SK Biopharmaceuticals, under the leadership of Donghoon Lee, announced its second-quarter results, showcasing a remarkable surge in U.S. sales for the innovative epilepsy drug 'Cenobamate' (known as Xcopri in the U.S.). The quarter witnessed a striking $47.3 million (63.4 million won) in sales, signaling a substantial $7 million (9.5 billion won) upswing from the preceding quarter.

During the second quarter of the current year, Cenobamate achieved U.S. sales of $47.3 million (63.4 million won), reflecting a growth of 17.6% compared to the previous quarter and an impressive 57.5% increase from the same period last year. The cumulative prescriptions count (TRx) within the United States continues to steadily ascend. In June alone, 21,841 prescriptions were recorded, approximately 2.1 times higher than the average prescription rate of competing new drugs launched 38 months earlier.

SK Biopharma’s overall sales for the second quarter surged by 44% compared to the corresponding period in the previous year, reaching $57 million (77 billion won). Despite this growth, the company posted an operating loss of $14 million (18.9 billion won). Notably, despite an increase of about $5.3 million (7.1 billion won) in Selling, General, and Administrative expenses (SG&A expenses) from the first quarter, the company attributes the reduction in quarterly operating losses to the upward trajectory in Cenobamate’s sales and diligent streamlining of SG&A expenses. The operating loss in the first quarter of 2023 stood at $17 million (22.7 billion won), while the same in the second quarter of 2022 was approximately $30 million (40.1 billion won).

In 2023, SK Biopharma has introduced reforms in the incentive system for local sales personnel and implemented motivational measures to bolster on-site management. Their assertive marketing strategies aim to broaden the target audience from epilepsy specialists to encompass general neurologists. Consequently, a rising trend in new prescriptions and monthly prescriptions has been observed, contributing to more vigorous business operations. The company anticipates that these initiatives will drive accelerated sales growth in the second half of the year.

Cenobamate's global presence is expanding beyond the United States. In Europe, it has been launched under the name 'Ontozry' and has entered 18 countries, including the five major European economies – Germany, the United Kingdom, Italy, Spain, and France. Furthermore, ongoing Phase 3 clinical trials for Cenobamate are ongoing in three Asian countries, with the aim of broadening indications for generalized seizures and expanding the patient age range eligible for the medication. The company plans to submit New Drug Applications (NDAs) or Supplemental New Drug Applications (sNDAs) for all these trials by 2025.

According to the company's projections, Cenobamate is poised to become a blockbuster product, with annual U.S. sales estimated to reach approximately $747 thousand (1 billion won) by 2029. SK Biopharma also intends to amplify fixed-cost and operational leverage effects by incorporating a second commercially available product into Cenobamate's direct sales network in the U.S. by 2025.

Through its ventures in RPT (Radiotherapeutic Pharmaceuticals), TPD (Targeted Protein Degradation), and CGT (Cellular Gene Therapy), SK Biopharma is poised to achieve a complete bio-value chain within the SK Group, expecting synergies across its business operations.