Apellis announces corporate restructuring to drive growth of pegcetacoplan

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Apellis Pharmaceuticals Inc announced a corporate restructuring to drive growth of pegcetacoplan injection (SYFOVRE) and pegcetacoplan (EMPAVELI), which the company said in a release would "position it for long-term success."

According to a company news release, the planned 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, MD, PhD, co-founder and CEO of Apellis, said in the news release the company is positioning itself for future growth.

“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,” Francois said in the news release. “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.”

Moreover, Francois pointed out in the company’s statement that the decisions were difficult but necessary.

“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,” he explained in the news release. “As we move forward, we are committed to supporting our teammates throughout this process.”

According to the company, key elements of the plan include moves to maximize pegcetacoplan injection’s global leadership in geographic atrophy. The company also noted in its news release it continues to focus on backing the continued strong US commercial launch of pegcetacoplan injection and is preparing for potential ex-US launches, with an anticipated decision on regulatory approval by the European Medicines Agency (EMA) early next year.

According to the news release, pegcetacoplan injection generated $85.7 million in US net product revenues and Apellis delivered more than 50,000 vials to physician practices, including commercial vials shipped and sample vials distributed.

Earlier this month, the company reported that more than 26,000 vials had been distributed during the third quarter of the year.

Apellis also announced in its release it is poised to launch pegcetacoplan injection in the European Union (EU), with a focus on an initial launch in Germany. The company also noted in the release it has 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.

The company also will streamline its pegcetacoplan business by trimming EMPAVELI-related expenses through a more focused commercial and medical PNH organization.

During the first half of the year, the company noted that pegcetacoplan generated $42.7 million in US net product revenues. More than 230 people in the U.S. with PNH were on commercial treatment as of June 30, 2023.

Apellis also announced it will prioritize the development of systemic pegcetacoplan in immune complex membranoproliferative glomerulonephritis (IC-MPGN) and C3 glomerulopathy (C3G), rare kidney diseases with no approved treatments. The company said it expects top-line data from the Phase 3 VALIANT study in 2024.

The company added in its news release that it plans no new clinical development programs with systemic pegcetacoplan.

To drive future development, Apellis said it would prioritize its research initiatives, including focusing 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.

Apellis also said in the news release it will continue to work with Beam Therapeutics in a collaboration focused on applying base editing to discover novel therapies for complement-driven diseases.

The company also said in its statement it will work to improve its operational efficiencies by aligning the organization to reflect the priorities above, which includes eliminating about 225 employees, or approximately 25% of the current workforce across the organization.

Apellis said its field-based commercial and medical employees will be minimally impacted, and its layoffs will be completed during the third quarter of the year.

These actions, according to the news release, will lead to 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.

The company also anticipates a one-time cost of about $9 million to $11 million as a result of the workforce reductions, most of which are cash layouts during the second half of the year, according to its news release.

Apellis concluded in its news release it will offer an update during its third-quarter earnings update.