Apellis(US:APLS)2025-10-30 10:57Revenue Performance - For the three months ended September 30, 2025, the company generated $150.9 million in U.S. net product revenue from SYFOVRE, a slight decrease from $152.0 million in the same period of 2024[130]. - For the nine months ended September 30, 2025, the company reported $431.7 million in U.S. net product revenue from SYFOVRE, down from $444.0 million in 2024[130]. - EMPAVELI generated $26.8 million in U.S. net product revenue for the three months ended September 30, 2025, compared to $24.6 million in 2024[131]. - For the nine months ended September 30, 2025, EMPAVELI's U.S. net product revenue was $67.3 million, down from $74.7 million in 2024[131]. - Net product revenue for the three months ended September 30, 2025, was $177.8 million, a decrease of 0.7% from $176.6 million in the same period of 2024[178]. - Net product revenue for the nine months ended September 30, 2025, was $499.0 million, a decrease of 4% from $518.8 million in the same period of 2024[191]. Total Revenue and Income - For the three months ended September 30, 2025, total revenue increased by 133% to $458.6 million, compared to $196.8 million in the same period in 2024[177]. - Total revenue for the nine months ended September 30, 2025, increased by 41% to $803.9 million, compared to $568.8 million in 2024[190]. - Net income for the three months ended September 30, 2025, was $215.7 million, a significant increase compared to a net loss of $57.4 million in the same period in 2024, representing a 476% change[177]. - The company reported a net income of $81.3 million for the nine months ended September 30, 2025, compared to a net loss of $161.5 million in 2024, representing a significant turnaround[190]. Operating Expenses - Operating expenses decreased by 4% to $235.4 million, with cost of sales down by 27% to $24.5 million and research and development expenses down by 23% to $68.2 million[177]. - Research and development expenses decreased by 23% to $68.2 million for the three months ended September 30, 2025, from $88.6 million in 2024, mainly due to a reduction in program-specific external costs[184]. - Research and development expenses decreased by $29.6 million to $221.6 million for the nine months ended September 30, 2025, a decrease of 12% compared to $251.2 million for the same period in 2024[196]. - Selling, general and administrative expenses increased by 17% to $142.7 million for the three months ended September 30, 2025, from $122.0 million in 2024, attributed to higher general and administrative expenses[187]. - Selling, general and administrative expenses increased by $23.6 million to $403.2 million for the nine months ended September 30, 2025, an increase of 6% from $379.6 million in 2024[199]. Cash and Financing - As of September 30, 2025, the company had cash and cash equivalents of $479.2 million, including money market funds[221]. - The company expects to continue incurring expenses to support ongoing commercial activities related to product manufacturing and sales of EMPAVELI and SYFOVRE[215]. - The company anticipates that current cash and cash equivalents will be sufficient to fund projected operating expenses for at least the next 12 months[216]. - The company may need to finance its cash needs through external sources if sales of EMPAVELI and SYFOVRE are insufficient[218]. - The company has financed operations primarily through $2.6 billion in net proceeds from public offerings and $414.1 million in payments and royalties from Sobi[136]. Regulatory and Clinical Developments - The FDA approved EMPAVELI for the treatment of C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis in July 2025, based on a study showing a 68% reduction in proteinuria[131]. - The company expects to initiate two pivotal clinical trials for EMPAVELI by year-end 2025, targeting primary focal segmental glomerulosclerosis and delayed graft function[134]. Market Risks and Future Outlook - The company faces numerous risks and uncertainties in the commercialization of EMPAVELI and SYFOVRE, impacting future funding requirements[217]. - Future product development may be delayed or limited if the company cannot generate sufficient funds from sales or raise additional funds[219]. - The company is focused on establishing a commercial infrastructure and manufacturing capabilities to support the continued commercialization of its products[217]. - The company is unable to estimate increased capital outlays and operating expenses associated with research and commercialization due to various unknown factors[217]. - An immediate 10% change in interest rates would not materially affect the fair market value of the company's investment portfolio due to its low risk profile[221]. - The company is exposed to market risk related to changes in interest rates, which could impact its financial condition[221].