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CSL Seqirus, a Proud Champion of Pandemic Preparedness, Announces U.S. Government Award in Response to Avian Influenza
Prnewswire· 2024-05-30 13:00
Group 1: Company Overview - CSL Seqirus has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA) to complete the fill and finish process for a pre-pandemic vaccine as part of the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) program [2][3] - The company will deliver approximately 4.8 million doses of a pre-pandemic vaccine that is well-matched to the currently circulating H5N1 strain [3] - CSL Seqirus operates the largest cell-based influenza vaccine production facility in the world, located in Holly Springs, NC, capable of producing up to 150 million doses within six months of a pandemic declaration [4] Group 2: Industry Context - The recent outbreaks of highly pathogenic avian influenza (HPAI) in the U.S. have prompted increased preparedness efforts, with the CDC maintaining a low risk to public health while closely monitoring the situation [3][4] - Pre-pandemic vaccines are crucial for mitigating the risk of outbreaks and providing a first line of defense before a pandemic vaccine is declared [6] - The rise in avian influenza cases, particularly HPAI A(H5N1), highlights the ongoing need for effective pandemic preparedness strategies [7]
Nature Communications Publishes Pivotal Data Demonstrating Efficacy and Tolerability of CSL and Arcturus Therapeutics' COVID-19 Vaccine
prnewswire.com· 2024-05-20 12:30
Core Insights - The article discusses the approval and efficacy of ARCT-154, the world's first self-amplifying mRNA COVID-19 vaccine for adults, which has shown superior immunogenicity against the Omicron variant compared to traditional mRNA vaccines [1][2][4]. Company Overview - CSL is a global biotechnology company with a diverse portfolio of lifesaving medicines, including vaccines and therapies for various conditions, and has been operational since 1916 [10]. - Arcturus Therapeutics, founded in 2013, specializes in mRNA medicines and vaccines, and has developed the first approved self-amplifying mRNA COVID-19 vaccine [11]. Study Results - The integrated phase 1/2/3a/3b study of ARCT-154 involved 1,001 participants in the phase 1/2/3a study and 16,100 participants in the phase 3b study, demonstrating the vaccine's safety and efficacy [5][6]. - ARCT-154 showed 100% efficacy against severe COVID-19 in healthy individuals aged 18-59 and over 90% efficacy in at-risk populations [2][7]. - The neutralizing antibody seroconversion rate was 94.1% four weeks after the second dose, with an overall efficacy of 56.6% against any COVID-19 infection [7]. Vaccine Technology - Self-amplifying mRNA vaccines, like ARCT-154, enhance the immune response by instructing the body to produce more mRNA and protein compared to standard mRNA vaccines [9]. Collaboration and Funding - The study was co-funded by Vinbiocare Biotechnology Joint Stock Company in Vietnam and Arcturus Therapeutics, highlighting the collaborative efforts in vaccine development [8].
CSL(CSLLY) - 2024 Q2 - Earnings Call Transcript
2024-02-13 05:53
Financial Data and Key Metrics Changes - Revenue for the first half of 2024 was $8.1 billion, up 11% at constant currency, while NPATA was $2 billion, up 13% at constant currency, and net profit after tax was $1.9 billion, up 20% [66] - Gross profit was $4.491 billion, also up 11%, and the group operating result increased by 13% to $3.796 billion [116] - Cash flow from operations increased by 9% to $1.069 billion, primarily due to sales growth [119] Business Line Data and Key Metrics Changes - CSL Behring revenue was up 14% at constant currency, with the IG franchise growing 23% [71] - Specialty products, including KCENTRA and HAEGARDA, contributed significantly, with KCENTRA up 12% and HAEGARDA up 9% [75] - CSL Vifor generated over $1 billion in revenue, with strong performance in nephrology products like MIRCERA and TAVNEOS [93] Market Data and Key Metrics Changes - CSL Seqirus delivered solid sales growth, outperforming the market with a 2% increase in revenue at constant currency, driven by the adjuvanted FLUAD product, which grew 14% [81] - The iron market is transitioning with step edit measures impacting Injectafer, while Venofer has benefited from these changes [86] Company Strategy and Development Direction - The company is focused on expanding its gross margin and has made progress with a 10% reduction in cost per liter [79] - The rollout of the Rika plasmapheresis platform is expected to provide a 10% lift in yield across the fleet, with regulatory filing for Garadacimab accepted for review [78][68] - The company aims to leverage capabilities across its divisions to address public health needs, particularly in patient blood management [127] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the outlook for CSL Behring, citing strong demand for IG and ongoing initiatives in plasma collection [123] - The company expects revenue growth of approximately 9% to 11% for fiscal year 2024 at constant currency, with NPATA projected to be between $2.9 billion and $3 billion [128] Other Important Information - The company is navigating challenges in the dialysis market due to step edits and reimbursement issues affecting product usage [132] - The gross margin recovery for CSL Behring improved to 50% at reported rates, benefiting from earlier-than-anticipated price increases [121] Q&A Session Summary Question: What are the challenges specifically for dialysis and the run rate going forward? - Management indicated that there are strong commercial portfolios but limited growth in the near term due to market challenges, including step edits and reimbursement issues related to Kapruvia in the U.S. dialysis system [132]
CSL(CSLLY) - 2023 Q4 - Earnings Call Transcript
2023-08-15 06:37
CSL Limited (OTCQX:CSLLY) Q4 2023 Earnings Conference Call August 14, 2023 9:00 PM ET Company Participants Mark Dehring - Head of Investor Relations Paul McKenzie - Chief Executive Officer Joy Linton - Chief Financial Officer Bill Campbell - Executive Vice President and Chief Commercial Officer Conference Call Participants Lyanne Harrison - Bank of America Merrill Lynch Andrew Goodsall - MST Marquee Sean Laaman - Morgan Stanley Steven Wheen - Jarden Australia Pty Limited Saul Hadassin - Barrenjoey Markets P ...
CSL(CSLLY) - 2023 Q4 - Earnings Call Presentation
2023-08-15 02:14
Stephen McKeon Director, Investor Relations CSL Limited P: 61 402 231 696 E: stephen.mckeon@csl.com.au Jimmy Baker Communications CSL Limited P: +61 450 909 211 E: jimmy.baker@csl.com.au CSL Limited Mallizabet Street Mallizabet Street Malbourn Australia T +613 10 Australia CsLeon ASX Announcement For immediate release 15 August 2023 RESULTS PRESENTATION FOR THE FULL YEAR ENDED 30 JUNE 2023 Melbourne, Australia – CSL (ASX:CSL; USOTC:CSLLY) Please find attached the slides for the presentation on the full year ...
CSL(CSLLY) - 2023 Q2 - Earnings Call Transcript
2023-02-14 08:13
CSL Limited (OTCQX:CSLLY) Q2 2023 Earnings Conference Call February 13, 2023 7:00 PM ET Company Participants Mark Dehring - Head, Investor Relations Paul Perreault - Chief Executive Officer Joy Linton - Chief Financial Officer Paul McKenzie - Chief Operating Officer Conference Call Participants David Stanton - Jefferies Andrew Goodsall - MST Marquee David Low - JPMorgan Lyanne Harrison - Bank of America Chris Cooper - Goldman Sachs Steve Wheen - Jarden Sean Laaman - Morgan Stanley Saul Hadassin - Barrenjoey ...
CSL(CSLLY) - 2022 Q4 - Earnings Call Transcript
2022-08-17 07:11
Financial Data and Key Metrics Changes - Revenue increased by 3% at constant currency, totaling $10.7 billion, while net profit after tax (NPAT) was $2.25 billion, at the top end of financial guidance [9][46] - Gross profit remained steady at $5.8 billion, but EBIT decreased by 8% to $2.9 billion due to increased R&D investments [46][50] - Cash flow from operations fell by 27% to $2.6 billion, primarily due to a significant increase in inventory costs related to plasma [46][52] Business Line Data and Key Metrics Changes - CSL Behring's total revenue rose by 2% at constant currency, with immunoglobulin sales declining by 3% due to lower plasma collections [49][16] - IDELVION, a hemophilia B product, saw a strong performance with sales up 20%, while specialty products grew significantly, with HAEGARDA up 5% [13][25] - CSL Seqirus reported total revenue growth of 13%, driven by a 16% increase in seasonal influenza vaccine sales, particularly FLUAD, which rose by 41% [42][50] Market Data and Key Metrics Changes - North America remained the largest market for CSL Behring, accounting for 49% of total revenue, while Asia-Pacific grew by 21% due to strong albumin demand in China [17][21] - European revenue declined by 5%, impacted by immunoglobulin supply tightness [17] - The overall plasma collections increased by 24% year-on-year, indicating a recovery in supply [10][30] Company Strategy and Development Direction - The acquisition of Vifor Pharma is expected to enhance CSL's portfolio in renal disease and iron deficiency, with strong cash flow generation anticipated [5][6] - The company is focused on executing its 2030 strategy while continuing to invest in R&D for sustainable growth [8][11] - CSL aims to maintain its A credit ratings while expanding its strategic horizons post-acquisition [6][54] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the recovery of plasma collections and anticipated strong sales growth for immunoglobulin and albumin products [58] - The company expects revenue growth of 7% to 11% for fiscal year 2023, with NPAT projected between $2.4 billion and $2.5 billion [60] - Challenges such as inflationary pressures and staffing constraints were acknowledged, but the fundamentals of the business were deemed strong [59][60] Other Important Information - The company maintained its final dividend at $1.18 per share, translating to a total of $2.22 per share for the financial year [48] - CSL's sustainability strategy includes a target to reduce carbon emissions by 40% by 2030 [54][55] Q&A Session Summary Question: Organic basis for EBIT or NPAT amidst non-recurring items - Management indicated that the forward guidance of $2.4 billion to $2.5 billion NPAT reflects the underlying performance of the legacy business, excluding Vifor-related costs [63][64] Question: Green shoots in plasma business and exit rates - Management noted that the exit rate in the second half was a good indicator of improvement, despite challenges from COVID variants affecting staffing and donor availability [66] Question: Outlook for immunoglobulin and CIDP indication - Management remains bullish on immunoglobulin as a standard of care, indicating that new products may not significantly impact the existing market share [69][70] Question: Confidence in maintaining albumin sales amidst competitive pressures - Management expressed confidence in albumin demand, particularly in China, while acknowledging pricing pressures due to increased competition [73]
CSL(CSLLY) - 2022 Q4 - Earnings Call Presentation
2022-08-17 07:10
T +613 9389 1911 F +613 9389 1434 www.csl.com.au ASX Announcement For immediate release 17 August 2022 RESULTS PRESENTATION FOR THE FULL YEAR ENDED 30 JUNE 2022 Melbourne, Australia – CSL (ASX:CSL; USOTC:CSLLY) Please find attached the slides for the presentation on the full year results that will be given by the Chief Executive Officer and Chief Financial Officer shortly. The live briefing will be webcast and can be viewed at https://edge.mediaserver.com/mmc/p/4vrmr7kw. Please note that this link will expi ...
CSL(CSLLY) - 2022 Q2 - Earnings Call Transcript
2022-02-16 08:09
CSL Limited (OTCQX:CSLLY) Q2 2022 Earnings Conference Call February 15, 2022 7:00 PM ET Company Participants Paul Perreault - MD, CEO & Executive Director Joy Linton - CFO Mark Dehring - Head, IR Conference Call Participants Lyanne Harrison - Bank of America Merrill Lynch David Low - JPMorgan Chase & Co. Chris Cooper - Goldman Sachs Group Gretel Janu - Crédit Suisse Andrew Goodsall - MST Marquee Saul Hadassin - Barrenjoey David Stanton - Jefferies Steven Wheen - Jarden Limited Sean Laaman - Morgan Stanley C ...
CSL(CSLLY) - 2021 Q4 - Earnings Call Presentation
2021-08-18 09:11
T +613 9389 1911 F +613 9389 1434 www.csl.com.au ASX Announcement For immediate release 18 August 2021 RESULTS PRESENTATION FOR THE FULL YEAR ENDED 30 JUNE 2021 Melbourne, Australia – CSL (ASX:CSL; USOTC:CSLLY) Please find attached the slides for the presentation on the full year results that will be given by the Chief Executive Officer and Chief Financial Officer shortly. The live briefing will be webcast and can be viewed at https://csl.webcastcloud.com/event?eventid=cc1ba0b2-0ddc-4c36-a8bcda89aec8c6d8. P ...