Apellis(US:APLS)2025-07-31 10:52Revenue Performance - For the three months ended June 30, 2025, SYFOVRE generated $150.6 million in U.S. net product revenue, compared to $154.6 million for the same period in 2024, reflecting a decrease of 2.6%[123]. - For the six months ended June 30, 2025, SYFOVRE generated $280.8 million in U.S. net product revenue, down from $292.1 million in 2024, a decline of 3.9%[123]. - EMPAVELI generated $20.8 million in U.S. net product revenue for the three months ended June 30, 2025, compared to $24.5 million in 2024, a decrease of 15.1%[124]. - For the six months ended June 30, 2025, EMPAVELI generated $40.5 million in U.S. net product revenue, down from $50.1 million in 2024, a decline of 19.2%[124]. - For the three months ended June 30, 2025, total revenue decreased by 11% to $178.5 million from $199.7 million in the same period of 2024[173]. - Product revenue, net for the same period was $171.4 million, a decline of 4% compared to $179.1 million in 2024[173]. - Net product revenue for the three months ended June 30, 2025, was $171.4 million, a decrease of 4% from $179.1 million in the same period of 2024, driven by increased rebates and competitive pressure[174][190]. - Net product revenue for the six months ended June 30, 2025, was $321.3 million, a decrease of 6% from $342.2 million in 2024, attributed to competitive pressures and increased rebates[190]. - Total revenue for the six months ended June 30, 2025, was $345.3 million, down 7% from $372.0 million in 2024[189]. Financial Losses - The company incurred net losses of $42.2 million and $37.7 million for the three months ended June 30, 2025 and 2024, respectively, representing an increase in losses of 11.9%[130]. - The net operating loss for the quarter was $33.3 million, compared to a loss of $29.4 million in the prior year, representing a 13% increase in loss[173]. - The net loss for the quarter was $42.2 million, an increase of 12% from a loss of $37.7 million in 2024[173]. - Net loss for the six months ended June 30, 2025, was $134.4 million, an increase of 29% compared to a net loss of $104.1 million in 2024[189]. Expenses - Research and development expenses were $67.0 million, down 14% from $77.9 million in 2024[173]. - Selling, general and administrative expenses increased by 2% to $131.1 million from $128.1 million[173]. - Research and development expenses decreased by 14% to $67.0 million for the three months ended June 30, 2025, down from $77.9 million in 2024, mainly due to a reduction in program-specific external costs[180]. - Selling, general and administrative expenses increased by 2% to $131.1 million for the three months ended June 30, 2025, compared to $128.1 million in 2024, driven by higher professional and consulting fees[183]. - Research and development expenses decreased by $9.2 million to $153.4 million for the six months ended June 30, 2025, a decrease of 6% compared to $162.6 million for the same period in 2024[196]. - Selling, general and administrative expenses increased by $2.9 million to $260.5 million for the six months ended June 30, 2025, an increase of 1% from $257.6 million in 2024[199]. Financing and Cash Flow - The company has financed operations through $2.6 billion in net proceeds from public offerings and $413.5 million in payments and royalties from Sobi[129]. - The Credit Facility under the Sixth Street Financing Agreement allows for a senior secured term loan facility of up to $475.0 million, with an initial draw of $375.0 million[133]. - Net cash used in operating activities was $49.0 million for the six months ended June 30, 2025, compared to $141.3 million for the same period in 2024[211]. - Net cash provided by financing activities was $6.8 million during the six months ended June 30, 2025, a significant decrease from $150.7 million in 2024[214]. - As of June 30, 2025, the company had cash and cash equivalents of $370.0 million, including money market funds[221]. - The company currently lacks committed external sources of funds and may need to seek financing through equity offerings, debt financings, or collaborations[218]. Clinical Trials and Development - The company plans to initiate two pivotal clinical trials for EMPAVELI in the second half of 2025 targeting primary focal segmental glomerulosclerosis and delayed graft function[127]. - The ability to maintain collaborative relationships and achieve milestone payments is crucial for the development of systemic pegcetacoplan[217]. - The outcome and costs of clinical trials for product candidates will significantly impact future funding and development strategies[217]. - The company is assessing the impact of public health crises on its operations and clinical trials[217]. Market and Commercialization - The company is investing substantial resources in the commercialization of SYFOVRE for GA and the development of product candidates[217]. - Future funding requirements will depend on the successful commercialization of EMPAVELI and SYFOVRE in the U.S. and obtaining regulatory approvals for SYFOVRE globally[217]. - The company is focused on establishing commercial infrastructure and manufacturing capabilities to support product commercialization[217]. - Insufficient funds from EMPAVELI and SYFOVRE sales may lead to delays or reductions in product development and commercialization efforts[219]. - The company is exposed to market risk related to interest rate changes, with a low risk profile for its investments[221].