Apellis Announces Corporate Restructuring to Drive Growth of SYFOVRE (pegcetacoplan injection) and EMPAVELI (pegcetacoplan), Positioning Company for Long-Term Success - Seite 2
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 pegcetacoplan 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.
- The Company will provide an update on its expected cash runway in connection with its third quarter 2023 earnings update.
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