Apellis to Gain Up to $300 Million from Royalty Deal with Sobi for Aspaveli® Royalties

Apellis Pharmaceuticals, Inc., based in Waltham, Massachusetts, recently announced a significant financial agreement with Sobi®, a global biopharmaceutical company. This agreement involves a capped royalty purchase deal allowing Apellis to obtain up to $300 million. In return, Apellis will transfer 90% of its future ex-U.S. royalties for Aspaveli®, known as systemic pegcetacoplan, to Sobi. This arrangement is grounded in their 2020 collaboration agreement, which entitles Apellis to tiered royalties on ex-U.S. sales of Aspaveli, ranging from the high teens to high twenties percentages.

Apellis will maintain control over the commercialization of systemic pegcetacoplan within the United States, where it is marketed under the name EMPAVELI®. This transaction is perceived as a testament to the strong potential of Aspaveli/EMPAVELI in transforming treatment options for patients with rare diseases, particularly C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). Timothy Sullivan, the Chief Financial Officer of Apellis, highlighted that the non-dilutive nature of this financial boost significantly reinforces Apellis' financial standing, providing operational flexibility as they aim for sustainable profitability.

Aspaveli/EMPAVELI is a recognized treatment for paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder, with approvals in the European Union, several other countries, and the United States. Currently, the treatment is under regulatory review for C3G and IC-MPGN in both the EU and the U.S. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is expected to deliver its opinion by year-end, and in the U.S., the Prescription Drug User Fee Act (PDUFA) action date is set for July 28, 2025.

Guido Oelkers, CEO of Sobi, expressed confidence in their continued partnership with Apellis, emphasizing the potential of Aspaveli/EMPAVELI to achieve significant long-term growth. With regulatory approvals, Sobi aims to leverage its substantial commercial capabilities to reach patients worldwide suffering from C3G and IC-MPGN.

The financial particulars of the agreement state that Sobi will acquire 90% of Apellis’ ex-U.S. royalties for a payment of $275 million. Additionally, Apellis stands to receive up to $25 million in milestone payments contingent on EMA approval for the specified kidney diseases. The agreement has specific caps linked to Aspaveli's performance, with Sobi retaining the majority of royalties until these caps are met, after which all ex-U.S. royalties will revert to Apellis.

Apellis and Sobi have joint global co-development rights for systemic pegcetacoplan, with Sobi holding exclusive ex-U.S. commercialization rights. Their opt-in rights for future development programs remain unchanged and can be exercised before commercialization. Meanwhile, Apellis retains exclusive U.S. commercialization rights for systemic pegcetacoplan and global rights for its use in ophthalmology, including treatments for geographic atrophy.

C3G and IC-MPGN are rare kidney diseases that can lead to kidney failure due to excessive C3 deposits, which cause inflammation and damage. A significant percentage of patients experience kidney failure within five to ten years of diagnosis, often necessitating a kidney transplant or lifelong dialysis. The conditions affect an estimated 5,000 individuals in the U.S. and up to 8,000 in Europe.

Apellis Pharmaceuticals is dedicated to developing transformative therapies for challenging diseases, having introduced the first new class of complement medicine in 15 years. The company continues to explore the potential of targeting C3 across various serious diseases, aiming to improve patient outcomes globally.