CSL Ltd

CSL Ltd. is a biopharmaceutical company, which engages in the manufacture, marketing, and distribution of biopharmaceutical and allied products. It operates through the following segments: CSL Behring, CSL Seqirus, and CSL Vifor. The CSL Behring segment provides plasma products, gene therapies, and recombinants. The CSL Seqirus segment includes predominantly influenza related products and provides pandemic services to governments. The CSL Vidor segment focuses on the distribution of products in the therapeutic areas of iron deficiency and nephrology. The company was founded on November 2, 1961 and is headquartered in Melbourne, Australia.

SUMMIT, N.J. , March 6, 2024 /PRNewswire/ -- CSL Seqirus, a global leader in the protection of public health, confirmed it is fully prepared to deliver its influenza vaccine portfolio for the 2024/25 U.S. season, based on the trivalent strains recommended this week by the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC).

CSL Seqirus is Fully Prepared to Implement the FDA's Vaccines and Related Biological Products Advisory Committee Trivalent Influenza Vaccines Strain Selection for the 2024/25 U.S. Season

Travere Therapeutics

Committee for Medicinal Products for Human Use (CHMP) recommends approval of the conditional marketing authorization (CMA) for sparsentan for the treatment of IgA nephropathy (IgAN) in Europe Positive CHMP opinion is based on pivotal phase-III PROTECT study results European Commission decision is expected in Q2 2024 ST. GALLEN, Switzerland , Feb. 23, 2024 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that the European Medicines Agency's (EMA) CHMP has recommended approval of sparsentan for the treatment of adults with primary IgAN with a urine protein excretion >1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g).

CSL Vifor and Travere Therapeutics announce sparsentan receives positive CHMP opinion for the treatment of IgA nephropathy

CSL Ltd (CSLLY) Q2 2024 Earnings Call Transcript

Strong CSL Behring portfolio growth especially Ig FINANCIAL HIGHLIGHTS 4 Revenue $8.05 billion, up 11% at CC3 NPAT $1.90 billion 1, up 17% NPAT $1.94 billion 1 at CC3, up 20% NPATA $2.02 billion 1,2 , up 11% NPATA $2.06 billion 1,2 at CC3, up 13% NPATA1,2 earnings per share $4.18 2, up 11% NPATA1,2 earnings per share $4.26 at CC3 up 13% Interim dividend 5 of US$1.19 per share Converted to Australian currency, the interim dividend is approximately A$1.81 per share, up 12% Guidance reaffirmed – FY24 NPATA2,4 anticipated to be in the range of approximately $2.9 billion to $3.0 billion 2 at CC3  MELBOURNE, Australia, Feb. 13, 2024 /PRNewswire/ -- CSL Limited (ASX:CSL; USOTC:CSLLY) today announces a reported net profit after tax of $1.90 billion 1 for the 6 months ended 31 December 2023, up 20% on a constant currency basis3. Underlying profit (NPATA) was $2.02 billion 1,2, up 13% on a constant currency basis to $2.06 billion 1,2,3.

Half year reported NPATA US$2 billion¹,² Up 13% at constant currency³

KING OF PRUSSIA, Pa. , Feb. 11, 2024 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced top-line results from the Phase 3 AEGIS-II trial evaluating the efficacy and safety of CSL112 (apolipoprotein A-I [human]) compared to placebo in reducing the risk of major adverse cardiovascular events (MACE) in patients following an acute myocardial infarction (AMI).

CSL Announces Top-line Results from the Phase 3 AEGIS-II Trial Evaluating the Efficacy and Safety of CSL112 (apolipoprotein A-I [human])

Arcturus Therapeutics

Study conducted by Meiji Seika Pharma in Japan Short communication follows previously published data in The Lancet Infectious Diseases demonstrating Immunological  Non-Inferiority to Wuhan Strain and Superior Immunogenicity to Omicron BA.4/5 Variant Compared to First-Generation mRNA Vaccine Booster  Ne w data demonstrates continuous advantage of sa-mRNA over conventional mRNA vaccine in terms of duration of immune response These results follow approval of the world's first sa-mRNA COVID-19 vaccine for adults by Japan Ministry of Health, Labor and Welfare in November 2023 KING OF PRUSSIA, Pa. and SAN DIEGO , Feb. 5, 2024 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announced the results of a follow-up analysis of a Phase 3 study evaluating a booster dose of ARCT-154 , the world's first approved self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine, compared to a conventional mRNA COVID-19 vaccine.

New COVID-19 sa-mRNA Results from CSL and Arcturus Therapeutics Demonstrate Longer Duration of Immunity Compared to Conventional COVID-19 mRNA Vaccine Booster

Findings show that convenience of treatment and flexibility of administration, such as at-home treatment options, are of high importance to patients KING OF PRUSSIA, Pa. , Jan. 16, 2024 /PRNewswire/ -- CSL Behring, a business unit of global biotechnology leader CSL, today announced survey results showing that the majority of surveyed people living with chronic inflammatory demyelinating polyneuropathy (CIDP) agree they are interested in exploring more convenient treatment options (n=98, 82%) and that administering treatment at home is extremely/very important to them (n=100, 72%).

Harris Poll Survey Finds People Receiving Treatment for CIDP Are Interested in Exploring More Convenient Treatment Options

-    Hizentra® is the #1 immune globulin prescribed for Primary Immunodeficiency (PI) in the U.S.-    Hizentra is the first and only subcutaneous immune globulin (SCIg) treatment approved for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in the U.S. KING OF PRUSSIA, Pa. , Jan. 3, 2024 /PRNewswire/ -- CSL Behring, a business unit of global biotechnology leader CSL, today announced the availability of a 10g prefilled syringe for Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid).

CSL Behring Announces Availability of Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) 10g Prefilled Syringe

KING OF PRUSSIA, Pa. & SAN DIEGO--(BUSINESS WIRE)---- $ARCT #ClinicalTrial--Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announced the publication in Lancet Infectious Diseases of a Phase 3 study showing that a booster dose of ARCT-154, a novel, self-amplifying messenger RNA (sa-mRNA) vaccine, elicited a numerically higher immune response (meeting the non-inferiority criteria) against the original Wuhan-Hu-1 virus strain, and a superior immune response against Om.

CSL and Arcturus Therapeutics' ARCT-154 Demonstrates Non-Inferiority to Original Strain and Superior Immunogenicity to Omicron BA.4/5 Variant Compared to First-Generation mRNA Vaccine Booster

These regulatory milestones bring CSL one step closer to delivering on our promise to patients with a first-in-class recombinant monoclonal antibody for people living with HAE, a community CSL has been serving for over 40 years, in the U.S. and European Union. KING OF PRUSSIA, Penn.

CSL's Garadacimab, a First-in-Class Factor XIIa Inhibitor, Receives FDA and EMA Filing Acceptance

uniQure

HEMGENIX® is the first and only gene therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of hemophilia B and to show sustained efficacy and safety at three years post-treatment Long-term data continues to show a one-time infusion of HEMGENIX offers elevated and sustained factor IX activity levels for years and significantly reduces the rate of annual bleeds versus factor IX prophylaxis with a favorable safety profile At three years post-treatment with HEMGENIX, 94% of patients remained free of continuous prophylactic treatment KING OF PRUSSIA, Pa. , Dec. 11, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX: CSL; USOTC: CSLLY) today announced the three-year results from the pivotal HOPE-B study confirming continued long-term durability and safety of HEMGENIX® (etranacogene dezaparvovec-drlb) following a one-time infusion in people living with hemophilia B.

CSL Behring's HEMGENIX® (etranacogene dezaparvovec-drlb) Demonstrates at Three Years Post-Treatment Long-Term Durability, Safety and Greater Bleed Protection Versus Prophylactic Treatment in People Living with Hemophilia B

Exclusive Partner in Japan, Meiji Seika Pharma  advances regulatory approval This historic approval of the world's first Self-Amplifying messenger RNA (sa-mRNA) COVID-19 Vaccine underscores CSL's promise to develop and deliver innovations when there is a public health need First marketing approval milestone for CSL and Arcturus Therapeutics since closing the Global Collaboration and Licensing agreement in 2022 With the approval of ARCT-154, CSL now offers an even more comprehensive portfolio of innovative vaccines that combat respiratory viral diseases. KING OF PRUSSIA, Pa.

Japan's Ministry of Health, Labour and Welfare Approves CSL and Arcturus Therapeutics' ARCT-154, the first Self-Amplifying mRNA vaccine approved for COVID in adults

KING OF PRUSSIA, Pa. & SAN DIEGO--(BUSINESS WIRE)---- $ARCT #ClinicalTrial--Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics today announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted approval for ARCT-154, a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for initial vaccination and booster for adults 18 years and older. “Self-amplifying mRNA technology has the potential to be an enduring vaccine option," said Nobel laureate Dr. Drew Weissman, "I look forward to s.

Japan's Ministry of Health, Labour and Welfare Approves CSL and Arcturus Therapeutics' ARCT-154, the First Self-Amplifying mRNA Vaccine Approved for COVID in Adults

Iron Deficiency Day unites a strong global coalition raising awareness on the serious health impact of iron deficiency and iron deficiency anemia1 This year, the spotlight is on the importance of early iron deficiency diagnosis and treatment and its impact on quality of life ST. GALLEN, SWITZERLAND , Nov. 24, 2023 /PRNewswire/ -- This Sunday, 26 November, marks Iron Deficiency Day, a day dedicated to raising awareness about the importance of diagnosing and treating iron deficiency and iron deficiency anemia.

Iron Deficiency Day 2023: CSL Vifor calls for access to iron deficiency diagnosis and treatment

CSL Limited might possibly embark on a new share buyback plan in the future, when its financial leverage ratio is reduced. CSL Limited is committed to allocating 10%-11% of its sales to R&D investments on a yearly basis, and this is supportive of the company's mid-term double-digit earnings growth target. CSLLY continues to warrant a Buy rating based on my assessment of its future shareholder return and bottom line expansion expectations.

CSL Limited: Positive Capital Return And Earnings Growth Expectations

HEMGENIX®, the first and only FDA-approved gene therapy for adults with hemophilia B, wins for Best Product for Rare/Orphan Diseases KING OF PRUSSIA, Pa. and LEXINGTON, Mass.

CSL and uniQure Win 2023 Prix Galien USA Award

Data evaluating the impact of cell-based quadrivalent influenza vaccines suggests an additional 31%–39% of influenza cases may have been prevented among persons 0–64 years of age during the 2017-2020 U.S. flu seasons.1 Vaccination of children 6 months to 17 years of age with cell-based quadrivalent influenza vaccines would be cost-effective in >95% of simulations, compared to traditional egg-based vaccines based on modeling data from 2011/12 and 2017/18 U.S. flu seasons.2 Influenza vaccination with an adjuvanted quadrivalent influenza vaccine or standard-dose egg-based quadrivalent vaccine significantly reduced cardiovascular, respiratory, and other complications of influenza among U.S. adults 65 years of age and older over the 2018/19 and 2019/20 influenza seasons.3 SUMMIT, N.J., Oct. 11, 2023 /PRNewswire/ -- CSL Seqirus, a business of CSL (ASX: CSL), today announced new data from three studies supporting the clinical, public health and economic value of both cell-based and adjuvanted seasonal influenza vaccines.

New Data Presented at IDWeek 2023 Demonstrates Public Health Benefit and Cost Savings Associated with Cell-Based and Adjuvanted Influenza Vaccines

Results from a retrospective cohort study from 2015 to 2020 demonstrated a notable rise with increasing age in pneumonia-related medical encounters following an influenza encounter.1 Results from a retrospective cohort study during the 2019/20 season demonstrated the benefit of an adjuvanted influenza vaccine in prevention of influenza-related medical encounters among adults 65 years and older. 2 Results from a study across three consecutive influenza seasons showed that vaccination with cell-based influenza vaccines resulted in lower rates of test-confirmed influenza compared with traditional egg-based vaccines.

CSL Seqirus Presents Real-World Evidence at ESWI Demonstrating the Impact of Influenza Vaccination Campaigns to Help Protect People and Healthcare Systems

CSL Limited has left its current fiscal year financial guidance unchanged, which I deem to be too conservative. There are various indicators suggesting that the company's actual topline expansion and profit margin improvement might surprise the market in a positive manner. I think that positive surprises relating to performance and guidance will be the key re-rating catalysts for CSL Limited, and this supports my Buy rating for the stock.

CSL: Watch Out For Positive Surprises

CSL Seqirus will deliver further H5N8 A/Astrakhan antigen to support the U.S. government's pandemic preparedness activities This is the third influenza pandemic preparedness award to CSL Seqirus in the last two years, building on a longstanding partnership with BARDA  SUMMIT, N.J. , Aug. 28, 2023 /PRNewswire/ -- CSL Seqirus, a business of CSL (ASX: CSL), was selected by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), to deliver one bulk lot of H5N8 A/Astrakhan antigen to the U.S. government.

CSL Seqirus Announces Third U.S. Government Award in Relation to Influenza A(H5N8) Candidate Vaccine

MELBOURNE, Australia , Aug. 17, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX: CSL) (USOTC: CSLLY) announced today that Jeffrey Ball , an established global leader across multiple disciplines and functions, has been appointed Chief Sustainability Officer effective immediately. Mr Ball is the first Chief Sustainability Officer of the Australia-based biotech company, which announced its updated Sustainability Strategy in August 2021 to advance its commitment to a healthier world.

CSL Appoints Jeffrey Ball as First Chief Sustainability Officer

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 Pty Limited David Low - JPMorgan Chase & Co. Laura Sutcliffe - UBS Craig Wong-Pan - Royal Bank of Canada Chris Cooper - Goldman Sachs Group, Inc. Mathieu Chevrier - Citigroup Inc. David Bailey - Macquarie Research Mark Dehring Ladies and gentlemen, good morning and welcome to CSL's Full-Year Results Call for Fiscal 2023. It's Mark Dehring speaking, and joining me online is Paul McKenzie, CSL's Chief Executive Officer; Joy Linton, CSL's Chief Financial Officer; and Bill Campbell, CSL's Chief Commercial Officer.

CSL Limited (CSLLY) Q4 2023 Earnings Call Transcript

Australia's CSL reported an annual profit on Tuesday that rose 8% as higher plasma collections helped the biotech company counter the impact of currency fluctuations and higher costs.

Biotech firm CSL's full-year profit rises on higher plasma collections

CSL Seqirus is the only influenza vaccine manufacturer that offers differentiated vaccine options for individuals six months of age and older. Since the COVID-19 pandemic, there has been a significant drop in influenza immunization rates and high levels of influenza-related illness, underscoring that flu is an ongoing threat.1,2 The Centers for Disease Control and Prevention (CDC) recommends annual influenza vaccination for all eligible people aged six months and older, as a critical tool to help prevent flu and lessen the severity of influenza-related illness and potentially life-threatening associated complications.3 SUMMIT, N.J.

CSL Seqirus Begins Shipping Portfolio of Innovative Influenza Vaccines for the 2023/24 U.S. Season

CSL Limited's FY 2024 profit guidance outlined in a recent announcement last week came in below expectations, and this led to a meaningful correction in its share price. The company's earnings guidance for the new fiscal year was negatively affected by unfavorable foreign exchange assumptions, while its other metrics relating to demand and expenses are pretty healthy. I view the recent correction in CSL Limited's shares as a buying opportunity, as I think that its actual FY 2024 performance should be better than what its guidance suggests.

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