Apellis Pharmaceuticals, Inc. (APLS)

In Q2 2025, Apellis reported steady demand growth for SYFOVRE, with total injections increasing, but revenue was impacted by high free goods usage due to funding shortages in copay assistance programs; the FDA approval of EMPAVELI for C3G and IC-MPGN was also highlighted. In Q3 2025, the company announced strong execution and progress, with SYFOVRE maintaining market leadership, but revenue was impacted by elevated free goods utilization; EMPAVELI showed a strong early launch in its new indications. Apellis announced positive five-year data from the GALE extension study, demonstrating that SYFOVRE delayed the progression of geographic atrophy by approximately 1.5 years in patients with nonsubfoveal GA. The New England Journal of Medicine published positive Phase 3 VALIANT results for EMPAVELI in C3G and primary IC-MPGN. Apellis reported preliminary U.S. net product revenues of $689 million for the full year 2025; SYFOVRE's Q4 revenues were down year-over-year, leading to a stock price decline, while EMPAVELI's Q4 revenues increased year-over-year. Mark DeLong, Chief Business & Strategy Officer, sold shares to cover tax withholding obligations. BlackRock, Inc. reported a passive beneficial ownership stake in Apellis Pharmaceuticals Inc.

Demand for Apellis Pharmaceuticals' products, particularly SYFOVRE, has shown some seasonality, with the Q4 2025 report noting consistent total injections quarter-over-quarter reflecting year-end seasonality. Patient assistance programs and their funding cycles can influence demand dynamics.

Apellis Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutic compounds within the Healthcare sector, specifically in the Biotechnology industry, by inhibiting the complement system to treat diseases with high unmet needs. Its major commercial products include SYFOVRE, the first FDA-approved treatment for geographic atrophy secondary to age-related macular degeneration, and EMPAVELI, approved for the treatment of paroxysmal nocturnal hemoglobinuria and also for C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis in patients aged 12 years and older. Apellis also has a pipeline of innovative therapies, including APL-3007 and APL-9.

Apellis Pharmaceuticals primarily concentrates its commercial efforts in the United States. EMPAVELI is marketed under the trade name EMPAVELI in the United States, Saudi Arabia, and Australia, and as Aspaveli in the European Union, Japan, and the United Kingdom for the treatment of PNH. The company has strategically reduced its ex-U.S. footprint to focus on key markets.

Apellis Pharmaceuticals' brand reputation has been significantly impacted by safety concerns surrounding SYFOVRE, specifically cases of retinal vasculitis, leading to a safety warning on the drug's label. This issue, along with competition from Astellas' Izervay, has contributed to revenue stagnation and profitability challenges for SYFOVRE. The EMA issued negative opinions on SYFOVRE's marketing authorization application, further affecting its international reputation and market access.

Apellis Pharmaceuticals, Inc. has a significant portion of its stock owned by institutional investors, including Avoro Capital Advisors LLC, Vanguard Group Inc., Morgan Stanley, Wellington Management Group Llp, Deep Track Capital, LP, and BlackRock, Inc. Individual ownership includes insiders such as Cedric Francois and Pascal Deschatelets.