Apellis Pharmaceuticals Reports First Quarter 2021 Financial Results
28 Apr 2021
Financial StatementOrphan DrugPriority ReviewFast Track
WALTHAM, Mass., April 28, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced its first quarter 2021 financial results and business highlights.
“With a potential U.S. approval for pegcetacoplan just a couple of weeks away, we are at the beginning of a transformational year for Apellis. Our commercial team is prepared to successfully execute our first product launch and meet the needs of PNH patients,” said Cedric Francois, M.D., Ph.D., co-founder and chief executive officer of Apellis. “At the same time, we are focused on advancing registrational programs of pegcetacoplan across several debilitating rare diseases and delivering on our goal to become number one in the retina. Geographic atrophy is the most significant remaining unmet need in the retina, and we are excited to see top-line results from our Phase 3 studies of pegcetacoplan in GA in the third quarter of this year.
“For more than a decade, our team has built the foundation for Apellis’ leadership in complement, and we look forward to seeing the results of those efforts come together this year for patients living with serious, complement-driven diseases,” Dr. Francois continued.
First Quarter 2021 Business Highlights and Upcoming Milestones:
Systemic Pegcetacoplan in Rare Disease
Intravitreal Pegcetacoplan in Ophthalmology
APL-9 in COVID-19
Pipeline Expansion
First Quarter 2021 Financial Results:
As of March 31, 2021, Apellis had $723.7 million in cash, cash equivalents, and short-term marketable securities, compared to $646.7 million in cash, cash equivalents, and short-term marketable securities as of March 31, 2020. This increase primarily reflects the addition of cash from the company’s convertible offering for gross proceeds of $328.9 million in May 2020, the receipt of $250.0 million in the upfront proceeds for the Sobi transaction in October 2020, and an additional $25.0 million receipt from Sobi in January 2021 less cash used in operations.
Apellis reported a net loss of $183.7 million for the first quarter of 2021, compared to a net loss of $168.8 million for the same period in 2020.
Research and development expenses were $84.0 million in the first quarter of 2021, compared to $69.3 million for the same period in 2020. The increase in R&D expense for first quarter 2021 was primarily attributable to an increase in clinical trial costs associated with the ongoing Phase 3 trials and the preparation and commencement of our clinical trials in other indications, personnel-related costs primarily due to the hiring of additional personnel, and increased quality and medical affairs expenses. We expect our research and development expenses to continue to increase as the number of patients in our trials increases and the number of ongoing trials increases.
General and administrative expenses were $40.6 million in the first quarter of 2021, compared to $29.5 million for the same period in 2020. The increase in general and administrative expenses for the first quarter 2021 was primarily attributable to an increase in employee-related costs, professional and consulting fees, general commercial preparation activities, director stock compensation expense, and insurance.
Conference Call and WebcastApellis will host a conference call and webcast to discuss its first quarter 2021 financial results and business highlights today, April 28, 2021, at 4:30 p.m. ET. To access the conference call, please dial (866) 774-0323 (local) or (602) 563-8683 (international) at least 10 minutes prior to the start time and refer to conference ID 7883183. A live audio webcast of the event and accompanying slides may also be accessed through the “Events and Presentations” page of the “Investors and Media” section of the company’s website at . A replay of the webcast will be available for 30 days following the event.
About Pegcetacoplan Pegcetacoplan is an investigational, targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. Pegcetacoplan is a synthetic cyclic peptide conjugated to a polyethylene glycol polymer that binds specifically to C3 and C3b. Pegcetacoplan is being evaluated in several clinical studies across hematology, ophthalmology, nephrology, and neurology. Marketing applications for pegcetacoplan for paroxysmal nocturnal hemoglobinuria (PNH) are under review by the U.S. Food and Drug Administration (FDA), which has granted the application Priority Review designation, and the European Medicines Agency (EMA). Pegcetacoplan was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of geographic atrophy and received orphan drug designation for the treatment of C3 glomerulopathy by the FDA and EMA. For additional information regarding pegcetacoplan clinical trials, visit .
About APL-9APL-9 is an investigational, targeted C3 therapy designed to control the complement cascade centrally and may have the potential to treat a range of diseases caused by excessive activation of complement. APL-9 leverages the same mechanism of action as Apellis’ lead compound, pegcetacoplan, but has a lower molecular weight and shorter half-life. APL-9 is designed to be intravenously administered for acute use.
About ApellisApellis Pharmaceuticals, Inc. is a global biopharmaceutical company that is committed to leveraging courageous science, creativity, and compassion to deliver life-changing therapies. Leaders in targeted C3 therapies, we aim to develop transformative therapies for a broad range of debilitating diseases that are driven by excessive activation of the complement cascade, including those within hematology, ophthalmology, nephrology, and neurology. For more information, please visit .
Apellis Forward-Looking StatementStatements 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 in respect of the expected closing of the exchanges. 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 the conditions for the closing of the exchanges will be satisfied and other factors discussed in the “Risk Factors” section of Apellis’ Quarterly Report on Form 10-Q with the Securities and Exchange Commission on April 28, 2021 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.
Investor Contact:Argot Partnersapellis@argotpartners.com +1 212.600.1902
Media Contact:Tracy Vineismedia@apellis.com617.420.4839
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