SK Biopharm, 3Q Sales 90.3 Billion KRW... "Xenobamate Achieves Highest Quarterly Sales Growth"

"Possible to Turn a Profit in Q4"
Indication and Age Expansion NDA Submission in 2025

SK Biopharm announced on the 9th that its consolidated sales for the third quarter of this year were preliminarily estimated at KRW 90.338 billion, an increase of 1.69% compared to the same period last year.

SK Biopharm Cenobamate (U.S. product name Xcopri). [Photo by SK Biopharm]

During the same period, operating loss increased by 15.84% to KRW 10.712 billion, and net loss also rose by 23.07% to KRW 18.414 billion. However, operating loss improved by 43.43% compared to the previous quarter.

Regarding the third-quarter operating loss, SK Biopharm explained, "From this quarter, SK Life Science Labs was consolidated, adding more than KRW 8 billion in selling and administrative expenses." They added, "Through efficient management of overall selling and administrative expenses and a sharp increase in sales of Cenobamate, the improvement in operating loss compared to the previous quarter was significantly increased, lowering it to the low KRW 10 billion range." SK Life Science Labs is SK Biopharm’s U.S. research and development (R&D) subsidiary, which is the renamed Proteovant acquired in June.

SK Biopharm emphasized that with the accelerated growth of Cenobamate, continuous efforts to improve selling and administrative expense efficiency, and seasonal effects at the end of the year, achieving a turnaround to profitability in the fourth quarter is expected.

The epilepsy drug Cenobamate (U.S. product name Xcopri) recorded the largest quarterly growth ever as its growth in the U.S. continued. Cenobamate’s U.S. sales in the third quarter of this year were KRW 75.7 billion, up about 19% from the previous quarter and about 60% from the same period last year. The company explained, "Cenobamate has entered a stage where annual sales exceeding KRW 300 billion are possible with U.S. sales alone, and it is growing every quarter."

Total prescriptions are also increasing as the trend of rising new patient prescriptions in the U.S. continues. This is a positive signal compared to last year when new patient prescriptions stagnated. From January to September this year, the average monthly new patient prescriptions increased by about 37% compared to the same period last year. Total prescriptions in the third quarter also increased by about 54% compared to the third quarter of last year. In September, the monthly prescriptions of Cenobamate in the U.S. were 22,985, which is twice the average prescription number at 41 months after the launch of competing new drugs.

SK Biopharm also revealed a mid- to long-term accelerated growth plan to achieve the blockbuster sales target of $1 billion for Cenobamate by 2029. Aggressive marketing will be conducted by expanding the focus of promotion from epilepsy specialists to general neurologists. In this process, accumulated data will be actively utilized, and new marketing tools suitable for the artificial intelligence (AI) era will be introduced.

Expansion of indications and age range for pediatric and adolescent patients is also proceeding as planned. SK Biopharm plans to apply for approval for indication and age expansion between 2025 and 2026. The ongoing clinical trials for expanding Cenobamate’s indication to generalized seizures and phase 3 trials in three Asian countries are expected to submit new drug applications (NDA) by 2025. Clinical trials to expand the eligible age group to pediatric and adolescent patients are also underway, with plans to complete and submit NDA before 2025.

SK Biopharm will also introduce new central nervous system (CNS) drugs following Xcopri, as the patent for Xcopri is expected to expire in 2033. Accordingly, SK Biopharm plans to introduce a 'second product' in the CNS category by 2025 to maintain growth. Funds secured through Cenobamate will be invested in acquiring CNS drugs.

The company will continue its strategy to leap forward through three new modalities (therapeutic approaches). In July, SK Biopharm announced its vision to become a 'big biotech' through three next-generation platforms: cell and gene therapy (CGT), radiopharmaceutical therapy (RPT), and targeted protein degradation (TPD). A SK Biopharm official explained, "Due to new drug achievements by global big pharma and technology export successes by domestic bio companies, the RPT and TPD fields are receiving attention faster than expected."

This content was produced with the assistance of AI translation services.