Investors interested in Medical stocks should always be looking to find the best-performing companies in the group. Has Apellis Pharmaceuticals, Inc. (APLS) been one of those stocks this year? A quick glance at the company's year-to-date performance in comparison to the rest of the Medical sector should help us answer this question.Apellis Pharmaceuticals, Inc. is one of 1071 companies in the Medical group. The Medical group currently sits at #5 within the Zacks Sector Rank. The Zacks Sector Rank gauges the ...

The market expects Apellis Pharmaceuticals, Inc. (APLS) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended December 2023. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The earnings report might help the stock move higher if these key numbers are better than expectations. On the ...

WALTHAM, Mass., Feb. 06, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) today announced that the company approved the grant of equity awards to 4 new employees with a grant date of February 1, 2024, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2020 Inducement Stock Incentive Plan) and material to the employees' acceptance of employment with the company. The equity awards were approved in accordance with Nasdaq Listing Rule 5 ...

Apellis Pharmaceuticals (APLS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has voted against the approval of intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).The negative opinion of the CHMP was expected as the company previously announced a negative trend vote on the marketing authorization application (MAA) for pegcetacoplan following an oral explanation meeting in ...

WALTHAM, Mass., Jan. 26, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a negative opinion on the marketing authorization application (MAA) of intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). As previously announced, this opinion was expected based on a negative trend vote following an ora ...

One stock that might be an intriguing choice for investors right now is Apellis Pharmaceuticals, Inc. (APLS) . This is because this security in the Medical - Biomedical and Genetics space is seeing solid earnings estimate revision activity, and is in great company from a Zacks Industry Rank perspective.This is important because, often times, a rising tide will lift all boats in an industry, as there can be broad trends taking place in a segment that are boosting securities across the board. This is arguably ...

Apellis Pharmaceuticals (APLS) reported net product sales of approximately $138 million in the United States for the fourth quarter of 2023, up significantly year over year. The company generates product revenues from the sale of its two marketed drugs, Empaveli (pegcetacoplan) and Syfovre (pegcetacoplan injection). Its top line also comprises of licensing and other revenues.The 39% sequential increase in product revenues (from $99.2 million) was driven by strong Syfovre sales. Syfovre recorded sales of $11 ...

Apellis Pharmaceuticals, Inc. (APLS) shares ended the last trading session 14.7% higher at $68.35. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 5% loss over the past four weeks.The sudden rise in the stock price can be attributed to the strong preliminary net product revenues reported in the United States for the fourth quarter and full year 2023. Apellis' marketed portfolio of drugs comprise Empaveli (pegcetaco ...

Financial Data and Key Metrics Changes - Total revenue for Q3 2023 was $110 million, consisting of $24 million from EMPAVELI U.S. net product revenue, $75 million from SYFOVRE U.S. net product revenue, and $11 million in collaboration revenue from Sobi [24][25] - R&D expenses were $79 million, G&A expenses were $146 million, resulting in a net loss of $140 million [25] - Cash and cash equivalents as of September 30, 2023, were $452 million, with an expected cash runway extending into at least the second quarter of 2025 [26] Business Line Data and Key Metrics Changes - SYFOVRE generated $75 million in U.S. net product revenue in Q3 2023, up approximately 12% quarter-over-quarter, totaling over $160 million in the first seven months since launch [6][13] - EMPAVELI generated $24 million in U.S. net product revenue for Q3 2023, with a year-to-date total of $67 million [9][16] Market Data and Key Metrics Changes - Over 100,000 vials of SYFOVRE have been distributed since launch, indicating strong demand and positive impact on patients [6][13] - The estimated rate of retinal vasculitis with SYFOVRE remains rare at 0.01%, with a significantly lower rate of irreversible vision loss [7][31] Company Strategy and Development Direction - The company is focused on maximizing SYFOVRE's global leadership in geographic atrophy (GA) and streamlining the EMPAVELI business, with a restructuring expected to yield cost savings of up to $300 million through 2024 [11][12] - Plans to launch SYFOVRE in Europe are underway, with a submission for reimbursement in the UK and expectations for a decision in the first half of 2024 [15][66] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of SYFOVRE and EMPAVELI, highlighting a rebound in demand and positive feedback from the medical community [27][28] - The company anticipates continued growth in the PNH market with EMPAVELI and is optimistic about the upcoming European Medicines Agency decision for SYFOVRE [8][66] Other Important Information - The company has received FDA approval for the EMPAVELI Injector, enhancing patient experience and simplifying administration [9] - Management noted that the ongoing efficiencies from restructuring will not be reflected in operating expenses until 2024 [26] Q&A Session Summary Question: Update on vials shipped and doses given - Management indicated that approximately 37,000 commercial vials were shipped in Q3, with an estimated 1 to 1.5 weeks of demand vials sitting in refrigerators [28][30] Question: Competitive landscape and feedback from the field - Management noted that feedback from physicians has been relatively quiet regarding competition, and they remain focused on executing their plan for SYFOVRE [33][36] Question: Utilization breakdown of SYFOVRE - Management reported continued enthusiasm from physicians, with double-digit new accounts starting SYFOVRE every week since launch [40][42] Question: Rate of vasculitis and updates - Management confirmed that the rate of vasculitis remains stable and low, with no individual case updates planned unless there are significant changes [53][55] Question: European market opportunity and physician feedback - Management expressed confidence in the European approval process and noted that KOLs in Europe are well-informed and supportive of SYFOVRE [62][66]

Third Quarter 2023 Financial Results Conference Call Apellis Participants CEDRI C F RANCO I S, M. D. , Ph . D. Co-Founder, President & Chief Executive Officer AD AM TO W NS E ND ...