Revenue and Product Performance - SYFOVRE generated $611.9 million in U.S. net product revenue for the year ended December 31, 2024, compared to $275.2 million in 2023, reflecting a 122% increase [635]. - EMPAVELI generated $98.1 million in U.S. net product revenue for the year ended December 31, 2024, up from $91.0 million in 2023, representing an 8% increase [636]. - Product revenue increased by 94% to $709.9 million in 2024 from $366.3 million in 2023, driven by sales of EMPAVELI and SYFOVRE [696]. - Total revenue rose by 97% to $781.4 million in 2024 compared to $396.6 million in 2023 [696]. - The company launched SYFOVRE in February 2023, following the FDA approval for EMPAVELI in May 2021, contributing to product revenue growth [786]. Financial Performance and Losses - The company has incurred net losses of $197.9 million, $528.6 million, and $652.2 million for the years ended December 31, 2024, 2023, and 2022, respectively, with an accumulated deficit of $3.0 billion as of December 31, 2024 [642]. - Net loss decreased by 63% to $197.9 million in 2024 from $528.6 million in 2023 [696]. - Net operating loss improved by 68% to $165.0 million in 2024 from $517.1 million in 2023 [696]. - The accumulated deficit reached $3.0 billion by December 31, 2024, primarily due to research and development expenses [780]. Expenses and Cost Management - Cost of sales increased by 101% to $117.7 million in 2024 from $58.5 million in 2023, primarily due to higher commercial sales volume and expenses related to excess inventory [699]. - Research and development expenses decreased by 8% to $327.6 million in 2024 from $354.4 million in 2023, mainly due to a reduction in compensation costs [702]. - Selling, general and administrative expenses slightly increased by 0.1% to $501.1 million in 2024 from $500.8 million in 2023 [705]. - The company anticipates an increase in selling, general and administrative expenses to support ongoing research and development activities and potential commercialization of product candidates [685]. - The company expects research and development costs to increase for the foreseeable future as product candidate development programs progress [683]. Financing and Capital Structure - The Sixth Street Financing Agreement provides for a senior secured term loan facility of up to $475.0 million, with an initial draw of $375.0 million [645]. - The company has financed operations through approximately $2.6 billion in net proceeds from public and private offerings and $401.5 million in payments and royalties from Sobi [640]. - The company entered into a Credit Facility agreement with an initial draw of $375.0 million and a potential additional draw of $100.0 million, maturing on May 13, 2030, with an interest rate of SOFR + 5.75% [714]. - The company reported net cash provided by financing activities of $149.2 million in 2024, primarily from the initial draw of the Credit Facility and capped call unwind transactions [726]. - The company issued 4,007,936 shares of common stock in February 2023, raising total net proceeds of $384.4 million after deducting underwriting discounts [719]. Clinical Trials and Development - The VALIANT trial for EMPAVELI showed a 68% reduction in proteinuria in C3G and IC-MPGN patients compared to placebo, with a p-value of <0.0001, indicating strong efficacy [637]. - The company plans to initiate two new Phase 3 clinical trials with EMPAVELI in the second half of 2025 for FSGS and DGF, both of which currently have no approved therapies [638]. - The company is developing a next-generation therapy by combining SYFOVRE with APL-3007, aiming to initiate a Phase 2 trial in Q2 2025 [635]. Cash and Liquidity - As of December 31, 2024, the company had cash and cash equivalents of $411.3 million, primarily in money market funds and U.S. treasury securities [749]. - Net cash used in operating activities for the year ended December 31, 2024, was $87.9 million, a significant improvement from $594.7 million in 2023 [721][722]. - The company expects to generate sufficient cash from sales of EMPAVELI and SYFOVRE to fund projected operating expenses for at least the next 12 months [729]. Obligations and Agreements - As of December 31, 2024, the company had total contractual obligations of $770.1 million, with $595.8 million related to the Credit Facility [735]. - The company has a license agreement with Penn requiring milestone payments of up to $3.2 million and royalties based on net sales of licensed products [740]. - The company has a Factoring Agreement allowing the sale of trade accounts receivable up to $100.0 million, which is accounted for as a sale under ASC 860 [810]. Assets and Equity - The total assets of the company increased to $885.1 million as of December 31, 2024, compared to $788.7 million in 2023 [766]. - The total stockholders' equity rose to $228.5 million as of December 31, 2024, from $194.5 million in 2023 [766]. - The company reported a significant increase in accounts receivable to $264.9 million as of December 31, 2024, compared to $206.4 million in 2023 [766].

Company Announcement - Apellis Pharmaceuticals will present at the TD Cowen 45 Annual Health Care Conference on March 3, 2025, at 10:30 a.m. ET [1] - A live webcast of the conference will be available on the company's website, with a replay accessible for approximately 90 days post-event [1] Company Overview - Apellis Pharmaceuticals is a global biopharmaceutical company focused on developing therapies for challenging diseases [2] - The company has introduced the first new class of complement medicine in 15 years, with two approved medicines targeting C3 [2] - Apellis has developed the first-ever therapy for geographic atrophy, a major cause of blindness globally, and aims to explore the potential of targeting C3 in various serious diseases [2]

Core Viewpoint - Apellis Pharmaceuticals, Inc. (APLS) is anticipated to report a year-over-year increase in earnings driven by higher revenues for the quarter ending December 2024, with the actual results being crucial for its near-term stock price movement [1][2]. Earnings Expectations - The earnings report is scheduled for release on February 28, 2025, and could lead to a stock price increase if the results exceed expectations, while missing estimates may result in a decline [2]. - The consensus estimate indicates a quarterly loss of $0.39 per share, reflecting a year-over-year improvement of 46.6%, with revenues projected at $195.95 million, a 33.9% increase from the previous year [3]. Estimate Revisions - Over the last 30 days, the consensus EPS estimate has been revised 1.77% higher, indicating a reassessment by analysts [4]. - The Most Accurate Estimate for Apellis is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -12.56%, suggesting a bearish outlook from analysts [10][11]. Earnings Surprise Prediction - The Zacks Earnings ESP model indicates that a positive or negative reading can predict deviations from consensus estimates, with a positive reading being a strong indicator of an earnings beat, especially when combined with a favorable Zacks Rank [6][8]. - Apellis currently holds a Zacks Rank of 3, making it challenging to predict an earnings beat conclusively [11]. Historical Performance - In the last reported quarter, Apellis was expected to post a loss of $0.32 per share but actually reported a loss of $0.46, resulting in a surprise of -43.75% [12]. - Over the past four quarters, the company has only surpassed consensus EPS estimates once [13]. Industry Comparison - Beam Therapeutics Inc. (BEAM), another player in the Zacks Medical - Biomedical and Genetics industry, is expected to report a loss of $1.10 per share for the same quarter, indicating a year-over-year decline of 163.6%, with revenues expected to drop 93.4% to $20.86 million [17]. - Beam Therapeutics has an Earnings ESP of -0.39% and a Zacks Rank of 2, making it similarly difficult to predict an earnings beat [18].

Core Insights - Apellis Pharmaceuticals and Sobi announced the validation of an indication extension application for Aspaveli (pegcetacoplan) by the European Medicines Agency (EMA) for treating C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), both rare chronic kidney diseases with no approved treatments [1][4] Company and Product Development - The Phase 3 VALIANT study demonstrated a statistically significant 68% reduction in proteinuria in pegcetacoplan-treated patients compared to placebo at Week 26, indicating the drug's efficacy [2][5] - Pegcetacoplan-treated patients also showed stabilization of kidney function and a significant reduction in C3c staining intensity, with favorable safety and tolerability profiles [3][5] - The EMA validation is a significant step towards bringing pegcetacoplan to European patients, with a potential U.S. launch in the second half of 2025 if approved [4][7] Market Context - C3G and IC-MPGN are severe kidney conditions affecting approximately 5,000 people in the U.S. and up to 8,000 in Europe, with a high risk of kidney failure within five to ten years of diagnosis [6] - There is a critical need for approved treatments for these conditions, as 50% of patients may require kidney transplants or lifelong dialysis [6] Collaboration and Commercialization - Apellis and Sobi have global co-development rights for systemic pegcetacoplan, with Sobi holding exclusive commercialization rights outside the U.S. and Apellis holding exclusive rights within the U.S. [8][9] Company Background - Apellis Pharmaceuticals is focused on developing therapies for serious diseases, having introduced the first new class of complement medicine in 15 years, including treatments targeting C3 [10] - Sobi is an international biopharmaceutical company specializing in rare diseases, with a revenue of SEK 26 billion in 2024 [11]

Core Viewpoint - Apellis Pharmaceuticals, Inc. will host a conference call and webcast to discuss its fourth quarter and full year 2024 financial results on February 28, 2025, at 8:30 a.m. ET [1] Company Overview - Apellis Pharmaceuticals is a global biopharmaceutical company focused on developing therapies for challenging diseases, having introduced the first new class of complement medicine in 15 years [3] - The company has two approved medicines targeting C3, including the first-ever therapy for geographic atrophy, a leading cause of blindness globally [3] - Apellis believes it has only begun to unlock the potential of targeting C3 across various serious diseases [3]

WALTHAM, Mass., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced today that the Therapeutic Goods Administration (TGA) has approved SYFOVRE® (pegcetacoplan) for the every-other-month treatment of adult patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an intact fovea and when central vision is threatened by GA lesion growth. SYFOVRE is the first and only approved treatment for GA in Australia. "The approval of SYFOVRE marks ...

Bronstein, Gewirtz & Grossman, LLC Is Investigating Apellis Pharmaceuticals, Inc. (APLS) And Encourages Shareholders to Connect ...

Bronstein, Gewirtz & Grossman, LLC Initiates an Investigation into Allegations Against Apellis Pharmaceuticals, Inc. (APLS) And Encourages Shareholders to Reach Out ...

Core Viewpoint - Apellis Pharmaceuticals, Inc. (APLS) is currently under investigation by Bronstein, Gewirtz & Grossman, LLC, which is encouraging investors to reach out for more information regarding the investigation [1] Group 1 - The investigation pertains to potential securities violations by Apellis Pharmaceuticals [1] - Investors are being urged to contact the firm to learn more about the implications of the investigation [1] - The investigation may impact investor confidence and the company's stock performance [1]

SYFOVRE Performance and Market Position - SYFOVRE achieved $611 million in U.S. net product revenues for full-year 2024, with $167 million in Q4 2024[5][19] - Over 510,000 SYFOVRE injections administered through December 2024, including clinical trials[3][6] - Distributed approximately 94,000 SYFOVRE doses (commercial and sample vials) to physician practices in Q4 2024[6] - SYFOVRE demonstrated more than 120% year-over-year net sales growth, solidifying its position as the market-leading treatment for GA[3] EMPAVELI Revenue and Development - EMPAVELI generated $98 million in U.S. net product revenues for full-year 2024, with $23 million in Q4 2024[5][19] - Apellis plans to submit EMPAVELI sNDA for C3G and primary IC-MPGN in early 2025, with a U.S. launch anticipated in 2H 2025 if approved[5][15] - EMPAVELI may cause embryo-fetal harm, requiring pregnancy testing and effective contraception for females of reproductive potential[34] Financial Position and Strategic Focus - Apellis ended 2024 with approximately $410 million in cash and cash equivalents, up from $351.2 million in 2023[18] - Apellis plans to reduce ex-U.S. footprint by approximately 40 employees as part of prioritizing U.S. commercial efforts[6] - The company's cash resources are expected to fund operations for a certain period, subject to adjustments and financial closing procedures[37] Clinical Trials and Future Plans - Phase 3 studies of pegcetacoplan in two additional nephrology indications planned for initiation in 2H 2025[5][15] - Phase 1b/2 multi-dose study of APL-3007 (siRNA) + SYFOVRE expected to initiate in Q2 2025[6] - The company plans to initiate Phase 3 studies of pegcetacoplan in FSGS and DGF[37] - Apellis expects to achieve profitability, with timing dependent on various factors including clinical trial results and regulatory approvals[37] Product Portfolio and Innovation - Apellis Pharmaceuticals has two approved medicines targeting C3, including the first-ever therapy for geographic atrophy[36]