Core Insights - Apellis is currently leading the field in complement therapies with two approved products, SYFOVRE and EMPAVELI, and has a promising pipeline ahead [2][3] - The company has been successfully launching EMPAVELI for PNH for a couple of years and recently received approval for C3G and IC-MPGN, presenting significant opportunities to impact patient lives [3] Company Overview - Apellis has established itself as a leader in complement therapies, focusing on complement factor C3, which plays a crucial role in controlling downstream effects of the complement cascade [2] - The company is positioned for growth with its innovative products and expanding indications, particularly in the latter part of the year [2][3]

Financial Data and Key Metrics Changes - The company has a strong balance sheet with a recent financing deal adding $275 million to its resources [11] - The company reported three approvals for its products in recent years, indicating significant progress in its commercial strategy [8][10] Business Line Data and Key Metrics Changes - SYFOVRE is the market leader in the geographic atrophy market, being the first product approved for this condition [9] - EMPAVELI has expanded its market by approximately 5,000 patients with recent approvals for C3G and IC-MPGN, in addition to its initial approval for PNH [10] Market Data and Key Metrics Changes - The company anticipates a steady growth trajectory in the ultra-rare disease market, particularly for EMPAVELI, with about 5,000 patients in the U.S. potentially qualifying for treatment [22][31] - The market for geographic atrophy is substantial, with estimates of over a million patients, indicating significant growth potential for SYFOVRE [45] Company Strategy and Development Direction - The company is focused on innovation and expanding its product pipeline, including the development of APL-3007, which aims to enhance the effectiveness of SYFOVRE [10][66] - The management emphasizes the importance of educating healthcare providers and patients about the benefits of their products to drive adoption [38][48] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early launch of EMPAVELI in C3G and IC-MPGN, noting strong interest from key opinion leaders and positive early data [13][14] - The company believes it has a blockbuster product with the potential for significant market penetration across its indications, including PNH, C3G, and IC-MPGN [31][32] Other Important Information - The company has a differentiated approach in targeting the complement system, which is believed to be more effective than other treatments currently in development [64] - Management highlighted the challenges of demonstrating significant improvements in best-corrected visual acuity (BCVA) in geographic atrophy studies, emphasizing the importance of lesion slowing as a key measure [57][58] Q&A Session Summary Question: What is the current state of the business? - The company has made significant progress with its two commercial products and a strong balance sheet, feeling positive about its current position [11] Question: How is the launch of EMPAVELI progressing? - The launch is going well, with a broad label from the FDA and strong interest from healthcare providers [13][14] Question: What is the market opportunity for EMPAVELI? - The company believes it has a blockbuster product with a potential market of 5,000 patients in the U.S. and possibly more as awareness increases [31][32] Question: How does the company view competition in the market? - The company feels confident in its differentiated product offerings and the efficacy of its treatments compared to competitors [27][64] Question: What are the growth expectations for SYFOVRE? - Management anticipates low to mid-single-digit growth for SYFOVRE, with ongoing efforts to educate healthcare providers and patients [38][39] Question: How does the company plan to manage its patent lifecycle? - The company is focused on lifecycle management and has a solid patent strategy in place, with extensions potentially extending to 2034 or 2035 [34]

Financial Data and Key Metrics Changes - Apellis Pharmaceuticals reported a strong balance sheet following a recent royalty deal that added $275 million to its resources [11] - The company has achieved three approvals for its products in recent years, indicating significant progress in its commercial strategy [8] Business Line Data and Key Metrics Changes - SYFOVRE, the company's product for geographic atrophy, is the market leader in its category and has shown substantial efficacy over four years of patient data [8][37] - EMPAVELI has expanded its market with recent approvals for C3G and IC-MPGN, increasing the potential patient base by approximately 5,000 patients [9] Market Data and Key Metrics Changes - The company estimates there are about 5,000 patients in the U.S. for C3G and IC-MPGN, with potential for more patients to be diagnosed as treatment options become available [31] - The market for geographic atrophy is large, with approximately 1.5 million patients identified, but only a small percentage currently receiving treatment [45] Company Strategy and Development Direction - Apellis aims to leverage its unique position in complement biology, focusing on the central component C3 to differentiate its products from competitors [5][64] - The company is committed to innovation, with ongoing development of pipeline products like APL-3007, which aims to enhance the effectiveness of SYFOVRE [65][66] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early launch of EMPAVELI for C3G and IC-MPGN, noting strong interest from key opinion leaders and a broad label from the FDA [13][14] - The company anticipates steady growth in the ultra-rare disease market, with a typical launch pattern expected for EMPAVELI [20] Other Important Information - Apellis is focused on educating nephrologists about the high unmet needs in pediatric and post-transplant patient populations [25] - The company has a strong competitive advantage due to its broad label and the efficacy of its products compared to oral alternatives [27][28] Q&A Session Summary Question: What is the current state of the business? - Management highlighted the strong position of Apellis with two commercial products and a robust balance sheet following a recent financing deal [11] Question: How is the launch of EMPAVELI progressing? - The launch is going well, with a broad label and significant interest from healthcare providers [13][14] Question: What is the market opportunity for EMPAVELI? - The company believes it has a blockbuster product with potential for more patients to be diagnosed as treatment options expand [31] Question: How does Apellis view the competitive landscape? - Apellis sees its broad label and efficacy as key differentiators that set it apart from competitors [27][28] Question: What are the growth expectations for SYFOVRE? - Management expects low to mid-single-digit growth as the brand stabilizes and continues to educate the market [38][39] Question: How does the company plan to innovate moving forward? - Apellis is committed to ongoing innovation and development of new products to address patient needs in both the kidney and retina markets [65][66]

Financial Data and Key Metrics Changes - The company has a strong balance sheet with a recent financing deal adding $275 million to its resources [11] - The company reported three approvals in recent years, with SYFOVRE being the first approved product for geographic atrophy and the market leader in that segment [8][9] Business Line Data and Key Metrics Changes - SYFOVRE is stabilizing with low to mid-single-digit growth expected, driven by real-world data and disease state education [38][39] - EMPAVELI has recently launched for C3G and IC-MPGN, with a broad label that includes pediatric and adult patients, showing strong early interest and connection with key opinion leaders [13][14] Market Data and Key Metrics Changes - The U.S. market for C3G and IC-MPGN is estimated to have about 5,000 patients, with potential for more patients to surface as diagnosed due to the availability of treatment [31][32] - The geographic atrophy market is large, with over a million patients identified, but many remain untreated [45][46] Company Strategy and Development Direction - The company aims to leverage its differentiated products in the complement biology space, focusing on innovation and expanding its pipeline, including APL-3007 [64][65] - The strategy includes enhancing the understanding of disease management among physicians and patients to drive adoption of treatments [47][48] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of both SYFOVRE and EMPAVELI, emphasizing the importance of education and patient engagement [39][40] - The company believes it has a blockbuster product with EMPAVELI, supported by strong clinical data and a unique delivery method [31][28] Other Important Information - The company is committed to continuous innovation and has plans for lifecycle management of its products, ensuring they remain competitive in the market [34][65] - The management highlighted the importance of real-world data in demonstrating the efficacy of their products, which is crucial for physician adoption [42][43] Q&A Session Summary Question: What is the current state of the business? - The company has two commercial products, SYFOVRE and EMPAVELI, with strong growth potential and a solid financial position [11][8] Question: How is the launch of EMPAVELI progressing? - The launch is going well, with a broad label and strong interest from key opinion leaders, although it is still early in the process [13][14] Question: What are the expectations for SYFOVRE's growth? - Management expects low to mid-single-digit growth, with ongoing efforts to educate physicians and patients about the product [38][39] Question: How does the company view the competitive landscape? - The company believes its broad label and efficacy will differentiate it from competitors, and it is focused on educating physicians about its advantages [26][28] Question: What is the market opportunity for EMPAVELI? - The company sees a significant market opportunity with approximately 5,000 diagnosed patients in the U.S. and potential for more as awareness increases [31][32] Question: How does the company plan to manage its pipeline? - The company is committed to innovation and lifecycle management, with plans to develop additional products and enhance existing ones [34][65]

Core Insights - Apellis Pharmaceuticals, Inc. reported a revenue of $178.49 million for the quarter ended June 2025, reflecting a year-over-year decline of 10.6% [1] - The earnings per share (EPS) for the same period was -$0.33, compared to -$0.28 a year ago, with a consensus EPS estimate of -$0.44, resulting in a surprise of +25% [1] Revenue Breakdown - Product revenue, net was $171.39 million, below the 10-analyst average estimate of $176.3 million, representing a year-over-year change of -4.3% [4] - Licensing and other revenue amounted to $7.11 million, significantly lower than the 10-analyst average estimate of $12.89 million, showing a year-over-year decline of 65.4% [4] - Product revenue from EMPAVELI was $20.8 million, compared to the seven-analyst average estimate of $21.74 million, indicating a year-over-year change of -15.1% [4] - Product revenue from SYFOVRE was $150.6 million, slightly below the seven-analyst average estimate of $153.77 million, with a year-over-year change of -2.6% [4] Stock Performance - Shares of Apellis Pharmaceuticals have returned +6.6% over the past month, outperforming the Zacks S&P 500 composite's +2.7% 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 Performance - Apellis reported approximately $151 million in GA (Geographic Atrophy) revenue for 2Q 2025[10] - EMPAVELI U S net product sales were $208 million in 2Q 2025[18] - SYFOVRE U S net product sales were $1506 million in 2Q 2025[18] - The company received $275 million upfront from a royalty purchase agreement for 90% of future ex-U S royalties for Aspaveli[17] - Total revenue for 2Q 2025 was $1785 million, compared to $1997 million in 2Q 2024[18] EMPAVELI and Pipeline - EMPAVELI received U S FDA approval for C3G and primary IC-MPGN[10] - Apellis plans to initiate pivotal studies in DGF (Delayed Graft Function) and FSGS (Focal Segmental Glomerulosclerosis) by year end[10, 21] - APL-3007 reduced circulating C3 concentration by up to 90% in a Phase 1 healthy volunteer study[25] SYFOVRE - SYFOVRE's overall GA market share exceeds 60%[10] - Apellis initiated a Phase 2 study of SYFOVRE + APL-3007[10, 23] Market and Strategy - Approximately 5,000 C3G and primary IC-MPGN patients are estimated in the U S [28, 29] - The company aims to raise awareness about EMPAVELI as a disease-modifying therapy and establish it as the treatment of choice for relevant conditions[33, 34]

Group 1 - Morgan Stanley analyst Judah Frommer raised the target price for Apellis Pharmaceuticals (APLS.US) from $25 to $26 while maintaining a "Hold" rating, based on the company's market position and recent financial strategy [1] - The significant licensing agreement between Apellis and Sobi is strategically important, ensuring Apellis can receive up to $300 million in revenue, including a $275 million upfront payment, while reducing Sobi's royalty obligations on Aspaveli sales by 90% [1] - This agreement provides immediate financial benefits to Apellis and may alleviate investor concerns regarding its profitability [1] Group 2 - Apellis is a commercial-stage biopharmaceutical company focused on discovering, developing, and commercializing innovative therapies for unmet medical needs [2] - The company's core product lines include EMPAVELI, used for treating paroxysmal nocturnal hemoglobinuria (PNH), and SYFOVRE, which treats geographic atrophy (GA) secondary to age-related macular degeneration [2]

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]

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 ...