The supplemental application submission supported by Phase 3 VALIANT results at Week 26: The U.S. Food and Drug Administration (FDA) on Tuesday accepted and granted Priority Review designation to Apellis Pharmaceuticals, Inc.'s APLS supplemental New Drug Application (sNDA) for Empaveli (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). C3G and primary IC-MPGN are rare kidney diseases. Excessive C3c deposits are a key marker of disease a ...

PDUFA target action date is July 28, 2025 WALTHAM, Mass., April 01, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation of the supplemental New Drug Application (sNDA) for EMPAVELI® (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are severe and rare kidney diseases. The Prescription Drug User Fe ...

Live Chat on The Biotech Forum has been dominated by discussion of these type of buy-write opportunities over the past several trading sessions. To see what I and the other season biotech investors are targeting as trading ideas real-time, just initiate your two-week no obligation free trial into The Biotech Forum by clicking HERE .Today, we put Apellis Pharmaceuticals, Inc. (NASDAQ: APLS ) in the spotlight. As can be seen below, the stock of this commercial stage mid-cap biopharma has been consistently gri ...

Apellis Pharmaceuticals (APLS) reported fourth-quarter 2024 loss of 29 cents per share, narrower than the Zacks Consensus Estimate of a loss of 39 cents. The company had incurred a loss of 73 cents in the year-ago quarter.Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.Total revenues in the fourth quarter amounted to $212.5 million and surpassed the Zacks Consensus Estimate of $196 million. In the year-ago quarter, the company had reported revenues of $146.4 million.The top line jum ...

Financial Data and Key Metrics Changes - Total revenue for Q4 2024 was approximately $13 million, with full-year revenue reaching $781 million, marking a nearly 100% increase compared to 2023 [48][50]. - The company reported a net loss of $36.4 million for Q4 2024 [49]. - Cash and cash equivalents at the end of 2024 stood at $411 million, indicating a strong financial position [51]. Business Line Data and Key Metrics Changes - Cipher generated over 120% year-over-year US net revenue growth, with nearly $900 million in sales for XIFAV in less than two years [5][7]. - XIFAV maintained a market share of over 60%, with approximately 94,000 doses delivered in Q4 2024 [21]. - Empavelli generated approximately $23 million in U.S. net product revenue in Q4 2024, with compliance rates at 97% [35]. Market Data and Key Metrics Changes - The overall GA market growth in Q1 2025 was tempered due to typical seasonal dynamics, including Medicare reverifications and winter storms affecting distribution [22]. - The company estimates that less than 10% of patients with geographic atrophy are currently receiving treatment, indicating significant growth potential [8][91]. Company Strategy and Development Direction - The company focuses on three key pillars: transforming the treatment of geographic atrophy, maximizing the impact of Empavelli in rare diseases, and advancing its innovative pipeline [5][6]. - Plans include launching Empavelli in C3G and ICMPGN in the second half of 2025, with ongoing development of next-generation treatments for GA [14][42]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to create significant value for patients and shareholders, emphasizing a strong market position and growth potential in 2025 [53]. - The competitive landscape is viewed positively, with management noting that recent regulatory developments have reinforced their market leadership [19][92]. Other Important Information - The company plans to initiate a Phase 2 trial for a next-generation treatment for GA in Q2 2025 [40]. - Management highlighted the importance of patient access to retinal specialists and the need for higher utilization from physicians already treating patients with XIFAV [25]. Q&A Session Summary Question: Insights on Empavelli and FDA submission - Management expressed excitement about the submission for Empavelli and highlighted the importance of consistent results across various disease phenotypes [60][62]. Question: Expectations for Q1 results - Management indicated that Q1 results are expected to be lower than Q4 due to temporary factors but anticipates continued growth in 2025 [70][72]. Question: Competitive dynamics and label changes - Management discussed the impact of label changes for competitors and emphasized the unique advantages of XIFAV, including preferred status with payers [74][78]. Question: Market share and payer positioning - Management noted that they have secured preferred positioning with several major payers, which is expected to enhance market share [115][116]. Question: Patient adherence and sample usage - Management reported that adherence levels for XIFAV are positive and that increased sample usage is a sign of demand, which they believe is temporary [160][162].

Fourth Quarter and Full Year 2024 Financial Results Conference Call February 28, 2025 Apellis Participants C E D R I C F R AN C O I S , M . D . , P h . D . Co-Founder, President & Chief Executive Officer D AV I D AC H E S O N Executive Vice President of Commercial C AR O L I N E B AU M A L , M . D . Chief Medical Officer T I M O T H Y S U L L I VAN Chief Financial Officer Statements in this presentation about future expectations, plans and prospects, as well as any other statements regarding matters that ar ...

Core Insights - Apellis Pharmaceuticals, Inc. reported a revenue of $212.53 million for the quarter ended December 2024, marking a 45.2% increase year-over-year and exceeding the Zacks Consensus Estimate by 8.46% [1] - The company's EPS was -$0.29, an improvement from -$0.73 in the same quarter last year, with a surprise of 25.64% over the consensus estimate of -$0.39 [1] Revenue Breakdown - Product revenue was $191.17 million, surpassing the average estimate of $185.27 million by analysts, reflecting a year-over-year increase of 37.9% [4] - Licensing and other revenue reached $21.36 million, significantly exceeding the nine-analyst average estimate of $12.51 million, representing a year-over-year change of 176.6% [4] - Product revenue from EMPAVELI was $23.36 million, slightly below the average estimate of $24.16 million [4] - Product revenue from SYFOVRE was $167.81 million, exceeding the average estimate of $161.56 million [4] Stock Performance - Over the past month, shares of Apellis Pharmaceuticals have declined by 14.5%, compared to a 2.4% decrease in the Zacks S&P 500 composite [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [3]

Core Viewpoint - Apellis Pharmaceuticals reported a quarterly loss of $0.29 per share, which was better than the Zacks Consensus Estimate of a loss of $0.39, and an improvement from a loss of $0.73 per share a year ago, indicating a positive earnings surprise of 25.64% [1] Financial Performance - The company achieved revenues of $212.53 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 8.46%, and showing a significant increase from $146.38 million in the same quarter last year [2] - Over the last four quarters, Apellis has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Stock Performance - Apellis Pharmaceuticals shares have declined approximately 18.5% since the beginning of the year, contrasting with the S&P 500's slight decline of -0.3% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.37 on revenues of $197.1 million, and for the current fiscal year, it is -$1.06 on revenues of $853.11 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Apellis belongs, is currently ranked in the top 29% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

Core Insights - Apellis Pharmaceuticals reported significant growth in 2024, driven by the success of its products SYFOVRE and EMPAVELI, positioning the company for continued expansion in 2025 and beyond [2][4]. Financial Performance - Total revenue for 2024 reached $781.4 million, marking a 97% increase year-over-year from $396.6 million in 2023 [4][14]. - SYFOVRE generated $611.9 million in net product revenue for 2024, while EMPAVELI contributed $98.1 million [4][11]. - The company reported a net loss of $197.9 million for the full year 2024, an improvement from a net loss of $528.6 million in 2023 [14][45]. Product Highlights - SYFOVRE, the first approved therapy for geographic atrophy, achieved $167.8 million in net product revenue for Q4 2024, with over 510,000 injections administered since its launch [5][17]. - EMPAVELI recorded $23.4 million in net product revenue for Q4 2024, with a supplemental new drug application submitted for its use in C3G and primary IC-MPGN, anticipating a U.S. launch in the second half of 2025 if approved [4][18]. Research and Development - The company plans to initiate two Phase 3 trials for EMPAVELI in focal segmental glomerulosclerosis (FSGS) and delayed graft function (DGF) in the second half of 2025 [4][12]. - A Phase 2 multi-dose study of APL-3007 combined with SYFOVRE is expected to begin in Q2 2025, targeting comprehensive complement activity blockade [5][6]. Organizational Updates - David Acheson has been appointed as the executive vice president of commercial, following the departure of the previous COO [13]. - Keli Walbert has joined the Board of Directors, bringing extensive biopharmaceutical commercial leadership experience [13]. Cash Position - As of December 31, 2024, Apellis had $411.3 million in cash and cash equivalents, an increase from $351.2 million in 2023, with expectations that this will be sufficient to fund operations until profitability [15][44].

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].