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SK Biopharmaceuticals Doubles Down: $795M Bet on Second Blockbuster Epilepsy Drug

양현우 기자

yhw@fntimes.com

기사입력 : 2026-08-27 09:07

Announces $795 million in-licensing deal for epilepsy drug candidate Opakalim
Moves beyond single-product reliance by leveraging its established U.S. direct-sales infrastructure
Secures patent protection through 2039, extending its cash cow deep into the 2040s

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[Korea Financial Times, Yang Hyunwoo] "SK Biopharmaceuticals has now entered a different league, one in which we compete directly with global big pharma companies in the United States and Europe, not just in Korea."

President Lee Dong-hoon of SK Biopharmaceuticals made this declaration at a press conference held on the afternoon of the 26th at the Westin Josun Hotel in Jung-gu, Seoul, where he abruptly unveiled the company's license-in (L/I) agreement to acquire opakalim, an epilepsy drug candidate from Ireland-based Biohaven.

Through the deal, SK Biopharmaceuticals aims to reduce its reliance on a single product — cenobamate — and transform itself into a "multi-product" company capable of directly marketing multiple innovative new drugs in the global market.

The license-in agreement is valued at up to USD 795 million (approximately KRW 1,099.5 billion), equivalent to 156% of the company's consolidated revenue for 2025.

A Bold $795 Million Bet: Meeting the Challenge Head-On with Strong Cash-Generating Power

The total value of the deal is up to USD 795 million (approximately KRW 1,099.6 billion). The non-refundable upfront payment totals USD 400 million (KRW 553.2 billion) in cash, structured as USD 350 million (KRW 484.4 billion) paid at deal closing and the remaining USD 50 million (KRW 69.2 billion) paid one year later. Additional milestone payments of up to USD 395 million (KRW 546.8 billion) will follow depending on development and regulatory progress, with further royalties tied to U.S. net sales after commercialization.

While the large initial cash outlay has raised concerns about deteriorating free cash flow, President Lee dismissed such worries with confidence. "Xcopri, three years after its launch, is selling well, generating KRW 190 billion in operating profit in the first half of this year alone," he said. "This investment was possible precisely because of our strong cash-generating capacity."

Opakalim is a selective potassium channel (Kv7.2 and Kv7.3) activator that suppresses neuronal hyperexcitability, positioning it as a next-generation epilepsy treatment candidate with a novel mechanism of action. It is currently undergoing Phase 2/3 clinical trials in adult patients with partial-onset seizures (POS).

Yoo Chang-ho, Head of the Business Development Division at SK Biopharmaceuticals, who also attended the briefing, said, "Opakalim has a significantly higher probability of clinical success compared to other drugs and has demonstrated an excellent tolerability profile." He added that the company is targeting an official U.S. market launch as early as 2029.

SK Biopharmaceuticals expects to leverage its already-established U.S. direct sales organization of more than 150 personnel, along with its network of leading neurologists, to maximize marketing impact.

President Lee cited the synergy between Xcopri and Opakalim as a powerful weapon for boosting global competitiveness. "Xcopri and Opakalim are remarkably complementary products," he said. "Even for the same condition of epilepsy, different doctors and patients seek different treatment options — some prioritize strong efficacy, while others place greater importance on tolerability." The calculation is that the company can deploy its already-established U.S. sales force for Xcopri, holding down additional SG&A spending while maximizing profitability.

Extending the Cash Cow into the 2040s: Securing Long-Term Growth Engines

The Opakalim deal carries significance well beyond a simple pipeline expansion — it plays a crucial role in "buying time" to defend the company's fundamentals. While the substance patent for Xcopri, SK Biopharmaceuticals' cash cow, is set to expire in October 2032, Opakalim's patent protection extends to 2039, pushing the company's stable cash flow nearly to the doorstep of the 2040s.

"A company with a single product and a biotech with multiple products are in completely different weight classes," President Lee said. "Carrying two blockbusters in succession is no easy feat, but the massive cash flow this generates will buy us time so that we are no longer chased by circumstance."

He added, "With this newfound time, we have completed a virtuous cycle that allows us to reinvest aggressively, with a long-term perspective, in oncology fields such as radiopharmaceutical therapy (RPT) and targeted protein degradation (TPD), as well as in disease-modifying therapies (DMT)."

Biohaven, the drug's original developer, cited SK Biopharmaceuticals' independent U.S. commercialization capabilities as the key backdrop to the deal. Vlad Coric, Chairman and CEO of Biohaven, said, "SK Biopharmaceuticals is the ideal partner, having successfully established Xcopri in the market," adding that it is "the only company to have introduced a new drug for the treatment of partial-onset seizures to U.S. patients since 2020."

Meanwhile, alongside the introduction of this new drug, SK Biopharmaceuticals plans to accelerate lifecycle management of its existing product, cenobamate, to further strengthen its fundamentals. Having completed a New Drug Application (NDA) for a cenobamate oral suspension formulation earlier this year, the company plans to sequentially complete additional supplemental New Drug Applications (sNDAs) within the year to expand the drug's indications and approved dosing age to primary generalized tonic-clonic (PGTC) seizures and pediatric patients.

Yang Hyunwoo (yhw@fntimes.com)

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