Takeda takes $770M in write-downs after Alofisel flop, Exkivity withdrawal decision

After one Takeda drug flunked a phase 3 trial and as the company pulls another from the market, the drugmaker is taking some hefty impairment charges.

In its most recent quarter, the Japanese company took 115.8 billion Japanese yen ($770 million) in impairment losses. The charges largely stem from recent setbacks for stem cell treatment Alofisel and cancer therapy Exkivity.

Takeda reported that Alofisel failed a phase 3 trial in Crohn’s disease complex perianal fistulas (CPF) just last week. In a study of 594 patients, the treatment missed the mark of combined remission at 24 weeks.

While the full data hasn’t yet been revealed, the company had flagged a potential revenue loss and expressed its disappointment with the trial outcome.

The write-down associated with that setback was worth 74 billion yen ($490 million), the company said Thursday.

Meanwhile, Exkivity’s voluntary market withdrawal also came earlier this month. The drug won approval under the FDA's accelerated pathway for certain adults with non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-based chemotherapy.

After a confirmatory trial flop over the summer, Takeda is now working with the FDA to withdraw the med in the U.S. It's also taking the same steps overseas.

With Exkivity, the company was gunning for full approval with its phase 3 study. Instead, the trial was cut early in July.

That setback resulted in an impairment charge of 28.5 billion yen ($190 million).

Overall, the company posted revenues of 2.1 trillion yen ($13.9 billion) for the first half of its fiscal year, a 6.4% increase from the same period last year. Meanwhile, operating profits took a big hit, falling by 53.2% from last year.

After the result, Takeda dialed down its operating profit forecast for the year to 225 billion yen ($1.5 billion), Reuters reports. That compared with a prior estimate of 349 billion yen.