SK Biopharm reported that its first-quarter revenue increased by 27% year-on-year to 144.4 billion won, and operating profit rose by 149% compared to the same period last year, reaching 25.7 billion won, as of the 9th. Net income for the period was approximately 102% higher at 19.6 billion won.
The company explained that it achieved solid performance driven by the revenue growth of the epilepsy drug Cenobamate (U.S. product name Xcopri®/XCOPRI®) in the United States.
However, compared to the previous quarter, revenue slightly decreased. The company stated that this was due to temporary factors, including the expiration of one-time revenue (related to the submission of a New Drug Application (NDA) for product approval in China), seasonal off-peak periods, and restructuring of external distribution channels.
Xcopri's revenue in the United States recorded approximately 47% increase year-on-year to 133.3 billion won, showing growth. This is about a 3% increase compared to the previous quarter's revenue in the U.S. The company explained that the number of prescriptions for Xcopri has shown a rapid rebound since March, with the average monthly number of new patient prescriptions (NBRx) surpassing 1,600 for the first time, gaining momentum again.
SK Biopharm plans to expand the recognition of Xcopri and strengthen patient touchpoints through its first direct-to-consumer (DTC) advertising campaign in the United States as early as May. The company noted, "Xcopri is implementing a more sophisticated and organic patient-centered touchpoint expansion strategy based on the U.S. direct sales system," and added, "We will continuously expand our market share in the U.S. through aggressive marketing and expansion of indications."
The company is also aiming to expand the market through the extension of indications and age for Cenobamate. This year, it plans to secure clinical 3-phase top-line results to expand indications beyond partial seizures to generalized tonic-clonic seizures (PGTC) and develop an oral suspension formulation to facilitate administration in pediatric patients for NDA submission.
The company explained that it has prepared countermeasures against uncertainties regarding the U.S. government's tariff on pharmaceuticals. The company noted, "We have already completed the U.S. Food and Drug Administration (FDA) approval process for additional contract manufacturing organizations (CMOs) in the U.S. and secured additional inventory for about six months," and added, "We established a system that can flexibly respond to global supply chain risks."
SK Biopharm plans to introduce a second product aimed at achieving the 'second Cenobamate' using its direct sales infrastructure in the U.S. The company is also accelerating the diversification of its portfolio centered on next-generation therapeutic technologies such as radiopharmaceuticals (RPT) and targeted protein degradation (TPD). In the RPT field, it is developing a solid tumor treatment candidate 'SKL35501.' In the TPD field, research and development is being actively pursued through SK Life Science Labs, SK Biopharm's local research subsidiary in the U.S.