The goal is to make the epilepsy treatment drug Xcopri (active ingredient cenobamate) the number one in the U.S. epilepsy treatment market unconditionally. We aim to achieve early entry into the annual '1 trillion club' by connecting it with a second product that will be launched in the future.
On the 19th (local time), Lee Dong-hoon, CEO of SK Biopharm, met with reporters at the BIO USA event held in Boston, saying, "We are working to accelerate the target date for achieving annual sales of 1 trillion won, initially set for 2029, by strengthening the market position of Xcopri in the U.S."
Xcopri is the first domestically developed drug that a Korean corporation independently conducted from drug development to approval and sale. It received product approval from the U.S. Food and Drug Administration (FDA) in November 2019 and has been on the market since May 2020. The active pharmaceutical ingredients are manufactured domestically, while finished goods are produced in Canada and exported to the U.S.
The CEO noted, "This year, we are focusing on strengthening our marketing strategy by expanding our outreach to specialists, following TV and online advertising targeted at patients." He added, "I plan to visit major cities in the U.S. and meet with 100 epilepsy specialists in person by the end of the year," stating, "Increasing meetings with doctors can enhance product credibility and help solidify follow-up strategies such as expanding indications, diversifying formulations, and extending patents by listening to feedback from the field."
To address uncertainties in tariffs originating from the U.S., SK Biopharm is considering a manufacturing facility located in Puerto Rico. The CEO mentioned, "Since Puerto Rico is a U.S. territory, production here is considered domestically produced in the U.S.,” and noted that they have completed the due diligence for the Puerto Rico facility, considering FDA approval, and are keeping a long-term reshoring strategy in mind.
The company is also preparing its next product. Currently, about 97% of SK Biopharm's revenue comes from cenobamate. Diversifying the product line is an essential task for sales and market expansion. The CEO stated, "We plan to introduce an external drug that can create synergies with Xcopri within this year," and added, "Adding a second product to the sales platform established by Xcopri will significantly increase sales momentum."
To achieve this, the emphasis was also placed on the open innovation strategy. The CEO stated, "We are preparing a structure to secure basic research and early pipelines (drugs under development) through collaborations with universities and biotechnology corporations," adding, "Recently, major pharmaceutical companies are tending to source basic research externally." He continued, "We plan to secure promising candidates for central nervous system (CNS) diseases currently being developed by biotechnology corporations to eventually expand into existing cancer pipelines (drug candidates)."
AI-based new drug development was also highlighted as a key strategy. SK Biopharm is pursuing various projects, including an EEG-based seizure prediction algorithm and automation of clinical protocols using AI. He stated, "It is impossible to develop new drugs without AI," and noted, "In the long term, we are also preparing a patient platform based on the global epilepsy patient community." This patient experience and data-based platform is expected to be utilized not only for sharing treatment information but also as a tool for clinical design and marketing.
The CEO remarked, "There are various risks, such as tariffs and drug prices, in the U.S. business, but we are thoroughly managing those risks by diversifying our manufacturing base and supply chain," and added, "We will grow into a global leader through the unique experience and platform of SK Biopharm."