Apellis cites current challenges with Syfovre launch but bright prospects in the long term

The first 12 months on the market for Apellis’ geographic atrophy (GA) drug Syfovre have been a roller-coaster ride. And there’s still more loops to negotiate.

On Tuesday, when Apellis presented its quarterly earnings, its report raised more questions about Syfovre than it answered. The Massachusetts company is not guiding to a quarterly or annual sales figure for the first-of-its-kind treatment, which was pegged with peak sales potential of $3 billion. Apellis also provided mixed messages on sales of Syfovre in the current quarter.

As for the lack of guidance, Chief Financial Officer Tim Sullivan explained that the past year is a case in point illustrating the difficulty in estimating sales. Syfovre’s launch was off to a flying start, pulling in $85 million in its first four-plus months on the market before reports of eight vasculitis cases created concern about the drug, which was evidenced in its third quarter sales of $75 million.

Sales of Syfovre rebounded in the fourth quarter, reaching $114 million, but there have been challenges in the current quarter, Apellis said. The issues include “weather delays” that have affected doctor visits and product shipments, added Chief Operating Officer Adam Townsend.

The company also owned up to being surprised by Medicare patient recertifications, which take place at the start of every year and can delay treatment.

“We’ve never been through a first quarter where we have recertifications or the like,” Sullivan said. “We’re just going to take our time and make sure we understand the dynamics over the course of a full year and we’ll get back to you on when we plan to guide.”

Despite the early-year issues, Townsend said that the company was encouraged by “demand growth” and that January and February have “been two of our biggest months since launch.”

January also brought bad news about Syfovre in the form of a negative opinion from Europe’s Committee for Medical Products for Human Use (CHMP), which the company is appealing.

The company’s case has been strengthened by physician and patient feedback that has been “extraordinary,” CEO Cedric Francois said. He added that Apellis has tweaked its application to ensure that key questions are addressed.

As for Syfovre’s safety issue—which Apellis originally speculated was a needle problem for the injected drug—the company now “firmly” believes it is caused by a pre-existing allergy toward polyethylene glycol, Francois said. The incidence of users developing vasculitis remains at .01% per injection, the company said.

Competing with Apellis in the indication is Astellas’ Izervay, which was approved in August and generated sales of 5.3 billion Japanese yen ($35 million) in its three-plus months on the market.

A time-adjusted comparison of the first four months of the launch of the two products, conducted by Apellis, showed that physician demand for Syfovre was three times greater than that for Izervay.

“We also see that the majority of new patients starts continue to be on Syfovre,” Townsend said. “And keep in mind that this market is much larger than we believed, from 1 million patients to 1.5 million. I think it can accommodate more than one product, but we truly believe that we are the number one product and we expect to maintain that leadership over time.”