Korean pharmaceutical and biotech companies are reaping tangible results in the US market through direct sales strategies led by their local subsidiaries. While building distribution networks and expanding personnel initially weighs on costs, the direct sales model is taking root, lifting both revenue and profitability at the US units. As successive new drug launches under direct sales prove highly profitable for these subsidiaries, other biotech firms are following suit and establishing their own direct sales operations.
According to the Financial Supervisory Service's electronic disclosure system Tuesday, Celltrion (068270.KS)'s US subsidiary Celltrion USA posted first-quarter revenue of 132.2 billion won, up 137% from 55.8 billion won a year earlier. Quarterly net profit swung to 16.7 billion won from a 25.6 billion won loss, while total comprehensive income, which reflects foreign exchange and overseas affiliate valuation gains, improved sharply to 52.3 billion won from a 25.9 billion won loss.
Celltrion sells its autoimmune disease treatment Zympentra directly through its US subsidiary. Given that direct US sales of Zympentra began in March 2024, the growth trajectory is steep. In the first quarter of 2024, when direct sales had just started, Celltrion USA's revenue stood at 15.3 billion won with a quarterly net loss of 13.6 billion won. Revenue has expanded nearly tenfold in two years. On an annual basis, Celltrion USA's revenue grew from 146.7 billion won in 2024 to 304.9 billion won in 2025, with net profit also rising from 3.6 billion won to 9.4 billion won.
The market views the impact of Zympentra's US direct sales as beginning to take full effect. First-quarter Zympentra prescriptions in the US jumped 185% year-on-year, marking the highest quarterly prescription volume on record. Celltrion has pursued a "3P marketing strategy" centered on its US subsidiary, targeting providers, payers, and patients. The company expects growth to continue in the second half, supported by reimbursement coverage exceeding 90% and rising local brand recognition.
SK Biopharmaceuticals (326030.KS) is another leading example of a US direct sales strategy. SK Biopharmaceuticals sells its epilepsy drug Cenobamate directly through its US affiliate SK Life Science. First-quarter revenue at SK Life Science came to 214.6 billion won, up 7.5% from 199.7 billion won a year earlier. Since launching US sales in May 2020, SK Life Science's revenue has expanded from 172.6 billion won in 2020 to 907.8 billion won last year. Net profit over the same period rose from 11.3 billion won to 30.1 billion won, breaking the 30 billion won mark for the first time. The growth was driven by Cenobamate's US sales, which jumped 44% year-on-year to 630.3 billion won last year, a record high.
First-quarter net profit, however, swung to a loss. "Changes in internal settlement methods and seasonal factors had an impact," an SK Biopharmaceuticals official said. "On an annual basis, much of the impact will be offset, and we expect to maintain a level similar to previous years."
Direct US sales bring heavy short-term burdens, including the cost of building distribution networks, expanding personnel, and increased marketing spending. The industry, however, views these costs as worth bearing, as the strategy can secure higher profitability and market dominance over the medium to long term.
A growing number of companies are turning to direct US sales. Hugel plans to move beyond its existing partner-centered distribution strategy and roll out a "hybrid sales model" combining partner distribution and direct sales in the US starting in the second half.
As the share of direct sales grows, earnings growth at US subsidiary Hugel America is also expected to accelerate. Hugel America posted first-quarter revenue of 14.4 billion won and quarterly net profit of 1 billion won. Given that revenue stood at around 5.8 billion won a year earlier, the top line is expanding rapidly. The company plans to raise the US subsidiary's operating margin target from 20% in 2026 to 40% by 2030.
