SK biopharmaceuticals said that it posted record third-quarter earnings for 2025, driven by strong U.S. sales growth of its anti-seizure medication Xcopri (ingredient: cenobamate). The company’s revenue and operating profit both exceeded market expectations, reflecting the continued momentum of its flagship neurology drug.

Total revenue in the third quarter reached 191.7 billion won ($132.3 million), up 40.4 percent year-on-year, while operating profit rose 262.4 percent to 70.1 billion won, surpassing the market consensus of about 46 billion won by more than 50 percent. Net profit climbed to 71.4 billion won, up 1,031.3 percent from a year earlier.

U.S. Xcopri sales increased 11.7 percent quarter-on-quarter and 51.9 percent year-on-year to 172.2 billion won, bringing cumulative sales for the first three quarters to 459.5 billion won. With a similar sales level in the fourth quarter, the company expects to approach the upper end of its full-year guidance.

SK biopharmaceuticals attributed the performance to operating leverage from higher-margin Xcopri revenue, despite lower other income and increased selling and administrative expenses.

Prescription growth accelerated compared with last year, supported by intensified marketing, including NBRx contests, direct-to-consumer advertising, and a “Line of Therapy” campaign encouraging earlier use.

The company is also expanding Xcopri’s indications and formulations. In September, it secured topline results from a phase 3 study in primary generalized tonic-clonic seizures, confirming efficacy and safety.

Detailed findings will be presented at the American Epilepsy Society 2025 meeting in December. To broaden patient access, the pediatric safety study has completed enrollment, and an NDA for an oral suspension formulation is planned within the year.

Regulatory progress in Asia is advancing, with Dong-A ST receiving MFDS approval for cenobamate in Korea on Monday. This follows last year’s China NDA filing by Ignis Therapeutics and a Japan NDA filing by Ono Pharmaceutical in September, positioning launches across Korea, China, and Japan beginning late 2025 through 2026.

Beyond epilepsy, SK biopharmaceuticals is diversifying through new modalities and partnerships to build what it describes as a balanced big biotech.

The company is preparing an IND for SKL35501, a radiopharmaceutical therapy candidate licensed last year, while evaluating additional assets in the field. It also joined the Ministry of Science and ICT’s AI Foundation Model Project in healthcare and, in partnership with Brazil-based Eurofarma, launched Mentis Care in Canada to develop AI-driven epilepsy management platforms and wearable-based digital therapeutics.

“Xcopri’s performance proves our ability to deliver global success in neurology,” SK biopharmaceuticals CEO Lee Dong-hoon said. “We will continue to expand our epilepsy franchise and pursue new therapeutic areas through AI-powered innovation and strategic partnerships.”