Apellis announced a corporate restructuring to drive growth of Syfovre pegcetacoplan injection and Empaveli. This restructuring will include cost reduction initiatives expected to result in up to $300M in total cost savings through 2024. The company remains focused on supporting the continued U.S. commercial launch of SYFOVRE and is preparing for potential ex-U.S. launches, with an anticipated decision on regulatory approval by the EMA in early 2024. In the first half of 2023, Syfovre generated $85.7M in U.S. net product revenues. 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 U.K. and Switzerland, with decisions expected in the first half of 2024. Reducing Empaveli-related expenses. In the first half of 2023, Empaveli generated $42.7M in U.S. net product revenues. The ompany does not plan to initiate any new clinical development programs with systemic pegcetacoplan. Intends to focus research initiatives on high-potential opportunities in retina and central nervous system diseases, and deprioritizing certain development initiatives. 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 Q3. Apellis expects these actions to result in total cost savings of up to $300M through 2024, which includes more than $70M in expected net cost savings related to the workforce reduction and up to $230M related to the elimination of planned external expenses. Apellis expects to incur one-time costs related to the workforce reduction of $9M-$11M, substantially all of which are cash expenditures. These costs are anticipated to be incurred primarily in the second half of 2023.
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