SK Securities evaluated on the 27th that SK Biopharm has secured medium- to long-term growth momentum through the introduction of the epilepsy drug candidate 'Opacalime.' The target price remains at 160,000 won, with an investment recommendation of 'buy.'
SK Biopharm announced on the 26th that it has signed an exclusive technology introduction agreement for the epilepsy drug candidate Opacalime and potassium channel drug discovery platform from Biohaven. The contract is valued at up to $795 million (approximately 1.996 trillion won), with a non-refundable upfront payment of $400 million (about 553.2 billion won). After commercialization, separate ongoing royalties will be paid based on net sales.
Lee Sun-kyung, a researcher at SK Securities, stated, "The patent expiration for Exkopia is scheduled for 2032, making reliance on a single product a key factor in SK Biopharm's earnings volatility. Opacalime is noteworthy as it can target the same epilepsy market as Exkopia."
The researcher added, "Opacalime not only has the potential to generate sales synergy with Exkopia but can also fill the revenue gap that may arise after the patent expiration. It is particularly significant that Opacalime demonstrates superior safety and tolerability compared to existing drugs."
Opacalime is currently in Phase 2/3 clinical trials. The primary results of the first Phase 3 trial are expected to be released by the end of this year, while the second Phase 3 results are anticipated to be announced in early 2028. If positive data is obtained, the goal is to apply for FDA approval in the first half of 2028 and launch in the U.S. in the first half of 2029.
The researcher noted, "Opacalime has shown competitive safety and tolerability data compared to Azetucalner in extended trials, and by securing a top-level candidate in the same mechanism, we can alleviate concerns about competitive product entry and reliance on a single product."
* This article has been translated by AI.
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