Takeda braces for impact as Vyvanse edges toward the patent cliff

As several of Takeda’s top-earning drugs veer toward the patent cliff, the Japanese drugmaker is buckling up for a bumpy ride.

Bracing for losses of exclusivity on a pair of drugs this year, Takeda has forecasted 3,840 billion Japanese yen (about $28.5 billion) in revenues for fiscal year 2023, an expected 4.7% drop from the sum the company reported in 2022.

Specifically, Takeda anticipates a 330 billion yen ($2.4 billion) revenue loss from patent expirations on hypertension med Azilva in Japan in June, plus attention-deficit/hyperactivity disorder drug Vyvanse in the U.S. starting in August.

The coming year will be “challenging” in the face of those patent expirations, Takeda CEO Christophe Weber told analysts on an earnings call this week.

Still, the company expects established drugs and new launches to “largely offset” the brunt of the patent expiration hit.

Takeda is enjoying positive momentum on a range of medicines such as Entyvio, Takhzyro, Livtencity and its plasma-derived therapies. Plus, the company expects to see a “meaningful contribution” from its dengue vaccine Qdenga.

Entyvio, Takeda’s top-selling product approved for ulcerative colitis and Crohn’s disease, reeled in 702.7 billion yen ($5.2 billion) during the company's 2022 fiscal year, rising about 35% over the amount the drug made during the prior fiscal year.

Meanwhile, hereditary angioedema med Takhzyro pulled down 151.8 billion yen (1.1 billion), while Livtencity generated 10.5 billion yen ($77.6 million).

As for Takeda’s plasma-derived therapies immunology business, the unit scored 678.4 billion yen (about $5 billion), increasing sales 34% year over year.

Any headwinds from Vyvanse and Azilva’s losses of exclusivity are “temporary” and they “do not alter the momentum of our growth and launch products nor our excitement in the pipeline to deliver major and long-term growth,” Weber said.

Takeda expects U.S. generic versions of Vyvanse to launch in August, which will likely trigger a decline in the company’s neuroscience business in the coming year, Takeda’s chief financial officer Costa Saroukos added on the company’s earnings call.

That sales slump, which Weber called “very significant,” will bleed over into fiscal year 2024, as well, although “much less than ’23,” Weber said.

The patent loss omens came as Takeda logged 4.03 trillion yen (29.77 billion) in revenues for the fiscal year that ended on March 31.

While Takeda remains confident in its growth and launch products to soften the blow from its patent expirations, the company faces “additional headwinds” tied to Novavax’s ill-fated COVID-19 vaccine Nuvaxovid.

“As a result of softening demand and the government cancelation of their order for Nuvaxovid, we now expect fiscal year 2023 revenue to be minimal,” Weber explained.