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Baiyueze sold 1.1 billion US dollars in half a year, and BeiGene's losses narrow

On the morning of August 8th, BeiGene (BGNE.NS, 06160.HK, 688235.SH) saw its stock price surge by more than 4% during the trading session on the Hong Kong stock market.

The previous evening, the company disclosed its main financial data for the first half of 2024, showing that the company's performance loss was narrowing. According to the data, in the first half of 2024, BeiGene achieved a total operating revenue of 11.996 billion yuan, a year-on-year increase of 64.4%; the net profit attributable to the shareholders of the listed company was a loss of 2.877 billion yuan, which was a 44.87% reduction compared to the loss of 5.219 billion yuan in the same period of 2023.

BeiGene also published the company's non-GAAP performance. According to the data, after excluding the impact of non-cash items such as share-based payment expenses, depreciation, and amortization expenses, the company's adjusted operating profit turned from loss to profit in the second quarter of 2024, achieving a profit of 345 million yuan.

This was mainly due to an increase in the company's product revenue. In the first half of 2024, the company achieved product revenue of 11.908 billion yuan, a year-on-year increase of 77.8%. The growth in product revenue was mainly due to the sales increase of self-developed products such as BRUKINSA (zanubrutinib capsules) and BALYNZA (tislelizumab injection), as well as authorized products from Amgen.

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Among these products, BRUKINSA's revenue dominated. The income from overseas accounted for nearly 90% of BRUKINSA's revenue. As one of BeiGene's star products, BRUKINSA is a cytoplasmic non-receptor tyrosine kinase and is a second-generation BTK inhibitor. It was first approved for marketing in the United States in November 2019, making it the first Chinese original anti-cancer drug to "go global" successfully. In 2023, BRUKINSA's global sales exceeded one billion US dollars for the first time, reaching 1.3 billion US dollars for the year, becoming the first "billion-dollar molecule" in China.

In the first half of 2024, BRUKINSA's global sales increased by 122.0% year-on-year, reaching 8.018 billion yuan (approximately 1.117 billion US dollars), approaching the full-year sales of 2023. BRUKINSA has been approved for multiple indications in over 70 markets, including the United States, China, the European Union, the United Kingdom, Canada, Australia, South Korea, and Switzerland.

Specifically, in the first half of 2024, BRUKINSA's sales in the United States totaled 5.903 billion yuan, a year-on-year increase of 134.4%, with more than 60% of the quarterly sequential demand growth coming from the expansion of use in the chronic lymphocytic leukemia (CLL) indication, while the product's market share among new CLL patients continued to increase. Sales in Europe totaled 1.057 billion yuan, a year-on-year increase of 231.6%, mainly due to an increase in the product's market share in all major markets, including Germany, Italy, Spain, France, and the United Kingdom. Sales in China totaled 873 million yuan, a year-on-year increase of 30.5%, mainly due to the growth in sales of the product in the approved indication areas.

BeiGene stated that the company continues to maintain a leading position in the Chinese BTK inhibitor market. Currently, five out of the six indications for which BRUKINSA has been approved in China and meet the inclusion criteria have all been included in the "National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog" ("National Insurance Drug Catalog").Among the independently developed products of BeiGene, in addition to BeiYiZe, another product has also achieved overseas market approval, namely BeiZeAn, which is a PD-1 monoclonal antibody. Starting from September 2023, it began to be approved for marketing in some overseas countries.

As of now, BeiZeAn has been approved in the United States, the European Union, the United Kingdom, and Australia for the second-line treatment of adult patients with esophageal squamous cell carcinoma (ESCC), and in the European Union and Australia for three indications: combined with chemotherapy for the first-line treatment and as a single drug for the second-line treatment of metastatic non-small cell lung cancer (NSCLC).

In the first half of 2024, BeiZeAn's total sales amounted to 2.191 billion yuan, a year-on-year increase of 19.4%. However, BeiGene has not yet disclosed the overseas revenue situation of this product. The company stated that the increase in BeiZeAn's sales is mainly due to the additional patient demand brought by the inclusion of new indications in the medical insurance and the increase in the number of hospitals where the drug is available. Currently, BeiZeAn has been approved for 13 indications in China, and all 11 indications that meet the inclusion criteria have been fully included in the national medical insurance directory.

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