BeiGene, Ltd. (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has released its financial results for the first quarter of 2024, revealing a total revenue of USD 752 million, marking a 68% year-on-year (YOY) increase. Product revenue specifically soared 82% YOY to USD 747 million. Notably, US sales experienced a significant surge, rising from USD 139 million in the same period last year to USD 351 million. Despite an operating loss of USD 261 million, which represents a 30% YOY decrease, the company’s cash and cash equivalents remained robust at USD 2.807 billion.
The substantial growth can be attributed to the strong performance of BeiGene’s core products, the BTK inhibitor Brukinsa (zanubrutinib) and the PD-1 inhibitor tislelizumab. Brukinsa achieved sales of USD 351 million in the US and USD 67 million in Europe, with respective YOY increases of 153% and 243%. Tislelizumab contributed USD 145 million to the revenue, up 26% YOY. Brukinsa received FDA approval for the treatment of adult patients with R/R follicular lymphoma in combination with obinutuzumab, following two or more lines of systemic therapy. Tislelizumab gained FDA approval for second-line esophageal squamous cell carcinoma (ESCC) and European Commission approval for non-small cell lung cancer (NSCLC) across three indications.
Research and development (R&D) expenses increased by 13% YOY to USD 460 million. BeiGene’s BCL-2 inhibitor, sonrotoclax, received FDA fast track designation for R/R mantle cell lymphoma (MCL), and the BTK CDAC BGB-16673 is on track to enter Phase III clinical trials for R/R CLL by year-end 2024. The company also anticipates the opening of a state-of-the-art biologics manufacturing facility and clinical R&D center at the Princeton West Innovation Campus in Hopewell, New Jersey, in July.
In a recent legal development, the US Patent and Trademark Office (USPTO) has granted BeiGene’s petition for post-grant review of the Pharmacyclics’ patent within an ongoing patent infringement lawsuit initiated by AbbVie in June 2023. AbbVie claimed that BeiGene’s Brukinsa infringed upon Pharmacyclics/AbbVie’s Imbruvica patent. The USPTO is expected to deliver a final decision on the patent’s validity within the next 12 months.- Fineline.com
