SK Biopharmaceuticals announced third-quarter results that far exceeded market expectations, backed by rising sales of its new epilepsy drug cenobamate.
SK Biopharmaceuticals said on the 5th that its operating profit in the third quarter of this year came to 70.1 billion won, up 262.4% from a year earlier. That is well above the earlier market consensus of 46.4 billion won. Third-quarter revenue rose 40.4% on-year to 191.7 billion won, and net profit jumped 1,031.3% to 71.4 billion won.
U.S. sales of the company's innovative epilepsy drug cenobamate (U.S. brand name XCOPRI®) are driving earnings growth. In the third quarter, U.S. sales of cenobamate increased 11.7% from the previous quarter and 51.9% from a year earlier to 172.2 billion won.
Cumulative sales of cenobamate for the first to third quarters reached 459.5 billion won, already surpassing last year's annual sales.
The company said, "Although other revenue decreased and SG&A expenses increased from the previous quarter, operating profit grew," and added, "This is the result of an expanded operating leverage effect from higher-margin U.S. XCOPRI sales." The official said, "If we post roughly the same level of sales in the remaining fourth quarter as in the third quarter, we expect to come close to the upper end of our annual guidance."
To sustain rapid growth, SK Biopharmaceuticals plans to keep strengthening new sales strategies and marketing activities and to pursue market expansion by broadening cenobamate's indications and age range.
On Sept., it secured topline results from a phase 3 clinical trial for an indication expansion to primary generalized tonic-clonic seizures (PGTC), and it plans to present the detailed results at the 2025 American Epilepsy Society (AES) meeting in Dec.
To expand the prescribing age group, the pediatric age-extension safety study recently completed patient enrollment, and the company said it plans to submit a new drug application (NDA) for an oral suspension formulation within the year.
Cenobamate received product approval from the Ministry of Food and Drug Safety on the 3rd, opening the door to a domestic launch. Dong-A ST, which is responsible for domestic authorization, will also handle sales and production in Korea. Earlier, in Jan. last year, SK Biopharmaceuticals transferred finished drug product (DP) manufacturing technology for XCOPRI to Dong-A ST to supply 30 countries at home and abroad. An SK Biopharmaceuticals official said, "We expect progress to materialize for entry into the three Asian countries—Korea, China, and Japan—between the end of this year and next year."