Workflow
Empaveli (pegcetacoplan)
icon
Search documents
Apellis Q4 Loss Wider Than Expected, Revenues Decline Y/Y
ZACKS· 2026-02-25 14:56
Core Insights - Apellis Pharmaceuticals reported a fourth-quarter 2025 loss of 47 cents per share, which was wider than the Zacks Consensus Estimate of a loss of 39 cents, compared to a loss of 29 cents in the same quarter last year [1][7] Financial Performance - Total revenues for the fourth quarter were $199.9 million, exceeding the Zacks Consensus Estimate of $194 million, but down 6% year-over-year from $212.5 million in the previous year [2] - Revenues included product sales from Empaveli and Syfovre, along with licensing and other revenues from a collaboration agreement with Sobi [3] - Syfovre sales were $155.2 million, an 8% decline year-over-year, although it slightly surpassed the Zacks Consensus Estimate of $154.2 million [4] - Empaveli recorded sales of $35.1 million, a 50% increase from the previous year, driven by early launch momentum in C3G and IC-MPGN, and also beat the Zacks Consensus Estimate of $28.5 million [9] Market Position and Product Performance - Syfovre holds approximately 60% market share in geographic atrophy treatment, with total injections growing about 17% year-over-year despite the revenue decline attributed to increased use of free goods [5] - Apellis delivered over 89,000 commercial vials and nearly 13,000 samples of Syfovre to doctors in the reported quarter [5] Cost Management - Research and development expenses decreased by 3% year-over-year to $74.2 million, attributed to lower program-specific external costs and personnel costs [10] - Selling, general, and administrative expenses rose by 21% year-over-year to $147.1 million, driven by higher professional fees and personnel costs [11] Cash Position - As of December 31, 2025, Apellis had cash, cash equivalents, and marketable securities totaling $466.2 million, down from $479.2 million as of September 30, 2025, with expectations that this will fund operations to profitability [12] Annual Performance - For the full year 2025, Apellis reported total revenues of $1.0 billion, a 28% increase year-over-year, surpassing the Zacks Consensus Estimate of $998.3 million, which included a one-time $275 million upfront payment from a royalty repurchase agreement [14] - The company reported earnings per share of 20 cents for 2025, compared to a loss of $1.60 per share in 2024, although it missed the Zacks Consensus Estimate of 24 cents [14] Pipeline Developments - Apellis has initiated two pivotal phase III studies of Empaveli for focal segmental glomerulosclerosis and delayed graft function, both of which are rare kidney diseases with no approved therapies [16] - A mid-stage multi-dose study of siRNA candidate APL-3007 in combination with Syfovre is ongoing, with top-line data expected in 2027 [17]
Apellis Pharmaceuticals (APLS) Surges 5.8%: Is This an Indication of Further Gains?
ZACKS· 2026-01-29 13:06
Company Overview - Apellis Pharmaceuticals, Inc. (APLS) shares increased by 5.8% to $23.07 in the last trading session, following a significant trading volume, contrasting with a 13.6% decline over the past four weeks [1] Product Performance - The rise in stock price is linked to growing investor optimism regarding Empaveli (pegcetacoplan), which is approved for treating paroxysmal nocturnal hemoglobinuria in the U.S. The drug generated approximately $35 million in preliminary U.S. net product revenues for Q4 2025, reflecting a 50% year-over-year increase [2] Financial Expectations - The company is projected to report a quarterly loss of $0.41 per share, marking a 41.4% decrease year-over-year. Expected revenues are $194.37 million, down 8.6% from the same quarter last year [3] - The consensus EPS estimate for the upcoming quarter has been revised 0.8% higher over the last 30 days, indicating a potential for price appreciation [4] Industry Context - Apellis Pharmaceuticals is categorized under the Zacks Medical - Biomedical and Genetics industry. Another company in the same sector, Lexicon Pharmaceuticals (LXRX), saw a 12.3% decline in its stock price, closing at $1.5, despite a 48.7% return over the past month [5] - Lexicon's consensus EPS estimate for its upcoming report remains unchanged at -$0.07, representing a 22.2% increase compared to the previous year [6]
Apellis Stock Crashes 23% in a Week: Here's What You Should Know
ZACKS· 2026-01-15 17:21
Core Insights - Apellis Pharmaceuticals (APLS) shares have dropped 22.6% in the past week following disappointing preliminary fourth-quarter U.S. net product revenues reported at the J.P. Morgan Healthcare Conference [2][6] Financial Performance - Preliminary U.S. net product revenues for Q4 2025 were reported at $190 million, which includes sales from two marketed drugs: Empaveli and Syfovre [3][6] - Syfovre generated approximately $155 million in Q4 2025, reflecting an 8% year-over-year decline, although it slightly exceeded the Zacks Consensus Estimate of $154 million [4][6] - Empaveli's sales rose 50% year-over-year to about $35 million in Q4 2025, surpassing the Zacks Consensus Estimate of $28 million [6][8] - For the full year 2025, Apellis reported preliminary U.S. net product revenues of approximately $689 million, down 3% year over year [11] Market Position and Sales Dynamics - Despite holding over 60% market share in geographic atrophy (GA), Syfovre's revenue decline disappointed investors, especially as Apellis' stock has only gained 2.9% over the past six months compared to the industry's 22.9% growth [5][6] - Apellis delivered over 89,000 commercial vials and nearly 13,000 samples of Syfovre to doctors in Q4 2025 [5] Regulatory and Pipeline Updates - Empaveli has received FDA approval for expanded use in treating C3 glomerulopathy and primary immune complex glomerulonephritis [9] - As of December 31, 2025, Apellis received 267 cumulative patient start forms for Empaveli, indicating over 5% market penetration within five months post-launch [10] - The company has initiated two pivotal phase III studies for Empaveli targeting focal segmental glomerulosclerosis (FSGS) and delayed graft function (DGF) [13] - A mid-stage study of siRNA candidate APL-3007 in combination with Syfovre is ongoing, with top-line data expected in 2027 [14] Financial Position - As of December 31, 2025, Apellis had cash, cash equivalents, and marketable securities totaling $466 million, down from $479.2 million as of September 30, 2025 [15]