Takeda is awaiting several US Food and Drug Administration (FDA) reviews of drug applications this year. Image credit: Shutterstock/Jonathan Weiss.

Takeda Pharmaceuticals has lowered its forecasted profit for 2023 by 36%, with the biopharma citing development setbacks of pipeline drugs.

Takeda revised the outlook in its FY2023 H1 results announcement. The new guidance places the company’s forecasted profit for the financial year at $1.5bn (Y225bn) . This is down from the $2.3bn (Y349bn) figure the company predicted in May 2023 when announcing full-year 2022 results.

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Takeda CEO Christophe Weber pointed to development setbacks with Exkivity (mobocertinib) and Alofisel (daradstrocel) – two of the company’s pipeline drugs. Exkivity is an oral tyrosine kinase inhibitor (TKI) and Alofisel is a stem cell therapy. 

Earlier in October, Takeda announced the start of  Exkivity’s voluntary withdrawal after it failed to reach its primary endpoint in a Phase III trial for non-small cell lung cancer (NSCLC). Last week, Takeda announced that Alofisel had failed a Phase III trial for the treatment of complex Crohn’s perianal fistulas.

Exkivity is approved for NSCLC in China. Alofisel is approved in the European Union, UK, and Japan for the treatment of complex Crohn’s perianal fistulas in patients who have not responded to previous therapies.

In a company statement, Weber said: “Development setbacks with Exkivity and Alofisel, which impacted our reported profit in FY2023 Q2, highlight the inherent risk in research and development in the pharmaceutical business, but do not hinder our strategy for a return to growth in the near-term.”

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Takeda reported FY2023 H1 revenue of $14bn (Y2.1tn), up 6.4% from last year. The company slightly raised its revenue forecast for the end of the financial year, expecting to bring in $26.4bn (Y3.98tn).

Takeda is awaiting several US Food and Drug Administration (FDA) reviews of drug applications. In May 2023, the FDA granted priority review to TAK-755 (recombinant ADAMTS13), an enzyme replacement therapy to treat the rare blood disorder thrombotic thrombocytopenic purpura. In the same month, the agency also granted priority review to fruquintinib for previously treated metastatic colorectal cancer. In September 2023, the FDA accepted a review for TAK-721 (budesonide oral suspension) for the treatment of eosinophilic esophagitis.