SK Bioscience achieved an annual surplus last year. This accomplishment was achieved through the single sales of the epilepsy treatment new drug Cenobamate (U.S. product name Xcopri®).
SK Bioscience noted that its annual sales last year rose 54.3% year-on-year to 547.6 billion won, and its operating profit switched to a surplus of 96.3 billion won. Net profit also turned positive at 227 billion won, exceeding the market forecasts initially presented.
The company's sales of Cenobamate, which it developed and successfully launched overseas, were about 438.7 billion won in the U.S. last year, an increase of 62% from the previous year. Notably, fourth-quarter sales increased by about 16 billion won compared to the previous quarter, the largest quarterly sales increase ever.
SK Bioscience stated that this sales achievement is significant as it marks the first annual surplus achieved solely through Cenobamate sales without the assistance of one-time revenues such as milestones, and added, "The year 2024 will be an important milestone for the commercialization of innovative new drugs."
SK Bioscience is actively pursuing a marketing strategy in the U.S. It strengthened its specialty sales organization and personnel last year to focus on epilepsy centers and long-term care for patients. This year, the company plans to implement aggressive marketing strategies, including its first direct-to-consumer advertisements, to expand touchpoints with patients.
Cenobamate is expanding its market reach. Due to strong global sales, the cumulative number of prescribed patients exceeded 140,000 last year. The company is in the process of entering approximately 17 countries in Latin America, starting with a New Drug Application (NDA) in Brazil. The submission of the NDA in China has also secured milestone revenue, contributing to strong sales last year. Based on successful clinical results in Korea, China, and Japan, partners in Korea and Japan intend to proceed with the approval application processes in their respective countries following China.
The company is also aiming to expand the market through the indication and age extension of Cenobamate. The company plans to secure top-line results from a Phase 3 clinical trial for the expansion of the indication to Generalized Tonic-Clonic Seizures (PGTC) this year and develop an oral suspension formulation to facilitate administration for pediatric patients for NDA submission.
SK Bioscience is also seeking new growth drivers. The company aims to achieve visible results in the first half of this year regarding the commercialization of products following Cenobamate.
The portfolio is also set to diversify through the expansion of research and development capabilities in the fields of radiopharmaceuticals (RPT), targeted protein degraders (TPD), and small molecules, which have been selected as next-generation new modalities.
To this end, in the RPT field, the company acquired the candidate substance ‘FL-091’ (currently SKL35501) from Full Life Technologies. It also secured stable radioisotope (RI) supply through a supply contract with TerraPower for Actinium-225 (Ac-225). Additionally, it has entered into collaborative research agreements with various corporations and organizations, including the Korea Institute of Radiological and Medical Sciences and Protherapeutics, for ongoing candidate substance discovery and independent research and development.
In the TPD area, SK Bioscience is focused on discovering and developing protein degraders based on the molecular glue innovation platform MOPED™ through SK Life Science Labs. The company plans to expand its research and development capabilities into oncology by developing new pipelines related to cancer and Parkinson's disease in the existing small molecule sector.