[Edaily Reporter Kim Hyung-il ] DS Investment & Securities maintained its “Buy” rating and target price of 155,000 won for SK BIOPHARMACEUTICALS(326030). The firm projected that earnings growth would be driven by increased prescriptions of the epilepsy treatment Xcopri in the U.S. and milestone revenue from its approval in Japan. In the medium to long term, it predicted that the resumption of clinical trials (RISE-3) for the new candidate drug Opakalim and a settlement of the pending patent litigation regarding Xcopri would be key factors in boosting the company’s value.

On the 21st, Kim Min-jeong, an analyst at DS Investment & Securities, estimated that SK BIOPHARMACEUTICALS’s third-quarter revenue would reach 247.7 billion won, a 29.2% increase year-over-year, while operating profit would rise 45.6% to 102.0 billion won. She projected an operating profit margin of 41.2%.

The firm analyzed that milestone revenue generated from obtaining approval for Excofry in Japan on September 16 would offset the impact of unfavorable exchange rates. With the number of Excofry prescriptions in the U.S. continuing to show steady growth, U.S. revenue is projected to reach 217.8 billion won, a 26.5% increase year-over-year.

The firm identified the resumption of clinical trials for Opacalym and the settlement of the Excofry patent litigation as key factors affecting the stock price going forward. SK BIOPHARMACEUTICALS acquired BHV7000, a new epilepsy drug candidate, from Biohaven on August 26. On September 10, they received notice of a “Partial Clinical Hold.” As a result, patient enrollment for RISE-2—one of two major clinical trials that was recruiting new patients—has been suspended.

SK BIOPHARMACEUTICALS aims to submit supplementary nonclinical data in October and lift the clinical hold in November. The company anticipates that if clinical trials resume smoothly, it will be able to establish a stable foundation for its epilepsy treatment business. Attention is also focused on the results of the RISE-3 trial, scheduled to be released this December.

RISE-3 is evaluated as a candidate with excellent tolerability. Analysts suggest that if the seizure reduction rate in RISE-3 reaches the mid-40s or higher, the drug could secure a competitive edge in the market. DS Investment & Securities assumed a seizure reduction rate of 15–20% for the placebo group. Previously, cenobamate recorded a seizure reduction rate of approximately 55.6% compared to 21.5% in the placebo group, while azetukalner recorded approximately 53.2% compared to 10.4% in the placebo group.

The U.S. patent litigation involving Excofry is also a key variable. On August 19, SK BIOPHARMACEUTICALS reached a settlement with Indian generic drugmaker MSN Laboratories regarding the U.S. Excofry patent lawsuit. The company expects the patent lawsuits with the two remaining defendants to be resolved by the first half of next year. This dispute centers on follow-on patents, which are separate from the substance patent; analysts suggest that the previous settlement could have a positive impact on the remaining lawsuits.

Researcher Kim stated, “In addition to securing mid- to long-term growth momentum through the introduction of new candidate compounds, the settlement of the remaining Excofry patent litigation could serve as a basis for upward revisions to future cash flow estimates and enterprise value.” He added, “In the short term, the results of the RISE-3 trial in December are the key variable; if the clinical trial confirms commercial potential, market confidence in SK BIOPHARMACEUTICALS’ sustained growth will also increase.”