Astellas' sales expectations are up for Padcev, down for Veozah

Less than two months after the FDA approved the combination treatment of Astellas and Pfizer’s Padcev and Merck’s Keytruda in first-line bladder cancer, the Japanese company has raised its peak sales potential for its antibody-drug conjugate by 100 billion Japanese yen ($673 million).

Astellas now estimates sales of Padcev to peak at between 400 billion to 500 billion Japanese yen ($2.7 billion to $3.4 billion), the company said on Monday in presenting (PDF) its quarterly sales.

During a conference call, Astellas’ chief commercial officer Claus Zieler explained that the upward revision is based on both the sales surge ignited by an FDA approval for the Padcev-Keytruda combo in April of last year to treat cisplatin ineligible patients, and on compelling trial results that showed the combo reduced the risk of death by 53% over chemotherapy for all patients in the indication.

Astellas reported sales of Padcev reached 55.6 billion yen ($374 million) over the last three quarters, which was a 68% increase year over year.

“We revised our FY23 forecast upwards on the basis of that very strong uptake in that partial first-line indication in the U.S.,” Zieler said. “Given that we had such a strong echo in the [European Society for Medical Oncology] conference when we presented the data to physicians, we really think that this has the potential to change practice in a significant way. That is what’s causing our optimism.”

The trial results were so convincing that the FDA signed off on the combo for cisplatin-eligible patients five months ahead of its regulatory deadline. One day before the endorsement, Pfizer completed its $43 billion acquisition of Seagen, which partnered with Astellas in developing Padcev.

On the flip side, Astellas reported that its launch of menopausal drug Veozah is progressing slower than expected. The company has adjusted its fiscal-year sales projection to 7.1 billion yen ($50 million) and said it is reviewing its peak sales projection of between 300 to 500 billion yen ($2 billion to $3.4 billion).

Astellas’ chief financial officer Atsashi Kitamura explained that the effect of its direct-to-consumer marketing efforts have been “lower than expected." Demand also has been limited by the hesitance of doctors to prescribe the medicine.      

“Based on market research, more [healthcare providers] than we assumed have a perception that the current coverage progress is not enough to actively prescribe Veozah, which is impacting the uptake,” Kitamura added.

Veozah has generated sales of 3.6 billion yen ($25 million) since the FDA approved it in May of last year. Europe followed with an endorsement two months ago.

As for Astellas’ new geographic atrophy (GA) drug Izervay, the company touted its “encouraging” launch, reporting sales of 5.3 billion yen ($36 million). Astellas estimated that it has achieved 55% brand awareness from GA patients and has captured 20% of the market.

“Taking into account of the fact that it’s just about four months since launch, we think this is an extremely positive number,” Kitamura said of the drug which is competing one-on-one with Apellis' newly-launched Syfovre in the indication.

For the first three quarters of its fiscal year, which ends on March 31, Astellas’ revenue came in at 1.189 billion yen ($8 billion), a 2% increase on the period year over year.