Xtandi’s days of growth are numbered, and an unflinching Astellas expects a series of new products to more than offset the decline in its blockbuster product partnered with Pfizer in fiscal 2026.
Xtandy’s global sales will reach 960.8 billion yen ($6 billion) in Astellas Pharma’s fiscal year 2025, “reaching the peak sales level expected 13 years after launch,” CEO Naoki Okamura said on an English-dubbed investor conference call on Monday.
However, while sales of Xtandi rose 5.3% in fiscal 2025, Astellas expects sales of the prostate cancer drug to decline 5.3% during fiscal 2026, which ends in March 2027.
Growth is unlikely to return to Xtandi. Astellas blamed the expected decline on price cuts under the Inflation Control Act starting in 2027, when the drug is also scheduled to lose exclusivity on the U.S. market.
Astellas Pharma is bracing for a drop in group-wide revenue if its anti-androgen drugs fall off the patent cliff. However, at least in FY2026, the Japanese pharmaceutical company expects its five strategic brands to bring in additional sales of 130 billion yen, equivalent to 27% growth, thus boosting overall company growth by 4% year-on-year at constant exchange rates.
The five products are the antibody-drug conjugate Padocef, which is affiliated with Pfizer, the eye drug Izervay, the CLDN18.2 anti-cancer drug Viroy, the menopausal disorder treatment Veozer, and the leukemia treatment Zospata. Together, the five brands contributed to sales of 480.3 billion yen (approximately $3 billion) in fiscal 2025, an increase of 43% from the previous year.
Starting this fiscal year, Astellas Pharma will no longer publish sales forecasts for individual strategic brands.
Mr. Okamura said, “We believe it is important to grow the five strategic brands as one, and we would like to engage in dialogue with an eye toward medium- to long-term growth trajectories, rather than getting bogged down in short-term fluctuations in individual products.”
Among the five brands, Padcev is clearly the star. Following the FDA’s breakthrough approval in November as part of the Keytruda combination for the perioperative treatment of cisplatin-ineligible patients with muscle-invasive bladder cancer, Astellas Pharma’s year-over-year growth in U.S. sales of Nectin-4 accelerated to approximately 33% in the fourth quarter, reaching 38 billion yen ($239 billion), compared with 13% in the prior three months.
Based on the positive results in the EV-304 trial, Padcev plans to further expand its perioperative MIBC indication to include cisplatin-eligible patients. Under priority review, the FDA is expected to issue a decision by August 17, 2026.
Analysts at Jefferies argued in an April 27 note that the 130 billion yen growth forecast for Astellas’ strategic brands may be conservative, given Padcef’s rapid growth, strong demand for Astellas’ Vailoi, whose sales rose 133% in the fourth quarter, and the continued uptake of Izervay.
But on a conference call Monday, Klaus Zieler, Astellas’ chief commercial and medical affairs officer, warned that while uptake of Padgev’s MIBC has grown rapidly, it is expected to plateau about six months after launch. For companies outside the US, the company expects first-line metastatic indications to drive growth for the drug.
Okamura said in a conference call that to potentially maximize the value of Pasef, Astellas has begun developing a bladder-sparing treatment for MIBC. Astellas estimates that approximately 30% of MIBC patients are ineligible for or refuse radical cystectomy, a necessary step in Padchev’s existing perioperative indications.
A single-arm Phase 2 trial in patients who chose not to undergo cystectomy began in April, and another registered Phase 3 EV-309 is planned for the first half of 2026.
In addition to bladder-sparing MIBC, the potential for perioperative approval in China could further boost Padgef’s outlook, as these opportunities are not currently factored into Astellas’ peak sales forecasts, Okamura said.
At the corporate level, drug price uncertainty in the U.S. is a major burden for Astellas and other mid-sized pharmaceutical companies.
The Trump administration has entered into “most-favored-nation” agreements with all 17 of the major pharmaceutical companies that President Donald Trump initially targeted, offering them lower prices and making certain drugs available on the government’s direct-to-consumer portal Trumprx.gov in exchange for tariff exemptions and other benefits.
“We have not yet received a letter from the U.S. government, but we are working to open channels for consultation with government authorities,” Okamura said in a telephone conversation.
Astellas cannot currently quantify the potential impact of this policy, but the company has reviewed information from existing transactions to evaluate its options, the CEO said.
Astellas Pharma launched a multi-year cost optimization program in 2024 called “Sustainable Margin Transformation.” Astellas Pharma reduced selling, general and administrative expenses by approximately 11 billion yen in fiscal 2025 through organizational restructuring, rationalization of certain infrastructure, and reduced investment in mature products. Through continued cost reduction efforts, Astellas expects SG&A expenses to decline 7% to 800 billion yen in fiscal 2026.
