China-based biotech company BeiGene (SHA: 688235, HKG: 6160, NASDAQ: BGNE) has released its financial report for the second quarter of 2023, demonstrating strong year-on-year (YOY) growth of 81.8% in product revenues, reaching USD 553.7 million. Sales in China contributed USD 233.9 million, while the US market generated USD 223.5 million. The growth was primarily driven by the BTK inhibitor Brukinsa, PD-1 inhibitor tislelizumab, and products in-licensed from Amgen.
Key Regulatory Developments and Sales Performance
During Q2’23, BeiGene achieved several key regulatory milestones. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for tislelizumab as a second-line monotherapy for advanced or metastatic esophageal squamous cell carcinoma (ESCC) following prior platinum-based chemotherapy. The US FDA accepted a supplemental new drug application (sNDA) for Brukinsa in combination with obinutuzumab for the treatment of patients with R/R follicular lymphoma (FL). Additionally, Brukinsa received two sNDA approvals for CLL/SLL and Waldenström’s macroglobulinemia (WM), and two sNDAs for conversions from conditional approval to regular approval for certain patients with R/R CLL/SLL and R/R WM.
Global Sales and Market Penetration
Global sales of Brukinsa reached USD 308 million in the quarter, marking a 139% increase from the prior-year period and a 46% increase from the prior quarter. US sales accounted for USD 223.5 million of this total, growing at 152.9% YOY, while Brukinsa sales in China totaled USD 48.5 million, growing at 32.2% YOY. Tislelizumab’s China sales reached USD 149.5 million during the quarter, with a growth of 42.5% YOY. The increase in new patient demand, reimbursement of new indications, and expansion of salesforce efficiency and hospital listings contributed to market penetration, making tislelizumab the leading PD-1 inhibitor in the Chinese market.
Strategic Partnerships and Agreements
BeiGene entered into an agreement with DualityBio to acquire an exclusive option for a global clinical and commercial license to an investigational Antibody Drug Conjugate (ADC) therapy for patients with select solid tumors, complementing the company’s initial internally discovered ADC assets. The company also struck a partnership with The Max Foundation to provide access to Brukinsa for the treatment of adult patients with CLL in 29 countries over the next three years, aligning with BeiGene’s mission to treat more patients globally.
Financial Performance and Outlook
BeiGene continues to report a net loss of USD 381.1 million for the quarter, compared to USD 565.7 million in the same period of 2022. Profitability is not expected until 2024. However, as of June 30, 2023, BeiGene’s cash holdings and equivalents amount to USD 3.5 billion, down from USD 4.5 billion reported as of December 31, 2022.-Fineline Info & Tech
