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
Resolution of the Eylea biosimilar patent dispute and progress on Lorecivivint's US regulatory review have raised turnaround hopes, but five consecutive quarters of operating losses through H1 2026 mean earnings normalization has yet to be confirmed.
2025 revenue came to KRW 210.2bn (down year-on-year), with the operating loss widening to KRW 22.2bn.
The operating loss peaked at KRW 8.4bn in 1Q26 before narrowing modestly to KRW 6.3bn in 2Q26.
The patent dispute over the wet AMD drug Afilibu was resolved via a February 2026 settlement, allowing sales to resume.
Lorecivivint, an osteoarthritis drug candidate for which the company holds Korean exclusive rights, had its New Drug Application filed with the US FDA in January 2026.
The Vietnam eye-drop CDMO plant is pursuing Korean KGMP certification, seen as the turning point for expanding commercial production.
Founded in 1947, Samil Pharm is a mid-sized Korean pharmaceutical company specializing in ophthalmology, liver disease, gastrointestinal, and central nervous system therapeutics. Its revenue mix combines licensed and directly imported original products with self-manufactured generics and improved new drugs.
In ophthalmology, the company holds roughly 48 products spanning dry eye treatments, glaucoma drugs, and artificial tears, one of the largest such lineups domestically and a point of differentiation from competitors focused mainly on artificial tears.
Key licensed products include Restasis, a globally leading dry eye treatment from Allergan (now under AbbVie), and Afilibu, an Eylea biosimilar developed by Samsung Bioepis, while the company also maintains partnerships with global ophthalmic firms such as Nicox and Thea.
On the pipeline side, Lorecivivint, an osteoarthritis drug candidate licensed from US-based Biosplice in 2021, is a core asset. More recently, the company signed distribution and CMO agreements with Taiwan's Formosa for APP13007, a post-cataract-surgery anti-inflammatory eye drop.
Its Vietnam subsidiary, established in 2018, operates an eye-drop manufacturing plant near Ho Chi Minh City completed in 2022 with capacity exceeding 300 million units annually, positioned as an overseas production hub to reduce domestic revenue reliance.
Domestically, the Eylea biosimilar market has also drawn Celltrion (Eydenzelt) and Samchundang Pharm (Vigenpli), intensifying competition.
| Quarter | Revenue | Operating profit | Op. margin |
|---|---|---|---|
| 2025Q2 | ₩53.8B | -₩3.1B | −5.8% |
| 2025Q3 | ₩51.2B | -₩5.2B | −10.1% |
| 2025Q4 | ₩53B | -₩8.6B | −16.2% |
| 2026Q1 | ₩52.5B | -₩8.4B | −15.9% |
| 2026Q2 | ₩50.6B | -₩6.3B | −12.5% |
| Year | Revenue | Operating profit | Net income (parent) | Op. margin | ROE | Debt-to-equity |
|---|---|---|---|---|---|---|
| 2022 | ₩179.7B | ₩4B | -₩28,287,010 | 2.2% | 0.0% | 183.5% |
| 2023 | ₩196.3B | ₩6.5B | ₩1.7B | 3.3% | 1.3% | 190.0% |
| 2024 | ₩219.7B | ₩100M | -₩5.6B | 0.1% | −3.2% | 124.3% |
| 2025 | ₩210.3B | -₩22.2B | -₩34.7B | −10.6% | −26.0% | 178.9% |
Consolidated basis (financial statements including subsidiaries) · Final figures from DART filings · Net income attributable to owners of the parent · Data as of 2026-08-23
Consolidated 2025 revenue came to KRW 210.2bn, slightly below 2024's KRW 219.7bn, while the operating loss widened to KRW 22.2bn from a near-breakeven operating profit of KRW 0.1bn in 2024. Net loss attributable to owners also deepened sharply, from KRW 5.6bn in 2024 to KRW 34.7bn in 2025.
Looking at the multi-year path, the company posted a small net loss in 2022 (-KRW 0.03bn), then turned profitable in 2023 with revenue of KRW 196.3bn, operating profit of KRW 6.5bn (a 3.3% margin), and net income of KRW 1.7bn, before profitability deteriorated again in 2024-2025.
On a quarterly basis, the operating loss widened progressively from KRW 3.1bn in 2Q25 to KRW 5.2bn in 3Q25 and KRW 8.6bn in 4Q25, effectively peaking at KRW 8.4bn in 1Q26.
It then narrowed modestly to KRW 6.3bn in 2Q26, an early sign of improvement, even as revenue actually declined from KRW 53.8bn in 2Q25 to KRW 50.6bn in 2Q26. Net losses similarly eased from KRW 11.2bn in 4Q25 and KRW 10.8bn in 1Q26 to KRW 7.7bn in 2Q26, though the losses remain sizable.
The trailing four-quarter sum (3Q25-2Q26) of net loss attributable to owners reached KRW 37.6bn, indicating the loss trend has persisted on an annualized basis as well.
Operating cash flow fell sharply to KRW 0.57bn in 2025 from KRW 2.59bn in 2024, pointing to weakened cash generation alongside the earnings deterioration.
Korea's pharmaceutical sector is dominated by mid-sized companies combining licensed originals, generics, and improved new drugs rather than large-scale novel drug developers, and Samil Pharm has positioned itself in a niche strategy centered on ophthalmology, liver disease, and gastrointestinal treatments.
In the ophthalmic biosimilar space, patent disputes surrounding the global blockbuster Eylea (aflibercept) have directly affected the market entry timing and sales strategies of Korea's three key players—Celltrion, Samsung Bioepis, and Samchundang Pharm.
Afilibu's patent risk was largely resolved when Samsung Bioepis reached a licensing settlement with the original developer in February 2026, though price and reimbursement competition with Celltrion's already-marketed Eydenzelt and newly-entered Samchundang's Vigenpli is expected to continue.
The osteoarthritis treatment market remains dominated by symptomatic pain and anti-inflammatory therapies, leaving substantial unmet need for disease-modifying drugs (DMOADs); if Lorecivivint becomes the first such approved therapy, it could establish a new treatment paradigm.
In the eye-drop contract manufacturing (CMO/CDMO) space, the company's strategy of using Vietnam as a production base for global expansion has drawn attention, with a staged GMP certification approach—having secured Vietnam local and WHO-GMP certifications and now pursuing Korean KGMP followed by US cGMP and EU-GMP—aimed at sequentially securing overseas clients.
The broader domestic pharma-bio industry outlook is generally viewed as challenging, with small and mid-cap firms in a phase of shoring up fundamentals.
The company has positioned Afilibu's full-year revenue contribution and core business normalization as the central pillars of its 2026 earnings recovery.
In a February 2026 report, SK Securities noted Afilibu generated over KRW 1.5bn in sales in its first month back on the market and projected annual revenue recovery of roughly KRW 20bn (analyst Heo Seon-jae, February 2026).
The same report estimated standalone 2026 revenue of KRW 239.4bn (up 13.8% year-on-year) and an operating profit of KRW 11.3bn, marking a swing to profitability, though it did not issue an investment rating or price target.
On the pipeline front, Lorecivivint's NDA was filed with the US FDA in January 2026, with SK Securities projecting an approval decision within the fourth quarter.
The Vietnam CDMO plant secured local GMP and WHO-GMP certification in September 2025 and is now pursuing Korean KGMP certification, which if completed would enable domestic eye-drop volumes to shift to local production and open contract manufacturing services for other Korean pharma companies.
The company subsequently plans to pursue US cGMP and EU-GMP certifications targeted for the first half of 2027. It has already signed a roughly KRW 28bn, five-year CMO agreement with Taiwan's Formosa, and management has stated multiple additional CMO partnership discussions are ongoing.
The current share price sits close to net asset value, trading in a range without a large premium or discount relative to book value.
Operating results over the past three years have swung between profit and loss without establishing a clear direction, making earnings-based valuation approaches challenging to apply consistently. Dividend payments have not been confirmed recently, limiting any income-based valuation argument.
One brokerage noted that as the drivers behind 2025's weak results (sales suspension from the patent dispute, one-off clinical costs, delayed Vietnam plant certification) ease, the share price remains below its prior peak (SK Securities, February 2026), though this reflects that firm's own view rather than a settled conclusion.
Until the pace of earnings normalization and the concrete revenue contribution timing from the new drug and CMO pipeline become clearer, gauging the direction of valuation remains difficult.
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 2026-08-23
In February 2026, Samsung Bioepis reached a global patent settlement with the originator, including the US market, fully resolving the legal uncertainty surrounding Afilibu's domestic distribution and sale. Demand itself has been confirmed, with over KRW 1.5bn in sales recorded in the first month after resumption.
Price and reimbursement competition is still expected to persist given entries from Celltrion and Samchundang Pharm.
Lorecivivint, an osteoarthritis drug candidate for which the company holds Korean exclusive rights, had its NDA filed with the US FDA in January 2026, aiming to become the world's first approved disease-modifying osteoarthritis drug (DMOAD).
If approved, it is seen as having the potential to introduce a new treatment paradigm in the domestic market as well. However, the FDA review outcome remains undetermined.
The Vietnam eye-drop plant has already secured local GMP and WHO-GMP certification and signed a roughly KRW 28bn, five-year CMO agreement with Taiwan's Formosa.
Once Korean KGMP certification is completed, it is expected to enable domestic eye-drop volume transfer and expanded contract manufacturing, with the company stating multiple additional partnership discussions are underway. This could help reduce the company's domestic revenue concentration.
Operating losses persisted for five consecutive quarters from 2Q25 through 2Q26, and full-year 2025 results showed an operating loss of KRW 22.2bn and net loss of KRW 34.7bn, a sharp widening from the prior year. While 2Q26 losses narrowed slightly, revenue itself actually declined from the year-earlier quarter. Whether earnings normalization is a sustained trend requires confirmation from further quarters.
In the domestic Eylea market, Celltrion's Eydenzelt and Samchundang Pharm's Vigenpli have already entered or are preparing to enter, intensifying price and reimbursement competition. Some analysts note that resolving patent risk does not automatically translate into improved profitability. Securing market share in the roughly KRW 13tn global Eylea market remains a key question.
The company's overseas revenue share has remained below 1% until recently, and delayed GMP certification at the Vietnam plant was cited as one factor behind weak 2025 results. If Korean KGMP certification continues to be delayed, the ramp-up of CMO revenue could similarly be pushed back. Standalone first-half revenue still comes predominantly from domestic sources.
The patent risk surrounding Afilibu was largely resolved via settlements reached in January-February 2026, but litigation over Eylea has proceeded in a complex, country- and formulation-specific manner. The possibility of similar litigation recurring or new disputes emerging in other regions cannot be ruled out. Given the nature of the biosimilar business, patent issues remain a persistent risk factor.
Lorecivivint is under FDA review as the world's first DMOAD candidate, but new drug approvals can result in various outcomes including approval, a complete response letter, or rejection. Delayed or denied approval could affect valuations that have priced in related expectations.
Even after approval, commercialization-stage uncertainties such as reimbursement and pricing decisions would remain.
The 2025 debt-to-equity ratio stood at a high 178.9%, and operating cash flow fell sharply to KRW 0.57bn from KRW 2.59bn in 2024. Continued net losses could lead to erosion of shareholders' equity and accumulating financial burden. The funding load associated with large-scale investments such as the Vietnam plant also warrants monitoring.
The 3Q26 earnings release will show whether the operating loss narrowing seen in 2Q26 continues and how much of Afilibu's full-quarter revenue contribution materializes.
This is the period when the FDA decision on Lorecivivint is projected (per SK Securities) to be made, and whether the outcome is approval, a complete response letter, or rejection will shape the direction of the drug pipeline narrative.
Watch for completion of Korean KGMP certification at the Vietnam plant, subsequent transfer of domestic production volume, and any disclosed new CMO contract signings.
Whether the company achieves its targeted US cGMP and EU-GMP certifications will determine the next phase of its global CDMO business expansion.
Samil Pharm is a mid-sized pharma company with a specialized ophthalmology portfolio, a Vietnam CDMO production base, and drug pipeline momentum from Lorecivivint, yet its earnings normalization has not yet been confirmed numerically, with five consecutive quarters of operating losses through 2025 and the first half of 2026.
The resolution of Afilibu's patent risk and resumption of sales are positive signals, but whether this translates into improved profitability amid intensifying Eylea market competition requires verification through further quarterly results.
The outcome of the US FDA review for Lorecivivint and completion of Korean KGMP certification at the Vietnam plant stand out as the key events that will shape future earnings and business direction.
Financially, a high debt-to-equity ratio and weakened cash generation are also observed, warranting a balanced perspective. With the current share price trading close to net asset value, it remains difficult to assert a clear valuation direction until the pace and durability of earnings recovery are confirmed.
Report written 2026-09-05 · Data as of 2026-09-04
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