SK Biopharmaceuticals said on the 7th that operating profit under consolidation in the first quarter rose 250% from a year earlier to 89.8 billion won. Revenue in the same period climbed 57.8% to 227.9 billion won, marking a quarterly record.
The growth was led by the epilepsy treatment Cenobamate (U.S. brand Xcopri). U.S. revenue came to 197.7 billion won, up 48.4% on-year. The company said growth reaccelerated in the first quarter as year-end seasonal effects faded.
Prescription indicators also continued to rise. As of March, monthly total prescriptions neared about 47,000, and new-patient prescriptions set an all-time high on a first-quarter average basis. In particular, new-patient prescriptions in March surpassed 2,000 for the first time.
SK Biopharmaceuticals is strengthening marketing and sales based on its direct sales setup in the United States. Through the National Sales Meeting (NSM) and Plan of Action (POA), events for the U.S. sales organization, it is boosting execution of sales strategies, and from the second quarter it plans to expand direct-to-consumer (DTC) advertising and marketing aimed at medical professionals.
Cenobamate is also advancing label expansions and formulation diversification. In March this year, the company submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for a suspension formulation. It is also targeting within the year to apply for expanded indications for primary generalized tonic-clonic seizures (PGTC) and pediatric patients.
It is also reviewing the introduction of follow-on products. SK Biopharmaceuticals is considering bringing in candidates up to phase 3 using Cenobamate's U.S. sales network and is negotiating with the goal of producing results within the year.
Global market expansion is also continuing. In China, commercialization began in March this year through partner Ignis Therapeutics, and in Japan, the approval process is underway within the year.
SK Biopharmaceuticals is expanding investment in new pipelines such as radiopharmaceutical therapy (RPT) and targeted protein degradation (TPD), based on revenue and cash flow secured through Cenobamate. The company plans to accelerate the acquisition of next-generation therapeutic technologies leveraging its competitiveness in the central nervous system (CNS) field.
SK Biopharmaceuticals is reinvesting the sustainable profit and cash flow secured from Cenobamate sales into new growth engines and research and development (R&D). Building on its strengths in the central nervous system (CNS) field, it is also accelerating the expansion of next-generation modality pipelines such as radiopharmaceutical therapy (RPT) and targeted protein degradation (TPD).
An SK Biopharmaceuticals official said, "Going forward, we plan to actively share and collaborate on the new drug development experience and infrastructure we have accumulated with the domestic and broader Asian bio ecosystems as we grow."