After reporting a 15% sequential decline in Izervay sales for the opening quarter of this year, Astellas has reversed the momentum for its geographic atrophy (GA) treatment and is projecting the upward trend to continue this year.
In an investor event on Wednesday—three weeks ahead of its quarterly report—Astellas revealed a 22% sequential increase in Izervay sales for the period ending on June 30. The injected C5 inhibitor generated revenue of 15.9 billion Japanese yen ($110 million) in the most recent quarter, up from 13.8 billion Japanese yen ($91 million) in the first quarter.
Astellas sees Izervay’s growth continuing to track upward—in the “high 20s or above"—for the next three quarters and is reiterating its fiscal year sales guidance of 105 billion Japanese yen ($750 million).
In the longer term, Astellas is now tabbing peak sales for Izervay to reach between 200 billion and 400 billion Japanese yen ($1.3 billion to $2.6 billion) in the U.S. alone. Those figures match the company’s previous projection for peak global sales.
Some analysts, however, aren’t buying into Astellas’ rosy expectations just yet. Despite the increase in quarterly sales, the figures came up far short of consensus, which were based largely on the company’s annual sales projection, according to analysts from ISI Evercore.
“We wouldn’t be surprised to see Astellas miss their aggressive FY25 guidance,” they wrote in a note to investors.
Meanwhile, analysts at Mizuho Securities have doubts about the growth of the GA market as portrayed by the company. Astellas said on Wednesday that, by 2029, it expects to treat at least 35% of the GA patient population in the U.S., crediting “broader upstream awareness and more patient referrals to retina specialists.”
“Our biggest concern lies with an overall GA market where growth is potentially stalling,” Mizuho analyst Graig Suvannavejh, Ph.D., wrote in a note to investors, citing recent discussions with key opinion leaders (KOLs). “Despite Astellas' vision of future growth for Izervay in 2025 and beyond, we question what it will take for the CI class to meaningfully grow over time.”
It's uncertain what this all means for Astellas’ rival in the GA market, Apellis. Two months ago, the Massachusetts company revealed sales of $130 million in the first quarter for Syfovre, which were down 22% sequentially.
The company’s CEO, Cedric Francois, M.D., Ph.D., blamed inventory fluctuations and funding shortfalls in copay assistance programs for the sales decline.
Eyes will be on Apellis when it reports its second quarter sales to see if Syfovre gets a similar sequential bump, which would be “supportive of a growing market,” Mizuho wrote.
“On the other hand, given KOL feedback we've been hearing of a relatively slow-growing/flat market, there's potential of Izervay gaining at Syfovre's expense,” the analysts added.
Astellas has had its own set of problems hindering the launch of Izervay. Early this year, the company took an impairment charge of 115 billion Japanese yen ($760 million) because of regulatory setbacks, including an FDA rejection for Izervay to broaden its label.
In February, Astellas received a much-needed boost when the FDA lifted a 12-month restriction on the use of Izervay. With that and the sales upturn, the company said on Wednesday that it expects to hold 55% to 60% of the market share in the U.S. by 2029.