KOSPIBiotech & Pharma326030

SK biopharmaceuticals

₩76,200▼ 0.65%2026-10-02 close

Market Cap

₩5.9T

Turnover

₩4.8B

Volume

60,000 shares

Shares out.

78.3M

PER

16.9×

PBR

6.6×

EPS

₩5,120

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

Cenobamate Surges as a Second Drug Bet Lands

Direct U.S. sales of the epilepsy drug cenobamate have lifted the annual operating margin into the high-20% range, while an August 2026 in-licensing deal worth up to USD 795 million simultaneously addresses single-product concentration and adds clinical risk.

1
In 2025 consolidated revenue reached KRW 706.7 billion with operating profit of KRW 203.9 billion, a 28.9% operating margin, marking a complete exit from the heavy operating losses of 2022 and 2023.
2
Second-quarter 2026 revenue of KRW 247.4 billion and operating profit of KRW 97.1 billion pushed the quarterly operating margin into the 39% range, with first-half operating profit at KRW 186.8 billion.
3
The company disclosed second-quarter 2026 U.S. XCOPRI sales of KRW 224.4 billion and about 143,000 total U.S. prescriptions, and said close to 90% of total revenue comes from cenobamate.
4
On August 26, 2026 it licensed the epilepsy candidate Opakalim from Biohaven for up to USD 795 million, including a USD 400 million upfront, in pursuit of a second commercial product.
5
Topline data from the pivotal RISE-3 trial is expected at the end of 2026, bringing the validation point for that large upfront payment close at hand.

Business structure

SK Biopharmaceuticals is an SK Group affiliate focused on central nervous system (CNS) drug development, with its business built around cenobamate, a treatment for partial-onset seizures marketed in the U.S. as XCOPRI.

It sells cenobamate directly in the U.S. through its subsidiary SK Life Science, while collecting royalties via out-licensing in Europe, Asia and elsewhere, meaning most revenue is dollar-denominated. SK Life Science operates a local sales organization of more than 150 people.

Close to 90% of company revenue comes from cenobamate. Other revenue in the second quarter of 2026 totaled KRW 23.0 billion, consisting of KRW 13.3 billion in drug product and active ingredient sales and KRW 9.7 billion in service revenue.

Geographic expansion runs through partners: China approved the drug in December 2025 and launch followed in March 2026 via Ignis Therapeutics, while in Japan Ono Pharmaceutical filed for approval with the PMDA in September 2025.

On competition, UCB's Briviact and Eisai's Fycompa have long held share in the U.S. epilepsy market; Briviact's core patent expires in 2026, exposing it to generics, while cenobamate's patent runs to October 2032.

The company says direct U.S. sales have made cenobamate the most prescribed branded new drug in the local epilepsy treatment market.

In August 2026 it licensed a next-generation epilepsy candidate from U.S.-based Biohaven, pursuing a shift to a multi-product model selling several innovative drugs through its existing direct sales network.

Earnings trend

Quarterly revenue · Operating profit

₩176.3B₩61.9B25Q2₩191.7B₩70.1B25Q3₩194.4B₩46.3B25Q4₩227.9B₩89.8B26Q1₩247.4B₩97.1B26Q2

RevenueOperating profit

Annual revenue · Operating profit

₩246.2B-₩131.1B2022₩354.9B-₩37.5B2023₩547.6B₩96.3B2024₩706.7B₩203.9B2025

RevenueOperating profit

Quarterly results · Last 5 quarters
Quarter	Revenue	Operating profit	Op. margin
2025Q2	₩176.3B	₩61.9B	35.1%
2025Q3	₩191.7B	₩70.1B	36.6%
2025Q4	₩194.4B	₩46.3B	23.8%
2026Q1	₩227.9B	₩89.8B	39.4%
2026Q2	₩247.4B	₩97.1B	39.2%

Annual results
Year	Revenue	Operating profit	Net income (parent)	Op. margin	ROE	Debt-to-equity
2022	₩246.2B	-₩131.1B	-₩139.4B	−53.2%	−44.0%	109.8%
2023	₩354.9B	-₩37.5B	-₩35.4B	−10.6%	−12.5%	125.3%
2024	₩547.6B	₩96.3B	₩240.7B	17.6%	44.1%	80.6%
2025	₩706.7B	₩203.9B	₩267B	28.9%	32.8%	45.0%

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

The earnings trajectory has clearly inflected.

Consolidated revenue rose for three straight years, from KRW 246.1 billion in 2022 to KRW 354.8 billion in 2023, KRW 547.5 billion in 2024 and KRW 706.7 billion in 2025, while operating results swung from losses of KRW 131.0 billion in 2022 and KRW 37.5 billion in 2023 to profits of KRW 96.3 billion in 2024 and KRW 203.9 billion in 2025.

The operating margin improved from minus 53.2% in 2022 and minus 10.6% in 2023 to 17.6% in 2024 and 28.9% in 2025, indicating revenue growth has moved past the fixed-cost base.

Cash flow followed: operating cash flow turned from minus KRW 159.9 billion in 2022 and minus KRW 94.2 billion in 2023 to positive KRW 94.9 billion in 2024 and KRW 176.3 billion in 2025, while the debt-to-equity ratio fell from 125.3% in 2023 to 80.6% in 2024 and 45.0% in 2025.

Quarterly, revenue and operating profit grew from KRW 176.3 billion and KRW 61.9 billion in the second quarter of 2025 to KRW 227.9 billion and KRW 89.8 billion in the first quarter of 2026 and KRW 247.4 billion and KRW 97.1 billion in the second quarter of 2026, taking the quarterly operating margin into the 39% range, with first-half operating profit of KRW 186.8 billion.

The company said that in the second quarter of 2026 operating profit rose KRW 7.3 billion from the prior quarter despite the disappearance of a one-off milestone booking and higher R&D and marketing costs, while U.S. cenobamate sales reached KRW 224.4 billion, up 45.6% year on year.

By contrast, in the fourth quarter of 2025 revenue of KRW 194.4 billion came with operating profit of KRW 46.3 billion, below the prior quarter's KRW 70.1 billion; analysts at the time attributed the decline to the absence of one-off revenue and noted annual selling and administrative expenses of KRW 459.5 billion, below the initial guidance of KRW 490.0 billion.

Net income has repeatedly diverged from operating profit, with net income attributable to owners of KRW 136.6 billion in the fourth quarter of 2025, KRW 105.2 billion in the first quarter of 2026 and KRW 85.1 billion in the second quarter of 2026, reflecting sizable non-operating swings; Samsung Securities noted in a May 2026 report that a book-value revaluation during the pre-IPO capital increase at affiliate Ignis produced an equity-method gain recorded in non-operating income without any cash inflow.

For that reason, operating profit, operating margin and U.S. prescription metrics are the safer lenses on the earnings trend.

Industry analysis

Anti-seizure medication is a chronic-use market with substantial unmet need. About 50 million people worldwide live with epilepsy, and roughly 30% are estimated to be drug-resistant.

Market structure hinges on patent cycles: UCB's Briviact, the prescription share leader as of 2025, faces generic competition after its 2026 patent expiry, while cenobamate retains patent protection to October 2032.

Even after a competitor generic launched in the first quarter of 2026, XCOPRI prescriptions kept rising, which observers read as a strengthened U.S. market position. The next cycle variable is entry of new mechanisms.

Samsung Securities noted in a May 2026 report that Xenon Pharmaceuticals' azetukalner had positive Phase 3 data and targeted an FDA filing in the third quarter of 2026, and that Biohaven planned to release data from the same potassium-channel class in the second half of 2026, but that actual competitor launches remain one to two years away or more. iM Securities, as of July 2026, expected the closest competing product to launch in 2028.

The current phase can therefore be read as a window with limited direct competition in which prescription reach is being widened, with indication, formulation and age expansions acting as levers for penetration.

Currency sensitivity is another sector variable given the revenue mix: the won-dollar rate hovered around 1,550 in July 2026.

Outlook

Management's stated 2026 direction pairs cenobamate revenue expansion with securing a second product. Guidance for 2026 called for XCOPRI revenue of USD 550-580 million and other revenue of about KRW 110.0 billion, including KRW 45.0 billion from drug product and active ingredient sales plus service revenue.

KB Securities noted in an August 5, 2026 report that first-half U.S. XCOPRI revenue had reached 49% of the top end of annual guidance, with no guidance raise.

Life-cycle work is under way: a U.S. new drug application for an oral suspension formulation was filed in March 2026, and supplemental filings for primary generalized tonic-clonic seizures and pediatric patients are targeted within the year.

In Asia, Korean approval and a Chinese launch are complete and Japanese approval is targeted within 2026, while in Latin America a Brazil launch was slated for August 2026 following Peru and Chile. The follow-on product came via licensing.

The Opakalim agreement signed on August 26, 2026 is worth up to USD 795 million including milestones, with the USD 400 million upfront split into USD 350 million at closing and USD 50 million a year later.

The company expects first topline results from the RISE-3 trial at the end of 2026, followed by a second study readout in 2028 and a targeted U.S. launch as early as 2029. On sales-force leverage, management estimated that Opakalim would require only 10 to 20 additional sales staff.

For internal pipelines, CNS small molecules, radiopharmaceutical therapy (RPT) and targeted protein degradation (TPD) form the early-stage axes, and a joint AI-based drug discovery program with Insilico Medicine began in June 2026.

Valuation

PER

16.9×

PBR

6.6×

ROE

49.6%

EPS

₩5,120

BPS

₩13,047

Dividend per share

₩0

The company posted operating losses through 2023, so earnings-based multiples simply did not apply; only after the 2024 swing to profit did earnings-based comparison become possible.

Multiples on earnings have since been recalculated sharply lower, yet the stock still trades at a considerable premium to net assets, placing it in a different valuation framework from the average large Korean manufacturer.

No dividend is paid, so dividend-based comparison is unavailable, while on the balance sheet the debt-to-equity ratio fell from 125.3% in 2023 to 45.0% in 2025, easing financial burden.

Brokerage views diverge: KB Securities said in an August 5, 2026 report that it maintained a Buy rating and a target price of KRW 120,000 derived from a discounted cash flow model, adding that it had raised earnings estimates but lowered its terminal growth assumption because delayed second-product licensing left single-product dependence unresolved.

SK Securities said on August 27, 2026 that the Opakalim deal secured medium- to long-term growth drivers, maintained a Buy rating and a target price of KRW 160,000, and stated that single-product dependence tied to XCOPRI's 2032 patent expiry is the key factor behind earnings volatility.

Ultimately the multiple debate hinges on two variables, the year-end RISE-3 data and the cenobamate prescription trend, and the benchmark the market applies could shift depending on how each resolves.

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

Operating leverage from the direct sales model

The annual operating margin rose from 17.6% in 2024 to 28.9% in 2025, and in the second quarter of 2026 revenue of KRW 247.4 billion with operating profit of KRW 97.1 billion took it into the 39% range.

The company said operating profit grew even as a prior-quarter one-off milestone disappeared and R&D and marketing spending rose, demonstrating a structure in which U.S. revenue growth translates directly into profitability.

Management stated that adding a new product to the existing U.S. direct sales network keeps incremental costs contained while widening revenue and margin, and estimated only 10 to 20 additional sales staff for Opakalim.

With a largely fixed-cost sales network already in place, incremental revenue retention as margin is the core of this model.

Prescription trends and a competitive window

U.S. total prescriptions in the second quarter of 2026 were about 143,000, up 8.4% quarter on quarter, new-patient prescriptions held above a monthly average of 1,800 for a second straight quarter, and June monthly prescriptions came to 49,155.

Observers noted that prescription growth continued even after a competitor generic launched in the first quarter of 2026. iM Securities, as of July 2026, expected the closest competing product to launch in 2028.

The bull case argues that widening prescription reach combined with indication and formulation expansion leaves room for penetration to improve.

An attempt at structural change via a second product

On August 26, 2026 the company licensed worldwide exclusive development and commercialization rights to Opakalim from Biohaven for up to USD 795 million, with the agreement also covering the full Kv7 compound class and a discovery platform.

Opakalim is a selective Kv7.2/7.3 potassium channel activator; analysts argue it can be positioned complementarily to XCOPRI, whose strength is seizure suppression, by emphasizing tolerability, once-daily dosing and no need for titration.

The company's position is that securing Opakalim, with composition-of-matter protection to 2039, creates a base for bridging cash flow beyond cenobamate's 2032 patent expiry. Financially, 2025 operating cash flow of KRW 176.3 billion and a 45.0% debt-to-equity ratio are cited as the capacity behind such investment.

Bear factors

Concentration in one product and one market

Close to 90% of company revenue comes from cenobamate. One tally put XCOPRI at more than 98% of total revenue as of the first quarter of 2026.

Because revenue is concentrated in a single product, commentators have flagged the pace at which follow-on pipelines advance into clinical and commercial stages as the key medium-term growth variable. The bear case starts from the fact that any wobble in U.S. prescription momentum has almost no buffer.

A large upfront for a pre-validation clinical asset

The non-refundable upfront totals USD 400 million, more than half the headline deal value, with USD 350 million due at closing and the remainder a year later, even though pivotal efficacy data has not yet been released.

At the press briefing, questions were raised about the burden of prepaying half the total value for a clinical-stage asset. Because the disclosed 54% response rate came from an open-label extension study, whether seizure reduction is reproduced in a randomized, placebo-controlled setting was identified as the crux. Set against 2025 annual operating profit of KRW 203.9 billion, the upfront is far from trivial.

New mechanisms entering and the patent clock

Samsung Securities said in a May 2026 report that Xenon Pharmaceuticals' azetukalner showed placebo-adjusted seizure frequency reduction in Phase 3 and targeted an FDA filing in the third quarter of 2026, while Biohaven planned to release same-class results in the second half of 2026.

XCOPRI's U.S. composition-of-matter patent expires in October 2032, a persistent source of market concern about long-term growth. Even after second-quarter results, analysts argued that follow-on commercial products must be secured quickly to reduce reliance on XCOPRI.

With Opakalim targeted for U.S. launch in 2029, earnings during the intervening window still rest on a single drug.

Risk factors

Clinical and regulatory risk

Opakalim is in the RISE-2 and RISE-3 Phase 2/3 studies in adults with partial-onset seizures, and the company said it expects first RISE-3 topline results at the end of 2026.

The agreement is conditional: recognized costs may vary with trial success and approval outcomes, the contract can be terminated if development is halted or approval fails, and milestone obligations arise only upon completion of each stage.

On the cenobamate side, decisions on the suspension formulation and indication-expansion filings are still pending, so regulatory delays could push back the timing of expansion scenarios.

Currency and U.S. policy risk

With direct U.S. sales plus overseas royalties, most revenue is dollar-denominated, so a higher won-dollar rate works in favor of reported revenue. Conversely, a reversal in the exchange rate could pressure won-converted revenue and margins.

Hana Securities said in a January 2026 report that pharmaceutical tariffs capped at 15% lowered trade risk and that U.S. price negotiations could proceed similarly to those of global large pharma, allowing net revenue to be defended.

Still, U.S. pricing and distribution mechanics such as copay programs and insurer rebates directly affect net revenue recognition, leaving continuing exposure to policy shifts.

Volatility in reported results

One-off items repeatedly affect quarterly profit. Fourth-quarter 2025 operating profit of KRW 46.3 billion was down from KRW 70.1 billion the prior quarter, and in the second quarter of 2026 other revenue fell as the previous quarter's one-off milestone booking disappeared.

Samsung Securities said in a May 2026 report that a non-cash equity-method gain was recorded in first-quarter non-operating income. One analyst argued that investors should focus on steadily rising new-patient and total prescription data rather than quarterly results that vary with recognition timing.

In addition, the accounting treatment of the Opakalim upfront and clinical development costs could widen swings in future quarterly profit.

What to watch next

Late October to early November 2026
Third-quarter results and the earnings call. Key items are whether U.S. XCOPRI revenue, which reached 49% of the top end of annual guidance in the first half, stays on that track in the second half, plus the pace of selling and administrative spending and how Opakalim-related costs are recorded.
Fourth quarter 2026 (year-end)
First topline results from the Opakalim RISE-3 trial, which the company said it expects at the end of 2026. Analysts have said that if tolerability and efficacy are demonstrated, the visibility of approval and the assessed value of the U.S. direct sales network could change.
By end-2026
Whether supplemental applications for primary generalized tonic-clonic seizures and pediatric patients are actually filed, and the outcome of the Japanese approval process. Indication, age and geographic expansion determine the addressable patient pool and the royalty base.
Fourth quarter 2026 through 2027
The final closing of the Opakalim agreement. Closing depends on completion of antitrust review, including under the Hart-Scott-Rodino Act, and satisfaction of customary conditions, and since USD 350 million is payable at closing, resulting changes in cash and balance-sheet metrics warrant monitoring.
First quarter 2027
Confirmed full-year 2026 results and 2027 guidance. Alongside the review outcome for the oral suspension new drug application filed in March 2026, the scale at which Opakalim clinical development costs enter the selling and administrative expense plan is worth checking.

Overall view

SK Biopharmaceuticals exited the heavy operating losses of 2022 and 2023, turned profitable in 2024, and then expanded its earnings base in 2025 with revenue of KRW 706.7 billion and operating profit of KRW 203.9 billion, a 28.9% operating margin.

In 2026, first-quarter revenue of KRW 227.9 billion with operating profit of KRW 89.8 billion and second-quarter revenue of KRW 247.4 billion with operating profit of KRW 97.1 billion lifted the quarterly operating margin into the 39% range, with first-half operating profit of KRW 186.8 billion.

The substance of that growth is cenobamate, the epilepsy drug sold directly in the U.S., and prescription metrics kept improving, with about 143,000 total U.S. prescriptions in the second quarter of 2026 and 49,155 monthly prescriptions in June.

At the same time, the company's structural issue of single-product dependence entered a phase of direct response through the August 2026 Opakalim licensing deal worth up to USD 795 million, though the USD 400 million non-refundable upfront exceeds half the headline value while pivotal efficacy data remains unreleased, so both the potential payoff and the risk have grown.

The bull view rests on direct sales leverage and prescription expansion during a window of limited competition; the bear view rests on the 2032 patent clock and a large outlay for a pre-validation clinical asset.

The axes of debate ahead are therefore the year-end RISE-3 topline, whether XCOPRI stays on track for guidance in the second half, and actual progress on indication and geographic expansion. This material is for information purposes only and contains no buy or sell recommendation.

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.