Financial Data and Key Metrics Changes - The company is currently cash neutral and on a path to profitability, with over $450 million in cash available [6][64] - The company reported a dramatic reduction in proteinuria of approximately 68% in patients with C3 glomerulopathy and immune complex membranoproliferative glomerulonephritis [10][11] - The company has been skating close to cash operational expenses, indicating strong financial health [64] Business Line Data and Key Metrics Changes - Apellis has two approved drugs: EMPAVELI for paroxysmal nocturnal hemoglobinuria (PNH) and recently approved indications for C3 glomerulopathy and immune complex membranoproliferative glomerulonephritis [5][6] - SYFOVRE, the first treatment for geographic atrophy, was approved in 2023 and has stabilized its market share at just north of 60% [6][45] Market Data and Key Metrics Changes - The prevalence of C3G and IC-MPGN in the U.S. is approximately 5,000 patients, with about 50% progressing to end-stage renal disease over ten years [9] - The company has achieved around 5% market penetration with 225 start forms for the new indications within five months [14][32] Company Strategy and Development Direction - The company is focused on educating nephrologists about its new drug indications and differentiating its products from competitors [16][19] - Future trials are planned for FSGS and delayed graft function, with expectations of positive outcomes based on the underlying disease mechanisms [26][28] Management's Comments on Operating Environment and Future Outlook - Management noted that the competitive landscape for PNH has not led to significant patient loss, with 15% of patients returning to EMPAVELI after trying oral alternatives [24] - The company anticipates a strong 2026, with ongoing efforts to improve physician education and patient access to treatments [64][77] Other Important Information - The company is developing a siRNA combination therapy that aims to enhance the efficacy of SYFOVRE and potentially allow for less frequent dosing [67][69] - There is a focus on leveraging machine learning and AI to improve patient imaging and tracking disease progression [58][61] Q&A Session Summary Question: What is the opportunity with C3G and IC-MPGN? - The company highlighted the significant unmet need in these kidney diseases and the potential for its drug to provide a new treatment option [9][10] Question: How will the company increase its market share in the 5,000 prevalent pool? - Management emphasized the importance of education and building relationships with nephrologists to drive adoption [16][19] Question: What is the current status of SYFOVRE in the market? - The company reported stabilization in market share and ongoing efforts to communicate the drug's benefits to the retina community [40][45] Question: What are the timelines for upcoming studies? - The company indicated that trials for FSGS and delayed graft function have just opened, with updates expected next year [28][29] Question: How is the company addressing the impact of patient copay assistance foundations? - Management acknowledged the significant impact on patient access and is focusing on physician education to mitigate these challenges [75][76]

Financial Data and Key Metrics Changes - The company is currently cash neutral and on a path to profitability, with over $450 million in cash available [6][61] - The company reported a dramatic reduction in proteinuria of approximately 68% in patients with C3 glomerulopathy and immune complex membranoproliferative glomerulonephritis [10] Business Line Data and Key Metrics Changes - Apellis has two approved drugs: Empaveli for paroxysmal nocturnal hemoglobinuria (PNH) and recently for C3 glomerulopathy and immune complex membranoproliferative glomerulonephritis, and Syfovre for geographic atrophy [5][6] - The company has achieved approximately 5% market penetration in the C3G and IC-MPGN indications, with 225 start forms reported by the end of the year [13][31] Market Data and Key Metrics Changes - The prevalence of C3G and IC-MPGN in the U.S. is approximately 5,000 patients, with about 50% expected to progress to end-stage renal disease over ten years [8] - The company has seen a significant adoption of Empaveli in the pediatric population, with interest growing among adult nephrologists [18] Company Strategy and Development Direction - The company is focused on educating nephrologists about its new drug indications and the unique benefits of its therapies compared to oral alternatives [15][17] - Future trials are planned for FSGS and delayed graft function, with expectations of positive outcomes based on the underlying disease mechanisms [25][26] Management's Comments on Operating Environment and Future Outlook - Management noted that 2025 was a challenging year for retina practices due to funding issues affecting patient access to treatments, but they expect a gradual recovery [39][40] - The company is optimistic about the long-term data from the Gale study and the potential for Syfovre to improve patient outcomes in geographic atrophy [41][42] Other Important Information - The company is developing a siRNA combination therapy that aims to enhance the efficacy of Syfovre and potentially allow for less frequent dosing [64][66] - Management emphasized the importance of new imaging technologies to better track disease progression and treatment efficacy in retinal diseases [51][54] Q&A Session Summary Question: What is the potential for growth in PNH? - Management indicated that despite the introduction of oral alternatives, many patients have returned to Empaveli, demonstrating its strong efficacy and safety profile [22][23] Question: How does the company plan to increase market share in C3G and IC-MPGN? - The strategy focuses on education and building relationships with nephrologists, particularly in pediatric and transplant settings [15][18] Question: What is the current market share for Syfovre? - The company has stabilized its market share just north of 60%, with ongoing efforts to maintain and grow this position [43] Question: What are the timelines for upcoming trials? - Trials for FSGS and delayed graft function have just opened, with updates expected next year [27][28] Question: How is the company addressing the impact of patient copay assistance foundations? - Management acknowledged the significant impact of funding issues on patient access and is focusing on physician education to mitigate these challenges [72][74]

Financial Data and Key Metrics Changes - The company reported an uplift of approximately $60 million from Q3 to Q4, driven by three primary factors: the Genomics England contract, seasonal uplift in life sciences instrumentation, and strong performance in immunodiagnostics outside of China [2][4][54] - The foreign exchange (FX) impact was less favorable than anticipated, resulting in a $5-$7 million drag on absolute dollar amounts, which is about 1% less than expected [4] Business Line Data and Key Metrics Changes - The diagnostics segment saw contributions from the Genomics England contract, increasing from $2 million in Q3 to $7 million in Q4 [2] - The life sciences instrumentation side continued to show good activity, with seasonal uplift expected rather than a significant budget flush [3][14] - The reagents business, particularly from BioLegend, faced modest impacts from government shutdowns, but the pharma biotech sector showed signs of recovery [6][10] Market Data and Key Metrics Changes - The U.S. market for immunodiagnostics has grown from 5% to 15-20% of total EUROIMMUN revenue since acquisition, with expectations to reach 40-45% as more assays are introduced [39] - The China market is projected to stabilize, with diagnostics expected to contribute 5-6% of total revenue, while life sciences in China is anticipated to be around 10-12% [46][47] Company Strategy and Development Direction - The company aims to innovate in the Chinese market by operating as a local entity and focusing on reproductive health and newborn screening [45] - There is a strong emphasis on leveraging AI and machine learning across product lines, particularly in drug discovery and development, which is expected to drive future growth [23][38] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the recovery in the pharma biotech sector, indicating that increased activity and discussions with customers are signs of normalization [17][19] - The company is confident in its 2026 growth projections of 2-3% and 28% margins, having accounted for market stability and the impact of calendarization on China [60][61] Other Important Information - The software segment has outperformed expectations, growing over 20% each quarter, driven by diligent investment and customer engagement [21][22] - The company remains open to acquisitions but is focused on strategic and sensible opportunities rather than paying high multiples [61] Q&A Session Summary Question: Can you discuss the life sciences diagnostics and the impact of the government shutdown? - The reagents business, particularly from BioLegend, was modestly impacted by the shutdown, but the pharma biotech sector continues to perform well, indicating a return to normalcy [6][10] Question: How quickly can biotech recover and what are the signs? - Recovery in biotech is linked to market stability and increased M&A activity, which are expected to normalize over the next couple of quarters [8][9] Question: What is the outlook for the China diagnostics market? - The company anticipates that China diagnostics will stabilize, contributing around 5-6% of total revenue, with a focus on localizing operations and obtaining faster approvals [46][47] Question: How does the company view its software growth trajectory? - The software business is expected to continue growing, with a focus on annualized portfolio value rather than just organic growth metrics [29][30] Question: What are the capital allocation priorities moving forward? - The company remains acquisitive but is focused on strategic acquisitions that align with its core business, while also considering share repurchases as a priority [61]