Core Insights - Apellis Pharmaceuticals reported a total revenue of $199.7 million for Q2 2024, a significant increase from $95.0 million in Q2 2023, driven by strong sales of its products SYFOVRE and EMPAVELI [7][9]. Financial Performance - SYFOVRE generated $154.6 million in U.S. net product revenue in Q2 2024, compared to $67.3 million in Q2 2023, reflecting strong market demand [3][7]. - EMPAVELI contributed $24.5 million in U.S. net product revenue for Q2 2024, up from $22.3 million in the same period last year [4][7]. - The company reported a net loss of $37.7 million for Q2 2024, an improvement from a net loss of $122.0 million in Q2 2023 [9][36]. - As of June 30, 2024, Apellis had cash and cash equivalents of $360.1 million, up from $351.2 million at the end of 2023, indicating a stable financial position [9][33]. Product Highlights - SYFOVRE remains the market leader in treating geographic atrophy (GA), with over 84,000 doses delivered to physician practices in Q2 2024 [3]. - The company has initiated a re-examination of the marketing authorization application for SYFOVRE with the European Medicines Agency (EMA), expecting a final decision in Q4 2024 [3][5]. - EMPAVELI continues to show high patient compliance rates of 97% [4]. Research and Development - Topline data from the Phase 3 VALIANT study of systemic pegcetacoplan for C3 glomerulopathy (C3G) and primary immune complex glomerulonephritis (IC-MPGN) is expected in August 2024 [5][6]. - The VALIANT study involves 124 patients and aims to evaluate the safety and efficacy of systemic pegcetacoplan [5]. Market Position and Strategy - The company is well-positioned financially to support long-term business operations, with management expressing confidence in achieving positive cash flow [2][9]. - Apellis is focused on strong commercial execution in the U.S. and preparing for significant upcoming clinical data releases [2].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38276 APELLIS PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 27-1537290 (State or other jur ...

The market expects Apellis Pharmaceuticals, Inc. (APLS) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2024. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expecte ...

Core Viewpoint - Kuehn Law, PLLC is investigating potential breaches of fiduciary duties by officers and directors of Apellis Pharmaceuticals, Inc. related to misrepresentations regarding the clinical trials of SYFOVRE [1] Group 1: Legal Investigation - A federal securities lawsuit claims that Apellis insiders misrepresented the design of SYFOVRE's clinical trials, which was inadequate to identify retinal vasculitis incidents in patients [1] - The lawsuit indicates that the commercial adoption of SYFOVRE is subject to significant unknown risk factors due to these misrepresentations [1] - Consequently, statements made by the company regarding its business, operations, and prospects are deemed to lack a reasonable basis [1] Group 2: Shareholder Information - Shareholders who purchased Apellis stock prior to January 28, 2021 are encouraged to contact Kuehn Law for a free consultation regarding their rights [2] - Kuehn Law covers all case costs and does not charge its investor clients, emphasizing the importance of timely action for shareholders [2] Group 3: Importance of Participation - The involvement of shareholders is highlighted as crucial for maintaining the integrity and fairness of financial markets, reinforcing the idea that every investment and voice matters [3]

WALTHAM, Mass., July 18, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the company will host a conference call and webcast to discuss its second quarter 2024 financial results on Thursday, August 1, 2024, at 8:30 a.m. ET. To access the live call by phone, please pre-register for the call here. 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 compa ...

Late-breaking presentation shows SYFOVRE® (pegcetacoplan injection) demonstrated visual function benefit on prespecified endpoint in GALE long-term extension study WALTHAM, Mass., July 09, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) today announced that six abstracts, five of which are oral presentations, will be presented at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting to be held July 17 - 20 in Stockholm, Sweden. These data reinforce the robust effic ...

Late-breaking presentation shows SYFOVRE® (pegcetacoplan injection) demonstrated visual function benefit on prespecified endpoint in GALE long-term extension study WALTHAM, Mass., July 09, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that six abstracts, five of which are oral presentations, will be presented at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting to be held July 17 - 20 in Stockholm, Sweden. These data reinforce the robust effi ...

Apellis Pharmaceuticals (APLS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion for the second time on the marketing authorization application (MAA) for intravitreal pegcetacoplan to treat geographic atrophy (GA) in the EU. Despite this decision, there were several dissenting votes among CHMP members.Apellis plans to request a re-examination of the opinion and anticipates a final decision in the fourth quarter of 20 ...

WALTHAM, Mass., June 28, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the marketing authorization application (MAA) of intravitreal pegcetacoplan for the treatment of geographic atrophy (GA). Notably, there were multiple dissenting votes by CHMP members to this opinion. Apellis plans to seek re- examination and expects a final opinio ...

WALTHAM, Mass., June 28, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the marketing authorization application (MAA) of intravitreal pegcetacoplan for the treatment of geographic atrophy (GA). Notably, there were multiple dissenting votes by CHMP members to this opinion. Apellis plans to seek re-examination and expects a final opinion ...