Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $200 million, and for the full year 2025, it was $1 billion, which included a one-time $275 million upfront payment from the Sobi royalty repurchase agreement [20] - Syfovre net product revenue for Q4 was $155 million and $587 million for the full year 2025, with total injections growing approximately 17% year-over-year despite a modest decline in revenue due to elevated use of free goods [11][20] - Empaveli reported U.S. net product revenue of $35 million for Q4 and $102 million for the full year 2025, with a market penetration of over 5% after its first full quarter [22][9] Business Line Data and Key Metrics Changes - Syfovre continues to lead the geographic atrophy (GA) market, with strong physician and patient demand, and is expected to remain a stable revenue stream through 2026 [7][11] - Empaveli's launch trajectory is progressing well, with strong early market receptivity and a growing patient pipeline, particularly in C3G and primary IC-MPGN [8][12] - The company is advancing pivotal trials in nephrology for focal segmental glomerulosclerosis and delayed graft function, expanding the Empaveli franchise [10][18] Market Data and Key Metrics Changes - The company expects to strengthen Syfovre's leadership in geographic atrophy and drive growth with Empaveli across rare kidney diseases [7] - Empaveli's strong efficacy and safety profile are driving adoption, with expectations that it could ultimately be used by up to 50% of the estimated 5,000 U.S. patient population for C3G and primary IC-MPGN [9][15] Company Strategy and Development Direction - The company is focused on three strategic pillars: strengthening Syfovre's leadership, driving growth with Empaveli, and advancing an innovative pipeline [7] - The introduction of a best-in-class prefilled syringe and an AI-enabled approach for Syfovre is aimed at improving treatment accessibility and workflow efficiency [8][10] - The company aims to self-fund its pipeline and drive long-term value through disciplined financial execution [10][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term value creation potential of the company, emphasizing a strong balance sheet and disciplined execution [5][25] - The management highlighted the importance of patient access and the evolving dynamics of free goods utilization as third-party programs resume activity [21][57] - The company anticipates modest inventory reduction in Q1 2026 alongside typical seasonal dynamics, with a focus on maintaining a stable net price through the year [21][64] Other Important Information - The company ended 2025 with $466 million in cash and cash equivalents, providing substantial flexibility to fund operations [23] - A $25 million milestone payment was triggered by Sobi's European Commission approval for Aspaveli in C3G and primary IC-MPGN [23] Q&A Session Summary Question: Empaveli launch and growth potential - Management noted that Empaveli is on a clear path to blockbuster status, with a focus on broadening accounts and improving patient identification [29][30] Question: Syfovre five-year data significance - The five-year GALE data shows significant benefits in delaying progression of geographic atrophy, which may lead to earlier treatment for patients [34][36] Question: Empaveli penetration timeline - Management expects a steady ramp in penetration, with a focus on pediatric and post-transplant patients as key growth areas [39][40] Question: Prefilled syringe impact - The prefilled syringe is expected to enhance practice efficiency and support broader adoption of Syfovre [50][52] Question: Free goods dynamics - Management emphasized the commitment to patient access through free goods, which may impact new patient onboarding [97][98]

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $200 million, and for the full year 2025, it was $1 billion, which included a one-time $275 million upfront payment from the Sobi royalty repurchase agreement [20][21] - Syfovre net product revenue for Q4 was $155 million and $587 million for the full year 2025, with total injections growing approximately 17% year-over-year despite a modest revenue decline due to elevated use of free goods [11][21] - Empaveli reported U.S. net product revenue of $35 million for Q4 and $102 million for the full year 2025, with a market penetration of over 5% after its first full quarter [23][9] Business Line Data and Key Metrics Changes - Syfovre remains a stable revenue stream with strong underlying demand, leading the geographic atrophy market, while Empaveli is positioned as a near-term growth engine with strong early market receptivity [7][12] - Syfovre's total injections grew approximately 17% year-over-year, while Empaveli's launch trajectory reflects strong execution and early market receptivity [11][9] - The company is advancing pivotal trials for Empaveli in focal segmental glomerulosclerosis and delayed graft function, expanding its franchise into new indications [10][19] Market Data and Key Metrics Changes - Empaveli's launch has achieved more than 5% market penetration in the U.S. nephrology market, significantly outpacing other rare nephrology launches [9][12] - Payer coverage for Empaveli is favorable, with 95% of published policies reimbursing to label or with minimal restrictions, supporting strong demand [13][14] - Syfovre continues to lead the geographic atrophy market, supported by extensive clinical and real-world evidence [11][12] Company Strategy and Development Direction - The company focuses on three strategic pillars: strengthening Syfovre's leadership in geographic atrophy, driving growth with Empaveli across rare kidney diseases, and advancing an innovative pipeline [7][10] - The company aims to enhance Syfovre's efficacy and patient experience through next-generation strategies, including a combination with APL-3007 and the development of a prefilled syringe [10][18] - The company is committed to disciplined execution and long-term value creation, supported by a strong balance sheet [5][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in Empaveli's trajectory towards blockbuster status, with expectations of continued growth in 2026 [16][26] - The company anticipates a modest inventory reduction in Q1 2026 alongside typical seasonal dynamics, while maintaining a stable net price for Syfovre [22][24] - Management highlighted the importance of patient access and the resumption of co-pay assistance programs, which are expected to improve treatment access for patients [8][57] Other Important Information - The company ended 2025 with $466 million in cash and cash equivalents, providing substantial flexibility to fund operations [24] - The company is actively evaluating alternatives to address approximately $94 million of convertible debt maturing in September 2026 [25] Q&A Session Summary Question: Empaveli launch and growth potential - Management noted that Empaveli is on a clear path to blockbuster status, with a focus on broadening accounts and improving patient identification [29][30] Question: Syfovre's five-year GALE data - Management emphasized the significant benefits of Syfovre, including delaying progression of geographic atrophy by approximately 1.5 years [34][36] Question: Empaveli penetration timeline - Management expects a steady ramp in patient onboarding, with a focus on pediatric and post-transplant patients [39][40] Question: Prefilled syringe impact - Management indicated that the prefilled syringe will enhance practice efficiency and support renewed growth for Syfovre [50][52] Question: Free goods dynamics - Management highlighted the commitment to support patients unable to afford treatment, emphasizing the importance of patient access [97][98] Question: Enrollment expectations for new trials - Management expressed excitement about the upcoming phase 3 trials for Empaveli, noting strong interest from the nephrology community [59][60]

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $200 million, and for the full year 2025, it was $1 billion, which included a one-time $275 million upfront payment from the Sobi royalty repurchase agreement [17] - Syfovre net product revenue for Q4 was $155 million and $587 million for the full year 2025, with total injections growing approximately 17% year-over-year [8][17] - Empaveli reported U.S. net product revenue of $35 million for Q4 and $102 million for the full year 2025, indicating strong early market receptivity [19] Business Line Data and Key Metrics Changes - Syfovre experienced a modest decline in full-year revenue compared to 2024, primarily due to elevated use of free goods, but underlying demand remains strong [8] - Empaveli achieved over 5% market penetration after its first full quarter, significantly outpacing other rare nephrology launches [6][10] - The company is advancing pivotal trials in nephrology for Empaveli, targeting focal segmental glomerulosclerosis and delayed graft function [7] Market Data and Key Metrics Changes - Syfovre continues to lead the geographic atrophy market, with strong physician and patient preference due to its differentiated profile [8] - Empaveli's launch has been supported by favorable payer access, with 95% of published policies reimbursing to label or with minimal restrictions [10] Company Strategy and Development Direction - The company focuses on three strategic pillars: strengthening Syfovre's leadership in geographic atrophy, driving growth with Empaveli across rare kidney diseases, and advancing an innovative pipeline [4] - The introduction of a best-in-class prefilled syringe and an AI-enabled approach for Syfovre is expected to enhance treatment accessibility and workflow efficiency [5][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term value creation and the ability to self-fund the pipeline due to a strong balance sheet and growing commercial revenue base [7][23] - The company anticipates a modest inventory reduction in Q1 2026 alongside typical seasonal dynamics, indicating a disciplined approach to inventory management [18] Other Important Information - The company ended 2025 with $466 million in cash and cash equivalents, providing substantial flexibility to fund operations [20] - A milestone payment of $25 million was triggered by Sobi's European Commission approval for Aspaveli in C3G and primary IC-MPGN [21] Q&A Session Summary Question: Empaveli launch and growth potential - Management highlighted that Empaveli is on a clear path to blockbuster status, with a focus on broadening accounts and improving patient identification [25] - The epidemiology for C3G and IC-MPGN is approximately 5,000 patients in the U.S., with expectations of reaching up to 50% penetration [26][27] Question: Syfovre's five-year GALE data - The five-year data shows that Syfovre can delay progression of geographic atrophy by approximately 1.5 years, which is significant for patients [31][32] Question: Empaveli penetration and competitive dynamics - Management expects steady growth in Empaveli's adoption, with a clear differentiation in the pediatric segment and IC-MPGN [36][38] Question: Prefilled syringe impact on practice dynamics - The prefilled syringe is expected to enhance practice efficiency and patient treatment, providing a competitive advantage [48][50] Question: Free goods and patient assistance dynamics - The company remains committed to supporting patients who cannot afford copays, which has been integral to their strategy [98][99]

February 24, 2026 Forward-looking statements Statements in this presentation about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar ...

Core Insights - Apellis Pharmaceuticals reported its fourth quarter and full year 2025 financial results, highlighting significant progress and a strong foundation for future growth [1][2]. Financial Performance - Full-year 2025 net product revenues reached $689 million, with SYFOVRE generating $587 million and EMPAVELI contributing $102 million [6][10]. - Total revenue for Q4 2025 was $199.9 million, compared to $212.5 million in Q4 2024, while total revenue for the full year was $1.0 billion, up from $781.4 million in 2024 [9][10]. - The company reported a net loss of $58.9 million for Q4 2025, compared to a net loss of $36.4 million in Q4 2024, but achieved a net income of $22.4 million for the full year, a significant improvement from a net loss of $197.9 million in 2024 [10][11]. Product Highlights - SYFOVRE, the first approved therapy for geographic atrophy (GA), maintained a market share of approximately 60% and delivered around 102,000 doses in Q4 2025 [7][14]. - EMPAVELI showed strong momentum with a successful launch in C3 glomerulopathy (C3G) and primary immune complex glomerulonephritis (IC-MPGN), achieving over 5% penetration of the U.S. patient population [7][15]. - A regulatory submission for a prefilled syringe of SYFOVRE is planned for the first half of 2026, and pivotal trials for EMPAVELI in focal segmental glomerulosclerosis (FSGS) and delayed graft function (DGF) are underway [6][7]. Research and Development - The company is advancing its pipeline, including a Phase 2 study of SYFOVRE combined with APL-3007, with topline data expected in 2027 [7][8]. - Apellis is also progressing pre-clinical research on APL-9099, a potential one-time treatment using base editing technology, with an IND submission planned for the second half of 2026 [8]. Cash Position - As of December 31, 2025, Apellis had cash and cash equivalents of $466 million, an increase from $411 million in 2024, and expects this to be sufficient to fund operations to profitability [11][12].

Revenue Generation - SYFOVRE generated U.S. net product revenue of $586.9 million and $611.9 million for the years ended December 31, 2025 and 2024, respectively[665]. - EMPAVELI generated U.S. net product revenue of $102.4 million and $98.1 million for the years ended December 31, 2025 and 2024, respectively, along with royalties of $13.2 million and $18.4 million from Sobi[666]. - Total revenue for the year ended December 31, 2025, was $1,003.8 million, an increase of 28% compared to $781.4 million in 2024[722]. - Product revenue decreased by 3% to $689.4 million in 2025 from $709.9 million in 2024, primarily due to increased rebates[723]. - Licensing and other revenue surged by 340% to $314.4 million in 2025, driven by a $275.0 million upfront payment related to a Royalty Agreement[724]. - Revenue is derived from product sales of EMPAVELI and SYFOVRE, and from the Sobi Collaboration Agreement[700]. Financial Performance - The company has an accumulated deficit of $3.0 billion as of December 31, 2025, with net losses of $197.9 million and $528.6 million for the years ended December 31, 2025 and 2023, respectively[672]. - Net income for 2025 was $22.4 million, a significant turnaround from a net loss of $197.9 million in 2024[722]. - Interest income rose by 3% to $13.1 million in 2025, attributed to increased money market funds[734]. - Interest expense increased by 10% to $44.3 million in 2025, primarily due to interest incurred under a new Credit Facility[735]. Expenses and Costs - The company expects to incur significant commercialization expenses related to EMPAVELI and SYFOVRE, as well as ongoing clinical trials for product candidates[673]. - Selling, general and administrative expenses are anticipated to rise to support ongoing research, commercialization of products, and public company operations[712]. - Research and development expenses decreased by 10% to $295.9 million in 2025 from $327.6 million in 2024, mainly due to reduced program-specific external costs[728]. - Selling, general and administrative expenses increased by $49.2 million, primarily due to $34.0 million in contributions to patient assistance organizations[732]. - The company incurred royalty expenses of $19.1 million, $19.8 million, and $8.9 million on sales of SYFOVRE for the years ended December 31, 2025, 2024, and 2023, respectively[760]. Financing and Capital Structure - The Sixth Street Financing Agreement provides a senior secured term loan facility of up to $475.0 million, with an initial draw of $375.0 million[675]. - The company has financed operations through $2.6 billion in net proceeds from public offerings and $414.7 million in payments and royalties from Sobi[671]. - As of December 31, 2025, the company held Convertible Notes in principal amount of $425.4 million, classified as current liabilities[694]. - The company entered into capped call transactions to reduce potential dilution from Convertible Notes, with a strike price initially set at $39.4625[695]. - Cash proceeds of $98.8 million were received from unwinding a portion of the capped call transactions on February 27, 2024[696]. - The company has not called for redemption of any Convertible Notes as of December 31, 2025[692]. - The company entered into a sales agreement to offer and sell shares of common stock up to $300.0 million, with no sales made under this agreement during the year ended December 31, 2025[742]. - In February 2023, the company issued 4,007,936 shares and pre-funded warrants for 2,380,956 shares, generating total net proceeds of $384.4 million after deducting underwriting discounts and commissions of $18.8 million[743]. Cash Flow and Liquidity - For the year ended December 31, 2025, net cash provided by operating activities was $45.3 million, consisting of a net income of $22.4 million and adjustments for $108.1 million of non-cash items[746]. - The company reported a net cash used in operating activities of $87.9 million for the year ended December 31, 2024, primarily due to a net loss of $197.9 million[747]. - Net cash provided by financing activities was $8.9 million for the year ended December 31, 2025, mainly from proceeds of $5.5 million from stock options and $3.4 million from the employee stock purchase plan[749]. - The company expects its cash and cash equivalents as of December 31, 2025, along with anticipated sales from EMPAVELI and SYFOVRE, to be sufficient to fund projected operating expenses for at least the next 12 months[752]. - As of December 31, 2025, the company holds cash and cash equivalents of $466.2 million, primarily in money market funds and U.S. treasury securities[768]. Clinical Development and Collaboration - The company initiated a Phase 2 multi-dose clinical trial for a next-generation therapy combining SYFOVRE with APL-3007 in June 2025[665]. - The company is developing APL-9099, a first-in-class gene editing treatment, through collaboration with Beam Therapeutics[670]. - A Royalty Buy-Down Agreement with Sobi resulted in an upfront payment of $275.0 million and potential additional payments of up to $25.0 million upon EMA approval of Aspaveli[668]. - Sobi received EMA approval for Aspaveli in January 2026, triggering a $25.0 million milestone payment to the company[669]. - The company recognized $250.0 million in upfront payment from Sobi under the Collaboration Agreement, with potential milestone payments up to $915.0 million[697]. - The company earned a $50.0 million payment from Sobi in March 2022 related to the first regulatory milestone in Europe[699]. Risk Factors - The company's primary market risk exposure is interest rate sensitivity, which is affected by changes in U.S. interest rates[768]. - An immediate 10% change in interest rates would not materially affect the fair market value of the company's investment portfolio due to its short-term duration and low risk profile[768]. - If cash generated from sales of EMPAVELI and SYFOVRE is insufficient, the company may need to seek external funding sources, including equity offerings or debt financings[754]. - Significant contractual obligations as of December 31, 2025, total $746.7 million, including $553.7 million for the credit facility and $96.2 million for convertible notes[756]. - The company has non-cancelable purchase obligations totaling up to $69.1 million related to the manufacturing of drug substance and drug product, due by December 31, 2025[766]. - An expense of $6.4 million was incurred due to the termination of the minimum purchase obligation with NOF, included in cost of sales[766]. - Additional non-cancelable purchase agreements obligate the company to pay up to $6.7 million to vendors over the next three years[767].

Core Viewpoint - Apellis Pharmaceuticals is a biopharmaceutical company focused on complement science, developing innovative therapies for serious diseases, with two approved C3-targeting medicines [1] Financial Performance - Apellis is set to release its quarterly earnings on February 24, 2026, with Wall Street estimating an earnings per share (EPS) of -$0.39 and analysts predicting a slightly larger loss of -$0.41 per share [2][6] - Revenue projections are estimated at $199.4 million by Wall Street and $199 million by analysts [2] - The current stock price is $22.28, reflecting a 2.3% decrease, with a market capitalization of $2.82 billion and a price-to-earnings (P/E) ratio of 71.87 [3][6] Stock Performance - Over the past year, APLS stock has fluctuated between a low of $16.10 and a high of $30.48 [3] - The fifty-day simple moving average is $23.31, while the two-hundred-day simple moving average is $23.87 [3] Financial Ratios - The company maintains a quick ratio of 3.10 and a current ratio of 3.54, indicating strong liquidity [4][6] - The debt-to-equity ratio is 0.90, showing moderate financial leverage [4][6] - The price-to-sales ratio is 2.77, and the enterprise value to sales ratio is also 2.77, reflecting its market value compared to sales [4] Market Expectations - The upcoming earnings report is crucial for APLS as it could influence the stock's near-term price movement, with potential upward trends if results exceed expectations [5] - The sustainability of any immediate price changes will depend on management's discussion during the earnings call [5]

Company Overview - Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company focused on complement science to develop therapies for challenging diseases [2] - The company has introduced the first new class of complement medicine in 15 years, with two C3-targeting medicines approved for four serious diseases [2] - Notable breakthroughs include the first therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients aged 12 and older with C3G or primary IC-MPGN, both severe and rare kidney diseases [2] - Apellis believes it has only begun to unlock the potential of targeting C3 across various serious diseases [2] Upcoming Events - The company will participate in a webcast fireside chat at the TD Cowen 46th Annual Health Care Conference on March 2, 2026, at 9:50 a.m. ET [1] - The live conference webcast will be available on the company's website, with a replay accessible for approximately 30 days following the event [1]

Core Insights - Apellis Pharmaceuticals will present five-year results from the GALE study, highlighting the significant impact of early and continuous treatment with SYFOVRE (pegcetacoplan injection) for patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) [1][2][3] Group 1: Study Details - The GALE study is a Phase 3, multicenter, open-label extension study involving 792 participants, aimed at evaluating the long-term safety and efficacy of SYFOVRE in patients with GA secondary to AMD [4] - The study's objectives include assessing the long-term incidence and severity of treatment-emergent adverse events and measuring changes in the total area of GA lesions using fundus autofluorescence [4] - More than 80% of participants from the OAKS and DERBY studies transitioned into the GALE study [4] Group 2: Treatment Efficacy - The five-year results from the GALE study will demonstrate the importance of early treatment with SYFOVRE in preserving retinal tissue and delaying disease progression in GA patients [3] - The oral presentation titled "Earlier Treatment Yields Better Outcomes: 5-Years of Pegcetacoplan Treatment for Geographic Atrophy Secondary to AMD" is scheduled for February 27 [3] - In the OAKS and DERBY studies, SYFOVRE showed a reduction in GA lesion growth at 24 months, with increasing effects over time and a well-demonstrated safety profile [8][7] Group 3: Background on Geographic Atrophy - Geographic atrophy is an advanced form of AMD and a leading cause of blindness, affecting over one million Americans and five million people globally [10] - The disease is characterized by the growth of lesions that destroy retinal cells responsible for vision, leading to significant impairment in quality of life [10] - On average, GA lesions begin to impact the fovea, responsible for central vision, within 2.5 years [10] Group 4: Company Overview - Apellis Pharmaceuticals is a global biopharmaceutical company focused on developing therapies targeting the complement system for serious diseases [15] - The company has introduced the first-ever therapy for geographic atrophy and has two C3-targeting medicines approved for severe, rare kidney diseases [15] - Apellis aims to unlock the potential of targeting C3 across various serious diseases [15]

Core Viewpoint - Apellis Pharmaceuticals, Inc. (APLS) is anticipated to report a year-over-year decline in earnings due to lower revenues for the quarter ending December 2025, with a consensus outlook indicating a potential impact on its near-term stock price [1]. Financial Performance Expectations - The upcoming earnings report is expected to be released on February 24, and if the results exceed expectations, the stock may rise; conversely, missing estimates could lead to a decline [2]. - The consensus estimate predicts a quarterly loss of $0.39 per share, reflecting a year-over-year change of -34.5%, with revenues projected at $194.37 million, down 8.5% from the previous year [3]. Estimate Revisions Trend - Over the last 30 days, the consensus EPS estimate has been revised 0.84% higher, indicating a reassessment by covering analysts [4]. - The Most Accurate Estimate for Apellis is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -3.07%, suggesting a bearish outlook from analysts [12]. Earnings Surprise Prediction - The Zacks Earnings ESP model indicates that a positive or negative reading can predict the deviation of actual earnings from consensus estimates, with a positive ESP being a strong predictor of an earnings beat [9][10]. - Apellis currently holds a Zacks Rank of 3, which complicates the prediction of an earnings beat given the negative Earnings ESP [12]. Historical Performance - In the last reported quarter, Apellis was expected to post earnings of $1.03 per share but delivered $1.67, resulting in a surprise of +62.14% [13]. - Over the past four quarters, the company has beaten consensus EPS estimates three times [14]. Industry Comparison - In contrast, Axsome Therapeutics (AXSM), another player in the Zacks Medical - Biomedical and Genetics industry, is expected to post a loss of $0.7 per share for the same quarter, with revenues projected to be $193.01 million, up 62.5% year-over-year [18]. - Axsome's consensus EPS estimate has been revised 9.2% higher in the last 30 days, resulting in a positive Earnings ESP of +43.57%, suggesting a likely earnings beat [19][20].