Apellis APLS first marketed drug, Empaveli,has shown an encouraging trend since approval. The drug was approved for paroxysmal nocturnal hemoglobinuria (PNH) by the FDA in 2021. Empaveli is also approved in Europe under the brand name Aspaveli for the treatment of adult patients with PNH. The drug continues to be one of the growth drivers for Apellis with reported revenues of almost $42.7 million in the first half of 2023.
APLS’ performance in the second quarter was better than expected, as both earnings and sales beat their respective Zacks Consensus Estimate.
The other drug in Apellis portfolio is Syfovre, the first and only approved treatment for geographic atrophy (GA) secondary to age-related macular degeneration. The drug is witnessing robust initial uptake since its launch in March 2023. The company received regulatory approval for Syfovre in Feburary 2023 in the United States.
However, shares of the company plummeted in mid-July due to safety concerns regarding Syfovre. Apellis received six reports of retinal vasculitis(or inflammation) following treatment with Syfovre, occurring between seven and 13 days after the initial administration of the drug with no specific lots implicated.
The company partnered with external investigators to investigate the reported adverse events. Later, in a press release, Apellis updated the number of confirmed adverse events to seven (four occlusive, three non-occlusive) and one additional reported event, which is currently being evaluated by the company. Two of these events followed injections in April, two in May and three in June.
APLS has been carrying out a comprehensive investigation into possible causes of the reported adverse events. So far, the company has found no indication that the drug product or manufacturing issues contributed to the events.
On a positive note, the company is seeking to launch Syfovre in additional geographies. A regulatory application seeking approval of pegcetacoplan for the same indication as in the United States is currently under review in Europe and several other countries. A decision regarding the same from the European Medicines Agency is expected in early 2024, while those from regulatory bodies in other countries are expected in the first half of 2024.
The successful approval and launch in additional geographies will add an incremental stream of revenues to APLS. Syfovre generated revenues of almost $85.7 million in the first half of 2023.
Apellis faces competition for its drugs from other companies. Alnylam Pharmaceuticals ALNY is developing cemdisiran, an RNAi therapeutic targeting C5 for the treatment of complement-mediated diseases. ALNY’s cemdisiran is being evaluated in a mid-stage study. Several other companies are also developing their pipeline candidates using complement inhibition for the treatment of PNH.
Empaveli also faces competition from Soliris (eculizumab) and Ultomiris (ravulizumab), C5 complement inhibitors, developed and marketed by Alexion — now part of AstraZeneca AZN.
While its newly approved drug Syfovre (pegcetacoplan injection) is facing some safety concerns, continued strong performance of Empaveli fueled growth and is likely to maintain momentum.
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