Takeda, the Japanese pharmaceutical company, is grappling with significant impairment charges totaling 115.8 billion Japanese yen ($770 million) in its most recent quarter. These charges are primarily attributed to recent setbacks involving two of its drugs: Alofisel, a stem cell treatment, and Exkivity, a cancer therapy.
Also Read: Takeda Withdraw Global Lung Cancer Medication, Exkivity, Following Confirmatory Trial Failure
Last week, Alofisel encountered a major setback as it failed to meet the combined remission endpoint at 24 weeks in a phase 3 trial for Crohn’s disease complex perianal fistulas (CPF), involving 594 patients. Although the full trial data has not yet been disclosed, Takeda had foreseen potential revenue losses and expressed its disappointment with the trial’s outcome. The resulting write-down associated with this development amounted to 74 billion yen ($490 million).
Simultaneously, earlier this month, Takeda made the decision to voluntarily withdraw Exkivity from the market. Exkivity had received FDA approval via the accelerated pathway for certain adults with non-small cell lung cancer (NSCLC) that had progressed after platinum-based chemotherapy. However, following a disappointing confirmatory trial outcome over the summer, Takeda is actively collaborating with the FDA to withdraw the drug in the U.S., with similar measures being taken in international markets. The early termination of the trial led to an impairment charge of 28.5 billion yen ($190 million).
Also Read: Takeda’s Alofisel Fails To Meet Primary Endpoint In Phase 3 Trial For Crohn’s Disease Complication
In terms of financial performance, Takeda reported revenues of 2.1 trillion yen ($13.9 billion) for the first half of its fiscal year, marking a 6.4% increase compared to the same period in the previous year. However, operating profits took a substantial hit, experiencing a 53.2% decline year-over-year. Consequently, Takeda has revised its operating profit forecast for the year to 225 billion yen ($1.5 billion), a notable reduction from the earlier estimate of 349 billion yen, as reported by Reuters.
