SK Biopharmaceuticals Sees 149% Surge in Q1 Operating Profit as U.S. Direct Sales Drive Growth

XCOPRI Achieves KRW 133.3 Billion in U.S. Sales
New Prescriptions and Direct Sales Marketing Strategy Drive Results

SK Biopharmaceuticals achieved solid results in the first quarter of this year, with operating profit increasing by 149%, driven by the growth of cenobamate (U.S. product name: XCOPRI®) sales in the United States.

According to SK Biopharmaceuticals on May 9, the company's first-quarter revenue reached KRW 144.4 billion, up approximately 27% from the first quarter of last year. Operating profit was KRW 25.7 billion, an increase of about 149%, and net profit for the period was KRW 19.6 billion, up about 102% year-on-year.

Although revenue declined slightly compared to the previous quarter, the company explained that this was due to temporary factors such as the expiration of a one-time milestone (related to the China NDA submission), seasonal off-peak periods, and restructuring of external distribution channels. Despite these external shocks, sales of the core product XCOPRI in the U.S. performed well, increasing by about 3% quarter-on-quarter, keeping the company on track to achieve its annual sales target.

XCOPRI's U.S. sales in the first quarter of this year recorded KRW 133.3 billion, up about 3% from the previous quarter and approximately 47% year-on-year. The number of XCOPRI prescriptions rebounded rapidly after March. In particular, the average monthly number of new patient prescriptions (NBRx) in the first quarter exceeded 1,600 for the first time, indicating renewed growth momentum. The company expects this to accelerate sales growth from the second quarter onward.

These results are attributed to the combination of a direct sales platform in the U.S. and a specialized sales strategy, with intensified marketing efforts such as NBRx contests led by local sales staff identified as key factors. In addition, SK Biopharmaceuticals plans to launch its first direct-to-consumer (DTC) advertising campaign for XCOPRI in the U.S. as early as this month to raise brand awareness and strengthen patient engagement.

SK Biopharmaceuticals is also aiming to expand the market by broadening the indications and age range for cenobamate. Within this year, the company plans to secure top-line results from a Phase 3 clinical trial for the expansion of indications to include primary generalized tonic-clonic seizures (PGTC), beyond partial-onset seizures, and to develop an oral suspension formulation to facilitate administration for pediatric patients, with plans to submit an NDA.

Regarding uncertainties related to pharmaceutical tariffs, the company has already completed FDA approval procedures for an additional contract manufacturing organization (CMO) in the U.S. and has increased inventory from the equivalent of about six months' supply, thereby establishing a system that enables flexible response to global supply chain risks.

SK Biopharmaceuticals stated, "Based on our direct sales system in the U.S., we are executing a more sophisticated and integrated patient-centric engagement strategy. Through aggressive marketing and expansion of indications, we will continue to increase our market share in the U.S."

SK Biopharmaceuticals also plans to introduce a "second product" within this year, aiming for a "second cenobamate" by leveraging its direct sales infrastructure in the U.S. The product will be selected to maximize the use of the existing sales network, enabling rapid market entry and early monetization.

At the same time, the company is accelerating portfolio diversification centered on next-generation therapeutic technologies such as radiopharmaceuticals (RPT) and targeted protein degradation (TPD).

In the RPT field, development is focused on the solid tumor treatment candidate 'SKL35501.' The company has strengthened its core raw material supply base by signing supply agreements not only with TerraPower in the U.S. but also with Pantera in Belgium, which will support the stable development of SKL35501.

In the TPD field, SK Biopharmaceuticals is ramping up R&D centered on its U.S.-based research subsidiary, SK Life Science Labs. The company has recently recruited additional researchers with experience at global pharmaceutical companies, thereby strengthening its R&D capabilities in oncology and targeted protein degradation therapeutics.

Furthermore, SK Life Science, the U.S. subsidiary, has also recruited researchers from global pharmaceutical companies to enhance R&D capabilities in oncology and rare diseases, as well as global clinical competitiveness in the CNS and RPT fields.

The company also plans to actively pursue the commercialization of an AI-based epilepsy management platform. In February, SK Biopharmaceuticals announced plans to establish an AI-based joint venture with the Brazilian pharmaceutical company Eurofarma, through which it will begin developing an epilepsy patient management platform and wearable device-based digital therapeutic solutions.

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