WALTHAM, Mass., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the company will present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025, at 9:45 a.m. PT. The live conference webcast will be posted on the “Events and Presentations” page of the “Investors and Media” section of the company’s website. A replay of the webcast will be available for approximately 90 days following the event. About ApellisApellis Pharmaceuticals, ...

Legal Investigation - Bragar Eagel & Squire, P C is investigating potential claims against Apellis Pharmaceuticals Inc on behalf of long-term stockholders following a class action complaint filed on August 2 2023 with a Class Period from January 28 2021 to July 28 2023 [2] - The investigation concerns whether the board of directors of Apellis breached their fiduciary duties to the company [2] Allegations - The Complaint alleges that Defendants made materially false and/or misleading statements and failed to disclose material adverse facts about Apellis Pharmaceuticals' business and operations during the Class Period [3] - Specifically, Defendants allegedly misrepresented and/or failed to disclose that the design of SYFOVRE's clinical trials was insufficient to identify incidents of retinal vasculitis in patients receiving SYFOVRE injections [3] - As a result, the commercial adoption of SYFOVRE was subject to significant unknown risk factors [3] - Therefore, Defendants' statements about the company's business operations and prospects lacked a reasonable basis [3]

Apellis Pharmaceuticals, Inc. (APLS) incurred third-quarter 2024 loss of 46 cents per share, wider than the Zacks Consensus Estimate of a loss of 32 cents. The company had incurred a loss of $1.17 per share in the year-ago quarter.Total revenues in the third quarter amounted to $196.8 million and missed the Zacks Consensus Estimate of $199 million. In the year-ago quarter, the company had reported revenues of $110.4 million.The top line jumped 78.3% year over year, owing to higher sales of Syfovre (pegcetac ...

Sales of the company's top commercialized product didn't meet expectations.Tuesday's big news with Apellis Pharmaceuticals (APLS -1.70%) wasn't all that favorable to the company. It released its third-quarter results, and the market wasn't all that pleased with the figures.In late-session trading, investors were selling out of Apellis, to the point where its price was down by nearly 6%. By contrast, the S&P 500 (^GSPC 1.23%) index was comfortably in positive territory, with a more than 1% gain at that stage ...

Third Quarter 2024 Financial Results Conference Call November 5, 2024 Apellis Participants | --- | --- | |-------------------------------------------------------------|----------------------------------------------------------| | Co-Founder, President & Chief Executive | C E D R I C F R AN C O I S , M . D . , P h . D . Officer | | AD A M T O W N S E N D Chief Operating Officer | | | C AR O L I N E B AU M A L , M . D . Chief Medical Officer | | | T I M O T H Y S U L L I VAN Chief Financial Officer | | 2 Forw ...

Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) Q3 2024 Earnings Conference Call November 5, 2024 8:30 AM ET Company Participants Meredith Kaya - Senior Vice President of Investor Relations and Strategic Finance Cedric Francois - Co-Founder and Chief Executive Officer Adam Townsend - Chief Operating Officer Caroline Baumal - Chief Medical Officer Tim Sullivan - Chief Financial Officer Conference Call Participants Jonathan Miller - Evercore Tazeen Ahmad - Bank of America Anupam Rama - JPMorgan Salveen Richter - ...

Apellis Pharmaceuticals, Inc. (APLS) reported $196.83 million in revenue for the quarter ended September 2024, representing a year-over-year increase of 78.3%. EPS of -$0.46 for the same period compares to -$1.17 a year ago.The reported revenue represents a surprise of -1.04% over the Zacks Consensus Estimate of $198.89 million. With the consensus EPS estimate being -$0.32, the EPS surprise was -43.75%.While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Stre ...

Apellis Pharmaceuticals, Inc. (APLS) came out with a quarterly loss of $0.46 per share versus the Zacks Consensus Estimate of a loss of $0.32. This compares to loss of $1.17 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -43.75%. A quarter ago, it was expected that this company would post a loss of $0.33 per share when it actually produced a loss of $0.28, delivering a surprise of 15.15%.Over the last four quarters, the compa ...

Financial Performance - Generated $196.8 million in total revenue for Q3 2024, including $152.0 million from SYFOVRE U.S. net product sales and $24.6 million from EMPAVELI U.S. net product sales [1][8] - SYFOVRE U.S. net product revenue grew to $152.0 million in Q3 2024, up from $75.3 million in Q3 2023 [8] - Total revenue increased by 78% year-over-year, from $110.4 million in Q3 2023 to $196.8 million in Q3 2024 [8] - Net loss decreased to $57.4 million in Q3 2024, compared to a net loss of $140.2 million in Q3 2023 [12] SYFOVRE Performance and Market Position - SYFOVRE demand grew by 7% quarter-over-quarter, with U.S. net product revenue of $152.0 million in Q3 2024 [1][3] - More than 88,500 SYFOVRE doses were delivered to physician practices in Q3 2024, including approximately 84,500 commercial vials and 4,000 samples [3] - SYFOVRE remains the market leader in geographic atrophy (GA), with over 420,000 injections administered through September 2024, including clinical trials [3] - A large Medicare Advantage plan will make SYFOVRE the only preferred product on its formulary starting January 1, 2025 [3] R&D and Regulatory Updates - On track to file a supplemental new drug application (sNDA) for pegcetacoplan in C3G and IC-MPGN in early 2025, based on positive 6-month Phase 3 VALIANT results [1][5] - Detailed results from the Phase 3 VALIANT study were presented at Kidney Week 2024, highlighting strong treatment effects in patients with C3G and primary IC-MPGN [5] - Sobi plans to submit a marketing application with the European Medicines Agency in early 2025 and with Japanese Health Authorities in 2025 [6] Cash Position and Financial Outlook - Cash and cash equivalents stood at $396.9 million as of September 30, 2024, up from $351.2 million as of December 31, 2023 [1][13] - The company anticipates that its cash, combined with expected product revenues, will be sufficient to fund operations to positive cash flow [1][13] EMPAVELI Performance - EMPAVELI generated $24.6 million in U.S. net product revenue in Q3 2024, with a high patient compliance rate of 97% [4] - EMPAVELI is approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in the U.S., European Union, and other countries globally [16] Pipeline and Future Milestones - Enrollment completed in the Phase 2 study evaluating systemic pegcetacoplan in patients with HSCT-TMA, with topline data expected in mid-2025 [6] - Topline data from the Phase 1 dose escalation study of APL-3007 (small interfering RNA silencing C3) is expected in Q1 2025 [6]

Revenue Generation - SYFOVRE generated $152.0 million and $444.0 million in U.S. net product revenue for the three and nine months ended September 30, 2024, respectively[133]. - EMPAVELI generated $24.6 million and $74.7 million in U.S. net product revenue for the three and nine months ended September 30, 2024, respectively, along with $5.0 million and $13.9 million in royalties from Sobi[135]. - For the three months ended September 30, 2024, the company recognized net product revenue of $176.6 million, compared to $99.2 million for the same period in 2023, representing a 78% increase[183]. - The net product revenue for the nine months ended September 30, 2024, included $24.6 million from EMPAVELI and $152.0 million from SYFOVRE sales[183]. - Total revenue for the three months ended September 30, 2024, was $196.8 million, an increase of 78% from $110.4 million in the same period of 2023[184]. - Net product revenue for the nine months ended September 30, 2024, was $518.8 million, a 128% increase from $227.6 million in the same period of 2023[200]. - Licensing and other revenue for the three months ended September 30, 2024, was $20.3 million, up 81% from $11.2 million in the same period of 2023[186]. - Licensing and other revenue increased to $50.1 million for the nine months ended September 30, 2024, compared to $22.6 million for the same period in 2023, representing a growth of 121%[201]. Financial Performance - The company has incurred net losses of $57.4 million and $140.2 million for the three months ended September 30, 2024 and 2023, respectively, with an accumulated deficit of $3.0 billion as of September 30, 2024[141]. - Net operating loss improved to $(47.3) million for the three months ended September 30, 2024, compared to $(137.1) million in the same period of 2023, a 66% improvement[184]. - Interest income decreased to $2.9 million for the three months ended September 30, 2024, down 42% from $5.0 million in the same period of 2023[195]. - Interest expense increased to $12.5 million for the three months ended September 30, 2024, up 71% from $7.3 million in the same period of 2023[196]. - Interest income decreased to $9.4 million for the nine months ended September 30, 2024, down from $16.4 million in 2023, a decline of 43%[209]. - Interest expense increased to $28.9 million for the nine months ended September 30, 2024, compared to $22.2 million in 2023, an increase of 30%[210]. Expenses - Research and development expenses are expected to rise as product candidate development programs progress, although specific program costs have not been tracked historically[177]. - Research and development expenses increased by 12% to $88.6 million for the three months ended September 30, 2024, compared to $79.4 million in the same period of 2023[189]. - Research and development expenses decreased by $33.9 million to $251.2 million for the nine months ended September 30, 2024, a decline of 12% from $285.1 million in 2023[204]. - Selling, general and administrative expenses decreased by 16% to $122.0 million for the three months ended September 30, 2024, from $145.6 million in the same period of 2023[193]. - Selling, general and administrative expenses increased by $20.5 million to $379.6 million for the nine months ended September 30, 2024, reflecting a 6% increase from $359.1 million in 2023[207]. - The company anticipates an increase in selling, general, and administrative expenses to support ongoing commercial activities and potential product commercialization[180]. Financing and Cash Flow - The Sixth Street Financing Agreement provides for a senior secured term loan facility of up to $475.0 million, with an initial draw of $375.0 million[144]. - The net proceeds from the initial draw of the Credit Facility were approximately $358.2 million, net of $16.8 million of issuance costs[146]. - The company has financed operations primarily through approximately $2.6 billion in net proceeds from public and private offerings, $392.0 million in payments and royalties from Sobi, and $532.5 million under various credit arrangements[140]. - Net cash used in operating activities was $107.2 million for the nine months ended September 30, 2024, compared to $496.9 million in 2023, indicating a significant reduction in cash outflow[219][220]. - Net cash used in operating activities for the nine months ended September 30, 2024 was $(107.2) million, a significant improvement compared to $(496.9) million for the same period in 2023, reflecting a reduction of approximately 78%[222]. - Net cash used in investing activities during the nine months ended September 30, 2024 was $(0.4) million, down from $(0.7) million in the same period of 2023, indicating a decrease of about 43%[221]. - Net cash provided by financing activities was $153.2 million for the nine months ended September 30, 2024, compared to $398.4 million for the same period in 2023, representing a decline of approximately 62%[223]. - The company expects its current cash and cash equivalents of $396.9 million will be sufficient to fund projected operating expenses and capital expenditures for at least the next 12 months[225]. - As of September 30, 2024, the company had cash and cash equivalents of $396.9 million, primarily in money market funds and U.S. Government obligations[231]. Product Development - The VALIANT trial demonstrated a 68% reduction in proteinuria in C3G and IC-MPGN patients compared to placebo (p < 0.0001)[136]. - The company is developing additional product candidates, including APL-3007, a small interfering RNA in Phase 1 clinical trial, and an oral complement inhibitor in preclinical development[138]. - The company plans to submit a supplemental new drug application to the FDA in early 2025 for systemic pegcetacoplan[137]. - The company is focusing on the ongoing development of systemic pegcetacoplan and prioritizing research initiatives on high potential opportunities[224]. - The company is investing substantial resources in the commercial infrastructure for SYFOVRE for GA and the development of product candidates[226]. - If cash generated from sales of EMPAVELI and SYFOVRE is insufficient, the company may need to seek external funding sources, including equity offerings or debt financings[228]. - The company may need to delay or limit product development if it cannot generate sufficient funds from sales or raise additional capital[229]. Inventory and Assets - The remaining pre-FDA approved inventory as of September 30, 2024, was valued at $15.4 million, primarily consisting of raw materials[188]. - As of September 30, 2024, the remaining pre-FDA approved inventory was valued at $15.4 million, primarily consisting of raw materials[203]. - As of September 30, 2024, the company held Convertible Notes in principal amount of $425.4 million, which had not been canceled[165]. - The company has not called for redemption of any Convertible Notes as of September 30, 2024[160]. - The conditional conversion feature of the Convertible Notes was not triggered as of September 30, 2024, meaning they are not convertible during the quarter ending December 31, 2024[165]. Market and Economic Factors - An immediate 10% change in interest rates would not materially affect the fair market value of the company's investment portfolio due to its short-term duration and low risk profile[231].