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Apellis and Sobi Announce EMPAVELI® (pegcetacoplan) Showed Sustained Efficacy at One Year in Phase 3 Study for C3G and Primary IC-MPGN
Globenewswire· 2025-06-06 13:15
Core Insights - Apellis Pharmaceuticals and Sobi presented new data from the Phase 3 VALIANT study for EMPAVELI (pegcetacoplan) targeting C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) at the European Renal Association Congress [1][5] Study Results - EMPAVELI showed a statistically significant 68% reduction in proteinuria compared to placebo at Week 26, with effects sustained for one year [2][4] - Patients switching from placebo to EMPAVELI also experienced similar benefits in proteinuria reduction and kidney function stabilization [3] Efficacy and Safety - The study confirmed EMPAVELI's efficacy and safety profile across a diverse patient population, including adults and adolescents with both native and post-transplant kidney disease [4][7] - No new safety signals were reported, indicating favorable safety and tolerability consistent with its established profile [4][7] Clinical Significance - The results highlight the urgent need for effective treatments for patients with C3G and primary IC-MPGN, as approximately 50% of these patients may face kidney failure within five to ten years of diagnosis [6] - The VALIANT study is the largest trial conducted in these populations, involving 124 patients aged 12 and older [8] Future Prospects - Marketing applications for EMPAVELI are currently under review with the FDA and EMA, with an FDA decision expected this summer [4][7] - The collaboration between Apellis and Sobi aims to expedite the availability of EMPAVELI for patients suffering from these rare kidney diseases [10]
Pacira(PCRX) - 2025 Q1 - Earnings Call Presentation
2025-05-09 17:31
1Q25 Earnings PCRX | May 2025 Forward-looking statements and where to find additional information Any statements in this presentation about Pacira's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as ...
Greystone Housing Impact Investors Reports First Quarter 2025 Financial Results
GlobeNewswire News Room· 2025-05-07 12:15
OMAHA, Neb., May 07, 2025 (GLOBE NEWSWIRE) -- On May 7, 2025, Greystone Housing Impact Investors LP (NYSE: GHI) (the “Partnership”) announced financial results for the three months ended March 31, 2025. Financial Highlights The Partnership reported the following results as of and for the three months ended March 31, 2025: Net income of $0.11 per Beneficial Unit Certificate (“BUC”), basic and dilutedCash Available for Distribution (“CAD”) of $0.31 per BUCTotal assets of $1.54 billionTotal Mortgage Revenue Bo ...
BioAtla(BCAB) - 2025 Q1 - Earnings Call Transcript
2025-05-06 20:30
Bioatla (BCAB) Q1 2025 Earnings Call May 06, 2025 04:30 PM ET Speaker0 Good day, everyone, and welcome to today's BioAtlas First Quarter twenty twenty five Earnings Call. At this time, all participants are in a listen only mode. Later, you will have the opportunity to ask questions during the question and answer session. I will be standing by should you need any assistance. And it is now my pleasure to turn the conference over to Bruce Mackle with LifeSci Advisors. Please go ahead. Speaker1 Thank you, opera ...
数读科创板药企年报:过半净利增长,平均研发费用超3.5亿
Bei Jing Shang Bao· 2025-05-05 14:17
科创板已成为生物医药产业聚集地,截至目前,科创板药企2024年年报出齐。Wind数据显示,目前科创板共有115家生物医药企业,2024年,有超过半数药 企净利同比出现增长。其中微电生理(688351)净利增幅最猛,同比增逾8倍。多家"U"标企业首次实现盈利,成功摘"U"。研发能力是科创板药企竞争力的 重要体现,2024年,115家科创板药企平均研发费用为3.53亿元,其中百济神州研发费用"一骑绝尘",为141.4亿元。不过,2024年,有部分医药股研发费用 出现大幅下降,其中科兴制药研发费用同比"腰斩"。此外,荣昌生物等医药股研发人员数量出现大幅下降。 | 序号 | 证券代码 | > 证券简称 | レ ا | レ 归属母公司股东的净利润 | 归属母公司股东的 | | --- | --- | --- | --- | --- | --- | | | | | [报告期] 去年年报 [报表类型] 合并报表 | | [报告期] 去年年捉 [单位] % | | | | | [单位] 亿元↓ | | | | 1 | 688506 SH | 百利天恒 | 3 | 37.0750 | | | 2 | 688578.SH | 艾 ...
Bio-Rad(BIO) - 2025 Q1 - Earnings Call Transcript
2025-05-01 21:30
Financial Data and Key Metrics Changes - Net sales for Q1 2025 were approximately $585 million, representing a 4.2% decline compared to $611 million in Q1 2024. On a currency neutral basis, this reflects a 1.5% year-over-year decrease, primarily driven by lower sales in the Life Science Group [11][12] - GAAP gross margin for Q1 2025 was 52.3%, down from 53.4% in Q1 2024, attributed to increased restructuring costs [13] - Non-GAAP gross margin for Q1 2025 was 53.8%, lower than 54.2% in Q1 2024, while non-GAAP operating margin improved to 10.8% from 9.7% year-over-year [15][16] - GAAP net income for Q1 2025 was $71 million, or $2.54 diluted earnings per share [17] Business Line Data and Key Metrics Changes - Life Science Group sales in Q1 2025 were $229 million, down 5.4% on a reported basis and 3.5% on a currency neutral basis, reflecting ongoing softness in the biotech and academic research market [12] - Clinical Diagnostics Group sales were approximately $357 million, a decrease of 3.2% on a reported basis, but effectively flat on a currency neutral basis [13] - Process Chromatography business experienced mid-teens growth year-over-year, with expectations of high single-digit growth for 2025 [12][19] Market Data and Key Metrics Changes - In the Americas and Asia Pacific, currency neutral sales decreased, partially offset by increased sales in EMEA [12] - Demand for consumables remained strong, while instrument sales faced challenges, particularly in the academic and biotech sectors [41][71] Company Strategy and Development Direction - The company is focused on driving consistent top-line growth and operational efficiency to achieve substantial margin expansion over the coming years [27] - The acquisition of Stila Technology is on track for closing by the end of Q3 2025, which will enhance the company's digital PCR offerings [8][10] - The company is implementing mitigation strategies for tariff impacts, including surcharges and regionalizing supply chains [7][23] Management's Comments on Operating Environment and Future Outlook - Management acknowledged a challenging macro environment with academic market headwinds due to government funding and global trade disruptions [5] - The company expects total currency neutral revenue to decline by approximately 1% to 1.5% for 2025, reflecting softer academic research funding and reduced demand from biotech customers [20][21] - Management remains optimistic about the long-term growth potential in life sciences and diagnostics despite current challenges [28][29] Other Important Information - The company generated $130 million in net cash from operating activities in Q1 2025, compared to $70 million in Q1 2024 [18] - Free cash flow for Q1 2025 was $96 million, significantly higher than $30 million in Q1 2024, with a full-year target of approximately $310 million to $330 million for 2025 [18][19] Q&A Session Summary Question: Impact of tariffs on guidance - Management discussed the gross impact of tariffs and mitigation efforts, including potential surcharges and pre-positioning inventory [33][36] Question: Academic funding expectations - Management noted a 28% reduction in overall funding and challenges in instrument sales, while consumables remained strong [39][40] Question: Growth gap between consumables and equipment - Instrument sales saw a sequential decline of about 10%, while consumables held up well [46] Question: Tariff exposure specifics - Management clarified that the majority of revenue in China comes from U.S. products, with ongoing evaluations of tariff impacts [47][49] Question: Free cash flow maintenance despite lower operating margin - Management emphasized focus on working capital management and inventory control to sustain free cash flow [96]
Bio-Rad(BIO) - 2025 Q1 - Earnings Call Transcript
2025-05-01 21:30
Bio-Rad Laboratories (BIO) Q1 2025 Earnings Call May 01, 2025 05:30 PM ET Company Participants Edward Chung - VP, IRJonathan DiVincenzo - President & Chief Operating OfficerRoop Lakkaraju - Executive VP & CFONorman Schwartz - Chairman & CEOBrandon Couillard - Managing Director Conference Call Participants Patrick Donnelly - Managing Director, Equity Research AnalystDan Leonard - Managing Director & Research AnalystMatthew Stanton - AnalystConor McNamara - Equity Research AnalystJack Meehan - Equity Research ...
NexPoint Real Estate Finance(NREF) - 2025 Q1 - Earnings Call Presentation
2025-05-01 14:22
NYSE:NREF 1Q 2022 FINANCIAL SUPPLEMENT 1Q 2025 Financial Supplement May 1, 2025 CONTACT NEXPOINT REAL ESTATE FINANCE (NYSE:NREF) 300 Crescent Court, Suite 700 Dallas, Texas 75201 (w) nref.nexpoint.com INVESTOR RELATIONS Kristen Griffith (e) kgriffith@nexpoint.com 28 APRIL 2022 NYSE:NR EF Cautionary Statements FORWARD LOOKING STATEMENTS This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on management's current expe ...
CYBER ENVIRO-TECH CRITICAL TESTING OF PROPRIETARY WATER SYSTEM COULD LEAD TO MAJOR CONTRACTS
Prnewswire· 2025-04-30 15:13
SCOTTSDALE, Ariz., April 30, 2025 /PRNewswire/ -- Cyber Enviro-Tech, Inc. (OTCQB: CETI) announced today that it is conducting critical testing of its advanced water purification technology for the oil and gas industry. If successful, the results could lead to contracts potentially valued at over $100 million annually, as referenced in the Company's April 17, 2025 press release.Produced water — a byproduct of oil and gas extraction — typically contains high concentrations of salts, hydrocarbons, heavy metals ...
汇丰:亚洲经济评论 - 中国与 “关税连锁反应”
汇丰· 2025-04-21 05:09
Asia Economics Comment Economics China and the 'tariff cascade' China Trade tensions between the US and China cast a wide shadow. Bilateral trade is bound to suffer, of course, even if tariffs may be rolled back under an eventual deal. However, the bigger issue for China, and arguably the world, is whether restrictions will also be imposed by other economies on Chinese imports. Two mechanisms are at play. One, competitive pressure from US-diverted Chinese shipments could raise protectionist demands. Two, th ...