Apellis(US:APLS)2025-02-28 12:00Revenue 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].