Astellas Reports Strong Growth for Izervay, Projects Continued Upward Trend

Astellas Pharma has announced a significant sales increase for its geographic atrophy (GA) treatment Izervay, reporting a 22% sequential rise in the quarter ending June 30. The Japanese pharmaceutical giant is projecting continued growth for the drug, despite some analysts expressing skepticism about the company's optimistic outlook.

Izervay Sales Performance and Projections

Izervay, an 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. This growth marks a reversal from the 15% sequential decline observed in the opening quarter of the year.

Astellas is maintaining its fiscal year sales guidance of 105 billion Japanese yen ($750 million) for Izervay, anticipating growth to continue in the "high 20s or above" for the next three quarters. The company has also revised its long-term projections, now estimating 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. market alone.

Market Outlook and Analyst Perspectives

Despite Astellas' positive projections, some analysts remain cautious. ISI Evercore analysts noted that the quarterly figures fell short of consensus expectations, which were based largely on the company's annual sales projection. They suggested that Astellas might miss its "aggressive FY25 guidance."

Mizuho Securities analysts have expressed concerns about the growth of the GA market. Astellas expects to treat at least 35% of the GA patient population in the U.S. by 2029, citing "broader upstream awareness and more patient referrals to retina specialists." However, Mizuho analyst Graig Suvannavejh, Ph.D., questioned this outlook, citing recent discussions with key opinion leaders that suggest the GA market growth may be stalling.

Competitive Landscape and Market Dynamics

The performance of Izervay has implications for Astellas' main competitor in the GA market, Apellis Pharmaceuticals. Apellis reported a 22% sequential decline in first-quarter sales for its GA treatment Syfovre, generating $130 million. The company attributed this decrease to inventory fluctuations and funding shortfalls in copay assistance programs.

Analysts will be closely watching Apellis' second-quarter results to determine if Syfovre experiences a similar sequential increase to Izervay, which would support the notion of a growing market. However, if the market remains stagnant, there is potential for Izervay to gain market share at Syfovre's expense.

Astellas projects that it will hold 55% to 60% of the U.S. market share by 2029, bolstered by recent regulatory developments. In February, the FDA lifted a 12-month restriction on the use of Izervay, providing a significant boost to the drug's market potential.