Apellis Q4 Loss Narrower Than Expected, Syfovre Sales Drive Revenues

Apellis Pharmaceuticals APLS reported fourth-quarter 2024 loss of 29 cents per share, narrower than the Zacks Consensus Estimate of a loss of 39 cents. The company had incurred a loss of 73 cents in the year-ago quarter.Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.Total revenues in the fourth quarter amounted to $212.5 million and surpassed the Zacks Consensus Estimate of $196 million. In the year-ago quarter, the company had reported revenues of $146.4 million.The top line jumped 45% year over year, owing to higher sales of Syfovre (pegcetacoplan injection) in the fourth quarter. Syfovre was approved for treating geographic atrophy (GA) secondary to age-related macular degeneration by the FDA in February 2023.More on APLS' Q4 ResultsRevenues in the reported quarter included product sales of the marketed drugs — Empaveli (pegcetacoplan) and Syfovre — and licensing and other revenues under the collaboration agreement with Sobi.Syfovre recorded sales of $167.8 million in the fourth quarter, which rose 47% year over year, owing to continued strong demand. Syfovre's sales beat the Zacks Consensus Estimate of $161.6 million as well as our model estimate of $155.5 million.Apellis delivered more than 89,000 commercial vials and nearly 4,600 samples of Syfovre to doctors in the reported quarter. As of Dec. 31, 2024, the total number of doses of the drug delivered since its launch was 510,000. The potential approval and successful launch of Syfovre in additional geographies will add an incremental stream of revenues to APLS in the future.In the past three months, shares of Apellis have plunged 19.7% compared with the industry’s decline of 0.6%.Image Source: Zacks Investment ResearchEmpaveli recorded sales of $23.4 million, down 4% from the year-ago quarter’s figure, despite continued high patient compliance rates of 97%. Empaveli sales missed the Zacks Consensus Estimate of $24.2 million and our model estimate of $26 million.Empaveli is approved in the United States for the treatment of paroxysmal nocturnal hemoglobinuria. The drug is also approved in Europe under the brand name Aspaveli for the same indication.Licensing and other revenues came in at $21.4 million, up significantly year over year.Research and development expenses increased 10% from the prior-year quarter’s level to $76.4 million. This was due to an increase in program-specific external costs.Selling, general and administrative expenses totaled $121.5 million, down 14% year over year. This was due to decreases in personnel-related costs and professional and consulting fees.As of Dec. 31, 2024, Apellis had cash, cash equivalents and marketable securities worth $411.3 million compared with $396.9 million as of Sept. 30, 2024. APLS expects its cash balance, combined with cash anticipated from sales of marketed products, to be enough to fund its operations to profitability.APLS’ Full-Year ResultsIn 2024, Apellis recorded total revenues of $781.4 million, representing 97% year-over-year growth.The company incurred a loss per share of $1.60 in 2024, narrower than the loss of $4.45 incurred in 2023.APLS' Recent Pipeline UpdateIn August 2024, Apellis and partner Sobi announced that the phase III VALIANT study evaluating systemic pegcetacoplan in C3 glomerulopathy (C3G) and primary immune complex glomerulonephritis (IC-MPGN) patients met its primary and key secondary endpoints with statistical significance.Based on the positive data readout, Apellis recently submitted a supplemental new drug application seeking approval for pegcetacoplan in C3G and IC-MPGN. Subject to approval, the company expects the U.S. launch of Empaveli for this additional indication in the second half of 2025. A similar regulatory filing by Sobi is also currently under review by the regulatory body in the EU.In the earnings release, Apellis stated that it is on track to initiate two phase III studies of Empaveli in focal segmental glomerulosclerosis (FSGS) and delayed graft function (DGF) in the second half of 2025. Both FSGS and DGF are rare kidney diseases in which the complement pathway plays a significant role and there are no approved therapies.APLS also recently presented 48-month data from the GALE extension study at The Macula Society Annual Meeting in February 2025. Per the data, early monthly treatment with Syfovre in non-subfoveal patients helps preserve retinal tissue — about 1.5 disc areas in size (roughly equivalent to 2 foveal areas).The company is also looking to initiate a mid-stage multi-dose study of siRNA candidate APL-3007 in combination with Syfovre in the second quarter of 2025, which has the potential to comprehensively block complement activity in the retina and choroid.Apellis Pharmaceuticals, Inc. Price, Consensus and EPS Surprise Apellis Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Apellis Pharmaceuticals, Inc. QuoteAPLS’ Zacks Rank and Stocks to ConsiderApellis currently sports a Zacks Rank #3 (Hold).Some other top-ranked stocks from the sector are Gilead Sciences GILD, BioMarin Pharmaceutical BMRN and Amicus Therapeutics FOLD, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.In the past 30 days, Gilead Sciences’ earnings estimates for 2025 have improved from $7.56 to $7.85 per share. During the same timeframe, the earnings per share for 2026 have improved from $7.82 to $8.17. In the past three months, shares of Gilead Sciences have gained 24.8%.GILD’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.47%.In the past 30 days, estimates for BioMarin Pharmaceutical’s 2025 earnings per share have increased from $4.01 to $4.21. Estimates for 2026 earnings per share have decreased from $5.21 to $5.17 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have gained 7%.BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 32.36%.In the past 30 days, the estimate for Amicus Therapeutics’ 2025 earnings per share has remained constant at 43 cents. The estimate for 2026 earnings per share has deteriorated from 72 cents to 71 cents. In the past three months, shares of Amicus Therapeutics have lost 3.8%.FOLD’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 45.42%.Just Released: Zacks Top 10 Stocks for 2025Hurry – you can still get in early on our 10 top tickers for 2025. Handpicked by Zacks Director of Research Sheraz Mian, this portfolio has been stunningly and consistently successful. From inception in 2012 through November, 2024, the Zacks Top 10 Stocks gained +2,112.6%, more than QUADRUPLING the S&P 500’s +475.6%. Sheraz has combed through 4,400 companies covered by the Zacks Rank and handpicked the best 10 to buy and hold in 2025. You can still be among the first to see these just-released stocks with enormous potential. See New Top 10 Stocks >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report BioMarin Pharmaceutical Inc. (BMRN): Free Stock Analysis Report Gilead Sciences, Inc. (GILD): Free Stock Analysis Report Amicus Therapeutics, Inc. (FOLD): Free Stock Analysis Report Apellis Pharmaceuticals, Inc. (APLS): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks