SK Biopharm Reports Q4 Sales of 15.8 Billion KRW, Up 300% from Previous Quarter

Q4 Operating Loss of 53.8 Billion KRW

[Asia Economy Reporter Kim Ji-hee] SK Biopharm announced on the 8th that it recorded sales of 15.8 billion KRW and an operating loss of 53.8 billion KRW in the fourth quarter of last year based on consolidated financial statements.

Despite the impact of COVID-19, the fourth-quarter sales increased by 302% compared to the previous quarter due to the growth of the independently developed epilepsy drug Cenobamate (product name: Xcopri) in the U.S. and the contract payment from the technology export of Cenobamate to Ono Pharmaceutical in Japan. Additionally, royalties from global sales of the sleep disorder drug Solriamfetol (product name: Sunosi), which was licensed out to Jazz Pharmaceuticals, also contributed to the sales increase.

Selling and administrative expenses slightly increased due to costs for the Phase 3 clinical trial of Cenobamate in Asia, other new research expenses, and increased marketing costs related to the U.S. launch. However, operating loss improved by 14.6% compared to the previous quarter due to increased sales.

SK Biopharm expects to obtain marketing authorization from the European Commission within the second quarter of this year after Cenobamate received a positive recommendation for approval from the Committee for Medicinal Products for Human Use under the European Medicines Agency on the 29th of last month (local time). Accordingly, SK Biopharm will receive milestone payments of up to 430 million USD from its European partner Angelini Pharma. Once sales in Europe begin in earnest, royalties based on sales will also be received separately. Furthermore, through Angelini Pharma’s acquisition of Avel Therapeutics, SK Biopharm sold its 12% stake in Avel to Angelini Pharma, securing 31.76 million USD from the sale proceeds. SK Biopharm will additionally receive up to 22.47 million USD in milestone payments related to future European marketing authorization and sales.

The number of prescriptions (TRx) for Cenobamate in the U.S. in the fourth quarter showed steady growth despite difficulties caused by the resurgence of COVID-19. Total prescriptions in the fourth quarter reached 11,092, a 68% increase compared to the third quarter. The number of prescriptions in December was more than 60% higher than the average prescriptions at the eighth month after launch of three other new drugs with the same indication released in the past 10 years.

SK Life Science, SK Biopharm’s U.S. subsidiary, is strengthening non-face-to-face sales activities based on digital platforms such as remote detailing, webinars, and online campaigns amid the limited sales environment caused by the spread of COVID-19.

SK Biopharm continues to invest in R&D and focuses on new drug development. Karisbamate, a rare pediatric epilepsy treatment, aims to submit an NDA in 2024. Cenobamate will begin Phase 3 clinical trials this year targeting Japanese, Chinese, and Korean populations for entry into the Asian market. In Europe, Cenobamate is scheduled to be launched under the product name Ontozry in the second half of the year through Angelini Pharma. Angelini Pharma plans to actively market and sell the drug in major European countries such as Germany, France, the UK, and Switzerland through its 15 local subsidiaries and distribution networks in over 70 countries.

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