Zasocitinib

The Japanese drugmaker is looking to embark on a new path for growth as it leaves generics-ridden ADHD med Vyvanse behind. This time last year, Takeda was scrambling to accommodate for rapidly sinking profits from the hasty decline of ADHD mainstay Vyvanse with a 140 billion Japanese yen ($899 million) restructuring campaign. Now, things are looking up for the Japanese drugmaker with several key products keeping it afloat as it looks to unlock a new path to growth with upcoming launches.While six new launches are expected to help weather the storm ahead of biosimilar competition to lead sales driver Entyvio at the end of the decade, three “potentially life-transforming” new treatment options are on track for phase 3 readouts this year, the company said in its 2024 full-year earnings release. Takeda’s fiscal year just wrapped up in March 2025 and began in April 2024.2025’s fiscal year, meanwhile, will be “pivotal” as it invests in launch readiness, which is key for the company’s long-term growth potential despite a flat 2025 outlook, CEO Christophe Weber commented. Rusfertide, a treatment for chronic blood disorder polycythemia vera that Takeda bought from Protagonist Therapeutics for $300 million last year, already delivered a phase 3 win in March. The company expects that the buy will be well worth it with $1 billion to $2 billion in potential peak revenue and previously noted that FDA submissions are expected in 2025.  Elsewhere, the first half of the year should see a phase 3 readout for narcolepsy type 1 treatment oveporexton, which is looking at $2 billion to $3 billion in peak sales, while the latter half of the year should have phase 3 data from zasocitinib, a TYK2 inhibitor that could “redefine what is possible” as an oral therapy for psoriasis. That one has the greatest potential revenues with $3 billion to $6 billion.Together, the three make an “inflection point” for the company, said Chief Financial Officer Milano Furuta, who is “excited about our growth trajectory." Takeda is hoping that the boosts to come will help it shake off the ghost of its Vyvanse past, its longtime top-selling ADHD med that succumbed to generic competition in late 2023 after 16 years of market exclusivity. The company described its 2025 outlook (PDF) as the final year of “significant” generic headwind to the med, although it may be worth noting that it said the same last year about its 2024 expectations. Nonetheless, the new launch preparations and an expected 30% sales slide for Vyvanse are anticipated to leave revenue at a “broadly flat” 4.5 trillion yen ($31 billion).That forecast does not reflect the potential impact of pharmaceutical-specific tariffs, Takeda noted, although it will “continue to monitor the situation.” Since 50% of its revenue comes from the U.S. and its imports make up only about 8% to 10% of its total U.S. revenue, the company’s potential exposure to tariffs are “limited,” it explained. The drugmaker is meanwhile taking “mitigation measures” for imports that may be impacted by tariffs, detailing its current global manufacturing network as 22 internal sites with 20 that supply the U.S. and 7 located in the U.S.Takeda did however also make some major cuts across its experimental drug pipeline. This includes the axing of three cancer candidates that has now halved the number of all oncology meds in Takeda’s phase 1 and 2 pipeline.Over 2024, Takeda reported a 7.5% boost in revenue to 4.6 trillion Japanese yen ($31.8 billion), although net profit fell 25.1%. Weber attributed its “multi-year efficacy program” to the company’s 4.9% bump in core operating profit growth.  So fair, said program, which was unveiled last year to reduce layers and encourage organizational simplicity, added up to around 200 billion Japanese yen ($1.38 billion) in annualized savings to date and has prompted 3,000 layoffs (PDF) so far.The company’s "growth and launch" collection includes several products across its six key business areas and made up 48% of its total core revenue. Inflammatory bowel disease (IBD) drug Entyvio is Takeda’s top growth driver and is “maintaining share leadership” even as the IBD market becomes more and more crowded with fierce competition from AbbVie's Skyrizi and Rinvoq, among others. Still, the company touts it as the #1 brand in IBD and is bolstered by its newly launched pen option.Other growth drivers include metastatic colorectal cancer (mCRC) treatment Fruzaqla, which grew 351% to 48 billion Japanese yen ($331 million) and is seeing “strong uptake” in the U.S., while dengue vaccine Qdenga is on track to hit 100 million manufactured doses by 2030. 

Takeda said Thursday that sales and operating profit this year — one that it is billing as "pivotal" in terms of late-stage readouts — will be "broadly flat" versus the previous 12-month period, impacted by the final significant headwinds from Vyvanse generics. Revenue is forecast to be JPY 4.53 trillion ($31.7 billion), compared to JPY 4.58 trillion in fiscal year 2024, when it grew 7.5%, with operating profit of JPY 475 billion.Chief financial officer Milano Furuta said the guidance demonstrates Takeda's "ability to manage through one of the largest generic impacts on our business…while progressing a highly promising late-stage pipeline."Revenues from Vyvanse are expected to decline around 30% this year to JPY 241 billion, having fallen 21.6% in fiscal 2024 to JPY 350.6 billion. Teva added that its guidance does not include the impact of potential tariffs from the Trump administration on the import of pharmaceutical products.Last year, profit was JPY 107.9 billion, down 25.1%.Reached 'inflection point'"Takeda is now at an inflection point, with multiple anticipated Phase III data readouts this fiscal year," remarked Furuta. In March, Takeda reported that the late-stage VERIFY trial of rusfertide in patients with polycythemia vera met its main goal, setting up marketing applications for the hepcidin mimetic peptide therapeutic.The company expects further Phase III readouts for the oral orexin agonist oveporexton in narcolepsy Type 1 in the first half and for the oral TYK2 inhibitor zasocitinib in psoriasis in the second half.($1 = JPY 144.675)