Takeda Lowers Profit Outlook Amid Vyvanse Loss of Exclusivity, Eyes $900M Restructuring in 2024

Takeda US_iStock, hapabapa

Pictured: Takeda's office in Cambridge, Massachusetts/iStock, hapabapa

Takeda on Thursday released the business report for its 2023 fiscal year, touting a modest increase in annual revenue while forecasting a profit hit for the coming year tied to the continued sales erosion of its ADHD therapy Vyvanse (lisdexamfetamine dimesylate).

For the fiscal year that ended March 31, 2024, Takeda booked more than $27 billion in revenue. This figure represents a 1.5% increase at constant exchange rates from its fiscal year 2023 revenue of $25.8 billion. Despite the revenue bump, Takeda’s net profit for the year dropped 57% to $925 million, from approximately $2 billion during the previous fiscal year.

Takeda’s reported operating profit likewise took a 50.3% hit, dropping from $3.15 billion to $1.37 billion in the fiscal year 2023.

According to the pharma’s investor presentation, the drop in reported operating profit could be attributed to higher operating expenditure as well as “impairments” with its Crohn’s disease stem cell therapy Alofisel (darvadstrocel) and lung cancer tyrosine kinase inhibitor Exkivity (mobocertinib).

In October 2023, Alofisel failed its Phase III ADMIRE-CD II study, unable to significantly improve 24-week combined remission in patients with complex Crohn’s perianal fistulas. The company subsequently decided not to file for regulatory approval in the U.S., according to its presentation on Thursday. The same month, Takeda withdrew Exkivitiy globally after it failed the confirmatory Phase III EXCLAIM-2 study.

Looking ahead to the rest of the current fiscal year, Takeda tempered investor expectations and lowered its core operating profit guidance by approximately 10%. The Japanese multinational now anticipates booking around $6.4 million (or ¥1 billion) in the coming year. Takeda’s forecast also includes a “flat to slightly declining” annual revenue.

This annual guidance reflects the continued sales erosion that Takeda is expecting to weather as generic versions of its ADHD medicine Vyvanse hit the market. First approved in 2003, Vyvanse lost several crucial patent protections in 2023, including those that covered adult indications in February, and those for pediatric use in August. There are at least 12 impending generic version of Vyvanse from companies such as Sandoz, Teva and Mylan.

Takeda has lined up several upcoming pipeline milestones to make up for Vyvanse’s loss of exclusivity. In the coming fiscal year, for instance, it is planning to launch a Phase III study of its tyrosine kinase 2 inhibitor zasocitinib in psoriatic arthritis, as well as a head-to-head study versus BMS’s Sotyktu (deucravacitinib) in psoriasis.

The pharma is also awaiting a Phase III readout for its cholesterol 24-hydroxylase inhibitor soticlestat in the first half of the fiscal year. The drug candidate is being studied for Dravet syndrome or Lennox-Gastaut syndrome, two rare epileptic conditions.

Aside from its promising pipeline, Takeda will also implement an “enterprise-wide efficiency program,” which will start in fiscal year 2024, according to its business report. The pharma expects this strategic initiative to cost nearly $900 million.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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