KOSDAQBiotech & Pharma347850

D&D Pharmatech

₩43,300▼ 4.31%2026-10-02 close
Market Cap
₩2T
Turnover
₩18.2B
Volume
420,000 shares
Shares out.
46M
PER
—
PBR
—
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

MASH Data In Hand; Licensing Remains the Test

DD01 met all key histological endpoints in its 48-week liver biopsy readout, yet revenue is confined to licensing and service fees while operating losses widen, leaving most of the equity story hinged on whether an out-licensing deal materializes.

  1. 1

    In the 48-week liver biopsy data disclosed on May 27, 2026, DD01 showed fibrosis improvement without MASH worsening in 50.0% of patients, MASH resolution without fibrosis worsening in 62.5%, and 37.5% on the composite endpoint, all statistically significant versus placebo.

  2. 2

    However, the analysis set covered 35 patients who completed both baseline and week-48 biopsies with full protocol adherence (16 on drug, 19 on placebo), and the final clinical study report covering all patients is scheduled for receipt in the third quarter.

  3. 3

    Revenue shrank from KRW 18.68bn in 2023 to KRW 11.44bn in 2024 and KRW 4.30bn in 2025, while the operating loss widened from KRW 13.49bn to KRW 33.99bn over the same period.

  4. 4

    The obesity pipeline agreement with Metsera expanded from the April 2023 transfer of DD02S and DD03 (about KRW 550bn in total including a KRW 13bn upfront) to a combined KRW 1,046.6bn after DD14, DD07 and DD15 were added in March 2024.

  5. 5

    By contrast, MET-224o, an oral obesity candidate using the OraLink platform, was classified in Pfizer's second-quarter pipeline disclosure as a program discontinued after May 5, 2026, a reminder that partner-led assets can drop out.

02

Business structure

D&D Pharmatech, founded in 2014, develops peptide drugs centered on the GLP-1 class, targeting not only obesity but also high-unmet-need metabolic diseases such as metabolic dysfunction-associated steatohepatitis (MASH) through global trials.

Its top in-house asset is DD01 (zabopegdutide), a long-acting dual agonist hitting both GLP-1 and glucagon receptors, which ran a Phase 2 trial in US patients with MASLD and MASH.

The company retains global development and commercialization rights to DD01 excluding China, and has said it intends to pursue a technology transfer deal based on the Phase 2 data.

The second pillar is out-licensed obesity assets: after transferring the oral GLP-1 candidate DD02S and triple agonist DD03 to Metsera in April 2023, the scope was widened in March 2024 with DD14, DD07 and DD15, taking the aggregate deal value to about KRW 1,046.6bn.

With no product sales, revenue consists of out-licensing income and joint R&D service fees from Metsera.

In neurology, NLY01, which completed a global Phase 2 in Parkinson's disease, is the most advanced program, and it has also received US Food and Drug Administration clearance for a Phase 2 investigational new drug application in multiple sclerosis.

The multiple sclerosis Phase 2 is led by the Johns Hopkins multiple sclerosis center and the Icahn School of Medicine at Mount Sinai, dosing more than 120 patients aged 60 or under over 96 weeks.

In liver fibrosis it holds TLY012, a first-in-class agent that directly improves fibrosis through selective apoptosis of myofibroblasts, and the company said its FAP-targeting positron emission tomography imaging agent completed first-patient dosing in Phase 2, with a milestone payment expected.

The competitive field is crowded: Eli Lilly, Boehringer Ingelheim, Hanmi Pharmaceutical and others are developing GLP-1 class drugs for MASH.

03

Earnings trend

Quarterly revenue · Operating profit
RevenueOperating profit
Annual revenue · Operating profit
RevenueOperating profit
Quarterly results · Last 5 quarters
QuarterRevenueOperating profitOp. margin
2025Q2₩900M-₩8.1B−871.7%
2025Q3₩1B-₩6.2B−640.5%
2025Q4₩1B-₩10.4B−1051.6%
2026Q1₩100M-₩11.1B−8636.7%
2026Q2₩700M-₩9.9B−1492.3%
Annual results
YearRevenueOperating profitNet income (parent)Op. marginROEDebt-to-equity
2023₩18.7B-₩13.5B₩3.9B−72.2%8.4%43.4%
2024₩11.4B-₩25B-₩28.6B−218.7%−40.8%40.1%
2025₩4.3B-₩34B-₩23.6B−791.0%−29.6%23.5%

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 a consolidated basis, revenue fell for two straight years: KRW 18.68bn in 2023, KRW 11.44bn in 2024 and KRW 4.30bn in 2025.

With the top line dependent on licensing and service income, fewer newly recognized contracts combined with R&D spending pushed the operating loss from KRW 13.49bn in 2023 to KRW 25.02bn in 2024 and KRW 33.99bn in 2025.

Net profit attributable to owners swung from a KRW 3.93bn profit in 2023 to losses of KRW 28.62bn in 2024 and KRW 23.55bn in 2025; because the 2023 profit came alongside an operating loss, it should be read as driven by non-operating items.

Operating cash flow was negative KRW 21.80bn in 2024 and negative KRW 21.14bn in 2025, two consecutive years of outflows above KRW 20bn, showing that losses translate into real cash burn.

Quarterly, revenue hovered near KRW 1bn at KRW 0.92bn in 2Q25, KRW 0.97bn in 3Q25 and KRW 0.99bn in 4Q25, then collapsed to KRW 0.13bn in 1Q26 before partially recovering to KRW 0.66bn in 2Q26.

The operating loss narrowed to KRW 6.21bn in 3Q25 but widened again to KRW 10.41bn in 4Q25, KRW 11.12bn in 1Q26 and KRW 9.88bn in 2Q26, reflecting trial costs concentrated around the completion of 48-week dosing and data analysis.

In 4Q25 the company posted net profit attributable to owners of KRW 1.81bn despite the KRW 10.41bn operating loss, underscoring volatile non-operating items, while 1Q26 and 2Q26 showed net losses of KRW 9.50bn and KRW 8.27bn.

Summing the four quarters from 3Q25 to 2Q26 gives revenue of KRW 2.75bn, an operating loss of KRW 37.62bn and a net loss attributable to owners of KRW 21.60bn.

At the end of 2025 total equity was KRW 78.98bn against total liabilities of KRW 18.56bn, a liability-to-equity ratio of about 23.5%, but the KRW 226.5bn private placement convertible bond approved on April 15, 2026 and maturing on April 30, 2031 was raised afterwards, so year-end figures alone do not describe the current balance sheet.

05

Industry analysis

MASH is a disease in which triglycerides accumulate in liver cells even without alcohol consumption, marked by hepatic inflammation and fibrosis, and capable of progressing to cirrhosis and liver cancer. Market researcher GlobalData projected the global MASH therapeutics market at USD 25.3bn in 2026.

Yet Madrigal's Rezdiffra remains the only US Food and Drug Administration-approved MASH drug, while the obesity drug market is forecast to reach USD 173.4bn by 2031 with oral development competition still at an early stage.

The regulatory gate centers on histology: the US Food and Drug Administration emphasizes liver biopsy in MASH because it is regarded as the most definitive way to directly confirm hepatic inflammation, fat accumulation and, above all, improvement in fibrosis, which drives patient prognosis.

The difficulty of that gate is visible in peer outcomes: Altimmune's pemvidutide secured strong weight-loss and liver fat reduction data but failed to reach statistical significance on biopsy-based fibrosis improvement, meeting only the MASH resolution endpoint while keeping follow-on development alive.

On the deal side, efimosfermin, licensed in by GSK, posted 49% liver fat reduction, 39% MASH resolution, 24% fibrosis improvement and 21% on the composite at 24 weeks before a transaction totaling USD 2bn was struck, while DD01 recorded 68.2%, 57%, 34% and 32% respectively at 48 weeks.

Analysts caution that differing trial designs and assessment periods make direct comparison difficult, while also noting that the scarcity of late-stage MASH assets available for licensing may add negotiating leverage.

Histology reading practices are also shifting: persistent concerns over inter-pathologist variability have made artificial intelligence-based standardization of histological assessment a new trend across the global industry.

06

Outlook

The most immediate item to verify is the final clinical study report for DD01, scheduled for receipt in the third quarter.

The EASL presentation analyzed 35 protocol-adherent patients out of 52 evaluable for histology, and whether the same efficacy is consistently reproduced in the full evaluable population within the final report is cited as the last hurdle for licensing talks.

The report is seen as the watershed that will fix deal size during global pharma due diligence, where full-analysis-set data and the handling of missing values are expected to be the key points of contention.

Management's stated preference is partnering over an in-house Phase 3: Vice President Hong Sung-hoon said the company has no plan to run Phase 3 itself for now, judging that good data would create an environment conducive to licensing, and has set its strategy in that direction.

On timing, Chief Executive Lee Seul-ki said at a June 11, 2026 briefing for domestic institutional investors that the company has a licensing agreement within the year in mind.

Among follow-on programs, an investigational new drug clearance for TLY012 in cirrhosis patients is slated for the second half of 2026, and the NLY01 multiple sclerosis Phase 2 is also under way.

On intellectual property, a Mexican patent registration decision for zabopegdutide was notified on August 10, 2026, following sequential registrations in the United States, China, Japan and other major markets since the first Korean filing in 2019.

On the partnered side, by contrast, Pfizer classified the oral obesity candidate MET-224o as a program discontinued after May 5, 2026 in its second-quarter pipeline disclosure, without disclosing specific reasons.

07

Valuation

PER
—
PBR
—
ROE
-20.2%
EPS
-₩490
BPS
—
Dividend per share
₩0

The company has been posting operating and net losses on both an annual and quarterly basis, so earnings-based multiples cannot be calculated and the price-to-earnings field on the screen is not displayed.

That leaves book-value multiples and pipeline value as the axes of assessment, and the price-to-book multiple sits in a range that embeds a large premium to net assets, typical of a clinical-stage biotech whose balance sheet is mostly cash and research assets.

No dividend is paid, so there is no basis for a dividend yield comparison.

The yardstick the market actually references is the price of comparable transactions rather than profits: specialists argue that the practical benchmark for DD01's licensing value is not approved drugs but assets that big pharma has acquired or licensed in at the Phase 2 or Phase 2b stage.

On that point, Heo Hye-min, analyst at Kiwoom Securities, said in a May 2026 report that with 48-week histological improvement following the 12-week liver fat reduction, best-in-class and licensing prospects had risen materially and that the market capitalization could be re-rated toward the level of large domestic biotechs, while Kim Sun-a, analyst at Hana Securities, said in May 2026 regarding the EASL presentation that if efficacy and side effects prove comparable to competing drugs, licensing could be targeted.

Note, however, that after total equity of KRW 78.98bn at end-2025, the KRW 226.5bn convertible bond with a conversion price of KRW 77,736 and a conversion window opening on April 30, 2027 altered the capital and liability structure, so net-asset-based multiples should be checked against the latest quarterly statements.

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

All Three Core Histology Endpoints Statistically Significant

The company said it secured statistically significant results versus placebo across every histological endpoint, including the two core registration endpoints of fibrosis improvement without MASH worsening and MASH resolution without fibrosis worsening, as well as the composite measure.

MASH resolution without fibrosis worsening reached 62.5% versus 5.3% on placebo, a 57.2 percentage point gap; fibrosis improvement without steatohepatitis worsening was 50.0% versus 15.8%; and the share achieving both was 37.5% versus 5.3%.

Using the artificial intelligence tool qFibrosis alongside pathologist reading, the fibrosis improvement rate was 72.7% against 12.5% on placebo, with statistical significance also confirmed under pathologist-only and combined artificial intelligence-pathologist reading.

Kiwoom Securities assessed that confidence in the trial results increased further as a consistent fibrosis improvement effect was confirmed across three mutually independent analytical methods.

Milestone Structure From Already Out-Licensed Obesity Assets

The Metsera licensing arrangement expanded from DD02S and DD03 in April 2023 (about KRW 550bn in total including a KRW 13bn upfront) to KRW 1,046.6bn after DD14, DD07 and DD15 were added in March 2024.

Metsera paid a USD 10m upfront and is due to pay up to USD 130m upon development milestones and up to USD 247.5m upon commercialization. Partner Metsera was acquired by Pfizer in November 2025 in a transaction valued at more than USD 10bn. Through this partnership the company generates either out-licensing revenue or joint R&D service revenue.

Pre-emptive Funding Ahead of Any Negotiation Delay

The company raised funds through a KRW 226.5bn convertible bond in April 2026, a move read as pre-emptively securing financial headroom against uncertainty over licensing and future development strategy ahead of the biopsy data release.

The bond carries a 0.0% coupon with no interest paid before maturity and repays principal in a lump sum at maturity, limiting near-term interest burden.

Even at end-2025, total liabilities of KRW 18.56bn against total equity of KRW 78.98bn implied a liability-to-equity ratio of about 23.5%, a relatively light debt load.

That said, with operating cash outflows above KRW 20bn in both 2024 and 2025, the pace at which the raised funds are consumed is a separate item to monitor.

09

Bear factors

Shrinking Revenue Alongside Widening Losses

Revenue shrank to about a quarter of its level, from KRW 18.68bn in 2023 to KRW 4.30bn in 2025, while the operating loss expanded from KRW 13.49bn to KRW 33.99bn over the same period. Quarterly revenue came in below KRW 1bn at KRW 0.13bn in 1Q26 and KRW 0.66bn in 2Q26, nowhere near enough to offset trial costs.

Over the four quarters from 3Q25 to 2Q26, the combined operating loss of KRW 37.62bn was more than ten times combined revenue of KRW 2.75bn. Unless a licensing agreement is signed, revenue will remain driven by small service fees and milestones.

Licensing Not Yet Secured and a Small Analysis Set

The company had aimed to license out DD01 before releasing the biopsy data, but as of the run-up to the EASL topline presentation no deal had been concluded.

The trial enrolled 67 patients and 52 were evaluable for histology, yet the presented analysis covered 35 patients who completed both baseline and week-48 biopsies with protocol adherence (19 on placebo, 16 on drug).

Cases involving concomitant medication use or protocol violations were excluded from the evaluation set, which could become a point of contention during due diligence.

Because the disease requires long-term dosing, safety and tolerability are also decisive value variables, with analysts noting that high discontinuation rates or gastrointestinal adverse events would inevitably lower asset value.

Convertible Bond Overhang and a History of Volatility Flags

Conversion rights were exercised on KRW 29.92bn of the first perpetual convertible bond, issuing 1,423,762 shares at a conversion price of KRW 21,017 with a listing date of July 9, 2026, equal to 3.21% of shares outstanding after exercise.

The second convertible bond of KRW 226.5bn, paid in during April 2026, carries a conversion price of KRW 77,736 and would add 2,913,691 shares, about 6.65% of total shares, with conversion possible from late April 2027.

The bond allows downward conversion price adjustment if the market price falls, with a floor adjustment price stated at KRW 54,416.

The stock had also been released from investment warning designation after a sharp rally, with re-designation flagged as possible and a caution that re-designation warrants attention to heightened short-term volatility.

10

Risk factors

Clinical and Regulatory Risk

The US Food and Drug Administration treats liver biopsy as effectively the most definitive assessment method in MASH, meaning the same endpoints must be reproduced in far larger populations at Phase 3.

Whether efficacy is consistently reproduced in the final report covering all evaluable patients is cited as the last hurdle for licensing negotiations. As peer cases show, strong weight loss and liver fat reduction have not always translated into statistical significance on biopsy-based fibrosis improvement. Either the regulatory path or the data interpretation could still diverge from expectations.

Partner Dependence and Pipeline Attrition

Once out-licensed, the obesity pipeline is driven by the partner, leaving the company with limited control over timelines and priorities.

In its second-quarter pipeline disclosure Pfizer classified MET-224o, a Phase 1 oral GLP-1 candidate using the OraLink platform, as discontinued after May 5, 2026, without disclosing specific reasons.

Companies whose business model rests on technology transfer struggle to generate large revenue because the timing of contracts and milestones is hard to pin down. The timing of milestone recognition can also swing quarterly results sharply.

Funding Needs and Share Dilution

Operating cash flow was negative in consecutive years at KRW 21.80bn in 2024 and KRW 21.14bn in 2025, and operating losses continued into 2026 at KRW 11.12bn in the first quarter and KRW 9.88bn in the second.

Observers note the company is a late entrant in MASH development and therefore needs to run a global Phase 3 faster and across many sites, which makes a partnership with a sufficiently capable global pharmaceutical company essential.

Delays in securing a partner would raise the need for additional funding, and full conversion of the second convertible bond at KRW 77,736 would add shares equal to roughly 6.65% of the total.

The KRW 4.40bn of first-series bonds repurchased via call option, equivalent to about 209,000 shares if converted, awaits a board decision on resale or cancellation, and remains potential supply while resale stays open.

11

What to watch next

  1. September to October 2026

    Whether and how the final clinical study report for DD01, due in the third quarter, is disclosed. Since full-analysis-set data and the treatment of missing values are expected to be the key issues in due diligence, the question is how the endpoints seen in the 35-patient set read across the full evaluable population.

  2. Fourth quarter of 2026

    Progress on the investigational new drug clearance for TLY012 in cirrhosis patients, slated for the second half of 2026. Both the widening of the in-house pipeline and the scale of incremental trial costs should be checked together.

  3. Mid-November 2026

    The third-quarter 2026 report. This is the point to check recognized licensing and service revenue, the quarterly operating loss that has been running near KRW 10bn, and the remaining balance and burn rate of the funds raised through the April convertible bond.

  4. Late December 2026

    Whether the goal stated by Chief Executive Lee Seul-ki is met, after he said at a June 2026 investor briefing that the company has a licensing agreement within the year in mind. If a deal is signed, the mix of upfront, development and commercial milestones and the territorial scope will determine the timing of actual cash inflows.

  5. Late April 2027

    The opening of the conversion window for the second convertible bond in late April 2027. Because the terms include a downward conversion price adjustment clause with a floor of KRW 54,416, any adjustment filing and the resulting change in potential share count should be monitored.

12

Overall view

For D&D Pharmatech, 2026 can be summarized as the year it cleared a data gate: the 48-week liver biopsy results disclosed on May 27 showed 50.0% fibrosis improvement, 62.5% MASH resolution and 37.5% on the composite endpoint, all statistically significant versus placebo.

Its profit and loss profile, however, remains typical of a clinical-stage biotech: as revenue fell from KRW 18.68bn in 2023 to KRW 4.30bn in 2025, the operating loss widened from KRW 13.49bn to KRW 33.99bn and operating cash flow posted outflows above KRW 20bn for two consecutive years.

Operating losses continued into 2026 at KRW 11.12bn in the first quarter and KRW 9.88bn in the second, keeping late-stage development beyond the reach of internally generated funds.

Against that backdrop, management said it has set its strategy toward licensing rather than running Phase 3 itself, and reproduction of the efficacy in the final report covering all patients is cited as the last hurdle for negotiations.

On the other side of the ledger sit Pfizer's discontinuation of MET-224o and the potential dilution from the second convertible bond, convertible from April 2027.

What ultimately needs verifying comes down to three facts: the content of the third-quarter final clinical study report, whether a licensing deal is signed within the year, and the pace at which the raised funds are consumed. This report is for informational purposes and contains no investment opinion or price target.

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. pharm.edaily.co.kr
  2. press9.kr
  3. medicaltimes.com
  4. m.thebell.co.kr
  5. newspim.com
  6. ddpharmatech.com
  7. m.thinkpool.com
  8. pharmnews.com
  9. dealsite.co.kr
  10. ibtomato.com
  11. hitnews.co.kr
  12. pharm.edaily.co.kr
  13. smedaily.co.kr
  14. finance-scope.com
  15. smarttoday.co.kr
  16. thebionews.net
  17. thebionews.net
  18. mt.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.