BeiGene (688235): "Global Gene" Benchmark for Innovative Pharmaceutical Companies Accelerating Transformation to BIOPHARMA
DATE:  Feb 20 2025

The benchmark of "international gene" innovative pharmaceutical companies, differentiated R&D layout, efficient and high-quality team, and global sales network lead the company to accelerate its growth. Founded in 2010, the company has gradually grown from a biotech to a comprehensive global enterprise after more than ten years, and is the first innovative pharmaceutical company listed on NASDAQ, Hong Kong Stock Exchange and Science and Technology Innovation Board in China. The company has a management team with a global background and deep industry experience, and in the early stage of development, the company has established strategic cooperation with many global pharmaceutical companies such as Celgene, Amgen, Novartis, etc., reflecting the company's "international vision" in the early stage. The company continues to complete the challenges of innovative pharmaceutical companies such as "0-1 sales system construction" and "0-1 breakthrough of self-developed pipeline":

(1) In terms of sales system, in 2017, the company acquired Celgene's domestic commercial operation business, and built a domestic sales team based on it, and since 2019, the company's self-developed products tislelizumab (PD-1), zanubrutinib (BTK inhibitor) and pamiparib (PARP inhibitor) have been launched in China. At the same time, the domestic sales team continues to mature and grow; In 2019, zanubrutinib was approved for marketing in the United States, achieving "zero breakthrough" in the overseas expansion of domestic innovative drugs, and also driving the construction of the company's efficient overseas sales network, with the company's global commercialization team of more than 3,700 people as of 2024H1.

(2) In terms of R&D system, the company is committed to the research and development of first-in-class innovative products, continues to explore the innovation value of mature products, and actively deploys innovative technologies and innovative targets. Representative blockbuster products such as zanubrutinib showed superior efficacy in head-to-head first-generation BTK inhibitor ibrutinib; Tislelizumab has been approved for 14 indications in China by the end of 24, making it the largest number of PD-1 products approved in China, and has been approved for marketing and commercial sales in Europe and the United States. The company strengthened its product matrix layout, and in the field of hematological tumors, it holds BTK inhibitors zanubrutinib, BCL2 inhibitors and BTK CDAC; In the field of solid tumors, the deployment of next-generation IO therapies, new technologies and new targets is expected to solve the problems faced by existing therapies such as drug resistance or lack of safety.

The high-speed volume of self-developed products has led to the improvement of the company's profitability, and the company's annual operating profit is expected to be positive in 2025. (1) Zanubrutinib: Since its approval in the U.S. in 2019, commercial sales have been strong. From 2021 to the first three quarters of 2024, the global sales of zanubrutinib were 2.18/5.65/12.9/1.816 billion US dollars, respectively, and the sales revenue in the United States accounted for the majority of global zanubrutinib sales, and the sales share of the United States/Europe/China in the first three quarters of 2024 was 73.5%/13.5%/10.5%, respectively. (2) Tislelizumab: Approved for marketing in China in 2019, domestic sales in the first three quarters of 2021-2024 were US$2.55/4.23/5.37/467 million, with a year-on-year growth rate of 56%/66%/27%/14% respectively; In addition, as of the end of 24, the company's PD-1 has been approved for 6 indications in Europe and 2 indications in the United States, and overseas sales are expected in the future.

From the perspective of gross profit margin, the gross profit margin of the company's products in the first three quarters of 2021-2024 was 73.99%/77.17%/82.65%/83.71% respectively; From the perspective of operating profit, in 2024Q2 and Q3, it achieved positive non-GAPP revenue for two consecutive quarters, reaching US$0.48/US$65 million, respectively; From the perspective of cash reserves, as of 2024Q3, the company's cash reserves were 2.7 billion US dollars, an increase of 100 million US dollars compared with the end of 2024Q2, indicating that the company has begun to be able to carry out large-scale clinical research and development while self-"hematopoietic transfusion" under the substantial growth of product revenue, and the cash reserves have ushered in a turning point of increasing instead of decreasing.

Deeply cultivate hematological tumors to build a product matrix, and a number of clinical phase III will be promoted in 2025. The company's zanubrutinib is the world's first head-to-head ibrutinib BTK inhibitor, helping the company to gradually strengthen its leading position in the field of hematologic malignancies. At present, the company's zanubrutinib in combination with sonrotoclax 1L CLL patients is in Phase 3 clinical trial, and enrollment is expected to be completed in 2025Q1, in addition to the Phase 3 clinical trial of sonratoclax monotherapy in 2025H1. In response to the problem of drug resistance, the company has deployed oral BTK CDAC, and is expected to start Phase 3 clinical trial of R/R CLL in 2025H1, and is expected to start Phase 3 clinical trial of R/R CLL with head-to-head non-covalent BTK inhibitor pirtobrutinib in 2025H2.

A number of NMEs in the field of solid tumors have been promoted to clinical practice, and high clinical efficiency has achieved "rapid proof of concept". In 2024, the company will advance 13 new molecular entities (NMEs) into clinical development. In 2025, PoC data will be disclosed for a number of early-clinical molecules: CDK4 inhibitors are expected to disclose PoC data in 2025H1, and Phase 3 clinical studies of 1L and 2LHR+ breast cancer will be conducted in 2025Q4; In the second half of 2025, CDK2 inhibitors, EGFR CDAC, PanKras, IRAK4 CDAC, B7H4 ADCs, etc., will read out PoC data. We believe the company's high-performance clinical team has the potential to help achieve "rapid proof-of-concept" for early-stage molecules.

Investment suggestion: As the first domestic innovative drug company to go overseas, BeiGene's core product zanubrutinib has been sold globally and has exceeded US$1 billion in sales revenue, and the company has a comprehensive layout for hematologic tumors, exploring new technologies such as next-generation tumor immunotherapy, ADC, and bispecific antibody for solid tumor research and development. We expect the company to achieve revenue of 264.98/364.07/43.954 billion yuan from 2024 to 2026, and net profit attributable to the parent company of -44.01/2.05/2.178 billion yuan respectively. The company has a cutting-edge innovative layout on the R&D side, a global sales network on the sales side, and a high-quality and efficient clinical development, and is given a "recommended" rating for the first time.

Risk warning: the risk that drug approval is less than expected; the risk that the new drug launch volume is less than expected; risks associated with intellectual property; the impact of national policies, risks, etc.

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