Financial Data and Key Metrics Changes - In Q1 2025, Cifovri net product revenue was $130 million, which was down due to inventory dynamics and funding shortages at third-party co-pay assistance programs [12][14][23] - Cifovri injection demand grew 4% quarter over quarter, indicating a positive trend in market demand despite revenue shortfalls [8][12] - The company ended Q1 2025 with $358 million in cash and cash equivalents, indicating a strong liquidity position to fund operations towards profitability [17] Business Line Data and Key Metrics Changes - Cifovri maintained over 60% market share in geographic atrophy, with new patient starts exceeding 50% in Q1 and reaching 55% by late April [9][17] - Empavedi generated $20 million in net product revenue in Q1, with high compliance rates of 97% and a consistent safety profile [23] - The supplemental NDA for Empavedi was accepted by the FDA with a PDUFA date of July 28, indicating a significant upcoming launch opportunity [10][11] Market Data and Key Metrics Changes - The geographic atrophy market is expected to see continued but modest growth, with Cifovri positioned as a market leader [9] - The U.S. commercial opportunity for C3G and iCMPGN is estimated at 5,000 patients, with expectations for Empavedi to be used across all patient groups [22] Company Strategy and Development Direction - The company aims to capitalize on strong physician demand for Cifovri and is preparing for the launch of Empavedi in C3G and iCMPGN [24] - Strategic initiatives include enhancing disease state awareness and ensuring seamless access to treatment upon approval [20][22] - The company is focused on maintaining financial discipline while driving revenue growth and delivering meaningful treatments to patients [24] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in the market, including funding shortages impacting demand but expressed confidence in the long-term growth potential of Cifovri [6][8] - The company is optimistic about the upcoming launch of Empavedi and its potential to transform treatment in C3G and iCMPGN [24] - Management emphasized the importance of transitioning patients from samples to commercial doses to mitigate the impact of co-pay assistance program funding issues [113] Other Important Information - The company welcomed Craig Wheeler to its Board of Directors, highlighting his extensive experience in the biopharmaceutical industry [25] - The management is closely monitoring tariff situations and is prepared to take steps to mitigate any adverse impacts [17] Q&A Session Summary Question: Clarification on Q1 volume dynamics - Management clarified that Q1 saw a 4% growth in injections, with a drawdown of inventory impacting the number of vials delivered [30][34] Question: Expectations for copay assistance underfunding - Management does not expect the copay assistance underfunding issue to be resolved soon, but they are working to transition patients from samples to commercial doses [36][38] Question: Sales guidance considerations - Management indicated that they are not likely to provide sales guidance this year due to recent dynamics affecting the market [50][52] Question: Payer landscape post-label update - Management confirmed that Cifovri maintains preferred positioning with several large Medicare Advantage plans, and no significant changes were noted post-competitor label update [60] Question: Launch plans for C3G and ICMPGN - Management is actively profiling accounts and building relationships with key physician accounts in preparation for the launch of Empavedi [117]

Financial Data and Key Metrics Changes - Apellis Pharmaceuticals reported a net product revenue of $130 million for Q1 2025, which was down due to inventory dynamics and funding shortages at third-party co-pay assistance programs [10][12][19] - The company ended Q1 2025 with $358 million in cash and cash equivalents, indicating confidence in funding operations to profitability [12] Business Line Data and Key Metrics Changes - Cifovri injection demand grew by 4% quarter over quarter, but revenue fell short of expectations due to inventory drawdown and funding issues [5][10] - Empaveli generated $20 million in net product revenue for Q1 2025, with high compliance rates of 97% [19] Market Data and Key Metrics Changes - Cifovri maintains over 60% market share in geographic atrophy, with new patient starts exceeding 50% in Q1 and reaching 55% by late April [6][14] - The U.S. commercial opportunity for Empaveli in C3G and iCMPGN is estimated at 5,000 patients, with expectations for broad usage across patient groups [18] Company Strategy and Development Direction - The company is focused on expanding its market leadership in geographic atrophy and preparing for the launch of Empaveli in C3G and iCMPGN [4][7] - Apellis aims to drive revenue growth while maintaining financial discipline and delivering meaningful treatments to patients [20] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in Q1 but expressed confidence in the growth potential of Cifovri and the upcoming launch of Empaveli [4][20] - The company is preparing for pivotal studies in focal segmental glomerulosclerosis and delayed graft function in the second half of 2025 [8] Other Important Information - Apellis announced the addition of Craig Wheeler to its Board of Directors, bringing extensive biopharmaceutical leadership experience [21] - The company is actively working on educational programs to help practices manage patient reimbursement amid co-pay assistance funding shortages [15][16] Q&A Session Summary Question: Clarification on Q1 volume dynamics - Management clarified that Q1 saw a 4% growth in injections, with the reduction in vials delivered due to inventory drawdown and increased sample usage [27][30] Question: New patient share calculation - The company uses a site of care data set covering about 50% of the market for accurate new patient share calculations, differing from competitors' claims data [41] Question: Impact of co-pay assistance program - Management does not expect the co-pay assistance underfunding issue to resolve soon, and they are working to transition patients from samples to commercial doses [32][34] Question: Launch plans for C3G and ICMPGN - The company is actively profiling accounts and engaging with KOLs to ensure a strong launch for Empaveli upon approval [108][109] Question: Tariff exposure and manufacturing - The company is analyzing potential tariff exposure but has not disclosed specific details about manufacturing locations or IP domicile [74] Question: Net price dynamics in Q1 - Management noted that revenue recognition occurs when doses are shipped to distributors, which may not directly correlate with vials shipped to physicians [80][82]

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 ...