On May 8, BeiGene (688235)'s US stock performance report for the 2024 Q1 quarter and the A-share performance report were freshly released.

Financial reports show that during the reporting period, BeiGene's total revenue reached 5.359 billion yuan, up 74.8% year on year; thanks to the rapid release of the two core self-developed products, the company's global product revenue reached 5.325 billion yuan, up 89.6% year on year and 17.8% month on month, exceeding market expectations.

At the same time as revenue increased sharply, thanks to strict expense management, BeiGene's operating expenses grew slowly. Current sales and management expenses fell 23 percentage points to 57% compared to 80% of product revenue in the same period last year. Operating efficiency improved markedly, and losses narrowed further. Under non-GAAP (non-GAAP), the company's adjusted operating losses for the current period fell 47% year over year, making steady progress towards sustainable profits.

With its strong internal capabilities in commercialization, R&D, and production, BeiGene is now in the top 15 global oncology treatment innovation companies (based on 2024Q1 oncology drug sales), bringing significant benchmarking effects to the innovative pharmaceutical industry.

Global commercialization potential continues to be tapped, and growth certainty is steadily increasing

Under the current uncertain global biomedical environment, BeiGene was still able to achieve significant growth, showing strong endogenous growth and resilience to risks.

Following the “billion dollar molecule” milestone last year, Zebutinib (Baiyuze), the core product of BeiGene, continued to increase this year. Global sales in the Q1 quarter reached 3.476 billion yuan, a sharp increase of 140.2% over the previous year.

Among them, zebutinib maintained rapid release in the global market, led by the United States. During the reporting period, zebutinib's sales in the US were 2,496 billion yuan, up 162.7% year on year; in Europe, zebutinib also continued to expand its market share, with European sales reaching 476 million yuan in the Q1 quarter, a sharp increase of 256.8%; domestically, zebutinib's performance was also remarkable, with current sales reaching 413 million yuan, an increase of 25.5% year on year, and continued to lead the BTK market share.

It is worth mentioning that zebutinib is currently the first and only BTK inhibitor with excellent ORR and PFS efficacy compared to ibutinib in CLL patients. It was also recommended at the highest level in the 2023 NCCN Guidelines for the Treatment of CLL/SLL.

Furthermore, as the world's “best-in-class” BTK inhibitor, zebutinib has now been approved for multiple indications in 70 markets around the world. In data from the phase 3 ALPINE and phase 3 ASCEND trials disclosed earlier, zebutinib compared to ibutinib and arcotinib showed continuous progression-free survival (PFS) efficacy, complete remission (CR) advantages, and safety characteristics. The “best in class” status has been confirmed once again.

Financial reports show that zebutinib is already ahead of similar drugs in new patients with recurrent or refractory (R/R) CLL, and has been covered by medical insurance in many parts of Europe. For example, for the first time in France, the drug was reimbursed for indications such as CLL, Fahrenheit macroglobulinemia, and marginal zone lymphoma.

While the “quantity” and “quality” of BTK inhibitors have risen sharply, BeiGene's global expansion in the PD-1 field is also progressing steadily. Financial reports show that another of BeiGene's core products, tirelizumab (Baizean), achieved total sales of 1,044 billion yuan in the current period, an increase of 32.8% over the previous year.

According to the Zhitong Finance App, tilaserizumab has received numerous breakthroughs since its launch, and the indicative layout is far ahead.

In the domestic market, tirelizumab has gained a leading market share in the PD-1 field. Recently, the drug was successfully approved for first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Up to now, tirelizumab has been approved for 12 indications in China, 11 of which have been included in the medical insurance drug catalogue, covering a wide range of high-incidence cancers in China, such as lung cancer and liver cancer.

In the US market, tiralizumab received the first indication approval for second-line ESCC treatment, and was listed as a priority recommended treatment plan for second-line or post-line ESCC treatment in the NCCN guidelines recently published this year. In addition, tirelizumab also has a new indication BLA accepted by the FDA for first-line treatment of gastric or gastroesophageal conjunctional adenocarcinoma. During the reporting period, tiralizumab was newly approved for first-line and second-line treatment of three non-small cell lung cancer (NSCLC) indications in the European Union. Currently, tirelizumab has been approved in many markets including the European Union, the United Kingdom, the United States, South Korea, and Switzerland.

It is easy to see that while promoting zebutinib and tirelizumab to the global market, BeiGene has established a complete international commercialization system, paving the way for subsequent major pipelines to enter the international market, and the large-scale effect continues to be highlighted.

Differentiated innovation continues to raise the value curve

According to the Zhitong Finance App, with strong R&D support, BeiGene is currently developing more than 60 drug pipelines, covering various technology platforms and drug models, including monoclonal antibodies, double/multiple antibodies, ADC, cell therapy, mRNA, etc., and has established a complete product pipeline with potential FIC/BIC capabilities in the field of hematoma and solid tumors.

In addition to the 3 self-developed products that have been approved, BeiGene also has products such as sonrotoclax, osperimab, BGB-A445, and BGB-16673 in its self-developed product pipeline. Among them, sonrotoclax and osperimab are already in phase 3 clinical stages.

Take the BCL-2 inhibitor Sonrotoclax as an example. Currently, BeiGene is implementing a progressive layout in the field of hematoma using zebutinib as the foundation, and sonrotoclax is the key anchor point.

As a second-generation highly selective and potent BCL-2 inhibitor developed by BeiGene, compared to the BCL-2 inhibitors that have already been marketed, sonrotoclax showed a shorter half-life and no drug accumulation. In previous clinical studies on more than 500 patients, sonrotoclax achieved a long-lasting therapeutic response at low doses, and showed good safety characteristics as a single drug or in combination with zebutinib.

It is worth mentioning that in previous studies, SonrotocLAX showed stronger activity than venclexta (venecla), the world's first BCL-2 inhibitor, and also had a better inhibitory effect on BCL2 G101V mutations.

In terms of commercialization potential, Vinecla's sales in 2023 reached 2,288 billion US dollars, an increase of 13.9% over the previous year, and AbbVie's sales peak is expected to reach 6 billion US dollars. Supported by the BIC attributes of BeiGene products and the global commercialization layout, Sonrotoclax is expected to show great potential to enter the global competitive market for BCL-2 inhibitors.

To further unlock Sonrotoclax's “best-in-class” potential in hematoma, BeiGene has initiated 4 global registration trials, including a global phase 3 registration trial for first-line treatment of chronic lymphocytic leukemia (CLL). The differentiated BTK CDAC project BGB-16673 initiated two global expansion cohort studies targeting BTK inhibitor resistant patients and a wider patient population.

BeiGene is advancing potentially differentiated projects, including ADCs, degradant platforms, and targeted therapies for key cancer types, covering diseases such as lung cancer, breast cancer, and gastrointestinal cancer.

According to financial reports, 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 multiple antibody-conjugated drug (ADC) molecules and double antibodies, including pan-KRAS inhibitors, MTA co-PRMT5 inhibitors, EGFR-CDAC, CEA-ADC, and FGFR2b-ADC to accelerate the next phase of differentiated innovation research and development.

According to public information, in 2024, BeiGene will continue to push forward global registration applications for the two core products, and is expected to welcome further progress in its BCL-2 and BTK CDAC projects.

Recently, many investment banks such as Dongguan Securities, Lyon, and TD Cowen gave BeiGene “increase in holdings” and “buy” ratings. According to institutional research, as a leading innovative drug company, BeiGene Shenzhou has a rich product structure and strong R&D strength. The release of core products is accelerated, and the international layout continues to accelerate.