SK biopharmaceuticals on Friday released robust financial results for the first quarter of 2025, driven by sustained growth in U.S. sales of its epilepsy treatment cenobamate, marketed as Xcopri.

The company posted revenue of 144.4 billion won ($102.4 million), up 26.7 percent from the same period last year. Operating profit surged 149.3 percent year-on-year to 25.7 billion won, while net income rose 102.3 percent to 19.6 billion won.

While revenue decline by 11.4 percent compared to the previous quarter, due to the absence of milestone payments related to a China NDA submission, seasonal effects, and restructuring among external distribution partners, Xcopri sales in the U.S. remained in an upward trajectory, increasing approximately 3.1 percent compared to the previous quarter and 46.6 percent compared to the same period last year to reach 133.3 billion won.

The company emphasized that prescription volumes for Xcopri rebounded sharply in March, with the average number of new-to-brand prescriptions (NBRx) exceeding 1,600 per month for the first time in the first quarter. The company expects that this positive momentum will drive accelerated revenue growth in the second quarter and beyond.

SK biopharmaceuticals attributed the strong performance to its direct sales infrastructure in the U.S. and tailored marketing strategies, including a recent NBRx sales contest targeting field representatives. In addition, the company plans to launch its first direct-to-consumer (DTC) advertising campaign for Xcopri in the U.S. as early as May, aiming to boost brand awareness and strengthen patient engagement.

Further expansion of cenobamate’s clinical indications and formulations is also underway. The company expects topline results this year from a phase 3 clinical trial evaluating cenobamate in primary generalized tonic-clonic seizures (PGTC). It also plans to file a New Drug Application (NDA) for an oral suspension formulation to facilitate pediatric use.

In response to growing uncertainties around pharmaceutical tariffs, SK biopharmaceuticals has completed FDA approval processes for an additional contract manufacturing organization (CMO) in the U.S. and is continuing to expand its inventory beyond a six-month supply, strengthening its resilience against global supply chain risks.

“The U.S. direct sales model allows us to execute a more sophisticated and patient-centric commercial strategy,” a company official said. “We plan to further expand our market share in the U.S. through aggressive marketing and by broadening therapeutic indications.”

Looking beyond Xcopri, SK biopharmaceuticals is moving quickly to identify the next product to commercialize through its U.S. direct sales network. The company said it expects to introduce the product within the year, selecting a candidate that aligns with its existing commercial infrastructure to enable rapid market entry and early revenue generation.

The company is also diversifying its R&D pipeline with a focus on emerging therapeutic platforms such as radiopharmaceutical therapy (RPT) and targeted protein degradation (TPD).

In the RPT domain, SK biopharmaceuticals is developing its solid tumor candidate SKL35501, having recently secured key raw materials through additional supply agreements with Belgium-based Pantera and existing partner TerraPower in the U.S.

For TPD, the company’s U.S. research subsidiary, SK Life Science Labs, is leading development efforts. SK biopharmaceuticals has recently recruited researchers from leading global pharmaceutical companies to strengthen its capabilities in oncology and TPD-based therapies.

In parallel, SK Life Science, the company’s U.S. commercial subsidiary, has also expanded its R&D workforce to enhance its clinical competitiveness in CNS, oncology, rare diseases, and RPT fields.