Get ready to see more of Henry Winkler on TV talking about geographic atrophy (GA).
During a quarterly conference call, as Apellis Pharmaceuticals discussed its plan to increase sales of GA treatment Syfovre, it stressed the importance of attracting more patients to the market, including via an ongoing direct-to-consumer ad campaign starring Winkler.
“We are still in the early phases of growth and estimate that only half of diagnosed GA patients are seen by an eyecare professional. Of those, less than 10% are receiving treatment,” said Cedric Francois, M.D., Ph.D., CEO of Apellis. “Building a new market takes time.”
In its head-to-head market battle with Astellas and its GA drug Izervay, Apellis got a head start by winning approval for Syfovre six months earlier, in February 2023, and remains in the lead.
Last month, Apellis revealed that Syfovre sales reached $167 million in the fourth quarter, which was a 10% increase from the third quarter. Earlier this month, Astellas countered with its own report that sales in the same period for Izervay reached $107 million, a 4% sequential increase.
Friday, however, Apellis’ new commercial chief, David Acheson, said that first-quarter sales of Syfovre will be lower than they were in the fourth quarter because of “temporary factors.” He added that the company is not guiding to a sales figure for the quarter.
“Overall GA market growth has been tempered due to typical Q1 dynamics of Medicare reverifications and winter storms affecting distribution and patient visits,” Acheson said. “We have also seen a spike in sample usage over the past two months.”
With the quarterly report, Apellis’ share price had fallen by 3% by noon. Analysts at Mizuho Securities said that the sampling increase was a surprise and likely caused the decreased share price.
It wouldn’t be the first time Apellis saw a sequential drop in sales for Syfovre. It also happened last year, with a decline from sales of $155 million in the second quarter to $152 million in the third.
Friday, to allay concerns of a slowdown in growth, Apellis pointed out that it has seen injections grow in the first quarter compared to the fourth quarter.
“That is a reflection of the unmet need in this disease,” Francois said.
Francois also highlighted the FDA’s rejection of Astellas’ bid to expand Izervay’s label to treat patients whose GA is a secondary condition to age-related macular degeneration for longer than 12 months. While the regulator did eventually sign off on the expansion earlier this month, the preceding complete response letter caused some patients to halt their Izervay treatments, with some switching to Syfovre instead.
“The CRL for our competitor—beyond whether it’s resolved or not now—really called out the shortcomings that our competitor has, most notably the fact that there was a 12-month limitation initially, which a lot of physicians did not know,” Francois said. “It was important to kind of level-set the knowledge around the two products so that physicians can make the right decisions.”
That leaves it up to Apellis and its Syfovre pitchman, Winkler, to grow the market.
During Friday’s earnings call, Acheson said the company is pursuing that growth in several ways, including “broadening our reach to the eye care community, amplifying real-world data through key forums, educating payers on Syfovre’s differentiated value proposition and connecting with patients through our DTC campaign.”
In the case of the latter, he noted that it's "a little early" to predict the full effects of the DTC campaign on sales, saying, “It’s gonna take time for us to see the total impact throughout the next several months.”
Still, he did share that during the recent “Saturday Night Live” 50th anniversary TV special, a newly launched Syfovre ad featuring Winkler garnered 15 million views, which the company credited with driving 3,000 visitors to the company’s website.