Japan-based multinational Takeda (TYO: 4502) has released its financial report for the fiscal year 2023 Q1 period ended June 30, 2023. The company reported revenues that grew at 3.7% year-on-year (YOY) in constant exchange rate terms to JPY 1.058 trillion (USD 7.44 billion). Takeda CEO Costa Saroukos highlighted that priority growth products and new launches were the key revenue drivers, expanding sales by 16.2% YOY, which will be crucial in navigating the expected ongoing generic erosion to off-patent brands for the remainder of the year.
Key Growth Drivers and Regional Revenues
Key growth driver products include the ulcerative colitis and Crohn’s disease drug Entyvio (vedolizumab), with sales up 7% at JPY 192 billion (USD 1.35 billion), CMV drug Livtencity (maribavir), growing at 71%, and in oncology, the lung cancer therapies Alunbrig (brigatinib) and Exkivity (mobocertinib), with sales up 41% and 192% respectively. The newly launched Qdenga (dengue vaccine) and plasma-derived sales (immunoglobulin and albumin) contributed significantly, with a 24% growth.
Takeda is currently facing the loss of exclusivity for three key products: the myeloma and lymphoma therapy Velcade (bortezomib), gastric acid drug Dexilant (dexlansoprazole) in the US, and hypertension brand Azilva (azilsartan) in Japan. There was also a significant impact from the loss of COVID-19-related revenues, particularly in Japan. China was noted as a source of significant demand for albumin, Adcetris (brentuximab vedotin), and Alunbrig, the latter now reimbursed nationally in China.
Pipeline Development Setbacks and Future Prospects
Takeda has encountered recent setbacks in its pipeline development. Exkivity, which received accelerated approval in the US in September 2021 for advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, was recently “stopped for futility” in the Phase III EXCLAIM-2 trial. Takeda’s R&D president Andy Plump stated that the company will engage with regulators regarding these data and determine next steps for the program. Additionally, in early July, Takeda announced a temporary withdrawal of its BLA for dengue vaccine Qdenga (TAK-003) to the US FDA following discussions regarding the scope of data collection used to support the filing.
A potential respite for Takeda may come through the USD 1 billion+ partnership with HutchMed signed in January this year, under which Takeda acquired ex-China development rights to the Chinese firm’s Elunate (fruquintinib). The US FDA set a PDUFA decision date for that drug’s use in colorectal cancer at November 30, 2023.-Fineline Info & Tech