Core Points - The European Commission has converted the conditional marketing approval of FILSPARI (sparsentan) into a standard marketing authorization for the treatment of IgA nephropathy (IgAN) [1][2] - This decision follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) in February 2025 [1][2] - The approval is based on comprehensive data from the phase-III PROTECT study, which demonstrated that FILSPARI significantly slowed kidney function decline compared to irbesartan [1][2][9] Company Overview - CSL Vifor is a global partner specializing in pharmaceuticals and innovative therapies for iron deficiency and nephrology, headquartered in St. Gallen, Switzerland [3] - Travere Therapeutics is a biopharmaceutical company focused on developing therapies for rare diseases, emphasizing the urgent need for treatment options [5] Product Information - FILSPARI is the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved in Europe for IgAN, currently available in Germany, Austria, and Switzerland [3][11] - It is a non-immunosuppressive therapy with high selectivity for the endothelin A receptor and the angiotensin II subtype 1 receptor [10][11] Clinical Study Insights - The PROTECT study is one of the largest interventional studies in IgAN, involving 404 patients and comparing the efficacy of FILSPARI to irbesartan [8][9] - The study met its primary endpoint, showing a mean reduction in proteinuria of 49.8% for FILSPARI compared to 15.1% for irbesartan after 36 weeks [9]

- KOSTAIVE represents a significant advancement in vaccine technology, demonstrating superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trialsWALTHAM, Mass. and SAN DIEGO, Feb. 14, 2025 /PRNewswire/ -- Global biotechnology leader CSL (ASX: CSL; USOTC: CSLLY) and sa-mRNA pioneer Arcturus Therapeutics (Nasdaq: ARCT) today announced that the European Commission has granted marketing authorization for KOSTAIVE ® (ARCT ...

Fiona Mead Company Secretary For further information, please contact: Investors Media Chris Cooper Investor Relations CSL Limited P: +61 455 022 740 E: chris.cooper@csl.com.au For immediate release 11 February 2025 Results Presentation for the Half-year ended 31 December 2024 Melbourne, Australia – CSL (ASX:CSL; USOTC:CSLLY) Please find attached the slides for the presentation on the half year results that will be given by the Chief Executive Officer and the Chief Financial Officer shortly. The briefing wil ...

Financial Data and Key Metrics Changes - Revenue for the first half of fiscal year 2025 was AUD 8.5 billion, up 5% at constant currency [8] - NPATA was AUD 2.1 billion, also up 5%, while net profit after tax increased by 7% to AUD 2 billion [8][41] - Gross profit was AUD 4.728 billion, reflecting a 5% increase [41] - Cash flow from operations rose by 18% to AUD 1.259 billion [44] Business Line Data and Key Metrics Changes - CSL Behring reported a strong growth of 10%, driven by a 15% increase in the Ig franchise and a 9% growth in the albumin portfolio [9][13] - CSL Seqirus experienced a revenue decline of 9%, primarily due to decreased immunization rates in the US [24][48] - CSL Vifor's revenue increased by 6%, supported by growth in iron and nephrology products [31][48] Market Data and Key Metrics Changes - Immunization rates in the US have significantly declined, particularly in the 18 to 64 age group, impacting CSL Seqirus [11][25] - Vaccination rates outside the US are stabilizing, providing some optimism for future market conditions [11][25] - In China, CSL Behring's albumin portfolio saw exceptional performance, contributing to overall growth [16][95] Company Strategy and Development Direction - The company is focused on maintaining leadership in the iron market and expanding CSL Vifor's portfolio into new geographies [52][36] - CSL Behring is preparing for the global launch of ANDEMBRY and aims to complete the rollout of Rika technology across US plasma centers [50][51] - The company is confident in achieving its financial guidance for fiscal year 2025, expecting revenue growth of approximately 5 to 7% [52] Management's Comments on Operating Environment and Future Outlook - Management reaffirmed guidance for NPATA growth of 10% to 13% for fiscal year 2025, despite challenges in the Seqirus business [7][64] - The company anticipates increased revenue from avian flu vaccine contracts in the second half of the fiscal year [51][67] - Management expressed confidence in the long-term growth potential of the Ig franchise and the successful launch of new products [50][92] Other Important Information - The gross margin for CSL Behring improved by 170 basis points to 51.7% at constant currency [46] - General and administrative costs increased by 27% due to one-off project costs, expected to normalize in the second half [43][120] - The interim dividend was increased by 9% to US$1.30 per share [44] Q&A Session Summary Question: What is the expectation for Behring's gross margin in the second half? - Management indicated that while the first half showed strong performance, they expect the second half to be slightly lower, maintaining a full-year guidance of 100 basis points plus gross margin expansion [58][60] Question: How does Seqirus' performance impact overall guidance? - Management acknowledged Seqirus' weaker performance but noted that pandemic contracts in the second half would help offset this [64][67] Question: What are the drivers behind the strong growth in the Ig franchise? - Management attributed the growth to successful product launches and increased capacity, allowing them to meet patient needs effectively [70][71] Question: Can you provide details on the avian flu contracts? - Management confirmed that contracts have been signed and revenue will be recognized in the second half, but specific volumes were not disclosed [75][79] Question: What is the outlook for KCENTRA following the loss of a contract? - Management stated that KCENTRA remains a market leader despite the contract loss and expects growth moving forward [86][87] Question: How is HEMGENIX performing in the market? - Management expressed optimism about HEMGENIX, citing positive patient feedback and ongoing reimbursement efforts in Europe [90][92] Question: What is the impact of generic competition on FERINJECT? - Management acknowledged the presence of generic competition but emphasized their ability to grow volume and maintain market leadership [134][135]

Core Insights - CSL Limited and uniQure Inc announced the four-year results from the pivotal HOPE-B study, confirming the long-term durability and safety of Hemgenix for adults with hemophilia B [1][2] Group 1: Study Results - Hemgenix demonstrated sustained factor IX activity levels over four years, providing long-term bleed protection compared to prophylactic treatment [2][4] - The mean factor IX levels were recorded at 41.5 IU/dL in year one, 36.7 IU/dL in year two, 38.6 IU/dL in year three, and 37.4 IU/dL in year four [4] - The adjusted annualized bleeding rate (ABR) for all bleeds decreased by approximately 90% from lead-in to year four, with joint bleeds reducing from a mean ABR of 2.34 to 0.09 [5] Group 2: Patient Outcomes - In year four, 94% of patients remained free of continuous prophylaxis treatment, and no patients returned to continuous prophylaxis between year three and year four [5] - There were no serious adverse events related to the treatment throughout the study [5] Group 3: Product Information - Hemgenix, approved by the FDA in 2022, is the first gene therapy for adults with hemophilia B, applicable to patients with or without AAV5-neutralizing antibodies [3]

Core Insights - CSL announced the four-year results from the pivotal HOPE-B study, confirming the long-term durability and safety of HEMGENIX for adults with hemophilia B [1][4] - HEMGENIX is the first gene therapy approved for hemophilia B, providing significant long-term bleed protection and reducing the need for routine factor IX prophylaxis [1][11] Study Results - The HOPE-B trial involved 54 adult male participants, with 51 completing four years of follow-up [2][8] - Mean factor IX levels were sustained at 37.4 IU/dL at year four, with a 90% reduction in the adjusted annualized bleeding rate (ABR) from 4.16 (lead-in) to 0.40 [2][5] - Joint bleeds decreased from a mean ABR of 2.34 at lead-in to 0.09 during year four, with 94% of patients remaining free of continuous prophylaxis [2][5] Safety Profile - No serious adverse events related to HEMGENIX were reported, and it was generally well-tolerated [3][9] - The most common treatment-related adverse events were increases in alanine transaminase (ALT), with 16.7% of participants requiring supportive care [3][16] Company Commitment - CSL is dedicated to ongoing data analyses of HEMGENIX to provide healthcare providers and patients with necessary information for informed treatment decisions [4][20] - The company has established a post-marketing registry to gather additional evidence on the long-term safety and efficacy of HEMGENIX [4][20]

Core Findings - The first season results of a randomized study indicate that adjuvanted and high-dose influenza vaccines have comparable effectiveness against PCR-confirmed influenza, with a relative vaccine effectiveness (rVE) of 1.5% [2][3][4] Study Overview - The study is a collaborative effort between CSL Seqirus and a large health system, involving approximately 480,000 individuals aged 65 and older over two seasons [4][6] - The first season enrolled 429,600 individuals, with 212,877 receiving adjuvanted inactivated influenza vaccine (aIIV) and 216,723 receiving high-dose inactivated influenza vaccine (HD-IIV) [6] - The study aims to test the hypothesis that aIIV is non-inferior to HD-IIV, with a non-inferiority margin of -20% [5] Effectiveness and Recommendations - No significant difference was found in the effectiveness of aIIV and HD-IIV for preventing hospitalization or emergency department visits for PCR-confirmed influenza, as well as for all-cause community-acquired pneumonia [2][3] - The findings support the CDC's Advisory Committee on Immunization Practices (ACIP) recommendation for preferential use of adjuvanted or higher-dose influenza vaccines for adults aged 65 and older [3] Future Directions - The second season of the study is ongoing, with pooled analyses planned after the 2024-2025 season [4][6] - The study's design allows for routine clinical practice vaccination, enhancing the real-world applicability of the findings [5]

SAN DIEGO, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) and CSL Vifor today announced that Swissmedic has granted temporary marketing authorization for FILSPARI for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). "FILSPARI targets damage directly in the kidney and offers patients a convenient, once daily, oral, nonimmunosuppressive treatment that can provide superior result ...

Temporary marketing authorization is based on statistically significant and clinically meaningful results from the phase-III PROTECT trial ST. GALLEN, Switzerland and SAN DIEGO, Oct. 17, 2024 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that Swissmedic has granted temporary marketing authorization for FILSPARI for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). ...

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 ...