Core Viewpoint - The European Medicines Agency (EMA) has reset the review process for Apellis Pharmaceuticals' marketing authorization application for intravitreal pegcetacoplan, with an expected opinion from the Committee for Medicinal Products for Human Use (CHMP) by July 2024 [1][2]. Group 1: Regulatory Update - The EMA's decision follows a recent ruling by the Court of Justice of the European Union regarding the organization of EMA's expert groups, which affects how EMA manages competing interests among experts [2]. - The reset of the review process is procedural and does not pertain to the data package for pegcetacoplan [2]. Group 2: Company Overview - Apellis Pharmaceuticals is a global biopharmaceutical company focused on developing therapies for challenging diseases, having introduced the first new class of complement medicine in 15 years [3]. - The company has two approved medicines targeting C3, including the first therapy for geographic atrophy, a major cause of blindness globally [3].

Apellis Pharmaceuticals, Inc. (APLS) reported fourth-quarter 2023 loss of 73 cents per share, which was wider than the Zacks Consensus Estimate of a loss of 66 cents. The company had reported a loss of $1.50 per share in the year-ago quarter.Total revenues amounted to $146.4 million in the fourth quarter, matching the Zacks Consensus Estimate. In the year-ago quarter, the company had reported revenues of $22.6 million.The top line jumped almost 545% year over year owing to higher sales of Syfovre (pegcetaco ...

Financial Data and Key Metrics Changes - Total revenue for Q4 2023 was $146 million, with full-year revenue reaching $397 million [24] - SYFOVRE generated $114 million in Q4 and $275 million for the full year, while EMPAVELI contributed $24 million in Q4 and $91 million for the full year [24][25] - The company reported a net loss of $89 million for Q4 and $529 million for the full year [25] Business Line Data and Key Metrics Changes - SYFOVRE has distributed over 200,000 doses since its launch, with approximately 215,000 injections administered [6][7] - EMPAVELI's compliance rates remain high at 97%, with 10% of demand in 2023 coming from treatment-naive patients [16] - The EMPAVELI Injector was launched in Q4 2023, receiving positive feedback and adoption [9] Market Data and Key Metrics Changes - SYFOVRE holds a market share of approximately 90% in the GA treatment market [14][16] - The company is facing increased competition in the PNH market due to the recent approval of an oral product [16] Company Strategy and Development Direction - The company aims to maximize access to SYFOVRE in the U.S. and expand its availability for GA patients worldwide [7][29] - Plans for 2024 include focusing on EMPAVELI's market position in PNH and advancing early-stage R&D programs, including the siRNA program APL-3007 [10][29] - The company is committed to addressing unmet patient needs and enhancing shareholder value [11][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of SYFOVRE despite challenges faced in 2023 [5] - The company is optimistic about the re-examination of SYFOVRE's application in the EU, although it acknowledges the uphill battle ahead [8][9] - Management highlighted the importance of physician and patient support in the EU re-examination process [32] Other Important Information - The company expects total operating expenses in 2024 to be less than those in 2023 due to ongoing efficiencies from restructuring [26] - As of December 31, 2023, the company had $351 million in cash and cash equivalents, which is expected to fund projected operating expenses and capital expenditures for the foreseeable future [27][28] Q&A Session Summary Question: Impact of physician enthusiasm on EU reexamination - Management noted that letters of support from physicians and patient groups are important but uncertain in their impact on the reexamination process [32] Question: Growth expectations for Q1 relative to Q4 - Management indicated that despite seasonality impacts, they expect robust growth in March following January and February's strong performance [33] Question: Financial runway and capital flexibility - Management expressed confidence in their financial position with the capped call and cash reserves, allowing for flexibility without immediate capital raises [37] Question: GA population size estimation - Management explained that increased interactions with physicians revealed a larger GA patient population than previously estimated [44][46] Question: Details on the EU application revision - Management stated that the revision focused on educating about geographic atrophy and included new analyses to support their case [50][51] Question: SYFOVRE market share attribution - Management attributed the 90% market share to strong execution, transparency with the retina community, and the drug's efficacy profile [76]

Apellis Pharmaceuticals, Inc. (APLS) reported $146.38 million in revenue for the quarter ended December 2023, representing a year-over-year increase of 546%. EPS of -$0.73 for the same period compares to -$1.50 a year ago.The reported revenue compares to the Zacks Consensus Estimate of $146.43 million, representing a surprise of -0.03%. The company delivered an EPS surprise of -10.61%, with the consensus EPS estimate being -$0.66.While investors closely watch year-over-year changes in headline numbers -- re ...

分组1 - Apellis Pharmaceuticals, Inc. reported a quarterly loss of $0.73 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.66, but an improvement from a loss of $1.50 per share a year ago [1] - The company posted revenues of $146.38 million for the quarter, missing the Zacks Consensus Estimate by 0.03%, but significantly up from $22.66 million year-over-year [1] - Over the last four quarters, Apellis has surpassed consensus revenue estimates three times, while it has only surpassed EPS estimates once [1] 分组2 - The stock has gained approximately 19.8% since the beginning of the year, outperforming the S&P 500's gain of 6.3% [2] - The current consensus EPS estimate for the upcoming quarter is -$0.46 on revenues of $158.9 million, and for the current fiscal year, it is -$1.10 on revenues of $784.78 million [4] - The Medical - Biomedical and Genetics industry, to which Apellis belongs, is currently ranked in the top 32% of over 250 Zacks industries, indicating a favorable outlook for the sector [5]

Fourth Quarter and Full Year 2023 Financial Results Conference Call Apellis Participants CEDRI C F RANCO I S, M. D. , Ph . D. Co-Founder, President & Chief Executive Officer ...

Core Insights - Apellis Pharmaceuticals reported a total revenue of $397 million for the full year 2023, with significant contributions from SYFOVRE® and EMPAVELI® [1][8] - The launch of SYFOVRE exceeded expectations, with over 160,000 doses distributed in 2023, and continued demand into 2024 [2][3] - The company is well-positioned for 2024, focusing on expanding SYFOVRE's reach and maximizing EMPAVELI's potential in PNH and C3G/IC-MPGN [2] Financial Performance - Total revenue for Q4 2023 was $146.4 million, a significant increase from $22.7 million in Q4 2022 [8] - For the full year 2023, total revenue was $396.6 million, compared to $75.4 million in 2022, marking a substantial growth [8] - The net loss for Q4 2023 was $88.5 million, while the full year net loss was $528.6 million, showing improvement compared to the previous year's losses [12] Product Highlights - SYFOVRE generated $275 million in revenue for the full year 2023, with Q4 revenue of $114.3 million [1][3] - EMPAVELI achieved $91 million in revenue for the full year 2023, with Q4 revenue of $24.4 million and a high patient compliance rate of 97% [4][8] - The company is advancing its pipeline, with topline data from the Phase 3 VALIANT study expected in mid-2024 [5] Research and Development - R&D expenses for Q4 2023 were $69.3 million, down from $99.4 million in Q4 2022, and full year R&D expenses were $354.4 million compared to $387.2 million in 2022 [10][11] - The company completed enrollment in the Phase 3 VALIANT study for systemic pegcetacoplan, with data expected in mid-2024 [5] Cash Position - As of December 31, 2023, Apellis had cash and cash equivalents of $351 million, down from $551.8 million in 2022 [7][8] - The company anticipates that its cash balance, along with expected revenue from SYFOVRE and EMPAVELI, will be sufficient to fund its projected operating expenses [7]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-38276 | --- | --- | --- | |---------------------------------------------------------------------------------------|------------------ ...

Earnings Season Overview - The fourth-quarter 2023 earnings season is showing better-than-expected results, with total earnings for S&P 500 companies up 4.9% year-over-year on 3.4% higher revenues [1] - As of February 20, 402 S&P 500 companies reported earnings, with 78.6% exceeding EPS estimates and 64.4% surpassing revenue estimates [1] - Total earnings for the S&P 500 in Q4 2023 are projected to increase by 5.5% with 3.2% higher revenues, following a 3.8% earnings growth in Q3 2023 [1] Top Stock Picks - Five stocks are identified as likely to beat earnings this week, all carrying a Zacks Rank 2 (Buy) and a positive Earnings ESP [2] - Stocks with a Zacks Rank 3 (Hold) or better and a positive Earnings ESP have a 70% chance of beating earnings estimates [2] HEICO Corp. (HEI) - HEICO has seen improved demand for its aerospace products due to a recovery in commercial air travel, with an expected earnings growth rate of 11.4% for the current year [3] - The company has an Earnings ESP of +1.77% and has recorded earnings surprises in the last four quarters with an average beat of 7.8% [3] Constellation Energy Corp. (CEG) - CEG operates in multiple power regions and has an Earnings ESP of +1.47%, with a Zacks Consensus Estimate for current-year earnings improving by 0.7% [4] - The company has recorded earnings surprises in two of the last four quarters, averaging a beat of 37% [4] Inter Parfums Inc. (IPAR) - IPAR is benefiting from favorable trends in the fragrance market and plans to allocate 21% of its annual net sales to advertising and promotion [5] - The company has an Earnings ESP of +7.14% and an expected earnings growth rate of 8.6% for the current year, with an average earnings surprise of 45.7% over the last four quarters [5] Apellis Pharmaceuticals Inc. (APLS) - APLS is experiencing strong sales growth due to the demand for its products, including Syfovre and Empaveli [6] - The company has an Earnings ESP of +28.35% and an expected earnings growth rate of 75.1% for the current year, with a significant improvement in the Zacks Consensus Estimate by 20.3% [6] Vaxcyte Inc. (PCVX) - PCVX is focused on developing novel protein vaccines and has an Earnings ESP of +12.29%, with a 4.6% improvement in the Zacks Consensus Estimate over the last 30 days [7] - The company has recorded earnings surprises in two of the last four quarters, averaging a beat of 1.5% [7]

WALTHAM, Mass., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc., (NASDAQ:APLS) today announced that the company will participate in the following March investor conferences: TD Cowen 44th Annual Healthcare Conference: Fireside chat on Monday, March 4, 2024, at 2:10 p.m. ETOphthalmology Corporate Panel Discussion on Tuesday, March 5, 2024, at 9:10 a.m. ET Raymond James & Associates' 45th Annual Institutional Investors Conference: Fireside chat on Tuesday, March 5, 2024, at 11:00 a.m. ET The l ...