With Xtandi's growth days numbered, an unfazed Astellas expects a group of new products will more than offset the decline of the Pfizer-partnered blockbuster in fiscal year 2026.
Xtandi global sales hit 960.8 billion Japanese yen ($6 billion) in Astellas’ fiscal 2025, “reaching projected peak sales levels 13 years after launch,” CEO Naoki Okamura said during an English-dubbed investor call Monday.
However, compared with a 5.3% increase in Xtandi sales in fiscal 2025, Astellas expects the prostate cancer drug’s revenue to drop by 5.3% in fiscal 2026, which ends in March 2027.
Growth will likely not return for Xtandi. Astellas attributed the projected decline to a price reduction under the Inflation Reduction Act beginning in 2027, the same year that the drug is also slated to lose U.S. market exclusivity.
Astellas is bracing for a group-wide revenue decline once the anti-androgen med falls off the patent cliff. But at least for fiscal 2026, the Japanese pharma hopes five strategic brands will deliver 130 billion yen in additional sales—which would represent 27% growth—and will therefore, drive overall company growth by 4% year over year based on unchanged exchange rates.
The five products are Pfizer-partnered antibody-drug conjugate Padcev, eye med Izervay, CLDN18.2 cancer drug Vyloy, menopause therapy Veozah and leukemia treatment Xospata. Together, the five brands contributed 480.3 billion yen (around $3 billion) in fiscal 2025 sales, up 43% year over year.
Starting from this year, Astellas will not provide sales forecasts for each individual strategic brand.
“We believe it is important to grow five strategic brands as one whole, and we hope to engage in dialogue focused on mid- to long-term growth trajectory, rather than being preoccupied with the short-term fluctuations in individual products,” Okamura said.
Among the five brands, Padcev is clearly the star. Following a landmark FDA approval as part of a Keytruda combination for the perioperative treatment of cisplatin-ineligible muscle-invasive bladder cancer patients in November, year-on-year U.S. sales growth of the Nectin-4 agent accelerated to roughly 33% in Astellas’ fourth quarter, reaching 38 billion yen ($239 billion), compared with 13% in the three months before.
Padcev is on track to expand its perioperative MIBC indication even further to reach cisplatin-eligible patients based on the positive EV-304 trial. With priority review, the FDA is scheduled to make a decision by Aug. 17, 2026.
Based on Padcev’s fast growth, as well as strong demand for Vyloy—which saw sales up 133% in Astellas’ fourth quarter—plus continued uptake of Izervay, Jefferies analysts argued in an April 27 note that Astellas’ 130-billion-yen growth projection for the strategic brands may be conservative.
However, during Monday’s call, Astellas’ chief commercial and medical affairs officer, Claus Zieler, cautioned that although Padcev’s uptake in MIBC shot up quickly, a plateau is expected about six months into the launch. For ex-U.S., the company expects the first-line metastatic indication will drive growth for the drug.
To potentially maximize Padcev’s value, Astellas has started developing the drug for bladder-sparing treatment of MIBC, Okamura said on the call. By Astellas’ estimate, about 30% of MIBC patients are ineligible for or refuse radical cystectomy, which is a necessary step in Padcev’s existing perioperative indication.
A single-arm phase 2 trial was initiated in April for patients who elected not to undergo bladder-removal surgery, and a separate registrational phase 3, EV-309, is planned for the first half of fiscal 2026.
Bladder-sparing MIBC, plus potential perioperative approval in China, could further boost Padcev’s outlook as these opportunities are not currently baked into Astellas’ peak sales forecast, Okamura said.
On a corporate level, drug pricing uncertainty in the U.S. has been a major overhang for Astellas and other mid-sized pharma companies.
The Trump administration has signed “most favored nation” deals with all 17 large pharma companies initially targeted by President Donald Trump, offering price reductions and making certain drugs available on the government’s direct-to-consumer portal, Trumprx.gov, in exchange for tariff exemptions and other benefits.
“We haven’t received a letter from the U.S. government,” Okamura said on the call, “but we try to open a channel to discuss with the government authorities.”
While Astellas cannot currently quantify the potential impact of the policy, the company has examined information from existing deals to evaluate its options, the CEO said.
Astellas launched a multi-year cost optimization program, called “sustainable margin transformation,” in 2024. Through organizational restructuring, streamlining certain infrastructure and reducing investments in mature products, Astellas saved about 11 billion yen in selling, general and administrative expenses during fiscal 2025. Through ongoing cost-reduction efforts, Astellas expects SG&A expenses to decrease by 7% to 800 billion yen in fiscal 2026.