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.
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.
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first-ever therapy for geographic atrophy, a leading cause of blindness around the world. With additional clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn.
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the regulatory approvals of SYFOVRE and the Company’s planned corporate restructuring and related reduction in workforce. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether SYFOVRE will receive approval from foreign regulatory agencies for GA when expected or at all; whether the results of the Company’s clinical trials will warrant regulatory submissions and whether systemic pegcetacoplan will receive approval from the FDA or equivalent foreign regulatory agencies for C3G and IC-MPGN when expected or at all; the Company’s ability to execute its planned corporate restructuring as currently contemplated; the risk that restructuring costs and charges may be greater than anticipated; the risk that the restructuring may adversely affect its ability to retain skilled and motivated personnel and may be distracting to employees and management; the risk that the Company’s restructuring efforts may negatively impact its business operations and reputation; the risk that the Company’s restructuring efforts may not generate their intended benefits to the extent or as quickly as anticipated; and other factors discussed in the “Risk Factors” section of Apellis’ Annual Report on Form 10-K with the Securities and Exchange Commission on February 21, 2023 and the Risk Factors section of Apellis’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on July 31, 2023 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.