Apellis Announces Corporate Restructuring to Drive Growth of SYFOVRE (pegcetacoplan injection) and EMPAVELI (pegcetacoplan), Positioning Company for Long-Term Success

• Maximizing global leadership of SYFOVRE in geographic atrophy (GA)

• Streamlining the EMPAVELI business and prioritizing development of systemic pegcetacoplan in IC-MPGN/C3G

• Focusing research initiatives on retina and CNS

• Anticipated total cost savings of up to $300 million through 2024, which includes an approximately 25% reduction in current workforce and a reduction in external expenses
  

WALTHAM, Mass., Aug. 29, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) (the “Company”), a global biopharmaceutical company and leader in complement, today 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.

Cedric Francois, M.D., Ph.D., co-founder and chief executive officer of Apellis, said, “We are taking important actions to strengthen our ability to invest in growth opportunities and support the Company's long-term success, including maximizing the significant opportunity with SYFOVRE. As a more focused organization, we believe these initiatives put Apellis in a stronger position to create value for shareholders and continue delivering on our mission for patients now and in the future.”

Dr. Francois added, “These were difficult, but necessary, decisions. We are thankful for the commitment and contributions of our colleagues who have worked relentlessly to advance life-changing medicines for some of the most challenging diseases patients face. As we move forward, we are committed to supporting our teammates throughout this process.”

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.