Apellis Pharmaceuticals, Inc. announced a corporate restructuring to drive growth of SYFOVRE (pegcetacoplan injection) and EMPAVELI (pegcetacoplan), positioning Apellis for long-term success. This restructuring will include cost reduction initiatives that align with the Company?s near-term priorities and are expected to result in up to $300 million in total cost savings through 2024. Key elements of the plan include: Maximizing SYFOVRE?s global leadership in GA.

The Company remains focused on supporting the continued strong U.S. commercial launch of SYFOVRE and is preparing for potential ex-U.S. launches, with an anticipated decision on regulatory approval by the European Medicines Agency (EMA) in early 2024. In the first half of 2023, SYFOVRE generated $85.7 million in U.S. net product revenues and the Company delivered more than 50,000 vials to physician practices, including commercial vials shipped and sample vials distributed. On August 22, the Company reported that over 26,000 vials had been distributed in the third quarter.

The Company is preparing to launch SYFOVRE in the EU, prioritizing an initial launch in Germany. Marketing applications for intravitreal pegcetacoplan are also under review in Canada, Australia, the United Kingdom and Switzerland, with decisions expected in the first half of 2024. Streamlining the EMPAVELI business Reducing EMPAVELI-related expenses through a more focused commercial and medical PNH organization.

In the first half of 2023, EMPAVELI generated $42.7 million in U.S. net product revenues. More than 230 people in the U.S. with PNH were on commercial treatment as of June 30, 2023. Prioritizing development of systemic pegcetaco plan in immune complex membranoproliferative glomerulonephritis (IC-MPGN) and C3 glomerulopathy (C3G), rare kidney diseases with no approved treatments.

Top-line data from the Phase 3 VALIANT study are expected in 2024. The Company does not plan to initiate any new clinical development programs with systemic pegcetacoplan. Prioritizing research initiatives.

Focusing research initiatives on high-potential opportunities in retina and central nervous system (CNS) diseases, and deprioritizing certain development initiatives (including siRNA with systemic pegcetacoplan, APL-1030, and APL-2006). Continuing collaboration with Beam Therapeutics focused on applying base editing to discover novel therapies for complement-driven diseases. Improving operational efficiencies.

Apellis is aligning the organization to reflect the priorities above, which includes reducing headcount by approximately 225 employees, or approximately 25% of the current workforce across the organization. Field-based commercial and medical employees are minimally affected. The planned workforce reduction is anticipated to be substantially completed in the third quarter of 2023.

Apellis expects these actions to result in total cost savings of up to $300 million through 2024, which includes more than $70 million in expected net cost savings related to the workforce reduction and up to $230 million related to the elimination of planned external expenses. Apellis expects to incur one-time costs related to the workforce reduction of approximately $9 million to $11 million, substantially all of which are cash expenditures. These costs are anticipated to be incurred primarily in the second half of 2023.