On May 8, BeiGene's (688235.SH) 2024 Q1 U.S. stock performance report and A-share performance report were released.
According to the financial report, during the reporting period, BeiGene's total operating income reached 5.359 billion yuan, a year-on-year increase of 74.8%; Thanks to the rapid volume of the two core self-developed products, the company's global product revenue reached 5.325 billion yuan, an increase of 89.6% year-on-year and 17.8% month-on-month, exceeding market expectations.
While the revenue increased significantly, BeiGene's operating expenses slowed down due to strict expense management, and the current sales and administrative expenses decreased by 23 percentage points to 57% of product revenue from 80% in the same period last year, significantly improving operating efficiency and further narrowing losses. On a non-GAAP basis, the company's adjusted operating loss for the period decreased by 47% year-over-year, and the company is on track to become sustainably profitable.
With its strong in-house capabilities in commercialization, R&D, and manufacturing, BeiGene is now among the top 15 global cancer innovators in terms of oncology drug sales in Q1 2024, bringing significant benchmarking effect to the innovative drug industry.
The potential for global commercialization continues to be tapped, and the certainty of growth is steadily improving
Despite the current uncertain global biopharmaceutical environment, BeiGene has been able to achieve significant growth, demonstrating strong endogenous growth and risk resistance.
Following the "billion-dollar molecule" milestone last year, BeiGene's core product zanubrutinib (BRUKINSA ®) continued its high growth momentum this year, with global sales reaching 3.476 billion yuan in Q1, a significant increase of 140.2% year-on-year.
Among them, zanubrutinib has maintained rapid growth in the global market led by the United States. During the reporting period, zanubrutinib's sales in the United States were 2.496 billion yuan, a year-on-year increase of 162.7%; In Europe, zanubrutinib is also expanding its market share, with sales in Europe reaching RMB476 million in Q1, a significant increase of 256.8% year-on-year. In China, zanubrutinib's performance was also remarkable, with sales of 413 million yuan, a year-on-year increase of 25.5%, and its market share in the BTK field continued to lead.
It is worth mentioning that zanubrutinib is currently the first and only BTK inhibitor to achieve dual efficacy of ORR and PFS compared to ibrutinib in CLL patients. It is recommended at the highest level in the 2023 NCCN guidelines for the treatment of CLL/SLL.
In addition, as a "best-in-class" BTK inhibitor in the world, zanubrutinib has been approved for multiple indications in 70 markets worldwide. In previously disclosed data from the Phase 3 ALPINE and Phase 3 ASCEND trials, zanubrutinib demonstrated sustained progression-free survival (PFS) superiority, complete response (CR) superiority, and safety profile compared with ibrutinib and aclotinib. Once again, the "best in class" status has been confirmed.
According to the financial report, zanubrutinib has led similar drugs in the market share of new patients with relapsed or refractory (R/R) CLL, and has been included in medical insurance in many places in Europe, such as France's first reimbursement of the drug in indications such as CLL, Waldenstrom macroglobulinemia and marginal zone lymphoma.
While achieving both "quantity" and "quality" in BTK inhibitors, BeiGene's global expansion in the PD-1 field is also steadily advancing. According to the financial report, BeiGene's other core product, tislelizumab (tislelizumab ®), achieved sales of 1.044 billion yuan in the current period, a year-on-year increase of 32.8%.
According to Zhitong Financial APP, tislelizumab has made many breakthroughs since its launch, and the indication layout is far ahead.
In the domestic market, tislelizumab has achieved a leading market share in the PD-1 field. Recently, the drug was successfully approved in combination with chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Up to now, tislelizumab has been approved for 12 indications in China, of which 11 have been included in the NRDL, covering lung cancer, liver cancer and other high-incidence cancers in mainland China.
In the U.S. market, tislelizumab received the first indication approval for the second-line treatment of ESCC, and in the latest NCCN guidelines released this year, it has been ranked among the preferred recommended treatment regimens for second-line or second-line treatment of ESCC. In addition, tislelizumab has a new indication for BLA accepted by the FDA for the first-line treatment of adenocarcinoma of the stomach or gastroesophageal junction. During the reporting period, tislelizumab was newly approved in the EU for the first- and second-line treatment of three non-small cell lung cancer (NSCLC) indications. Tislelizumab is currently approved in multiple markets, including the European Union, the United Kingdom, the United States, South Korea and Switzerland.
It is not difficult to see that while promoting zanubrutinib and tislelizumab to the global market, BeiGene has established a comprehensive international commercialization system, paving the way for the subsequent blockbuster pipeline to enter the international market, and the scale effect is constantly highlighted.
Differentiated innovation continues to raise the value curve
According to Zhitong Financial APP, with strong R&D support, BeiGene currently has a pipeline of more than 60 drug candidates, covering a variety of technology platforms and drug models, including monoclonal antibodies, bispecific antibodies/polyclonal antibodies, ADCs, cell therapy, mRNA, etc., and has established a complete pipeline of products under development with potential FIC/BIC strength in the field of hematological tumors and solid tumors.
In addition to the three approved in-house products, BeiGene has entered the clinical-stage in-house pipeline of sonrotoclax, osperlimab, BGB-A445 and BGB-16673, among which sonrotoclax and osperlimab are in Phase 3 clinical stage.
Taking the BCL-2 inhibitor sonrotoclax as an example, BeiGene is currently making a progressive layout in the field of hematological tumors with zanubrutinib as the cornerstone, and sonrotoclax is a key anchor in it.
As a second-generation highly selective and potent BCL-2 inhibitor developed by BeiGene, sonrotoclax exhibits a shorter half-life and no drug accumulation than marketed BCL-2 inhibitors, and has demonstrated a durable response at low doses in a previous clinical study of more than 500 patients, and has demonstrated a favorable safety profile both as a single agent or in combination with zanubrutinib.
It is worth mentioning that sonrotoclax has shown stronger activity than the world's first Bcl-2 inhibitor Venclexta (venetoclax) in previous studies, and also has a better inhibitory effect on BCL2 G101V mutation.
In terms of commercialization potential, venetoclax's sales in 2023 will reach $2.288 billion, a year-on-year increase of 13.9%, and AbbVie expects sales to peak at $6 billion. With BeiGene's BIC attributes and global commercialization, sonrotoclax is expected to demonstrate significant potential to compete in the global market for Bcl-2 inhibitors.
To further unlock the "best-in-class" potential of Sonrotoclax in hematological malignancies, BeiGene has initiated four global registrational trials, including a global Phase 3 registrational trial for the first-line treatment of chronic lymphocytic leukemia (CLL). BGB-16673, a differentiated BTK CDAC program, initiated two global expansion cohort studies targeting patients resistant to BTK inhibitors and the broader patient population.
BeiGene is advancing potential differentiation programs, including ADCs, degrader platforms, and targeted therapies for priority cancer types, including lung, breast, and gastrointestinal cancers.
According to the financial report, the company will continue to promote the registration and clinical progress of independent research and development projects and cooperative drug candidates, and in 2024, it is expected to launch a number of antibody-drug conjugate (ADC) molecules and bispecific antibody molecules, including pan-KRAS inhibitors, MTA synergistic PRMT5 inhibitors, EGFR-CDAC, CEA-ADC and FGFR2b-ADC, to accelerate the next stage of differentiated innovation and research and development.
According to public information, in 2024, BeiGene will continue to promote the global registration application of the two core products, and is expected to usher in more progress in its BCL-2 and BTK CDAC projects.
Recently, a number of investment banking institutions such as Dongguan Securities, CLSA, and TD Cowen have given BeiGene "overweight" and "buy" ratings. According to institutional research, BeiGene, as a leading innovative drug company, has a rich product structure and strong R&D strength, and its core products are accelerating in volume and its international layout continues to accelerate.