SK Biopharmaceuticals Licenses Opakalim to Reduce Reliance on Xcopri

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SK Biopharmaceuticals President Lee Dong-hoon speaks at a press conference on Aug. 26. Courtesy of SK Biopharmaceuticals

SK Biopharmaceuticals (326030) has reduced its reliance on Xcopri, its flagship epilepsy drug, by licensing in the epilepsy candidate Opakalim (BHV-7000), according to an analyst assessment. Because the asset has already entered late-stage trials and can be sold through the company’s existing U.S. sales network, it is seen as a realistic choice for a second commercial product.

Heo Hye-min, an analyst at Kiwoom Securities, said on the 27th that the Opakalim deal “partly eases concerns about a single growth driver centered on Xcopri,” describing it as “a strategic choice aimed at maintaining long-term dominance in the epilepsy market, where SK Biopharmaceuticals is strongest, rather than expanding into a new growth area.”

The company said the previous day that it would license Opakalim, currently in Phase 2/3 trials as a treatment for partial-onset seizures, from Biohaven for up to $795 million (about 1.1 trillion won). The upfront payment totals $400 million, with $350 million due at closing and $50 million a year later.

Opakalim is a once-daily oral epilepsy treatment that selectively activates the Kv7.2 and Kv7.3 potassium channels to suppress excessive neuronal excitation. It secured early proof of concept for efficacy and safety in an open-label extension of its Phase 2 trial, and two late-stage trials for approval are now underway.

“We judge that the company chose as its second product an asset with relatively low development risk, given the clinical data already accumulated, and high visibility toward commercialization in 2029,” Heo said. “Rather than broadening into new diseases, it can make maximum use of its existing sales infrastructure in the epilepsy market, where it has already established competitiveness, which makes this the most realistic strategic choice.”

Based on revenue estimates from an outside valuation firm, Opakalim’s U.S. sales are projected to grow from $21 million in 2029 to $100 million in 2030 and $190 million in 2031. Peak sales were estimated at about $2 billion in 2042. SK Biopharmaceuticals aims to file a new drug application with the U.S. Food and Drug Administration in the first half of 2028 and launch in the U.S. in the first half of 2029.

The short-term earnings impact of the large upfront payment is expected to be limited. The $350 million payable at closing will be recognized as an intangible asset rather than booked immediately as an expense. Amortization of the asset is expected to begin in 2029, when revenue starts to come in.

Rising research and development costs tied to the trials, however, were cited as a variable in earnings estimates. “Additional costs of roughly $20 million per quarter will arise from the remainder of this year through next year,” Heo said. Early R&D costs were estimated at about $48 million in 2026, $74 million in 2027 and $43 million in 2028.

The market took the Opakalim deal as easing concerns about a pipeline gap. Shares of SK Biopharmaceuticals rose 9% on the day the agreement was announced, adding 563.9 billion won to its market capitalization. “As the growth driver diversifies away from its concentration in Xcopri, the stock’s sensitivity to rival drug launches should also be relatively lower,” Heo said. “Compared with azetukalner, Xenon’s Kv7 activator expected to launch between late 2027 and 2028, Opakalim may be able to differentiate itself in terms of safety and tolerability.”

The key going forward is clinical data. Data from Opakalim’s RISE2 and RISE3 Phase 2/3 trials are due between late 2026 and early 2027, and the results could prompt a revaluation of SK Biopharmaceuticals, according to the analysis. Results from another late-stage trial are expected in early 2028. Opakalim’s compound patent runs through 2039, with the possibility of additional protection through patent term extension.

One risk factor cited is that Opakalim has failed in trials for other central nervous system disorders. “Opakalim failed to meet the primary endpoint in a Phase 2 trial for major depressive disorder last December, and it had earlier failed in a late-stage trial for bipolar disorder,” Heo said. “After the MDD failure, Biohaven said it would not conduct further trials in psychiatric conditions and would focus on programs in immunology, obesity and epilepsy.”

“It is positive that the company has resolved its one-product risk and secured a new growth driver from 2029 onward,” Heo said. “But further gains in corporate value will require clinical success for Opakalim at year-end and additional portfolio expansion beyond epilepsy.”