Sam Chun Dang Pharm

Samchundang Pharm began as a cardiovascular drug seller but shifted its center of gravity to ophthalmology after acquiring Opsus Pharm in 2013. Through eyedrop and ophthalmic contract manufacturing plus prescription drug sales, it has taken an early lead in Korea's single-use eyedrop market and holds the top share.

It expanded its Osong plant lines in 2022 to grow contract manufacturing orders and has outlined a KRW 86 billion investment in a second plant to more than double capacity.

Exports have widened as well: the company has built supply channels in around 30 countries including Europe under EU-GMP, North America and Southeast Asia, and US shipments of two eyedrop products ramped up in 2024, lifting North American sales. The second pillar is biosimilars.

VGENFLI (SCD411), an Eylea biosimilar under development since 2014, was built in both vial and pre-filled syringe formats and has won approvals in Canada and Europe as well as from Korea's drug agency and Japan's health ministry, with exclusive distribution and supply contracts signed for eight Eastern European countries.

The third pillar is oral conversion technology. S-PASS is an oral drug delivery platform for turning peptide and protein drugs into pills, and is being applied to oral semaglutide, tirzepatide and insulin.

Its commercial model leans on partners and profit sharing rather than direct selling: a nine-country Western European contract entitles it to 55% of partner gross sales, while the oral semaglutide license covering 11 European markets splits net profit 60% to Samchundang and 40% to the partner.

Competitively, it faces large peers such as Celltrion and Samsung Bioepis in Eylea biosimilars, while in oral GLP-1 generics the decisive entry condition is whether originator formulation patents can be avoided.

Annual results show steady top-line growth but volatile margins.

Revenue rose four years in a row, from KRW 177.3 billion in 2022 to KRW 192.7 billion in 2023, KRW 210.9 billion in 2024 and KRW 231.8 billion in 2025, while operating profit fell from KRW 12.2 billion (6.9% margin) in 2022 to KRW 9.6 billion (5.0%) in 2023 and KRW 2.6 billion (1.3%) in 2024 before recovering to KRW 8.5 billion (3.7%) in 2025.

Owner-based net income moved from losses of KRW 10.4 billion in 2023 and KRW 10.9 billion in 2024 to a profit of KRW 5.3 billion in 2025, and with consolidated net income of KRW 12.0 billion that year a large share accrued to non-controlling interests, underscoring the weight of subsidiary earnings (non-controlling equity of KRW 87.6 billion).

Quarterly, the trough was the second quarter of 2025 with revenue of KRW 56.9 billion and an operating loss of KRW 1.1 billion, followed by KRW 58.0 billion and KRW 3.4 billion in the third quarter and KRW 66.3 billion and KRW 5.4 billion in the fourth.

In 2026 the first quarter delivered revenue of KRW 64.9 billion with operating profit of KRW 5.4 billion and the second quarter KRW 70.7 billion with KRW 3.4 billion, taking first-half revenue to KRW 135.6 billion, and first-half consolidated revenue rose 26.1% year on year with both operating and net income swinging to profit, which the company attributed to the start of Canadian, Korean and European exports of its macular degeneration biosimilar and higher eyedrop sales at subsidiary Opsus Pharm.

Still, the quarterly operating margin eased from the 8% range in the first quarter of 2026 to the 4% range in the second, suggesting that early overseas launch costs and mix shifts weighed on profitability even as revenue reached its highest level in the period shown.

On the balance sheet, the debt-to-equity ratio climbed from 36.7% in 2023 to 48.8% in 2024 and 54.4% in 2025, while operating cash flow fell from KRW 23.4 billion in 2023 and KRW 21.8 billion in 2024 to KRW 9.8 billion in 2025, showing that profit recovery and cash generation are not yet aligned.

Dividends remain a small cash payout, consistent with a policy of redirecting most earnings into pipeline and capacity investment.

The first end-market, aflibercept, has entered full competition after patent expiry.

Expiry of the substance patent on the low-dose 2mg presentation opened the door for biosimilars, and as patent settlements and approvals progress in the US and Europe the contest has shifted to actual launch timing and revenue delivery.

Celltrion obtained US approval for its Eylea biosimilar Eydenzelt and completed a patent settlement with originator Regeneron.

Samsung Bioepis also reached a settlement and license with Regeneron and Bayer covering the low-concentration presentation outside the US and Canada, enabling staged launches in the UK in January 2026, major European markets in April 2026 and other countries in May 2026.

Samchundang therefore sits between first-mover and simultaneous-entrant status, with its differentiator framed as being the first in Europe to file an Eylea biosimilar in the pre-filled syringe format, in a market where PFS accounts for about 90% of aflibercept volumes.

Pricing pressure looks structural, however, since after patent expiry the contest among originator, biosimilars, high-dose presentations and follow-on novel drugs can persist for a considerable period. The second end-market, oral GLP-1, is large but gated primarily by patents.

With Rybelsus SNAC-related formulation patents registered through 2039, the company is developing what it aims to be the world's first SNAC-free oral semaglutide generic, and Japan's semaglutide market exceeds KRW 1 trillion a year on the diabetes indication and grows 25 to 30% annually, with a high oral share because injection preference is low.

In both arenas, legal certainty around patent avoidance and the execution capability of partner distribution networks will determine industry positioning.

The verifiable schedule the company has laid out clusters around regional expansion of the Eylea biosimilar and regulatory steps for the oral pipeline.

According to the company it has secured firm purchase orders for 750,000 vials in Europe and Canada, roughly 15 times its total 2025 export volume, and it stated that after Canadian reimbursement listing in late September 2025 it recorded revenue of KRW 9.7 billion and operating profit of about KRW 5.7 billion during roughly three months of effective selling (company statement, reported February 2026).

On coverage ambitions, recent investor materials said it is operating on the premise of roughly 80% global market coverage by combining partner sales networks with price competitiveness.

For oral semaglutide, it has signed an exclusive US deal securing about USD 100 million in milestones plus 90% of partner sales profit for ten years from first sale and an exclusive license covering 11 European countries including the UK, with upfront and milestones totaling EUR 30 million (about KRW 50.8 billion).

On the regulatory side, it received an FDA Pre-ANDA response on 20 July 2026 and said the agency confirmed a development path allowing an ANDA filing based on bioequivalence data without additional clinical trials.

Building on that, it began talks with Japanese partner Daiichi Sankyo Espha to fix detailed economic terms including upfront payments, stage milestones and supply prices.

For oral insulin, the global Phase 1 study of S-PASS-based SCD0503 is running at the German diabetes trial specialist Profil, with one third of target subjects dosed after the first patient in June, and the company targets trial completion and results in the fourth quarter.

As business goals it has cited at least two additional country-level global supply contracts in the second half of 2026, regular quarterly IR events, a dedicated PR and IR organization and a pre-consultation framework with the Korea Exchange.

That said, key pipelines still face product approvals, clinical data collection and final contract terms before commercialization, making delivery against this timetable the thing to watch.