Cenobamate, sold in the United States under the brand name Xcopri. [SK Biopharm]
Cenobamate, sold in the United States under the brand name Xcopri. [SK Biopharm]

SK Biopharm extended its run of record quarterly earnings Wednesday, driven by strong US sales of cenobamate — its flagship epilepsy treatment sold in the United States as Xcopri — while continuing to expand research and development and marketing investment. The company has established what analysts describe as a self-sustaining profit cycle built on its own proprietary drug.

SK Biopharm reported consolidated second-quarter sales of 247.4 billion won ($173 million) and operating profit of 97.1 billion won, the company disclosed Wednesday. Sales jumped 40.3 percent year-on-year and operating profit jumped 56.9 percent. Excluding quarters that included one-time service revenue, the results mark yet another all-time quarterly record. Net profit for the period rose 188.1 percent year-on-year to 85.1 billion won.

Cenobamate was the primary driver. The drug posted US sales of 224.4 billion won in the second quarter, up 45.6 percent year-on-year, bringing cumulative first-half US sales to 422.1 billion won. Total US prescriptions in the second quarter reached approximately 143,000, up 8.4 percent quarter-on-quarter, while June monthly prescriptions came in at 49,155, underscoring steady prescription momentum. New patient prescriptions also held above a monthly average of 1,800.

SK Biopharm plans to broaden its marketing reach to physicians and patients in the second half of the year through direct-to-consumer advertising campaigns resumed in April and new ad placements, aiming to further improve product accessibility.

Efforts to extend the drug's life cycle through new formulations and expanded indications are also on track. The company completed a new drug application to the US Food and Drug Administration for a cenobamate oral suspension formulation in March and plans to submit a supplemental NDA this year to seek approval for primary generalized tonic-clonic seizures and pediatric patients. Internationally, the company is working toward regulatory approval in Japan by year-end, while Brazil is set for an official commercial launch in August.

SK Biopharm is using the stable cash flow generated by cenobamate to accelerate investment in its next-generation R&D platform. Alongside central nervous system drugs, the company has designated radiopharmaceutical therapy and targeted protein degradation as two additional pipeline pillars. Since June, it has also been conducting joint AI-driven drug discovery research with Insilico Medicine to improve the efficiency of early-stage candidate identification.

Cenobamate's direct US commercial success and the self-sustaining profit structure it has enabled are widely seen as a model for how a domestic biotech can move beyond reliance on one-off technology licensing deals and build toward world-class "big biotech" status.

"It is very encouraging that operating profit continues to grow even as selling, general and administrative expenses and R&D investment increase," SK Biopharm President Lee Dong-hoon said. "We will work to ensure SK Biopharm plays a central role in restoring confidence in the pharmaceutical and biotech sector in the second half of the year."


silverpaper@heraldcorp.com