Failed Drugs, Loss of Patent: Japanese drugmaker Takeda slashes full-year profit forecast by 36 percent

Takeda lowered its operating profit forecast to 225 billion yen ($1.5 billion) in the financial year ending March 2024, it said in its mid-year results.

The forecast is well below its earlier guidance of 349 billion yen and consensus expectations for full-year operating profit of 400.3 billion yen, based on an LSEG survey of 17 analysts.

The company posted operating earnings of 490.5 billion yen the previous year.

Takeda has flagged this year as a rebuilding phase. It is seeking to deepen its bench of drugs in development as it loses sales exclusivity on main sellers, such as blood pressure drug Azilva in Japan and hyperactivity drug Vyvanse in the United States.

But that effort has been dealt setbacks from recent clinical trial failures of lung cancer treatment Exkivity and Crohn's disease drug Alofisel.

Impairment losses in the second quarter ended Sept. 30 will hurt reported operating income, while core operating profit is still expected to exceed 1 trillion yen this fiscal year, in line with previous guidance, Takeda said.

Takeda did not have major sales ambitions for the two failed drugs, but their write-downs had an outsized impact on reported results and the full-year outlook, Chief Executive Christophe Weber said.

"We expect to rebound into growth territory in 2024, 2025, so these two products do not change our big picture," he said in an interview before the release of mid-year results.

Takeda is anticipating regulators will grant three drug approvals and one expanded use authorisation by the end of the year, including nods for colorectal cancer drug Fruquintinib and Eohilia, a treatment for inflammation of the oesophagus.

"Just these two products are potentially as big as Exkivity and Alofisel that resulted negatively in the last quarter," Weber said about the potential approvals.

A bright spot for the company's development pipeline has been its dengue vaccine QDENGA, approved by regulators in Europe and other regions over the last year. Demand for the vaccine is expected to grow as climate change expands the reach of the tropical disease, which sickens millions every year.

Takeda voluntarily pulled its application for the shot in the United States in July, citing data collection issues, and there is no immediate plan to resubmit it for approval in that market, Weber said.

Its pipeline also includes an experimental psoriasis drug that it agreed to buy last year from U.S.-based Nimbus Therapeutics for as much as $6 billion, marking its first major purchase since its $59 billion takeover of Shire Plc in 2019.

For the second quarter ended in September, Takeda reported an operating loss of 49.3 billion yen compared with profit of 104.4 billion yen a year earlier and the consensus estimate of 129.4 billion yen in positive earnings.

Takeda shares are up 8.1% this year, compared to a 17% advance in the benchmark Nikkei gauge.