SK Biopharmaceuticals has surpassed the 8th mark in achieving annual surplus

In fact, Cenobamate’s U.S. sales in the third quarter of 2024 are 113.3 billion won, growing by about 8% compared to the previous quarter and about 49.8% compared to the same period last year. Despite a slight slowdown in U.S. sales growth in the third quarter due to some sales being carried over to October due to the impact of hurricanes and fewer business days at the end of September, overall sales grew solidly.

In particular, it is explained that Cenobamate’s operating leverage effect began to appear in earnest from the previous quarter. Operating leverage refers to the rapid increase in operating profit due to increased sales in an industry with high fixed costs. Considering the sales growth in the fourth quarter, the company expects to achieve the upper level of the US sales guidance presented at the beginning of the year. We expect rapid profit growth in the future through a high gross profit ratio in the mid-90% and operating leverage, which is only possible when selling new drugs directly in the United States.

Cenobamate’s sales growth in the third quarter of 2024 is interpreted to be due to the high number of new patient prescriptions (NBRx) in the US market. The total number of monthly prescriptions in September 2024, 53 months after the launch of cenobamate, is approximately 31,000, which is approximately 2.2 times the number of prescriptions 53 months after the launch of competing new drugs.

SK Biopharmaceuticals plans to continue the growth of Cenobamate by recruiting technical sales personnel dedicated to KOL (Key Opinion Leader) doctors and LTC (long-term care) personnel and restructuring the sales incentive structure. In particular, we began investing in P4 clinical trials and researcher clinical trials in the second half of the year, and next year, we plan to increase contact points with more new patients through DTC advertisements that directly target patients and their guardians.

SK Biopharm is aiming for a quantum jump in sales by expanding the indications for cenobamate to generalized seizures and expanding the age range to include children and adolescents. The company’s goal is to secure the top line results of phase 3 cenobamate generalized seizures by the end of 2025. In addition, prior to applying for approval for children/adolescents, we are discussing with the FDA a plan to apply for approval in 2025 for an oral suspension formulation for children who have difficulty swallowing tablets.

The company said, “Work for the global launch of cenobamate is also continuing,” adding, “Clinical trials in Korea, China, and Japan for launch in Asia have successfully entered the completion phase, and the results will be presented in LA in early December. “We plan to present a poster at the American Epilepsy Society AES 2024,” he said. Some Asian partners plan to begin the process of applying for regional approval based on clinical results.

Along with the growth of Cenobamate, SK Biopharmaceuticals is growing at an accelerated rate by introducing commercial products from outside that utilize the existing marketing infrastructure, and based on the enormous surplus cash coming from this, the company is developing a new modality technology platform and anti-cancer technology. The plan is to expand the scope and advance towards ‘Big Biotech’.

SK Biopharmaceuticals is the only Korean pharmaceutical company that has a direct sales system and sells self-developed innovative new drugs in the U.S. market. Cenobamate is guaranteed high profitability by operating through a direct sales system, with a gross profit ratio in the mid-90% range in the United States. SK Biopharmaceuticals is working to secure concrete results with regard to the introduction of a ‘second commercial product’ that can make full use of the U.S. direct sales infrastructure within next year at the latest.

SK Biopharmaceuticals has selected RPT (radiopharmaceutical treatment) and TPD (targeted protein degradation treatment) as the next-generation new modalities, and is accelerating R&D in each field based on synergy with SK Group.

In the TPD area, we are discovering protein degraders that can act on targets for which there are no existing treatments through MOPED, an innovation platform for discovering molecular glue (MG) acquired through the successful acquisition of SK Life Science Labs last year. and are under development.

In the RPT field, the company acquired Full Life Technology’s ‘FL-091’ candidate (currently SKL35501) and introduced an external pipeline for the first time since its founding. Recently, we are accelerating the RPT business by stably securing therapeutic radioisotopes (RI) through the announcement of the RPT business roadmap, including a supply contract with Terra Power. The company plans to additionally announce the progress of RPT research within the year.