Attributing losses to exchange rate and pipeline impairment losses, the Japanese biopharma dropped its reported net profit forecast of 142 billion yen ($945.1 million) to 93 billion yen ($618.8 million).
Pictured: Red and white Takeda sign on a brick wall/iStock, jetcityimage
Takeda shared financial results for the first half of fiscal year 2023 on Thursday, reporting a disappointing net loss from Phase III fails while dropping net profit projections for the fiscal year by 71%.
The Japanese company attributed losses to the exchange rate, tax assumptions and developmental setbacks from two asset failures. As a result, Takeda announced it was taking a 74 billion yen—or $770.5 million—write-down.
Last week, the biopharma announced its Phase III study of Alofisel, a stem-cell therapy for Crohn’s disease, failed to meet its primary endpoint. The drug had already been approved in the European Union and a handful of other countries based on previous positive data. The trial was intended to support a U.S. filing.
Earlier this month, Takeda voluntarily withdrew Exkivity from the U.S. and global markets. The non-small cell lung cancer drug failed to meet its primary endpoint in a confirmatory Phase III trial after its initial accelerated approval in 2021.
At the time of the announcement, Takeda stated it would update its full-year forecast. This week’s earnings call revealed a drop from the original reported net profit forecast of 142 billion yen to 93 billion yen, or approximately $945 million to $618 million.
The operating profit forecast was also lowered from $2.3 billion to $1.5 billion for the fiscal year running from April 2023 to March 2024. The reported operating profit for the first half of the year was 53% less than that of the same period in the prior year.
Takeda maintains that Entyvio is a key driver for growth. The biologic is the only FDA-approved therapy for ulcerative colitis with both IV and subcutaneous options. A BLA to add Crohn’s disease to its approved indications was accepted by the FDA in September 2023. Phase III trials of the drug in psoriasis and psoriatic arthritis are anticipated to start in fiscal year 2023 and 2024, respectively.
While approved in Europe and other countries, Takeda withdrew the application for U.S. approval for its dengue vaccine, Qdenga, in July 2023 following discussions with the FDA regarding additional data collection. The company is pursuing private and public partnerships to expand access to the vaccine.
Takeda has a potential first oral treatment option for a rare, inflammatory disease of the esophagus. After receiving a CRL nearly two years ago, the company revised its new drug application, which the FDA accepted in September 2023.
CEO Christophe Weber assured investors on a Wednesday call that he expects to return to growth “in the near term” in 2024 or 2025. Takeda’s stock dropped 7% in trading this morning on the news.
Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.
