Group 1 - The market is highlighting the free cash flow (FCF) potential of Syfovre and Empaveli, with Syfovre projected to exceed $1 billion in annual sales despite initial rollout challenges due to infection reports [1] - The firm faced difficulties in launching Syfovre, but the outlook for its sales remains strong, indicating a recovery in market confidence [1] - A holistic investment approach is emphasized, considering both top-down and bottom-up valuation techniques, with a focus on capital structure and debt covenants impacting equity valuation [1]

Summary of Apellis Pharmaceuticals Conference Call Company Overview - **Company**: Apellis Pharmaceuticals (APLS) - **Event**: Bank of America Healthcare Conference - **Date**: May 13, 2025 - **Speakers**: Cedric Francois (CEO), Tim Sullivan (CFO) Key Points Industry Context - Discussion on the impact of recent executive orders related to drug pricing, particularly the "most favored nation" clause, which may affect Medicare pricing for Apellis' products [4][5][6] - Monitoring of tariff situations and their potential impact on gross margins [9] Product Insights - **Cyfoviry**: - Patients are responsible for approximately 20% copay, around $400 per injection [11][12] - A significant drop in funding from charitable foundations has affected patient access, leading to increased sample usage by physicians [14][15][19] - Despite challenges, there was a 4% quarter-over-quarter growth in patient treatments from Q4 to Q1 [19] - The company is only treating about 10% of the geographic atrophy patient population, indicating substantial unmet demand [20] Competitive Landscape - Apellis has gained market share against competitors, with a shift from 40% to 55% in new patients treated for Cyfoviry compared to 45% for the competitor [32][33] - Differentiation in efficacy and dosing frequency (every other month) is cited as a key driver for market share gains [34] Financial Health - Apellis ended the quarter with $358 million in cash, sufficient to reach profitability without needing to raise additional capital [45] Upcoming Launches - **C3G Program**: - Launch expected in August, targeting a patient population of approximately 5,000 [46][47] - Promising data showing 70% of patients had no trace of disease after six months of treatment [49] - Administered subcutaneously twice a week, similar to PNH [50] Future Directions - Plans to leverage learnings from previous product launches to ensure a strong market entry for C3G [56] - Ongoing development of a siRNA program in geographic atrophy, aiming to synchronize treatments for improved patient outcomes [58][59] - Two phase three trials in nephrology are set to begin in the second half of the year [60] Marketing and Awareness - A direct-to-consumer (DTC) campaign featuring Henry Winkler has shown early success in driving patient awareness and engagement [66][71] Guidance and Market Outlook - The company is cautious about providing sales guidance until after the C3G launch, given the recent challenges faced with Cyfoviry [62] Miscellaneous - Apellis has received recognition for its advertising campaigns, indicating effective marketing strategies [67][71] This summary encapsulates the critical insights and developments discussed during the conference call, highlighting Apellis Pharmaceuticals' strategic positioning, product performance, and future growth potential in the biotech industry.

Core Viewpoint - Apellis Pharmaceuticals reported disappointing first-quarter 2025 results, with a wider loss per share and lower revenues than expected, leading to a significant drop in share price [1][2][5] Financial Performance - The company incurred a loss of 74 cents per share, exceeding the Zacks Consensus Estimate of a loss of 36 cents, and a loss of 54 cents in the same quarter last year [1] - Total revenues for the first quarter were $166.8 million, missing the Zacks Consensus Estimate of $192 million and down from $172.3 million in the prior year [1][2] - Syfovre sales were $130.2 million, a 5% decline year over year, and missed the Zacks Consensus Estimate of $156.9 million [3][4] - Empaveli recorded sales of $19.7 million, down 23% from the previous year, also missing estimates [7] Market Position and Product Performance - Syfovre is the market leader in geographic atrophy (GA) with over 60% market share, and new patient starts increased to 55% by late April [4] - The company delivered over 82,000 commercial vials and nearly 10,000 samples of Syfovre to doctors in the reported quarter [4] Revenue Streams and Expenses - Licensing and other revenues increased by 83% year over year to $16.9 million [8] - Research and development expenses rose by 2% to $86.4 million, while selling, general, and administrative expenses remained flat at $129.3 million [8] Cash Position - As of March 31, 2025, Apellis had cash, cash equivalents, and marketable securities totaling $358.4 million, down from $411.3 million at the end of 2024 [9] Pipeline Developments - Apellis is awaiting FDA decision on a supplemental new drug application for systemic pegcetacoplan, with a decision expected on July 28, 2025 [10][11] - The company plans to initiate two pivotal phase III studies of Empaveli in the second half of 2025 [12] - A mid-stage multi-dose study of siRNA candidate APL-3007 in combination with Syfovre is also planned for the second quarter of 2025 [13]

Core Insights - Apellis Pharmaceuticals, Inc. reported a revenue of $166.8 million for Q1 2025, reflecting a year-over-year decline of 3.2% and a significant EPS of -$0.74 compared to -$0.54 a year ago, indicating a worsening financial performance [1] - The revenue fell short of the Zacks Consensus Estimate of $192.44 million by 13.33%, and the EPS also missed the consensus estimate of -$0.36 by 105.56% [1] Revenue Breakdown - Product revenue was reported at $149.90 million, which is 8.1% lower than the year-ago quarter and below the average estimate of $181.79 million from 10 analysts [4] - Licensing and other revenue reached $16.90 million, exceeding the average estimate of $13.31 million and showing a year-over-year increase of 82.7% [4] - Specific product revenues included EMPAVELI at $19.73 million, below the average estimate of $23.67 million, and SYFOVRE at $130.17 million, which also fell short of the $156.94 million average estimate [4] Stock Performance - Over the past month, shares of Apellis Pharmaceuticals have returned +2.3%, underperforming compared to the Zacks S&P 500 composite's +10.6% change [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]

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]