China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) released its Q3 2022 earnings report, showing robust growth with revenues reaching USD 387.6 million, an 88% year-on-year (YOY) expansion. Sales from products totaled USD 349.5 million during the period, up 82% YOY, driven primarily by Brukinsa (zanubrutinib) and the anti-PD-1 tislelizumab, alongside products licensed from Amgen and Bio-Thera Solutions Ltd. R&D expenses were USD 426.4 million, while cost of sales were USD 76.5 million, resulting in net losses of USD 557.6 million, a significant increase from USD 438.1 million during the same period in 2021.
Brukinsa Performance
Brukinsa, a Bruton’s tyrosine kinase (BTK) inhibitor, generated USD 155.5 million in global sales during Q3, up from USD 65.8 million the previous year. This growth was driven by increasing prescription volumes in the United States. The drug won market approvals in another 10 markets worldwide in 2022 and demonstrated superior progression-free survival (PFS) versus ibrutinib in a final analysis of the Phase III ALPINE study.
Tislelizumab Performance
Tislelizumab, a humanized IgG4 anti-PD-1 monoclonal antibody (mAb), took home USD 128.2 million in Q3 revenues, representing a 67% YOY increase. This reflected new indication approvals and inclusion in China’s National Reimbursement Drug List (NRDL). During the period, a supplemental biologics application (sBLA) for tislelizumab in combination with chemotherapy as a first-line (1L) treatment for esophageal squamous cell carcinoma (ESCC) was accepted for review by China’s Center for Drug Evaluation (CDE). An NDA for tislelizumab as a first- and second-line treatment for non-small cell lung cancer (NSCLC) and second-line in ESCC is under review by MedSafe in New Zealand. An NDA for tislelizumab in second-line ESCC is also under review by South Korea’s Ministry of Food and Safety (MFDS). Meanwhile, in the Phase III RATIONALE 301 trial, tislelizumab met its primary endpoint of non-inferiority in overall survival (OS) versus sorafenib as a first-line treatment for adult patients with unresectable hepatocellular carcinoma (HCC).
Collaboration and Licensing Revenue
Sales of Amgen in-licensed products in China generated USD 27.5 million in Q3 2022, compared to USD 20.8 million in the prior-year period, a 32% increase. Sales of BMS in-licensed products in China were USD 22.4 million during the period, compared to USD 26.0 million in the prior year period, a 14% decrease. Collaboration revenue for the three months ending September 30, 2022, was USD 38.1 million, resulting from partial recognition of the upfront payments from Novartis of USD 650 million related to the tislelizumab agreement and USD 300 million related to the ociperlimab option agreement, entered into during the first quarter and fourth quarter of 2021, respectively.-Fineline Info & Tech
