Despite Vyvanse's loss of exclusivity, Takeda treads water thanks to launch momentum

Despite the recent loss of exclusivity on Takeda's attention-deficit/hyperactivity disorder (ADHD) heavy hitter Vyvanse, the company's portfolio of newer products continues to hold the sales line.

During the first nine months of Takeda's 2023 fiscal year, the drugmaker's growth and launch products grew sales 12.7% at constant currencies, Takeda said in a Thursday earnings presentation (PDF). The portfolio accounted for 43% of Takeda’s total sales haul for the period, which ended Dec. 31.

Overall, Takeda's global revenues for the nine-month period came to 3.21 trillion Japanese yen (about $22 billion). The number was flat from the prior year at constant exchange rates, but Takeda appears to be taking that performance in stride considering the fact that it’s facing “significant” pressure from Vyvanse generics in the U.S.

On that front, Vyvanse sales fell 12.1% to 312.9 billion yen ($2.14 billion), a performance that was “as expected” following the blockbuster’s loss of exclusivity in August. Takeda reports that nine generics to the drug have launched since Aug. 24.

Vyvanse's market-share erosion in the U.S. was “slightly milder than initially anticipated,” Takeda said, thanks to constraints on generic supplies of the med. But the generic supply constraints should ease in the coming months, according to Takeda.

Meanwhile, Takeda has recently added a pair of new drugs to its launch roster: Fruzaqla, approved in previously treated metastatic colorectal cancer, and Adzynma, an enzyme replacement therapy for congenital thrombotic thrombocytopenic purpura.

The stars of Takeda’s drug debut catalogue, however, are its Entyvio pen for inflammatory bowel disease (IBD) and its dengue fever vaccine Qdenga.

In recent months, Entyvio maintained its top position in the U.S. IBD market, Takeda said, growing global sales 7% during the first nine months of the company's fiscal year.

Entyvio launched in pen form for ulcerative colitis in the U.S. in November. Since then, the drug-device combo has witnessed a “high level of interest and growing formulary access,” Takeda pointed out. Early this year, Takeda hopes to secure a nod for Entyvio in Crohn’s disease.

Moving over to Qdenga, the dengue vaccine has now launched in Indonesia, Brazil, Thailand and Argentina. Plus, the shot has experienced “strong initial demand” in private markets, Takeda said.

Qdenga has made its way onto some formal government immunization programs, including in Brazil. Elsewhere, Takeda says it’s engaged in “productive discussions” with governments in endemic regions to get the vaccine added to national immunization programs.

In the aftermath of Vyvanse’s loss of exclusivity, Takeda is making bold pledges to investors to get its business back on track.

In the near term, meaning fiscal year 2024 through 2025, Takeda aims to return to sales, profit and margin growth, the company said in its earnings presentation.

Over the medium term, which runs into the early 2030s, Takeda plans to continue expanding the reach of its new medicines. In addition, Takeda hopes to secure more launches from its late-stage pipeline and enjoy “limited” generic competition before the advent of Entyvio biosimilars.