Based on September WAC, $324 million, approximately 434.1 billion won... SC proportion in Keytruda is 15.7%
Expansion of sales market with approval in China and Japan… Additional technology fees expected from Alteogen
The prescription amount for ‘Keytruda Qlex’, an immunotherapy drug using Alteogen’s subcutaneous injection (SC) formulation conversion technology, exceeded 430 billion won in September. The SC formulation's share of the total Keytruda prescription amount also exceeded 15%. Although the recent European patent dispute is putting pressure on stock prices, actual product sales indicators show rapid growth.
According to Bloomberg aggregate data shared by Alteogen (196170) on the 12th, the prescription amount for Keytruda Curex based on wholesale acquisition price (WAC) in September was $324 million (about 434.1 billion won), an increase of about 34% compared to the previous month. The proportion of SC formulations in the entire Keytruda franchise increased by 3.3 percentage points from 12.4% in August to 15.7% in September.
Keytruda Curex is a product that applies Alteogen's human hyaluronidase technology, ALT-B4, to Merck & Co.'s (MSD) blockbuster immunotherapy drug Keytruda. Since the administration time can be significantly reduced compared to the existing intravenous (IV) method, sales have been expanding since approval by the U.S. Food and Drug Administration (FDA) in September last year.
Monthly WAC-based prescriptions increased from $168 million in June of this year to $203 million in July, $241 million in August, and then to $324 million in September.
Merck officially announced that Keytruda Curex sales in the first half of this year were approximately $590 million. If we add the estimate of $768 million based on WAC from July to September compiled by Bloomberg, the cumulative amount from January to September amounts to about $1.358 billion (approximately 1.82 trillion won). This figure is a combination of official sales and WAC estimates and is different from actual accounting cumulative sales.
Merck has set a goal of increasing the adoption rate of SC formulations in the U.S. market to 30-40% by the end of 2027. In the second quarter performance announcement, it was explained that adoption by medical staff and patients is increasing after the application of the US insurance claim code (J-code).
Overseas market expansion continues. China's National Medical Products Administration (NMPA) approved Keytruda SC for 19 solid cancer indications on the 29th of last month, and approval was also received in Japan for all of Keytruda's existing approved indications. In Korea, product supply began on the 1st of this month.
The expansion of Keytruda SC sales is linked to Alteogen's additional technology fee revenue. Alteogen received the first sales milestone of $25 million from Merck, and additional milestones and royalty income may be generated depending on future sales performance.
Meanwhile, uncertainty remains due to the European patent dispute. The Dutch court recently accepted Halozyme's application for a patent infringement injunction and restricted the manufacture, sale, and import of Keytruda SC in eight European countries. Alteogen estimates the actual business impact in the region to be about 3%, and invalidation decisions for related patents are being made one after another in the United States.
The expansion of Keytruda SC's sales shows that Alteogen's technology transfer performance is leading to actual profits. In Merck's official third quarter earnings announcement, it is expected that actual sales of the SC formulation and the trend of conversion from the existing intravenous formulation will be confirmed.
