核心产品销售额保持较快增长，呋喹替尼海外商业化有望加速。公司肿瘤/自免业务24 年全年收入指引维持3-4 亿美元。公司3 款已商业化核心产品中，1）呋喹替尼凭借优异的临床效果，24H1 国内收入增长9%至4600万美元（按固定汇率计算为14%），在国内三线结直肠癌市场保持领导地位。呋喹替尼24H1 海外销售额1.31 亿美元，放量迅速，公司相应获得海外特权使用费和生产收入0.43 亿美元，伴随后续欧洲市场商业化，呋喹替尼海外销售额有望加速提升。2）索凡替尼持续进行市场推广活动，24H1收入增长12%至2540 万美元（按固定汇率计算为17%）。3）赛沃替尼销售额保持较快增长，24H1 收入下降14%至1310 万美元（按固定汇率计算为10%），主要受生产收入减少影响但被特权使用费增加所部分抵消。Matters:
On July 31, Hehuang Pharmaceutical announced its 2024 semi-annual report. The company's total revenue was 0.306 billion US dollars (-42.6%), of which the comprehensive revenue from the oncology/immunization business was 0.169 billion US dollars (-53%), which was mainly affected by the high base of down payment of furoquintinib during the 23H1 period. The company's net profit to mother was 0.026 billion US dollars, achieving profit, and the performance slightly exceeded expectations.
Ping An's point of view:
Sales of core products have maintained rapid growth, and overseas commercialization of furoquintinib is expected to accelerate. The company's revenue guidance for the full year of oncology/immunization business remained at $0.3-0.4 billion for 24 years. Among the company's 3 commercialized core products, 1) furoquintinib increased domestic revenue by 9% to 46 million US dollars (14% at a fixed exchange rate) due to excellent clinical effects, maintaining a leading position in the domestic third-tier colorectal cancer market. Overseas sales of fruquintinib 24H1 were 0.131 billion US dollars, and the volume was rapidly released. Accordingly, the company received overseas preferential royalties and production revenue of 0.043 billion US dollars. With subsequent commercialization in the European market, overseas sales of furoquintinib are expected to accelerate. 2) Surufatinib continued marketing activities, and 24H1 revenue increased 12% to 25.4 million US dollars (17% at a fixed exchange rate). 3) Sales of sevotinib continued to grow rapidly, with 24H1 revenue falling 14% to 13.1 million dollars (10% at a fixed exchange rate), mainly affected by a decrease in production revenue but partially offset by an increase in privileged royalties.
Additionally, the company 24H1 confirmed a total revenue of $33.8 million (23H1 confirmed revenue of $0.269 billion) from Takeda, including down payments and milestone payments.
The company's annual R&D expenditure was drastically reduced year on year, and sales and administrative expenses were effectively controlled. The company's 24H1 R&D expenditure was drastically reduced by 34% to 0.095 billion US dollars (23H1 was 0.145 billion US dollars), mainly due to the company's strategic prioritization of pipeline products, especially pipeline products outside of China. The company's 24H1 sales and administrative expenses were $0.058 billion (23H1 was $0.068 billion), a year-on-year decrease, mainly due to the company's tighter control over expenses and greater use of existing infrastructure to drive further revenue growth.
The company's global innovation pipeline continues to gain strength, catalyzing the company's value increase. Many of the company's major products with major indications are expected to be approved or declared for NDA in '24. 1) Fruquintinib submitted an NDA in Japan for third-line colorectal cancer indications and is expected to be approved for marketing in '24. 2) Fruquintinib's domestic second-line gastric cancer indication 24H1 was accepted by the CDE and is expected to be approved for marketing in 24Q3. 3) Is sevotinib used in second/third-line treatment of MET abnormalities? The phase III clinical study of refractory non-small cell lung cancer completed patient enrollment in February 2024. Based on the accelerated approval granted by the FDA, it is expected that an NDA will be submitted at the end of 24 and approved for marketing in '25. 4) Solepinib second-line treatment for immune thrombocytopenia (ITP). The application for marketing of the new drug was accepted by the CDE in January '24 and included in priority review, and is expected to be approved for marketing in 24/25. The approval of a number of major products for major indications is expected to continuously catalyze the company's value increase.
Investment advice: We expect the company's main business revenue in 2024-2026 to be 0.671, 0.861, and 1.027 billion US dollars, respectively, and the company's net profit in 2024-2026 will be -0.107, 0.02, and 0.095 billion US dollars, respectively, which is consistent with the previous period. Considering that the indications for the company's listed products are still expanding, and the company is also rich in research pipelines, pipeline valuation is expected to further improve and maintain the “recommended” rating.
Risk warning: 1) Drug approval falls short of expectations: the company's innovative products may be delayed in approval; 2) the marketing volume of new drugs falls short of expectations: whether each node progresses smoothly after the launch of the company's innovative products has a significant impact on the company's product sales volume; 3) Impact of national policies: Health insurance negotiation policies may be adjusted, thereby affecting the company's innovative drug sales.
