[Edaily Reporter KIM SAE-MI ] SK Biopharm ( SK BIOPHARMACEUTICALS(326030)) announced on the 5th that its consolidated operating profit for the third quarter of this year was 116.3 billion won, a 65.9% increase compared to the same period last year. During the same period, revenue rose 34.8% to 258.4 billion won, while net income fell 23.9% to 54.3 billion won.

Cumulative revenue for the first three quarters of this year reached 733.7 billion won, a 43.2% increase compared to the same period last year. Cumulative operating profit rose 92.3% to 303.1 billion won, while cumulative net income increased 100.9% to 242.1 billion won.

In particular, the company explained that this quarter’s operating profit exceeded 100 billion won for the first time, excluding quarters in which one-time service revenue was reflected.

This earnings growth was driven by “cenobamate” (U.S. brand name: Xcopri), a new drug for epilepsy. Third-quarter U.S. sales of cenobamate totaled $156.81 million (approximately 223.6 billion won), representing a 26.4% increase year-over-year and a 4.9% increase quarter-over-quarter in dollar terms. Due to the decline in the won-dollar exchange rate, sales in won terms decreased by 0.3% compared to the previous quarter.

Cumulative U.S. sales of cenobamate for the first three quarters of this year totaled $441.29 million, reaching approximately 76% of the upper end of the annual sales guidance of $580 million. SK BIOPHARMACEUTICALS maintained its annual guidance range of $550 million to $580 million.

Total prescriptions (TRx) in the U.S. for the third quarter were 152,000, a 6.0% increase from the previous quarter. The monthly average number of prescriptions exceeded 50,000 for the first time, while the number of new patient prescriptions (NBRx) remained at a monthly average of approximately 1,800.

Third-quarter other revenue totaled 34.8 billion won, consisting of 5.9 billion won in revenue from finished pharmaceutical products and active pharmaceutical ingredients (DP/API) and 28.9 billion won in service revenue. Service revenue included royalties, as well as revenue from ongoing Asian clinical trials and milestone payments. Third-quarter selling, general, and administrative expenses (SG&A) totaled 133.1 billion won, a decrease of 2.1 billion won from the previous quarter.

SK BIOPHARMACEUTICALS plans to reinvest the cash generated from direct sales of cenobamate in the U.S. into the introduction of new products and the research and development of next-generation drugs.

SK BIOPHARMACEUTICALS is pursuing the introduction of Biohaven’s epilepsy drug candidate “Opacalym” (BHV-7000) as the second product to be marketed through its direct sales network in the U.S. However, the closing of the transaction is being delayed because the U.S. Food and Drug Administration (FDA)’s partial clinical hold has not yet been lifted. The company expects to secure the first topline results from RISE3, a key clinical trial, by the end of the year.

An SK BIOPHARMACEUTICALS official explained, “Procedures to lift the clinical hold are underway, led by Biohaven,” adding, “Both companies agree to finalize the transaction once this issue is resolved.” The official further clarified, “The RISE3 clinical topline results scheduled for year-end are a separate matter from the lifting of the clinical hold.”

The company is also expanding its development of next-generation new drugs. SK BIOPHARMACEUTICALS aims to submit two to three Investigational New Drug (IND) applications next year. The company plans to submit an IND for the p300-selective proteasome inhibitor “SKT-18416” in the first half of next year and for the radiopharmaceutical therapy (RPT) candidate “SKL37321” in the second half. The Parkinson’s disease treatment candidate “SKL32276” is also preparing to enter clinical trials.

Lee Dong-hoon, President of SK BIOPHARMACEUTICALS, stated, “Despite technology acquisitions and expanded R&D investments, our operating profit is growing rapidly, allowing us to accumulate cash reserves sufficient for substantial investments.” He added, “We are strengthening a virtuous cycle by extending the value of our direct-to-consumer platform to our next products and reinvesting the profits generated from this into the development of subsequent new drugs.”