Apellis to Receive up to $300 Million from Royalty Purchase Agreement with Sobi for Ex-U.S. Royalties of Aspaveli® (systemic pegcetacoplan)
- Apellis to receive $275 million upfront and up to $25 million in milestone payments upon EMA approval in C3G and IC-MPGN
- Non-dilutive financing further strengthens Apellis' balance sheet
- Apellis retains full U.S. commercialization rights for systemic pegcetacoplan
- Transaction underscores shared confidence in the meaningful growth potential in rare kidney diseases
WALTHAM, Mass., July 01, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) today announced a capped royalty purchase agreement with Sobi® under which Apellis will receive up to $300 million in exchange for 90% of Apellis' future ex-U.S. royalties for Aspaveli® (systemic pegcetacoplan). Under the companies' 2020 collaboration agreement, Apellis is eligible for tiered royalties on ex-U.S. sales of Aspaveli ranging from high teens to high twenties. Apellis retains exclusive commercialization rights for systemic pegcetacoplan in the United States, where the product is marketed as EMPAVELI®.
"This transaction reflects our shared conviction in the potential of Aspaveli/EMPAVELI to transform the treatment landscape for patients with rare diseases, including C3G and IC-MPGN," said Timothy Sullivan, chief financial officer, Apellis. "Through our collaboration, Sobi has developed a deep understanding of Aspaveli/EMPAVELI's potential to significantly improve patient outcomes and deliver long-term value as a rare disease franchise. Importantly, the non-dilutive funding from this transaction further strengthens our balance sheet and provides significant operational flexibility as we approach sustainable profitability, expand the reach of our approved products, and advance our innovative pipeline."
Aspaveli/EMPAVELI is approved in the European Union, other countries globally, and the U.S. for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder. It is currently under review in the European Union and the U.S. for the treatment of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), rare kidney diseases. An opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) is expected before year-end. In the U.S., the Prescription Drug User Fee Act (PDUFA) action date is July 28, 2025.
"We are pleased to reaffirm our ongoing partnership with Apellis and share their strong belief in Aspaveli/EMPAVELI's potential to deliver significant long-term growth," said Guido Oelkers, chief executive officer, Sobi. "We are confident in our ability to reach patients with C3G and IC-MPGN globally following regulatory approvals, by leveraging our broad commercial footprint, deep rare disease expertise, and proven success in PNH."
Transaction details
Under the terms of the agreement, Sobi will acquire 90% of Apellis' ex-U.S. royalties for Aspaveli for $275 million in cash. Apellis will also be eligible for up to $25 million in milestone payments upon EMA approval of Aspaveli for C3G and IC-MPGN.
The agreement is subject to defined caps tied to Aspaveli's performance. Sobi retains 90% of ex-U.S. royalties until these caps are achieved, after which 100% of all ex-U.S. royalties revert to Apellis.
About the Apellis and Sobi Collaboration
Apellis and Sobi have global co-development rights for systemic pegcetacoplan. Sobi has exclusive ex-U.S. commercialization rights for systemic pegcetacoplan, and its opt-in rights for future development programs are unchanged, exercisable at any time prior to commercialization. Apellis has exclusive U.S. commercialization rights for systemic pegcetacoplan and worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy.
About C3 Glomerulopathy (C3G) and Primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
C3G and primary IC-MPGN are rare and debilitating kidney diseases that can lead to kidney failure. Excessive C3 deposits are a key marker of disease activity, which can lead to kidney inflammation, damage, and failure. Approximately 50% of people living with C3G and primary IC-MPGN suffer from kidney failure within five to 10 years of diagnosis, requiring a burdensome kidney transplant or lifelong dialysis.1 Additionally, approximately 90% of patients who previously received a kidney transplant will experience disease recurrence.2 The diseases are estimated to affect 5,000 people in the United States and up to 8,000 in Europe.3
About Apellis
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. 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 X and LinkedIn.
Apellis Forward-Looking Statement
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 regarding regulatory approval for the treatment of patients with C3G and IC-MPGN in the United States and other jurisdictions and commercial growth or prospects for systemic pegcetacoplan for those indications in the United States and other jurisdictions. 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 systemic pegcetacoplan will receive approval for those indications from the FDA or equivalent foreign regulatory agencies when expected or at all; whether the commercialization of systemic pegcetacoplan for C3G or IC-MPGN in the United States or other jurisdictions will provide significant additional revenues or allow the Company to achieve profitability; and any other factors discussed in the "Risk Factors" section of Apellis' Annual Report on Form 10-K with the Securities and Exchange Commission on February 28, 2025 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.
Contacts:
Media
Tracy Vineis
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617.420.4839
Investors
Neil Carnahan, CFA
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References
1. C3 glomerulopathy. National Institute of Health, Genetics Home Reference. https://ghr.nlm.nih.gov/condition/c3-glomerulopathy#resources. Accessed November 21, 2019.
2. Tarragón, B, et al. C3 Glomerulopathy Recurs Early after Kidney Transplantation in Serial Biopsies Performed within the First 2 Years after Transplantation. Clinical Journal of the American Society of Nephrology. August 2024; 19(8)1005-1015. doi: 10.2215/CJN.0000000000000474.
3. Data on file using literature consensus.
