Apellis Pharmaceuticals, Inc. (APLS) came out with a quarterly loss of $0.74 per share versus the Zacks Consensus Estimate of a loss of $0.36. This compares to loss of $0.54 per share a year ago. These figures are adjusted for non-recurring items. What's Next for Apellis Pharmaceuticals? While Apellis Pharmaceuticals has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measu ...

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 March 31, 2025 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 ju ...

Core Insights - Apellis Pharmaceuticals reported a total revenue of $166.8 million for Q1 2025, a decrease from $172.3 million in Q1 2024, primarily due to funding shortages at co-pay assistance programs and inventory dynamics [5][13] - The demand for SYFOVRE injection, a key product, grew by 4% quarter-over-quarter, with U.S. net product revenue of $130.2 million [5][6] - The company is on track for potential FDA approval of EMPAVELI for C3G and IC-MPGN, with a decision expected in July 2025 [2][5] Financial Performance - Total revenue for Q1 2025 was $166.8 million, including $149.9 million from U.S. net product sales of SYFOVRE and $19.7 million from EMPAVELI [5][13] - The net loss for Q1 2025 was $92.2 million, compared to a net loss of $66.4 million in Q1 2024 [12][44] - Cash and cash equivalents stood at $358.4 million as of March 31, 2025, down from $411.3 million at the end of 2024, but projected to be sufficient to fund operations to profitability [12][39] Product Highlights - SYFOVRE is the market leader in geographic atrophy (GA) with over 60% market share and a new patient start share reaching 55% by late April 2025 [6][15] - EMPAVELI generated $19.7 million in U.S. net product revenue in Q1 2025, with a high patient compliance rate of 97% [6][16] - The company plans to initiate pivotal trials for EMPAVELI in focal segmental glomerulosclerosis (FSGS) and delayed graft function (DGF) in the second half of 2025 [5][7] Organizational Updates - Craig Wheeler was appointed to the Board of Directors, bringing over 30 years of leadership experience in the biopharmaceutical industry [9]

Core Viewpoint - Apellis Pharmaceuticals, Inc. will host a conference call and webcast to discuss its first quarter 2025 financial results on May 7, 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 major 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., April 21, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) today announced that Craig Wheeler, founder and chief executive officer of Headwaters Biotech Advisors, will join the Apellis Board of Directors, effective immediately. Mr. Wheeler is a highly accomplished executive with more than 30 years of leadership experience across the biopharmaceutical industry. "We are thrilled to welcome Craig to the Apellis Board of Directors," said Cedric Francois, M.D., Ph.D., chief ex ...

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].