Analysis from a dynamic model showed the need to increase influenza vaccination rates in the U.S. to at least 45% to avoid saturation of hospital system resources, particularly in intensive care units (ICUs).1 Results from multiple real-world evidence (RWE) studies over different seasons showed improved relative vaccine effectiveness (rVE) of cell-based vaccines compared with egg-based vaccines in preventing outpatient test-confirmed influenza across different age groups, including as young as 6 months.2,3 ...

CSL Seqirus has received a Biomedical Advanced Research and Development Authority (BARDA) award to complete the fill and finish process for additional pre-pandemic vaccines to further support the U.S. government's outbreak and preparedness response. BARDA has requested adjuvanted H5N1 pre-pandemic vaccines and additional H5N8 antigen as part of its decision to expand its portfolio of pre-pandemic vaccines. This $34 million investment is the sixth avian influenza pandemic preparedness award made to CSL Seqir ...

Results from real-world evidence (RWE) studies to be presented at OPTIONS XII show the effectiveness of cell-based and MF59® adjuvanted influenza vaccines. Results from different studies suggested improved relative vaccine effectiveness (rVE) of cell-based vaccines compared with egg-based vaccines in preventing test-confirmed influenza across different age groups, including children as young as six months.1,2 Results from a real-world study covering the 2023/24 season showed that cell-based vaccine was effe ...

Core Points - CSL Seqirus, in partnership with BARDA, will expand its MF59® adjuvant reserves to support U.S. pandemic preparedness efforts, increasing the inventory to the equivalent of 40 million doses through a $121.4 million multi-year award [1][2][3] Company Overview - CSL Seqirus is a major player in the global influenza vaccine market and is part of CSL (ASX: CSL), which has a diverse portfolio including treatments for hemophilia and immune deficiencies [7][9] - The company operates state-of-the-art production facilities in the U.S., U.K., and Australia, utilizing advanced technologies to produce a wide range of influenza vaccines [7][9] Industry Context - The MF59® adjuvant is crucial for pandemic preparedness as it enhances immune response while reducing the amount of antigen needed, thereby increasing the number of available vaccine doses [3][5] - The current public health risk from avian influenza A(H5) is low, but the CDC is monitoring the situation closely due to recent outbreaks in poultry and dairy cows [4][6] - Historical data indicates that pandemics can occur unpredictably, with the 1918 influenza pandemic being the most severe, resulting in an estimated 50 million deaths worldwide [5]

Veltassa® offers effective and well-tolerated long-term potassium control in chronic kidney disease and chronic heart failure patients 1-5 Zeria Pharmaceutical Co., Ltd. to market Veltassa® in Japan ST. GALLEN, Switzerland, Sept. 24, 2024 /PRNewswire/ -- CSL Vifor today announced that Japan's Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical Co., Ltd. (Zeria), marketing authorization approval for Veltassa® for the treatment of adult patients with hyperkalemia, a condi ...

Core Perspective - The Mark Cuban Foundation, in collaboration with CSL, is launching a free AI bootcamp for high school students in Philadelphia, aimed at equipping the next generation with essential AI skills and knowledge [1][5]. Program Overview - The AI bootcamp features a custom curriculum focused on the latest developments in AI and Generative AI, designed to educate and inspire students [2]. - Students can choose from six tracks: healthcare, arts and entertainment, business and entrepreneurship, computer science, sports science, or education and career readiness [3]. - The program is accessible to students in grades 9-12, regardless of their prior experience in computer science or programming [3]. Target Audience - The bootcamp specifically targets underserved high school students, with a focus on recruiting girls, students of color, first-generation college students, and those from low to moderate-income households [4]. - The initiative aims to foster interest in AI among young people to prepare them for future careers [3][7]. Logistics and Support - The bootcamp will provide students with lunch, snacks, transportation assistance, and technology equipment during the program [4]. - The event is scheduled for November 2nd, 9th, and 16th, 2024, and applications are open until September 30, 2024 [5][7]. Company Background - CSL is a global biotechnology leader involved in developing lifesaving medicines and has been a partner in the AI bootcamp for four consecutive years [5][11]. - CSL operates three businesses: CSL Behring, CSL Seqirus, and CSL Vifor, providing products to patients in over 100 countries [11].

Industry Collaboration and Membership - Accumulus Synergy welcomes CSL as its first member organization, marking significant progress in advancing critical therapies globally [1] - The membership model aims to shape regulatory policy, raise awareness of global harmonization, and drive digital transformation to accelerate therapies worldwide [2] - Membership is open to life sciences organizations, health associations, private/non-profit foundations, and other institutions, offering access to resources, thought leadership, and networking opportunities [4] Strategic Vision and Impact - Accumulus Synergy is described as a catalyst for change, pioneering an industry paradigm shift for regulatory harmonization and digital transformation [3] - The collaboration between Accumulus and CSL is expected to amplify their collective impact and drive positive change on a global scale [2] - The focus is on advancing opportunities for regulatory data convergence, data harmonization, and digital transformation [5] Company Overviews - Accumulus Synergy is a global nonprofit industry association developing a transformative data exchange platform to enhance collaboration between life sciences organizations and global Regulatory Authorities [6] - CSL is a global biotechnology company with a portfolio of lifesaving medicines, vaccines, and therapies, operating in over 100 countries with 32,000 employees [7] Media Contact - Media inquiries can be directed to Allison Mari at Accumulus Synergy [8]

josefkubes/iStock Editorial via Getty Images CSL Limited (OTCQX:CSLLY) (OTCQX:CMXHF) [CSL:AU] stock is still assigned a Hold investment rating. CSLLY is expected to register a decent low-teens percentage bottom line growth for fiscal year 2025 (YE June 30, 2025), taking into account the positive prospects for the Behring segment. But the company's Seqirus and Vifor segments are likely to underperform going forward, and this has resulted in a FY 2025 earnings guidance miss. The mixed outlook for CSL Limited' ...

Financial Data and Key Metrics Changes - Revenue for fiscal year 2024 was $14.8 billion, an increase of 11% at constant currency [11] - NPATA was $3 billion, up 15%, while net profit after tax was $2.6 billion, up 25% [11] - Gross margin for CSL Behring improved by 120 basis points to 50.3% at constant currency [27] Business Line Data and Key Metrics Changes - CSL Behring's revenue grew by 14% at constant currency, driven by a 20% increase in the Ig franchise [15] - CSL Seqirus achieved revenue growth of 4% at constant currency, with the FLUAD product growing 14% [20] - CSL Vifor generated over $2 billion in revenue, maintaining volume growth despite competitive pressures [22] Market Data and Key Metrics Changes - CSL Behring's Ig products saw strong growth across all geographies, with intravenous Ig products up 21% and subcutaneous product HIZENTRA up 19% [15] - The albumin portfolio grew by 12%, with solid growth in China, the U.S., and Europe [15] - CSL Seqirus outperformed the market, with pandemic revenue increasing by 9% due to a sole awardee status for the U.K. Advanced Purchase Agreement [20] Company Strategy and Development Direction - The company aims for sustainable profitable growth, focusing on expanding geographic footprint and advancing R&D pipeline [5][6] - CSL is committed to operational efficiencies and leveraging contract manufacturing organizations to optimize capital expenditure [9][60] - The company plans to continue driving yield initiatives and expanding its plasma collection capabilities [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving annualized double-digit earnings growth over the medium term [11] - The company anticipates strong demand for Ig products and is preparing for regulatory approval of garadacimab [35] - Management acknowledged challenges in the evolving iron market but remains optimistic about growth in the nephrology franchise [36] Other Important Information - The company has realized over $100 million in synergies from the integration of CSL Vifor [6] - CSL Seqirus received regulatory approval for the world's first self-amplifying mRNA vaccine, KOSTAIVE, for COVID-19 [13] - The company is focused on cash flow efficiency and expects improvements in the cash conversion cycle in FY '25 [34] Q&A Session Summary Question: Guidance on Vifor revenue growth and gross margins - Management expects Vifor revenue growth to be flattish, with gross margins broadly stable in FY '25 [38][39] Question: Gross margin expansion for Behring - Management anticipates a gross margin increase of around 100 basis points for Behring in FY '25 [42] Question: Rika plasma donation system performance - Rika has shown a 30% reduction in collection time, enhancing center efficiency [46] Question: HAE market growth and garadacimab impact - The HAE market continues to grow, and garadacimab is expected to be a standard of care with high efficacy [47][48] Question: Cash conversion cycle expectations - Management does not expect the cash conversion cycle to worsen and aims for improvements in FY '25 [43] Question: Albumin sales growth in China - Albumin sales grew 12% year-on-year, with high single-digit growth expected in China [58] Question: Contract manufacturing impact on CapEx - Utilizing contract manufacturing is expected to make capital expenditure more efficient, with CapEx anticipated to remain low [59][61]

CSL Seqirus is the only manufacturer to offer a differentiated influenza vaccine for all eligible people aged six months and older in the United States. Centers for Disease Control and Prevention (CDC) trend findings indicate a significant decline in influenza vaccination rates, which poses a serious risk to public health infrastructure and underscores the importance of receiving an annual influenza vaccination.1,2 According to the CDC, it is recommended that all eligible people aged six months and older re ...