis registrational study and the cutaneous lupus erythematosus Phase 2 study are events whose outcomes can break in binary fashion. Favorable interim analysis does not preclude a different result in final placebo-controlled data.

Tanfanercept previously missed its primary endpoints in VELOS-3, so the VELOS-4 outcome cannot be treated as settled.

Partner dependence

Global development, approval and commercialization of the FcRn pipeline are led by Immunovant and Roivant, so strategy shifts outside the company's control directly affect value.

Even after a successful myasthenia gravis Phase 3, Immunovant did not file for approval in that indication, saying it would decide its commercialization strategy after seeing the thyroid eye disease results. That left the global commercialization timeline delayed.

Inventory and cost control

First-half inventory disposal losses of KRW 7.9bn were calculated at roughly 9.4% of revenue for the same period. Cited causes included expiry of expensive imported active ingredients, low process yields and quality shortfalls in specific batches, and demand-forecasting failures in distribution.

Inventory valuation losses were also assessed as more than four times higher than a year earlier. Without improvement in inventory management, revenue growth may keep failing to translate into margin.

11

What to watch next

  1. September-December 2026

    Watch for the placebo-controlled, double-blind difficult-to-treat rheumatoid arthritis results and the cutaneous lupus erythematosus proof-of-concept topline that Immunovant said would come in the second half. Whether the interim ACR response rates are replicated in final data sits at the center of the pipeline-value debate.

  2. Around late October 2026

    In the third-quarter 2026 results, check the operating margin and bottom line once the impairments, arbitration costs and inventory write-offs concentrated in the first half have cleared. The key question is whether operating profitability holds without the boost from deferred revenue recognition.

  3. Fourth quarter of 2026

    Confirm the timing and content of results from the dry eye Phase 3 VELOS-4 study, which targets a 2026 topline. It matters separately because it is the in-house asset closest to commercialization.

  4. January-February 2027

    The full-year 2026 disclosure will allow a check on pharmaceutical division growth and the actual contribution from the plan to launch eight new products in 2026. Settlement of the Harbour BioMed arbitration payables and the direction of annual operating cash flow are also worth verifying.

  5. During 2027

    Track whether the 2027 target for registrational toplines in Graves' disease, myasthenia gravis and difficult-to-treat rheumatoid arthritis holds. Schedule changes themselves affect assumptions on development progress and royalty timing.

12

Overall view

Hanall Biopharma grew revenue for four consecutive years to KRW 155.185bn in 2025 on its domestic prescription drug business, but its operating margin slid from 1.4% to -0.6% over the same span, splitting topline and profitability.

In 2026, operating results improved to KRW 0.839bn in the first quarter and KRW 5.598bn in the second, though the second-quarter gain included deferred revenue recognized upon completion of the thyroid eye disease Phase 3 trial, and the owners' net loss was KRW 19.229bn.

That loss traced to clearly identifiable items: an intangible asset impairment linked to HL161 and payables from the Harbour BioMed arbitration ruling.

On the pipeline, two opposing pieces of information coexist: the assessment that batoclimab's path to commercialization in that indication is effectively closed, and imeroprubart's interim data in difficult-to-treat rheumatoid arthritis.

With losses preventing calculation of earnings-based multiples and the shares trading at a large premium to net assets, much of the price is tied to clinical outcomes that are not yet determined.

The axes for verification are therefore the two second-half toplines, the dry eye Phase 3 result, and third-quarter margins stripped of one-off items. This report is for informational purposes and contains no buy or sell opinion or target price.

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. news.nate.com
  2. v.daum.net
  3. m.irgo.co.kr
  4. file.alphasquare.co.kr
  5. v.daum.net
  6. digitaltoday.co.kr
  7. cbci.co.kr
  8. digitaltoday.co.kr
  9. comp.wisereport.co.kr
  10. youtube.com
  11. mt.co.kr
  12. newsmp.com
  13. m.thebell.co.kr
  14. topdaily.kr
  15. hanall.com
  16. news.nate.com
  17. v.daum.net
  18. medifonews.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.